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The Executive MindXchange Chronicles

www.frost.com/medtech#FrostDEV

A FROST & SULLIVAN EXECUTIVE MINDXCHANGE

March 9 - 11, 2014Loews Coronado Bay Resort & Spa San Diego, CA

19th AnnualMedical Technologies 2014: Where Global Medical Devices, Life Sciences, and Connected Health Leaders Meet

The Executive MindXchange

Chronicles offer your very own

detailed summary of the event

presentations, general sessions

and interactive sessions. You will

benefit from a thorough and

focused chronicle of the Frost &

Sullivan Executive MindXchange,

including key take-aways and

action items to implement in your

own organization. These

collections ensure you don't miss

out on any of the event sessions.

Simply stated, we highlight the

golden nuggets of the event

for you.

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Medical Technologies 2014: A Frost & Sullivan Executive MindXchange March 9-11, 2014 | Loews Coronado Bay Resort and Spa, San Diego, CA

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TABLE OF CONTENTS

KEYNOTE

Healthcare's Three Ps: Personalized, Predictive and Preventive 4

EXECUTIVE BULLETIN

Behavioral Symphony of Wellness: An Exponential Leap for Persons, Communities & Our Future 8

EXECUTIVE INSIGHT

Patient Engagement and Adherence: New Technologies, New Opportunities 12

ASK THE EXPERTS! PANEL DISCUSSION

Handling the Regulatory Challenges of Bringing New Innovative Technology to Market 16

INTERACTIVE THINKTANKS

Getting Business Value from Big Data 20

The New Partnership Paradigm: Creating Strategic Relationships for Ground-Breaking, Timely Innovation 22

Enabling User-Centric Design within the Regulatory Landscape 24

BEST PRACTICES

mHealth: At the Forefront of Future Medicine 29

Cultivating Transformation, Facilitating Innovation: Organizing Your Development Organization to Deliver Progressive Technology 32

Leveraging Digital Health and Data for Better Patient Engagement 35

EXECUTIVE INSIGHT

Designing and Implementing a Successful Shared Risk Model 40

EXECUTIVE INSIGHTS PANEL DISCUSSION

Technology Integration and Industry Convergence: Bioinformatics, Patient-Empowered Point of Care, and Beyond 44

OPENING ADDRESS

Value Creation: Manufacturer/Provider Partnerships for Innovation & Growth 47

FIRESIDE CHAT

Executive Perspectives on Emerging Markets Innovation 50

INTERACTIVE ROUNDTABLES

Preparing for the Apocalypse: How to Make Sure You are in Business in 2020 53

Connected Health: Innovating a Holistic Interoperable Solution to Meet Your Customer’s Needs 56 .

Understanding the Shift in the Mindsets of Global Regulators 60

EXECUTIVE BULLETIN

Creating Value via 3D Printing 64

VISIONARY INSIGHT

The Healthcare Industry: Disrupt, Collapse and Transform 66

INTERACTIVE THINKTANK

Disrupt, Collapse, and Transform: Using Trends to Focus Your Growth 70

INTERACTIVE

Inspiration to Implementation: Developing Your Day-to-Day Action Plan 72

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KEYNOTE

Healthcare's Three Ps: Personalized, Predictive, and Preventive

PRESENTER Dr. Joseph M. Smith, Chief Medical Officer, Chief Science Officer, West Health

TIME

Monday, March 10, 2014, at 9:00 a.m.

SESSION ABSTRACT

The burning platform of our fiscally and logistically unsustainable US healthcare delivery system is creating enormous opportunities for those able to envision and embrace change. The medical device industry is positioned to be a powerful enabler of the more efficient, effective, and personalized healthcare delivery system of the future.

However, continued success in this industry also requires a move from stand-alone technologies to integrated, system-level solutions; from closed-end proprietary communication networks to completely interoperable systems; and from static, hard-wired products and services to adaptive, information-rich technology frameworks that enable continuous improvement.

As West Health’s Dr. Joseph Smith discussed in this keynote presentation, incremental innovation will be insufficient at this time. Transformative innovation is required to catalyze new economically and logistically sustainable platforms for healthcare delivery.

TAKE-AWAY

In an ever-changing healthcare system in the United States, the cost to provide top-notch healthcare has adversely affected patients as well as clinics, physicians, and the medical technology companies that serve them. Medical technology providers can work hard and tirelessly to help mitigate these costs not only for the hospitals that are their customers, but also for all patients.

According to statistics, Americans spend up to 20% of their income on health insurance premiums and other medical expenses. One critical goal today, Smith said, is to reduce these financial burdens through technology.

In the digital age, there is a diverse range of new technologies from industries both outside and inside the medical sphere that will reduce those costs through a variety of expedited patient care systems and technologies.

Healthcare providers currently struggle with in-patient care, Smith said, and they’re moving toward more streamlined and efficient technologies. The medical technology

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industry stands at a crucial junction, he said. It has the opportunity to serve as a major role player in this evolution into the digital age and the critical reduction of exorbitant healthcare costs.

BEST PRACTICES

To help lower the cost of care, medical technology companies must focus on innovation that streamlines and improves patient care while unburdening overwhelmed clinicians.

Recognizing that the lion’s share of our burden is in the care and management of chronic diseases and their exacerbations and decompensations, one can readily see a need for near- / on- / in-body sensors linked wirelessly to cloud-based analytics, and smart and learning algorithms that assist in the smooth and iterative adjustment of medical therapies to keep the chronically ill on a stable trajectory. Such a system allows for continuous monitoring and optimization of performance, independent of location, as opposed to sparsely scheduled interventions in expensive settings.

ACTION ITEM(S) TO IMPLEMENT

It’s crucial that innovation in medical technology focuses less on the gifted gadget and more on the integrated solution, as no single piece of hardware will save healthcare. With focus on integration, turning data into information, and information into knowledge and wisdom and ultimately to unassailable cues for action, all while decreasing the “cost of thinking” on already overburdened healthcare professionals, we can move to a more immediate, smarter, more connected, coordinated, and automatic form of healthcare delivery.

TAKE-AWAY

Chronic illnesses present one of the largest challenges for our healthcare delivery system, made more pressing by an aging demographic and a recognition that our current system was designed for acute illness rescue and recovery as opposed to chronic and continuous care. Going forward, it is essential that we innovate on the system of care delivery to meet this growing and unavoidable challenge.

BEST PRACTICES

Linking and integrating healthcare technology with appliances at home could be a way to overcome those challenges, Smith said.

Medical technology companies should look to create tools that can be easily accessed by patients in their homes and integrated into their daily lives. In turn, that would reduce the time physicians spend treating chronic diseases and providing basic patient care.

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Rather than the current model of managing chronic disease by waiting for it to break and then treating it, Smith said, the future of healthcare will require coordinated and continuous care and the prediction and prevention of illnesses.


Near-, on-, or in-body sensor technology can be used to provide actionable diagnostic information. Medical technology companies should work toward developing tools that utilize pervasive technologies such as ubiquitous sensing, wireless connectivity, cloud computing, and social networks that empower patients.

When developing new technologies it is crucial to emphasize their ability to cut the cost of care and deliver a return on investment for stakeholders and other investors. New technologies must be seamlessly integrated into the current system, Smith said.

Medical technology companies must also be aware of how new technology will be regulated and understand this landscape so they can better serve hospitals and patients, all while creating revenue for those investing in the product.

Smith listed several points of view medical technology firms need to keep in mind when finding solutions for the future:

Clinical perspective: There is a growing physician shortage, increasing rate of turnover, and increasing frustration by incumbents.

Hospital perspective: Hospitals face persistent pressure on pricing, quality, and safety transparency, as well as increasing requirements for non-traditional skills.

Vendor perspective: Vendors face pressure to balance cost-effectiveness with incremental innovation and demands for pricing transparency in the development of new products.

Insurer and payer perspective: There is a persistent drive for diversification from a traditional insurance role to adjacencies.

Patient and family perspective: Chronic disease among the aging population creates a swelling burden of “supervisory care.”

TAKE-AWAY

Hospitals, as well as insurers and other payers, are all behind a drive toward a data-driven rubric. As the information age continues to evolve there is enormous opportunity for medical technology companies to fill the gaps.

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BEST PRACTICES

Technology companies should look into incorporating big data as a means to drive the industry forward, Smith said. Information will provide a major method of tackling problems with high healthcare costs. Investment into these new technologies, partnerships with major telecommunication networks, and research and development in this field should begin as soon as possible to help kick start the data revolution in the medical industry.


Smith encouraged audience members to develop and integrate current systems with new technology and create partnerships to foster growth and utilize big data and the vast amounts of information available to better serve patients and help hospitals provide more effective and efficient care.

FINAL THOUGHT

There is no doubt a major revolution of the medical industry is under way. Innovative technology solutions are required so that clinicians can improve treatment and patients can lead healthier lives, but the full integration of all relevant data sources remains the most significant challenge and opportunity. Investment into smart and learning technology with clear focus on assuring smooth and seamless semantic interoperability lies at the heart of strategies to create the healthcare delivery system of the future. Moving healthcare for chronic diseases out of doctors’ offices, emergency rooms, and hospitals is essential to increasing quality outcomes and driving down costs, and empowering patients to play a more active and responsible role in their own health and simultaneously assure that clinicians will have the data they need, with sufficient context, as to provide timely and optimal care.

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EXECUTIVE BULLETIN

Behavioral Symphony of Wellness: An Exponential Leap for Persons, Communities & Our Future

PRESENTERS Dennis Robbins, Chief Business Development Officer, CINA-US, Director, Translational Policy & Ethics, PEARL Practice Based Translational Network

Frederick (Rick) A. Curro, Clinical Professor & Director, PEARL Practice Based Translational Network

TIME

Monday, March 10, 2014. at 9:30 a.m.

SESSION ABSTRACT

There has been a significant paradigm shift in the way in which we view health, healthcare, and social responsibility. In this session, the presenters offered a patient/person-centric approach that supersedes models of patient/consumer/client engagement, empowerment activation, participation or centeredness. This concept was explored in light of health, healthcare, translational studies and comparative effectiveness research utilizing an infrastructure to support such change.

TAKE-AWAY

Chronic disease prevention has been left out of the healthcare focus for a long time. However, the sickness-based concept of care – diagnosing and treating an illness once it has occurred, rather than preventing it from developing in the first place – is unsustainable.

If we can shift the approach to a person’s health rather than healthcare, costs will be greatly reduced. Patients must focus on healthy living and making good choices to prevent sickness.

One important step will be changing the approach to patients and the language used. Healthcare organizations should start looking at patients as people and focus on their overall health, according to the presenters. Moving to a more “person-centric” outlook could reduce the need for consistent healthcare in an increasingly unhealthy public.

Individuals should also be given opportunities to take advantage of new technologies and other innovations that can help them live healthier lives.

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The Affordable Care Act and programs like the Practitioners Engaged in Applied Research and Learning (PEARL) network are attempts to get people more engaged with their own healthcare.

In order to move these new avenues forward, technology companies need to create products that can be integrated into clinical systems with an infrastructure that contains actionable information, serves personal preferences, and engages communities.

BEST PRACTICES

Person-centered care must be the new focus for the medical industry. The person supersedes the patient/consumer/client relationship and supports directed engagement with new technology in order to empower individuals to take control of their own health.

Specifically, medical technology companies should be looking at the rapidly advancing technologies surrounding mobile devices and big data and apply them to the evolving healthcare landscape.

The new technology isn’t just for doctors; it must be easily accessible for individuals in their daily lives. Engaging technology will help them become the proprietors of their own well-being. That will help bend what the presenters call the “sickness curve” and reduce the growing cost of healthcare for everyone involved.

The focus on the patient should also include person-centric clinical studies, the presenters said. This is the antithesis of randomized trials; instead, data from patients contributes to growing knowledge about treatments and helps aid decision-making.

TAKE-AWAY

In order to move new technology forward and past regulatory phases quickly, products should be geared toward personal empowerment and the active engagement of individuals.

The focus must also be on tools that contain literal, transparent, and actionable information. To make the information acquired from those personal devices useful, an infrastructure to disseminate the data reliably and securely must be put into place.

BEST PRACTICES

Information and engagement are both crucial to this new development of an empowered individual and better and more cost-effective healthcare. Businesses must look into the advances being made in other industries and find innovative ways to apply them to healthcare.

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There are three key areas to focus on when it comes to empowering people. Person-centricity has the following components:

1. Healthcare literacy

2. Transparency

3. Actionable information

Patients need to be more informed about their health. Technology can give them access to information. Getting more people actively engaged in the collection of information will also help create better results for everyone.


The presenters recommended looking into systems and technologies that provide the tools to acquire data, as well as the means for individuals to upload and maintain information about their own health in ways that can be easily accessed by physicians when patients need care.

Developments to enable those capabilities will require cooperation among various industries currently involved in big data and analytics. Advances in smart technology being made in other industries must be integrated into medical technology as well. The future of medicine will require an infrastructure that can easily ascertain which information is valuable and how it affects patient care.

TAKE-AWAY

For medical technology companies, the challenge is two-fold, the presenters explained. They must be able to show how newly developed technology will help cut the costs of care, while also proving how it will provide a return on investment for hospitals.


Companies can conduct studies to show how actively engaged individuals could become when using tools that monitor their health or chronic illnesses. Actively researching those potential outcomes will help clarify the value of those technologies.

Aside from person engagement, those new technologies will also help healthcare providers overcome their current challenges. Physicians average 11-13 minutes of face time with each patient and carry an average of 30-40 patients. The strain on physicians needs to be addressed. Getting patients to live healthier lives will help prevent unnecessary doctor’s visits and reduce the burden.

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Additionally, physicians are being taught an overwhelming amount of information. Information is constantly changing and being updated, and doctors cannot possibly keep up. That’s another area where technology will help.

Medical technology companies will also need to help doctors when it comes to education. Physicians need ongoing training on how to use technologies. Currently, medical schools are training doctors on how to place and face a computer so that patients know their doctor is focused on them, not just on the machine. Tech firms must democratize and demystify those tools so they’re put to good use by both physicians and patients.

FINAL THOUGHT

The most critical factor for the success of new medical technology being developed today and in the future will be patient engagement, more accurately described as person centricity. Showing the public they have control of their own health and providing the technology to do so could dynamically alter the course of healthcare in the United States. In order to begin this reform, medical technology companies must find ways to capitalize on the vast amount of information available and the opportunity it presents.

Healthcare needs to be revolutionized, and everyone needs to be involved, including the technology companies that will provide the tools that make the changes possible.

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EXECUTIVE INSIGHT

Patient Engagement and Adherence: New Technologies, New Opportunities

PRESENTER Dana Webster, Marketing Manager, Medical Values, Roche Diagnostics

TIME

Monday, March 10, 2014, at 11:00 a.m.

SESSION ABSTRACT

Bringing value in a new world of healthcare will require engaging both patients and providers into recognizing patterns for enhanced clinical engagements. New medical technology tools can expedite the exchange of information and enhance patient engagement. In this session, Dana Webster of Roche Diagnostics discussed the importance of meaningful discussion between patients and providers, and how technology can help.

TAKE-AWAY

The top 1% of patients in the US account for about 25% of all health expenditures, Webster said. The current system relies on younger, seemingly healthy patients to cover the costs of those who need more care. Unfortunately, the system doesn’t incentivize people to get preventive assessments.

The industry must make adjustments at all levels to adapt to the changing healthcare landscape, changing customers, and more informed patients. According to Webster, the key drivers affecting healthcare today include:

Healthcare reform – Extensions and revisions to the law occur constantly.

Accountability – That currently rests on the shoulders of the providers and the payers, but there’s a need to shift some accountability to the patients.

Quality standards – Regulatory developments are changing the ways healthcare organizations are evaluated.

Reimbursement – New models are putting greater emphasis on preventive treatment and allowing for remote care delivery.

Technology and integrated healthcare networks – Currently, the burden falls on the patient to convey all medical information to doctors across networks. That data needs to be more easily accessed.

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Consumers – People don’t have the same interest in healthcare that they have in technology, such as the latest smartphones and fitness apps.

BEST PRACTICES

That last point is key for medical technology companies to understand. There are increasing opportunities to increase patient engagement with mobile apps.

In addition to more engaged patients, there are other potential benefits well-designed mobile apps might have for providers:

Access to real-time patient information

The ability to automatically load data collected with the app in an electronic health record (HER) system

The availability of information for back-end analysis

Increased opportunities to communicate with patients


Those apps can include, for example, testing reminders to increase participation in preventive care. To have a positive impact, Webster said, those applications should make it easy to transmit data to healthcare providers and provide multiple views of information using charts and graphs. Apps should also be able to send data to cloud-based portals to facilitate easy sharing of information, Webster said.

Despite the benefits, there are also some possible downsides that technology developers will have to help providers avoid, including:

Patients who are currently not highly engaged may not use those apps.

Ensuring interoperability with other tools and systems can be a challenge.

There could be a potential for increased liability – for example, do providers want access to real-time information? What if they cannot manage it all? Would doctors be on the hook if they miss something within the mass of information?

TAKE-AWAY

For medical technology providers, the focus of innovation must be on bringing their customers value. The current market demands a different approach to innovation than

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in the past, Webster said. There is a global emphasis on creating value, increasing access, and lowering costs. Experimentation will be key to meeting those goals.

BEST PRACTICES

One of the top challenges healthcare organizations are facing is how to effectively manage an abundance of patient information. Knowledge is power, and all the information collected will be used by doctors to improve care and cut costs.

However, providers need tools to help them deal with that data. New systems need to be developed to manage hundreds of data points for each patient.


Tools can be created that will plot the information that’s currently in logbooks – right now the traditional way of collecting patient data – onto graphs to provide more meaningful, visual information.

Webster recommended medical technology companies start looking into major data aggregators such as IBM, AT&T, Verizon, and others in order to foster partnerships and develop ways to access and organize information. Technology providers need to find ways to properly monitor the millions of data points and how to make the information interoperable among various platforms.

TAKE-AWAY

Webster gave the example of diabetes, which is a chronic yet preventable illness. A known 18.8 million and an additional 7 million undiagnosed Americans have diabetes, totaling nearly 26 million. The economic costs of diabetes have risen 41% in five years to reach $176 billion in direct medical costs. Diabetes management includes nutrition, activity, and medication, but there is currently no FDA-approved product that halts the progression of the disease.

For those preventable diseases, some amount of accountability needs to be shifted from healthcare providers to the patients. That will help to lower the costs of care, as well as the percentage of the population afflicted with those diseases.

BEST PRACTICES

The goal for organizations in the healthcare industry should be to accomplish these three things for both the individual and the population as a whole:

Lower per-capita cost

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Improved patient experience

Improved care outcomes


There’s an opportunity to cut costs and improve the health of patients with diabetes and other chronic conditions. The key for medical technology companies is to start from the bottom and use technology to support active patients and productive interactions with healthcare providers.

It is imperative for new technology to come forward to actively engage patients and clinics and get them to invest in these products as actively as they are with their iPhones and other new consumer technology, Webster said. Today, the success of new technology is heavily dependent on the level of involvement by the general public. There must be a strong emphasis on reduced costs and improved health for the community as a whole.

FINAL THOUGHT

The US healthcare system is in a constant state of flux and experimentation. The evolution of the system requires embracing the need for patients, providers, and payers to access information in order to make timely, meaningful decisions.

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ASK THE EXPERTS! PANEL DISCUSSION

Handling the Regulatory Challenges of Bringing New Innovative Technology to Market

MODERATOR Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare

PANELISTS Laetitia Cousin, Vice President, Clinical Affairs & Quality Assurance, Nuvasive

Frederick (Rick) A. Curro, Clinical Professor & Director, PEARL Practice Based Translational Network

Vinu Gurukar, Information Technology Leader, Product Development, Edwards Life Sciences

Michelle McMurry-Heath, Associate Director of Science, Office of the Center Director (OCD) at the Center for Devices and Radiological Health (CDRH), FDA

Robert Newman, Vice President, Regulatory Affairs, Apical Instruments

TIME

Monday, March 10, 2014. at 11:00 a.m.

SESSION ABSTRACT

In our ever changing world, innovation is an imperative for medical industries. We must have effective, safe solutions that are available quickly. Incremental changes used to be enough, but now with the increased needs and through the use of wireless communication, the Internet, and social media, it’s imperative that we find creative ways to get our ideas and solutions to market quickly. In this panel discussion, participants discussed challenges being faced and how companies might overcome them.

TAKE-AWAY

All sides agree that patients need access to innovative medical technologies sooner. In today’s highly globalized medical world, the amount of regulations around technology and products has slowed down the release of potentially life-changing technology. Medical tech companies, along with pharmacology and healthcare organizations, are trying to find the best ways to meet those guidelines without delaying new products.

BEST PRACTICES

One key to success for medical technology is to keep up to date with regulations and be heavily involved in learning those requirements.

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Speed will be important for products’ success. Companies need to think about how to have devices accepted by the FDA and CMS simultaneously.

That will require thinking about the regulatory process as products are designed. Developers must measure what is beneficial to patients versus which risks are tolerable. It’s also critical to maintain the ability to put in local flexibilities for other markets where the rules may be different.


For every aspect of development, all people involved need to be highly educated and informed on changes in regulations and laws, both nationally and globally. Employees must be trained on those regulations, so when products are moved into the regulatory phase, the process is as quick and efficient as possible.

Education is paramount. Companies must make sure they diversify their knowledge about the different levels of regulation so that people know exactly what needs to be done to meet the needs of the FDA and other agencies.

As advanced healthcare technology becomes accessible across the world, a global standard for approval and quality assurance needs to be set, panelists argued. However, in the meantime, it’s critical to make sure the company is knowledgeable about the regulations in all applicable areas.

TAKE-AWAY

Medical technology companies should also work to open communication pathways with regulators and innovators in order to increase the expediency of the regulation process. That will help pull ideas for projects and allow new medical technologies to make it through the FDA regulatory process at a much faster rate.

BEST PRACTICES

Consortiums and partnerships should be established to foster dialogue and breed ideas on solid solutions that will make it through the regulatory hurdles.


Panelists offered some of the steps medical technology companies can take to stay on the cutting edge of the regulatory environment and avoid delay in bringing new products to market:

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Offer training and classes on regulatory issues to all employees involved in developing new products

Network and foster relationships with the FDA, as well as other agencies and political figures. That will make sure the company understands the best ways to get approval as well as offer opportunities to educate regulators on the value of the products.

Maintain those relationships so the company always has up-to-date information.

TAKE-AWAY

One of the three top priorities for the FDA over the next few years will be to shift the balance of pre-market and post-market regulatory requirements. The goal is to make sure that only what is essential is required for pre-market data and allow for additional data to be collected post-market.

BEST PRACTICES

In that new environment, panelists encouraged companies to open lines of communication with regulators early on in the process. Pre-submission work will expedite the approval process by allowing companies to engage with review teams and get early feedback.


Companies should be in communication with the FDA and other agencies during the pre-submission phase and engage early on with review teams. Educate the agency on the existing property and which vendors will use the product. Present the product to different reviewers and educate them on the importance of the device.

Fortunately for medical technology companies, the FDA is working to expand its pre-submission base so that more companies can come to the FDA early on for a consultation.

FINAL THOUGHT

The FDA has developed a tracking system for applications in order to increase transparency. This system allows applicants to monitor the status of their application as it moves through the approval process. There are also new quality assurance measures in place, including more education and training for all new reviewers to make sure they are knowledgeable.

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Though the agency is working to streamline processes, there are still major hurdles in making potentially lifesaving technologies available quickly. Technology companies need to find the best ways to navigate the bureaucracy so they can deliver their products quickly to healthcare systems around the world.

It’s important for any business to educate itself on the changing regulation landscape within the United States and internationally. There is also a very important need to maintain and foster relationships with regulators around the world.

Information should be gathered quickly and efficiently when new products are developed in order to pass the information along to reviewers in a timely manner. Partnerships can also help in the expedition of approval for new devices.

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Getting Business Value from Big Data

FACILITATOR Sri Srinivasan, Global Industry Leader, Big Data Analytics, Healthcare Life Sciences, IBM

TIME

Monday, March 10, 2014 at 1:40pm

SESSION ABSTRACT

Technology has become an integral part of everyday life around the world. With the advent of smartphones and an increasing penetration of the Internet, data – or better yet, information – has become the driving force for competitive advantage and the underpinning of industry transformation. Couple this with mobility and you get an immense opportunity for extremely effective and personalized engagement.

The healthcare and life sciences industries are not lost on this opportunity, but instead have much to gain in personalizing care and, in turn, impacting the health and wellness of society. But, as with any new business venture, there are significant challenges to address, including privacy, security, and interoperability, as well as data quality, relevance, and context. Big data and analytics capabilities available today provide the framework to cost-effectively harness and extract actionable insights from all types of data.

This interactive session led by IBM’s Sri Srinivasan, Global Industry Leader, IBM Watson Foundations – Healthcare & Life Sciences, explored the value that big data and analytics can deliver for the healthcare and medical technology markets, and how innovative information management and analytics capabilities might be used across the healthcare spectrum to inform research & development and fuel tools for consumer and patient engagement.

Three areas were explored among the groups, including the driving force for big data, what’s holding organizations back, and what is needed to move forward:

1) The driving forces for big data included getting beyond clinical to consumer level data, and moving toward outcomes and value through better forecasting, identifying trends and enabling better diagnosis.

2) What’s holding organizations back is the lack of infrastructure, closed architectures, concerns over privacy and information sharing, inconsistent data structure, and a lack of community perspective. Additionally, there is a lack of specificity or trust in the veracity of the data, which in turn impacts the confidence in being able to effectively engage directly with the patient.

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3) The strategy to move forward included investing in an information and analytics platform, building a trusted data pipeline, and acquiring the right talent.

TAKE-AWAY

Many medical technology companies recognize the opportunity for big data and analytics, but aren’t there yet to harness it. Challenges around data governance, infrastructure, culture, and talent are common across the industry, but with a business case aligned to value these roadblocks can be overcome.


Build a business case focused on value. Identify a pain point, a challenge you’re trying to solve, and the stakeholders to help you define the problem, as well as who will benefit from an investment in the solution. Leverage organizations like IBM who have industry and technology experts who help clients around the world build the case for big data and analytics.

Build your requirements now for talented employees who understand how to leverage big data and analytics technology to extract meaningful insights for your industry and your business.

FINAL THOUGHT

Healthcare and medical technology companies must start embracing big data and analytics as a serious opportunity to capture rich insights in the evolving healthcare market. Companies like IBM, AT&T, and Verizon all have a wealth of solutions and resources to assist in developing a strategy that delivers near and long term ROI. Professionals from IT backgrounds must be hired in order to build integrated systems to link the vast amount of data in the digital realm to real-time information feeds that will improve insights and ultimately healthcare outcomes.

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The New Partnership Paradigm: Creating Strategic Relationships for Ground-Breaking, Timely Innovation

FACILITATOR Sean Macleod, President, Stratos

TIME

Monday, March 10, 2014, at 1:40 p.m.

SESSION ABSTRACT

Well-executed partnerships are innovation engines for driving revenue and market-share growth. How do you identify opportunities for growth, and how can the right partnerships foster proactive thinking and support, bringing the “next big idea” to fruition? In this interactive discussion led by Sean Macleod of Stratos, participants discussed how top companies are leveraging strategic partnerships to assess feasibility, validation, and the launch of concepts into the marketplace.

TAKE-AWAY

During the session, Macleod discussed the difference between creativity and innovation. Creativity, he said, is the ability to come up with great ideas, while innovation is bringing those ideas to the end user.

Audience members were split into groups to discuss ways to use innovation to solve a current medical problem, namely, how to distribute vaccines to rural areas in Africa. One of the greatest challenges, Macleod said, is the sensitive nature of vaccines themselves, which spoil if not kept at precise temperatures from manufacture to use. This is especially difficult because many regions lack the electricity and infrastructure needed to store temperature-sensitive vaccines.

BEST PRACTICES

The groups first discussed the ways companies can use strategic partnerships and tactical outsourcing to build product pipelines.

What’s the difference between those two? According to Macleod, a strategic attribute gives the company differentiation in the marketplace and is not easily replicated by anyone else. Tactics, on the other hand, are operational. It’s critical to understand the difference when going to market with one of these complex solutions, Macleod said.

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The groups identified areas for strategic partnerships to focus on, including government relationships, vaccine tracking and stabilization, and product formulation.

Some examples of areas for tactical outsourcing included vaccine delivery, sensors for monitoring and communication, and leveraging local sources for manufacturing.


Companies also need to identify their core competencies and enter into outside partnerships that will supplement those operations. The group members listed the core competencies of their organizations, including:

vaccine stabilization

communication, and

managing external partnerships.

Using strategic partnerships and tactical outsourcing can help companies focus more on their core competencies to get better results. Some of the outsourcing areas suggested by the groups were training, distribution, advocacy and awareness, and research and development.

To use strategic partnerships more effectively, participants said the company needs to answer “What’s in it for me?” for each partner. Partnerships must benefit both sides, and incentives must be in place for those relationships.

It’s also critical to make sure the company and its partners are culturally aligned, group members said. For those that aren’t, the relationships may need to be cut. For those that are aligned, companies can try to establish executive champions in each partner organization.

Communication is important, as well. Partners need up-to-date information, and companies should make sure they use PR, social media, and other channels to spread the word about the partnership.

FINAL THOUGHT

Transformative, innovative solutions are complex, Macleod said, and solving these problems requires more than any one organization. To end the session, Macleod revealed a real case study in which Stratos partnered with other organizations to design a new vaccine storage device.

http://www.stratos.com/project/intellectual-venture-lab

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Enabling User-Centric Design within the Regulatory Landscape

FACILITATOR David Strandberg, Director, Engineering Solutions, Plexus Corporation

TIME


SESSION ABSTRACT

Rapid advances in consumer electronics have raised not only users’ abilities to work with technology, but also their expectations. This interactive session led by Plexus Corporation’s David Strandberg focused on opportunities to leverage the paradigm and develop infrastructure of consumer electronics while staying within the bounds of a challenging regulatory environment.

TAKE-AWAY

Technology advances from outside the healthcare sphere, especially regarding mobile devices and social media, have raised end users’ expectations about medical technology. That’s only increasing as consumer technology companies such as Google and Apple begin to get involved in medical technology. Consumers now expect medical devices to keep up with the rapid pace of change in consumer technologies.

A few examples of how technology growth, consumer device trends, and changes in the healthcare landscape are converging to affect the medical device industry include:

Advances driving more processing power into a smaller footprint, and the expectation of “smart features” in previously simple devices

The proliferation of interface technologies that enable devices to communicate, pass information to each other, and be controlled remotely through network interfaces

Advances in the ease of use of handheld devices, driven by Apple and other large consumer electronics companies, including the prevalence of high-resolution touchscreen interfaces

Increased user expectations regarding reliability and simplicity

Outcome-centered healthcare buying decisions, which are increasing the need for real-time patient information

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Healthcare pricing pressures driving down the acceptable per-unit cost of devices

Reduced “half-life” for technology products driving frequent upgrades

Despite those trends demanding faster change from medical technology providers, regulatory limitations often affect the speed at which new technologies get to market.

BEST PRACTICES

Session participants agreed that companies must develop medical technologies with user-centric designs and the features people have come to expect from other devices.

Those tools need to be easy to use for everyone who will use them, including both medical professionals and their patients. Medical technology companies need to pay special attention to the elderly and others with difficulty reading small screens and pressing tiny buttons.

Overall, there is mounting pressure on device companies to consider user interface as a key component of their products, thanks to rising adoption of consumer mobile devices.

Mobile technology is also raising user expectations for other features of medical technology, including:

Use of device sensors to gather and communicate data

Location awareness and geocentric design

Touchscreen interfaces

Voice control mechanisms

As session participants pointed out, consumers also have heightened expectations when it comes to information, and that impacts what they look for in medical technology:

Users expect to be able to access data remotely and do something with it.

Completely paperless applications are becoming important.

People want devices and systems that are compatible with each other and exchange data seamlessly.

Users expect faster transfer speeds and shorter response times.

It’s important to be able to share information on social media.

There is a growing trend toward real-time monitoring of information.

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Companies must keep abreast of emerging markets and new trends from all over the technology sphere.

One big area medical technology companies should look at now is mobile software. Participants recommended making applications available on multi-platform app stores and offering standard features, such as:

Voice control

Simple graphical interfaces that can be easily read on a small screen

The ability to collect geographic information

Patient-centered design

In addition to making tools user-friendly, companies also need to focus on providing low-cost medical technologies, especially as they move into emerging markets.

The rate of change in technology is fast these days. Consumers expect their devices and software to be updated frequently, and that must be taken into account by medical technology companies, too.

TAKE-AWAY

One challenge medical device companies face is that regulatory practices haven’t kept up with changing customer preferences. That often prevents companies from responding to those changes in meaningful ways during product development.

Another trap is that future design choices are often made based on existing regulatory paths. For example, regulatory requirements often force design path selection based on 510(k) or pre-market approval (PMA). In addition, regulations around signal and data (e.g., wireless vs. wired) are effecting how devices are designed.

It’s also a challenge as innovation has pushed companies outside the US into emerging markets, giving them whole new sets of regulations to deal with. More countries are establishing additional requirements that are often incompatible with those in other locations.

BEST PRACTICES

Technology today advances so quickly with growth occurring so fast that guidance from the FDA and other agencies often can’t keep up. In addition, predicate devices are getting harder to find.

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According to session participants, that means companies must do even more to ensure the safety and reliability of medical device technology in order to combat skepticism of the underlying technology.


For example, many regulations require wired connections for security protection. In order for wireless medical devices to get approval, security technology must advance.

Companies must also make sure their devices remain HIPAA compliant and that they are reliable and secure. Increasing post-market surveillance can ensure that devices are meeting standards and are being used appropriately and in compliance.

To end the session, participants split into groups and discussed strategies companies can use to launch user-centered devices while coping with regulatory challenges. Some of the actions recommended for medical technology professionals include:

Cultivate relationships with the people involved in the approval and manufacturing process. That will help with keeping up to date with the consumer market, which is about three years ahead of medical devices.

Companies should ground themselves in what they do well today. Larger, established companies can fund smaller companies to take on riskier projects to help them through the initial 510k, then fold them back into the larger company.

Talk to the FDA at the appropriate time to get regulators’ guidance and input. Arrange pre-market discussions with the FDA to create an open submission dialogue. Be more involved with the regulatory bodies, and have a quality engineer analyze the product at all levels. In addition, talk with suppliers, who are one step closer to manufacturers, in order to screen potential products. Attend trade shows to stay abreast of new technologies.

Make sure technology is designed for the non-expert. If the goal of developing new medical technologies is to allow the consumer to engage in his or her healthcare, the device must be simple and intuitive enough for the average consumer to use. Additionally, emphasize things that might have been overlooked before, such as human factors, the voice of customer, and engagement with people you might not have talked to in the past.

Engage with users early and increase feedback from consumers, as well as nurses, doctors, and others. Try using products yourself. Create an early adopter strategy for more thoughtful pilots, and take notice of habits, norms, and values when designing products.

Engage the FDA and other regulatory bodies to gather advanced information. Get involved with those agencies, and don’t underestimate your influence. Strive

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for more pre-submission and pre-market discussions. Improve communications and increase transparency for better understanding and faster approval.

Think globally when developing your regulatory strategy. Think about localization. For example, approval may be faster when building and marketing in the same country.

Plan for future changes in regulations and customer preferences. Engage suppliers and platform developers to gather advanced information, and attend conferences to stay up to date. Don’t just consider the healthcare field. Gain insight from other industries; for example, go to CES to understand consumer device trends.

Plan strategies to compartmentalize risk, including the product release strategy. Separate the parts of a device into smaller pieces with lower levels of risk. Larger organizations can fund smaller companies to push products through regulatory approvals and establish a predicate.

FINAL THOUGHT

Technology 10 years from now will be vastly different from today’s technology. For instance, disposable devices may have as much power as today’s leading smartphones. Consumer technology moves faster than medical devices due to the regulatory restrictions imposed on the latter. Standardization across equipment and devices will help expedite the approval process, while strategizing locally will help companies get devices approved in specific markets.

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BEST PRACTICES

mHealth: At the Forefront of Future Medicine

FACILITATOR: Mark Kemp, Senior Vice President, Medical Devices, Flextronics

TIME


SESSION ABSTRACT

Patient monitoring and compliance issues continue to challenge effective medical treatments, resulting in millions of dollars being spent on preventable consequences. Innovation in multiple technologies not only promotes the creation of devices that address these issues, but also encourages treatment to shift from hospitals to homes.

Applying different technologies to medical devices requires in-depth understanding and expertise on how the convergence can impact patients, doctors, hospitals, and sponsors. In this interactive session, Mark Kemp of Flextronics led a discussion about the technologies of today and tomorrow, and how they fit into the creation of innovative medical devices that address those monitoring and compliance issues.

TAKE-AWAY

Mobile health (mHealth) is quickly becoming a very prominent player in the medical technology industry as more and more systems become integrated with one another in the 21st century. Businesses must begin to look at how they will integrate mHealth systems into their current strategy and how to sell their products to retailers and consumers across various international and national cultural differences.

BEST PRACTICES

During the session, audience members were split into groups. Participants were asked: How does your company plan to incorporate mHealth into its strategy?

One key for the transition, a participant stressed, will be to understand the differences between business-to-business (B2B) and business-to-consumer (B2C) selling. They require very different strategies, and B2B is likely going to be more successful for medical technology companies, the participant said. It will be tough to compete with larger electronics companies already selling to consumers.

Another participant talked about the need to maintain relationships with experts in mobile technology.

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The key is providing value. Medical technology companies need to ask what new products will be used for and what value they will bring to healthcare.

In addition, for new mHealth technologies to succeed, there needs to be seamless data exchange among systems and devices. That’s a challenge now because of a lack of standards.

There are legal consequences, too, one participant warned. Companies must be aware of the regulations that impact how mobile health data can be used.

TAKE-AWAY

Participants also discussed the value proposition of mHealth and what companies can do to develop successful mobile tools.

In the current environment, medical technology companies need to look at two areas as they consider the value proposition of mHealth:

reducing costs for doctors and hospitals, and

improving health and reducing the cost of care for patients by allowing them to monitor their health on their own.

Part of the value of mHealth is that it can allow more efficient access to data at a lower cost. That, in turn, will lower the cost of care and lead to improved wellness programs for patients.

Mobile tools will also allow healthcare providers to expand their pool of patients thanks to remote care. Remote monitoring also gives doctors more data to analyze for decision-making, provided they have the tools necessary to track and analyze a flood of information in a concise format they can understand.

BEST PRACTICES

Success will also require partnering with other organizations, session participants said. Mobile devices and technology and new technology from telecommunications are making their way into the medical world. That’s creating a dynamic shift and a need for new strategies, bringing new companies into the healthcare field that weren’t previously involved in medical technology. Those organizations can become valuable partners for medical technology companies.

It’s important to identify other organizations the company can share risk with, the group said. Examples listed include wireless communication companies like Epic and Qualcomm, as well as consumer-oriented companies such as Google and Apple that are developing disruptive technologies.

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Investment and research will be key to success. Companies should take a look at existing mobile health products and think about what has made them successful and use that insight when deciding what products to take to market. In addition, pilot studies and partnerships with other businesses can help companies gain that critical insight.

TAKE-AWAY

Medical technology companies need to pay attention to not only developed markets, but also emerging markets. In fact, emerging markets may actually adopt mHealth faster than developed markets, the group said, because they have fewer systems already in place and there is less regulation that can slow adoption.

BEST PRACTICES

There are some challenges and obstacles to successful mHealth products, according to participants in the session.

There is a need for greater interoperability, which will require more standards across systems and devices. It’s especially challenging to incorporate cell phones, because of a lack of standardization and because the forms of those gadgets change often. It will be critical to keep up to date with evolving standards and regulations.

One important rule to keep in mind, according to participants, is to keep the focus on value. For example, it’s not enough just to provide data because it can be captured – companies need to look for the problems that the data can help solve.

It’s increasingly important to focus on how mHealth can improve patient engagement. That requires designing technology so that it’s easy for non-experts to use.

Companies must also pay close attention to data security and controls for devices. They also need to consider multiple form factors in order to reach a greater number of customers.

FINAL THOUGHT

The mHealth industry is still in its beginning phases, with many medical technology companies trying to create value and benefits for their customers. In order to do that, they must conduct plenty of research to create tools that are interoperable and help manage increasing flows of information.

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BEST PRACTICES

Cultivating Transformation, Facilitating Innovation: Organizing Your Development Organization to Deliver Progressive Technology

FACILITATORS Stacey Pugh, Vice President, Medical Affairs, Covidien

Greg Dombal, Chief Operating Officer, Halloran Consulting

TIME


SESSION ABSTRACT

Traditional clinical organizations are built with the goal of delivering incremental improvement in products used in patients. Covidien has taken the innovative approach of dedicating itself to the path of transformation, organized in such a way to develop and produce something different for the market, and create pioneering technology while simultaneously delivering innovations to patients sooner.

With this adjustment, Covidien has succeeded in “leapfrogging” key products into the market to treat patients with newer and better devices sooner. As Vice President of Medical Affairs Stacey Pugh explained in this session, the company has also taken the crucial step of implementing key performance metrics to evaluate the internal operations to determine where and how resources can best be deployed for most impactful clinical outcome, which is a key factor to success.

TAKE-AWAY

Evaluation of Key Performance Indicators (KPIs) can be applied to patient-focused activities, Pugh said.

BEST PRACTICES

Companies should focus on developing metrics that matter. When set up correctly, metrics will help the organization drive economic value, challenge preconceived expectations, and address operational challenges.


It’s important to develop metrics for your own organization, even for a subset of your organization that may not traditionally utilize performance measurements. No matter

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how complex your organization may be, Pugh said, metrics should be actionable and timely to enable effective decision-making.

In Covidien’s case, the company has implemented a creative strategy in order to retain flexibility across various products and geographies, while at the same time maximizing potential efficiencies that can be gained from a centralized approach.

Approximately two years ago, Covidien started mapping the structure for the Covidien Clinical Operations (CCO) group within Global Medical Affairs. This group is a centralized organization that can be utilized by regional and global business units to perform monitoring, data management, biostatistics, and clinical system-related functions. It also includes a library resource and oversees approval of investigator-sponsored research activities. Covidien explored opportunities for efficiencies, quality, and compliance improvements. Some capabilities were obvious candidates for centralization, others less so. It was critical to strike the right balance between standardization across global and regional business units and autonomy and flexibility in the unit's decision-making.

In many areas, Pugh said, the company is still learning how to best leverage the new set-up.

TAKE-AWAY

Internal buy-in and commitment to such an approach from an organizational standpoint takes a long time to develop and demands long-term adherence to be successful.

BEST PRACTICES

Companies should not discount the importance of building awareness of the upcoming change. Building a coalition of sponsors, addressing resistance, and communicating priorities are some of the factors that can mitigate the uncertainty of success and fear of the unknown. The executive sponsor must be 100% committed to the effort and consistently reinforce the team's commitment to the initiative.


Prior to starting any transformative project, confirm that you have properly sized the opportunity and considered all possible scenarios. Ensure that you have the right team involved and the team understands any unique characteristics of the organizations involved. Be prepared to make changes to your strategy, revise the team structure, and/or source external expertise to deal with hurdles.

At Covidien, Xavier Lefebvre, Global VP, Medical & Regulatory Operations was committed to the initiative and pushed the team to explore innovative ways to set up the

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new organization. As a result, the team developed a very flexible contracting model that enables the organization to scale up and down as needed. It is a continuous effort and a Clinical Council has been formed with representatives from all Global Business Units to oversee the ongoing success of this initiative.

TAKE-AWAY

Established clinical development roles may not always be the best fit for an innovative program, Pugh said.

BEST PRACTICES

There is no perfect organizational set-up or management method. In today's world, most organizations, whether they grow organically or through a merger or an acquisition, end up facing issues challenging their established structure. For most companies, finding the right structure is a process of trial and error.


Carefully review alternative models against company's strategy and identify potential problem areas. This early research will assist you in establishing the right mix of structure and control with initiative and flexibility.

At Covidien, the traditionally separate Regulatory Affairs group was integrated into Global Medical Affairs, which enabled the organization to better achieve its strategic objectives. Many centralized services were set-up (e.g., monitoring, data management, etc.) and a single Oracle platform was implemented across the businesses. In order to retain a sufficient level of flexibility, a number of these services are not mandated for each business but are available if requested. This flexible approach allows users of these services to request a proposal internally, as well as from a contract research organization, which may ultimately be more cost-effective for a particular project.

FINAL THOUGHT

Develop actionable metrics that are applicable for your organization. As you embark on any sort of change management or transformation planning, ensure you have sponsorship across roles, executive buy-in, and organizational awareness, and don’t discount the importance of communication and flexibility as you get under way. Expect the unexpected and be open to new ideas, new strategies, and new ways of doing things. Be prepared to lose the old order and anticipate that your traditional, long-standing organizational structure may no longer be effective or applicable as you move forward.

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BEST PRACTICES

Leveraging Digital Health and Data for Better Patient Engagement

FACILITATORS Dr. Leslie Saxon, Chief of Cardiovascular Medicine, USC’s Keck School of Medicine Executive Director, USC Center for Body Computing

Stuart Karten, President, Karten Design

TIME


SESSION ABSTRACT

Though hospitals and doctors are currently leveraging data to improve workflow and reduce costs, patients are often still left in the dark, denied access to the physician-quality information produced by the plethora of worn and implanted sensors that doctors use for diagnostics and disease management. By contending that the information is too complex and easily misinterpreted by patients, the industry is missing out on an opportunity to create heightened patient engagement that will lead to beneficial behavior change.

How can digital device makers harness and interpret data to give physicians, as well as patients, new tools to manage their health? In this session, Dr. Leslie Saxon of USC’s Keck School of Medicine used real-life projects to illustrate best practices for making big data small enough to impact an individual’s life, turning patients into sophisticated, engaged health consumers who will partner with their doctors in care.

TAKE-AWAY

There is a new medical model affecting all organizations involved in healthcare, including technology companies: The patient as customer, Saxon said.

BEST PRACTICES

In light of that new trend, Saxon offered some steps companies can take as they develop innovative products to bring to the market today:

Explore unmet needs: Find out what patients really need from technology. Unless the company is meeting a real need, there won’t be demand for the products.

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Involve patients and caregivers early in the product development process: If the device or app is patient-driven, the company is more likely to create a viable solution in the marketplace, benefiting the organization and patients and their families. The earlier those end users are involved, the sooner the company will be able to validate or refine its chosen direction.

Understand that patients are more informed now: Patients – and caregivers – desire a more active role in their health and don’t want to be segregated from their data anymore. Products should facilitate a better, richer dialogue between patient and physician, and make conversations easier.

Tell stories: There is a large opportunity for medical device companies to reach out to patients and engage them in a unique and authentic way to further shape their brand. Companies should enlighten, engage, and expand the healthcare universe and how they tell healthcare stories. Saxon recommended telling medical brand stories from the patient/consumer’s point of view and providing content that isn’t product-specific to become a trusted brand.

Give patients a role to play: Make data and information relate to something the patient is already interested in, such as sports scores. Allow for patients to personalize their data and the information they receive.

It is critical to not only think about the patient, but also the caregiver, Saxon said. In fact, the role of the caregiver is almost more important than that of the patient. Caring for someone else has a huge impact on a caregiver’s quality of life, so they have a stake in the solutions as well as an influential voice in the decision-making process. By sharing data and including them in multiple ways, digital health management tools will reduce friction in families and improve the quality of life for those supporting the patient.

In fact, a study Saxon and her team ran revealed that patients’ families would spend a significant amount of money every month just to gain access to the implanted device information.

TAKE-AWAY

Another key trend in healthcare is the increasing focus on wellness and disease prevention, rather than treatment. When developing new technology tools, Saxon said, companies should make data “sticky” and emotionally engaging for patients to motivate long-term behavior change.

BEST PRACTICES

Saxon offered some other advice for new technology development:

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Look to other solutions: Technology that integrates with consumer platforms, such as Instagram, Spotify, and YouTube, draw on people’s impulses to be entertained and emphasize the need to marry health with fun.

Create connectivity with friends, relatives, doctors, etc.: It takes a village – there is always a caregiver or tribe of caregivers that are just as, if not more, invested in the patient as the doctor. Connect the communication gaps and allow a social network to connect to your device to enable sharing and transparency among care team and patients’ families.

Be interactive – patients transmit symptoms and receive feedback: Create an ongoing ability for patients and doctors to converse with each other.

Make information available in real time: Saxon called access to medical information one of the civil rights issues of our time. To motivate behavior change, people need big-picture information on how their lifestyle – factors like nutrition, hydration, sleep, and stress – affects their health.

Convert patient engagement into habitual behavior: The end goal is not just engagement, but measurable behavior change. The process of using a product and adapting behavior must integrate into the user’s lifestyle. Don’t overwhelm. Focus on simple change.

TAKE-AWAY

While there’s a lot of interest in new technology from all stakeholders in healthcare, doctors can be both the biggest opponents and the biggest champions of digital health solutions, Saxon said.

BEST PRACTICES

Technology companies can do more to get medical professionals on board. Here’s what Saxon recommended during the session:

Help providers see benefits: Through their marketing and outreach, device makers can help healthcare providers realize the benefits of digital health products, such as freeing up physical space and expanding patient reach. Show doctors that having patients transmit data daily increases their efficiency and helps patients live longer because doctors can spot warning signs and offer earlier treatment. With this data they can also focus their attention on the patients that truly need them, not the 90% that show up in the clinic when everything is normal.

Give doctors the software tools to manage their digital patients on mobile: Apps have already begun to demonstrate to doctors an increase in autonomy

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and quality of practice. Certain apps even allow doctors to market their practices or monetize new services. For many of these things, there is already a billing code. Taking advantage just requires a change in culture.

Medicine has deeply embedded cultures and practices, but many doctors, especially in younger generations, are open to change for the right reasons. Doctors hold an incredible amount of power in creating a paradigm shift in healthcare delivery if they adopt digital health solutions. Rather than patients coming into the clinic only when something is wrong, physicians can be proactive and reach out to patients before anything serious develops.

It is now up to doctors and traditional medicine systems to be open to this paradigm shift, Saxon said. What is required is a significant culture change. The evidence- and outcome-based information technology companies collect can help.

TAKE-AWAY

There are other entities besides doctors and patients that medical technology firms must work with, including payors and other companies. Pushing digital health solutions through the medical system involves working with company and industry stakeholders to see radical change.

BEST PRACTICES

Saxon offered some advice for bringing those organizations on board:

Corporations

o Think in terms of “ecosystems” – create new branded touch points and revenue streams for existing devices, such as implantable and digital devices: If there is an implantable product line, it is also important to have a digital product line. Make sure all devices are connected and flow together seamlessly for a pleasant user experience and a higher rate of adoption.

o Work with company revolutionaries: Find an internal champion for your product who is willing to take the risk and be the first to market. Build a coalition of “intrepreneurs.”

o Create B2B partnerships: Increase revenue streams through strategic partnerships. Use data as another revenue stream – many companies and businesses would pay for access to this data.

o Start small: Get your resources on the ground and get started. Don’t wait. It’s important to fail quickly so the company can move forward.

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o Don’t worry about revenue streams: Innovation often gets stuck on “Where is the money coming from?” Don’t worry about this and partner with those smarter than you to find solutions. If you get the users, you’ll get the income.

Payors

o Quantify results: Give numbers to show the benefit of adopting these digital health solutions. Build in a patient feedback system to know that the tool is working.

o Give payors big-picture information and improved cost/benefit analysis: Digital health tools have proven to show efficiency gains and cost reductions. According to a study Saxon conducted, patients live three times longer with implanted devices if they are actively engaged with transmitting their data and symptoms, rather than just showing up at the doctor every four months. This is really important because it also improves the cost/benefit analysis of the therapy, which makes the case for these technologies.

o Emphasize financial benefits: Digital devices and the information they give off allows for earlier treatment to be administered and moving care to lower levels, which significantly reduce costs.

Saxon is currently collaborating with not just traditional medical players, but also Yahoo, Instagram, and professional sports teams, among others, to drive this movement. She is creating strategic partnerships in different disciplines and with companies that have non-traditional technologies and products to affect the greatest change and ensure the greatest adoption and outcomes. This is just the beginning, she said, to exploiting the potential of digital devices and ecosystems to improve patients’ lives.

FINAL THOUGHT

Saxon believes that digital wireless medicine is the future and the only reason it’s not more of our present is because no one has done it properly yet. With a heavy influence from consumer products and technologies, patients want, need, and are beginning to expect continuous information streams and connectivity.

The company that has a vision and a program for how to blend ecosystems and deal with consent will be the winner. There are boundless and profound opportunities to take market share in this space and really make a difference in healthcare and for patients.

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EXECUTIVE INSIGHT

Designing and Implementing a Successful Shared Risk Model

PRESENTER Colin LeClair, Executive Director, Monarch Healthcare ACO

TIME


SESSION ABSTRACT

The Medicare Fee for Service (FFS) payment model is transitioning to a Fee for Value model with increased emphasis on care coordination and quality. The Center for Medicare and Medicaid Innovation (CMMI) is currently testing dozens of new care coordination models, some combination of which will ultimately replace the traditional Medicare FFS system.

In this presentation, Monarch Healthcare’s Colin LeClair described his organization’s experience in CMMI’s flagship care coordination pilot, the Pioneer Accountable Care Organization (ACO) program. LeClair discussed the hurdles that healthcare providers must overcome to be successful in this new paradigm, and the best practices that Monarch’s Pioneer ACO has deployed to become one of the highest-performing ACOs in the country. He also offered his predictions about the next phase of the accountable care movement.

TAKE-AWAY

Commercial ACOs, LeClair said, have a three-pronged objective:

Improve the quality of care.

Improve the health of populations.

Reduce the cost of care.

In line with those objectives, ACOs’ quality and performance are judged by the CMMI on 33 different measures across four primary domains:

1. Patient/caregiver experience

2. Care coordination/patient safety

3. Preventive health

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4. At-risk populations

BEST PRACTICES

Monarch was founded in 1994 with the consolidation of three independent practice associations.

The organization was one of 32 providers selected to participate in the Pioneer ACO program. LeClair shared the results of the Monarch program’s quality performance after the first year:

Monarch was a top performer in several “Patient/Caregiver Experience” metrics, scoring highest in “physician communication with the patient” and “patients’ overall satisfaction with their physician.”

The organization was also a top performer in several “Care Coordination/Patient Safety” metrics, scoring highest in prevention of admissions for ambulatory-sensitive conditions.

Overall, Monarch was the second-highest performer in the Pioneer program. The organization reduced medical cost by 5.4% in 2012 from its baseline, while national medical costs grew 1.1% for a comparable population.


That trend was driven primarily by reductions in hospital admissions and SNF utilization and unit costs. According to LeClair, key drivers for that success included:

Network selection and technology integration: Physicians from a narrow list of top performers (mostly PCPs) were invited to participate in the ACO, with 70% of aligned networks using a common EHR platform.

Performance-based incentives were offered for PCPs to perform annual wellness visits, health risk assessments, and key health screenings for each attributed patient. That resulted in more than 95% physician participation and collection of risk assessments for 38% of patients.

Targeted care management: High-risk patients were identified using optimum risk stratification tools and actuarial services.

Physician tools: Those included Annual Senior Health Assessment (ASHA) and Practice Connect, a proprietary point-of-care web interface that displays a summary of a patient’s 12-month medical history, highlights significant clinical events, and identifies patient diagnoses, recent lab results, a list of other attending physicians, and required preventive screenings.

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TAKE-AWAY

LeClair listed the lessons Monarch has learned from the ACO program:

Patient engagement remains challenging – Many are suspicious of ACOs and don’t understand the value of care coordination. However, patients are more likely to be engaged if their doctor endorses the ACO and if they’ve recently been discharged after an acute event.

Patient care is highly fragmented – During the first year, Monarch patients saw an average of 22 clinicians.

Physician engagement requires strong value proposition – Savings for clinicians are delayed and not guaranteed. Timely, meaningful incentives will be required to attract enough physicians to participate.

BEST PRACTICES

For the coming year, Monarch’s ACO strategy includes:

Improving specialist engagement – It’s important to acknowledge that specialists are the primary caregivers and they should be treated like PCPs for the chronically ill, LeClair said. Monarch plans to identify high-performance mini-networks of physicians and experiment with performance-based incentives for them.

Promoting price and quality transparency – Monarch’s goal is to increase confidence in ACOs through the publication of clinical outcomes and comparative hospital costs and quality performance.

Investing in partnerships with hospitals, SNFs, and ancillary vendors – Monarch’s plan is to offer incentives for lowering readmission rates, contributing to quality performance.

TAKE-AWAY

Medicare ACOs are gaining traction as legislators are finally making tough decisions with bicameral, bipartisan support, LeClair said.

Now, merit-based incentive payments and savings are available to physicians based on quality, efficiency, and EHR utilization.

The Better Care Lower Cost Act lead by Sen. Ron Wyden (D-OR) recommends enrollment of all poly-chronic Medicare patients in ACO-like models. In addition, the

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CMMI is exploring evolutionary changes to improve the attractiveness and longevity of the program.


As efforts are made to increase physician participation, LeClair listed some of the other ways to increase interest and willingness to participate in ACOs for doctors and patients:

Develop new methods of payment, including combination of capitation, shared savings, and episodic and bundled payments.

Offer patients incentives for choosing high-quality, low-cost services through preferred participating networks.

Limit ACO risk for attributed patients living outside an ACO’s service area.

FINAL THOUGHT

Just a few years ago, the ACO was called an “awesome consulting opportunity,” LeClair said. Today, ACOs are starting to take more defined shape and receive more support from the federal government. The emphasis on quality and measurable results for physicians will continue to grow, becoming the new currency of healthcare.

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EXECUTIVE INSIGHTS PANEL DISCUSSION

Technology Integration and Industry Convergence: Bioinformatics, Patient-Empowered Point of Care, and Beyond

MODERATOR Amir Jafri, Principal Partner, Executive Vice President, Netspective Communications

PANELISTS Joseph Boystak, Co-Chairman, Bessor-Brightwaters Pharma, Chief Executive Officer, Brightwaters Capital

Robin Farmanfarmaian, Vice President, Strategic Relations, Singularity University

Sanjay Shrivastava, Director, Global Marketing, Covidien

Barbara Sosnowski, Vice President, External R&D Inflammation, ERDI Lead WRD External Partnerships, Pfizer

Richie Etwaru, Group Vice President, Digital Innovation, Cegedim

TIME


SESSION ABSTRACT

The panelists in this session discussed value-driven healthcare and how to use big data, providing insights on the challenges and opportunities posed by the evolution of healthcare. The discussion, led by Amir Jafri of Netspective Communications, focused on emerging markets, handling mass amounts of data, and funding innovative R&D.

TAKE-AWAY

The major challenge facing big data in the medical technology world revolves around the question of what to do with the data. The information is there, but it’s important to build a model that can verify and validate the data for actionable use in medicine.

BEST PRACTICES

Technology needs to create analytic systems that can properly interpret data given through information avenues, and companies must develop ways to apply it and use it.


Medical technology companies must focus on devices that enable patient engagement, rather than just those used for record-keeping. Success in the changing world of

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healthcare will require developing products that can disseminate information provided by patients and make the information actionable. The goal must be to engage patients to participate in their own care.

TAKE-AWAY

Like they are in other fields, strategies and business models in the medical world are moving toward a more data-centric focus, with the goal of conducting healthcare in a more efficient and precise manner. The medical device industry must examine what its role is in that major paradigm shift, the panelists said.

BEST PRACTICES

Companies should look to develop new technologies to compile and acquire actionable data in order to allow healthcare industries to do what they do in a more proficient and nimble manner.

Medical device companies should begin to look into emerging markets and areas that serve countries such as India and China. Focus on these markets, which have a potential to be as vast as the domestic market.


Companies should begin to actively engage with the worldwide medical community in emerging markets like India and China. Open dialogue with physicians in those countries can show how they are looking to do things and what technology they need so they can provide better care for their patients.

TAKE-AWAY

Of course, new products require new capital. That’s why there must be collaboration with investors and others to determine the exact cost of developing new products throughout the world.

Only about 10% of the 3 billion people who live in China and India can afford the healthcare that Americans can. That means there are opportunities to find innovative and cost-effective solutions and increase access for people around the world.

BEST PRACTICES

Accumulating data should be the first step in this process, according to the panelists. Look for solutions to treat, manage, and prevent diseases where there currently aren’t any solutions.

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Opportunities for research exist in:

The decentralization of medicine

Value-based healthcare

Remote monitoring and wireless applications

Individualized health and therapeutics

Actionable data

The notion of competency and educational aspects

Patient compliance and engagement

Companies should take the data, partner with different groups, and work toward analyzing and interpreting the data.

Money can be brought in through partnerships and investments, with patient advocacy as a driver. Companies should look for partners in non-medical sectors, such as telecommunications.


Companies can launch ventures to acquire funding for new medical technology devices to bring big data to the healthcare system. Those tools must have the ability to analyze information and make it useful for physicians and patients.

Corporate innovation exchange programs with Fortune 500 companies allow small businesses to learn from large corporations and vice versa.

FINAL THOUGHT

For big data and new technology to thrive in the evolving medical world, technology companies must find ways to make data actionable and prove the benefits for the cost and quality of care.

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OPENING ADDRESS

Value Creation: Manufacturer/Provider Partnerships for Innovation & Growth

PRESENTER Gary Fingerhut, Executive Director, Cleveland Clinic Innovations

TIME

Tuesday, March 11, 2014, at 8:45 a.m.

SESSION ABSTRACT

Healthcare in the United States is dramatically changing and requires the optimization of both technology transfer and healthcare commercialization. Innovation service organizations have an opportunity to refine processes in support of providing better patient care, promoting advantageous monetization, and establishing an institute-aligned culture that helps to maintain relationships with key innovators while supporting staff effectiveness and retention.

In this session, Gary Fingerhut, Executive Director of Cleveland Clinic Innovations, highlighted the advancing technologies emerging from his organization. He emphasized the importance of innovation and invention in the evolution and commercialization of healthcare.

TAKE-AWAY

The world is changing more toward IT initiatives and better streamlined processes involving data and communication, Fingerhut said. Technology companies should leverage the expertise of medical experts. By doing this there will be greater clinical relevance as well as commercial outcomes, and enhanced quality and increased value in newly emerging medical technology.

BEST PRACTICES

Fingerhut recommended mining for ideas with clinically aligned institutes and developing deep specialty and subspecialty expertise to determine the clinical and scientific feasibility of new ideas for medical technology.


Alliances and scaling businesses can also help in the management of facilities all across the globe for potential new medical technology. Alliances allow technologies to come together and promote a better market strategy. They can also accelerate

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innovation and commercialization, and increase investor engagement in funding new projects. It’s also highly crucial to keep investor satisfaction high when looking to new projects, and to ensure a return on investment and a continued chance for economic growth.

TAKE-AWAY

Healthcare reform calls for the commercialization of healthcare through innovation and value-based invention, Fingerhut said.

BEST PRACTICES

To move healthcare forward, there’s a growing need to develop stronger industry-institute relationships and remove some of the cost from hospitals by identifying and streamlining clinical and operational processes.


Fingerhut recommended companies attend medical innovation summits to stimulate discussion and keep medical innovation a priority. Digital centers of excellence can help increase inventor engagement.

In addition, companies should engage investors by hosting summits or seminars for them to attend and to see the potential benefit of investing in new products coming out of the medical technology field.

The innovation process should not be focused on financing the idea; it’s also very important to engage in cross-fertilization of non-medical industries and healthcare providers to better serve their patients.

As healthcare becomes integrated, providers, payers, and the industry should be involved in patient-focused collaborations, Fingerhut said.

TAKE-AWAY

The healthcare industry must keep up with technological trends in order to engage inventors, patients, and physicians alike.

BEST PRACTICES

Companies should update old systems for ease of use and put them in line with the expectations surrounding current and developing consumer technology. To keep with changing trends, outdated equipment must be replaced with more streamlined products.

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Fingerhut said companies should develop software applications similar to the Cleveland Clinic’s iVHR, a system that takes EMR data and presents it in a more accessible visual format. The system allows physicians to provide better care and measure the outcomes.

And whenever possible, expensive and bulky clinical equipment should be replaced with mobile apps.

Companies can take ideas that have been successful in other areas and bring them into the healthcare market. Leverage industries to push innovation and engage investors by actively participating with them and showing the benefit of such products. Begin to look into advanced cognitive computing and evidence-based decision-making, and enhance the decision-making engines in order to better serve the healthcare industry.

FINAL THOUGHT

In order to develop technologies relevant to the future needs of patients, innovative companies need to:

Mine for new ideas

Engage clinical and technical investors to evaluate need

Assess commercial viability

Develop within a specific domain

Advanced technologies, such as IBM’s Watson supercomputer, allow for evidence-based decision-making and assist in medical school training. Companies developing innovative, easy-to-use, and mobile medical technologies must also consider the patient experience in order to remain successful.

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FIRESIDE CHAT

Executive Perspectives on Emerging Markets Innovation

Dr. Chandy Abraham, Chief Executive Officer, Health City Cayman Islands

Interviewed by: Reenita Das, Partner, Frost & Sullivan

TIME


SESSION ABSTRACT

Dr. Chandy Abraham is the CEO and Head of Medical Services for Health City, Cayman Islands. This is one of the first overseas ventures of the Narayana Health Group with a partner hospital chain from the US. He has had extensive experience working in clinical as well as academic settings in India and the United Kingdom. In addition, he has held many senior administrative positions throughout his career.

Dr. Abraham’s latest appointment, prior to his current position, was as the Facility Director of Narayana Hrudayalaya, the flagship hospital of the Narayana Health group of hospitals. This is a large, 800-bed cardiac hospital based at Bangalore. He was also the Group Head for Quality for the Narayana Health Group, which has expanded rapidly over the last few years to 22 hospitals in India.

While in the U.K., he worked at the Sheffield teaching hospitals in England, developed his surgical work in complex colorectal surgery, and obtained his membership to the Royal College of Surgeons in the U.K.

TAKE-AWAY

There is an enormous market for new medical technology outside of the United States, Abraham said. Emerging markets in China and India are expanding their healthcare initiatives to look for new, low-cost products to provide high-quality care. These markets have a huge need for new infrastructure and should be a strong focus for medical technology companies looking to expand globally.

BEST PRACTICES

To market new technology to emerging markets, companies must first begin to look at the economic limits of those areas; many have a large impoverished population. Therefore, frugal innovation should be a main focus for medical technology companies,

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Abraham said. High quality at a low cost will be the key factor for the success of new technology.

As an example of how emerging market companies employ innovative technology to reduce cost, Abraham discussed a hospital Narayana Health established in the Cayman Islands. The high-quality hospital was built at half a million dollars per bed, compared to the $1 million-$2 million/bed that’s standard in the US. The building, designed to keep out heat, is located near the ocean and, in the future, plans to utilize an ocean water cooling system.


Abraham stressed the importance of looking for innovative ways to lower the cost of production of new technology. Companies should look to reverse innovation – developing products in emerging markets that can later be sold elsewhere – and work with global industries to develop low-cost economic healthcare delivery models.

Begin to scale toward these markets and find ways to develop medical technology, not geared toward western standards, but emerging market standards, with the same level of proficiency.

Companies can simplify products to do more with less. Ensure quality by looking at the processes in play and reducing unnecessary components.

Not every hospital needs to be able to provide every service, Abraham said. More complex procedures can be directed to more highly-equipped central hospitals. A key strategy of Narayana Health in India has been to form central hub hospitals around common services such as radiology. The high volume of patients in central hospitals sharing resources reduces costs compared to small, individual hospitals that each have their own facilities.

TAKE-AWAY

For technology to be successful in emerging markets, Abraham said, its value must be relevant to healthcare. Companies must also make sure the technology fits with the needs of the social structure.

BEST PRACTICES

Companies can benefit from monitoring how nurses and doctors in emerging markets deliver care to see how technology fits in to those established customers and practices. Technology must be developed in ways so it can be applied within these healthcare systems around the world.

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TAKE-AWAY

Innovation that improves care and cuts costs goes beyond technology. Abraham discussed Narayana Health’s Companion Care Program, which the organization developed in collaboration with Stanford University. The program gives patients’ family members the training they need to assist with the patient’s care.

At the hospital, those family members or other caregivers are given a test and asked to do practical demonstrations. If they pass, they are allowed to be with the patient outside of visiting hours, make reports, and assist with physical therapy.


Training eligible family members to care for patients both inside the hospital and at home has helped patients feel more comfortable going home so they’re less likely to extend their stay at the hospital, Abraham said.

It has also increased patient comfort and satisfaction: 89% of trained family members said they felt more confident about taking the patient home, while 56% said it improved communication with medical staff.

FINAL THOUGHT

Emerging markets are looking to expand their healthcare coverage but need help from innovative technology to do so. This has created a major potential for medical technology companies to develop new devices that can be used in this market. However, there also needs to be an emphasis on low-cost/high-quality products due to the economic situation of countries in the developing world.

That innovation will not only lead to new products for emerging markets, but will also result in new, less expensive technology that can be sold in the developed world. This will lead to lower production costs for companies and could begin a new avenue for medical technology.

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INTERACTIVE ROUNDTABLE

Preparing for the Apocalypse: How to Make Sure You are in Business in 2020

FACILITATOR Erik Glitman, Chief Executive Officer, Fletcher/CSI

TIME


SESSION ABSTRACT

This interactive session led by Fletcher/CSI’s Erik Glitman explored how medical technology companies can survive and thrive in the emerging post-ACA regulatory environment. Glitman discussed a series of likely scenarios and potential changes in the market, including the emergence of new technologies such as mobile health, remote monitoring, integrated health management, new tax regimes, an aging population, and other as yet unidentified areas.

The discussion covered how companies can leverage adjacent and core market monitoring to identify destructive market changes before they have a direct impact. Participants talked about the tools used to monitor changes in direct and indirect markets and how to develop strategies based on the changes. Tools such as Five Forces, STEEP, and Four Corners were used to build strategy responses to emerging medical technology challenges.

TAKE-AWAY

The market, the consumer, and the roles of players within the healthcare industry have shifted. Previously, the payors were just insurance companies, but now, individuals are paying a greater share of the cost. As a result, consumers are transitioning from wanting the latest and greatest technologies to wanting to get the most for their money.

BEST PRACTICES

To meet those evolving demands, companies must increase the push for cost-effectiveness and a focus on consumers to ensure the company is offering the products and drugs that people are likely to purchase.

Companies should work toward developing comprehensive solutions targeted at relevant populations. To control costs, rather than relying on external reps, many companies are hiring internal, non-commissioned reps who handle processes within the company.

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To attract increasingly savvy buyers, new devices must have a high ROI. One way to find out what people are willing to spend money on is to talk to patients to determine what obstacles they see in the way of improving their health. Companies should look to creating products that can help patients address those individual barriers and empower them to make positive changes.

Over the next five to 10 years, as consumers see the cost of care and become responsible for paying a greater share, they will start to choose less expensive technology. They will not pay for more advanced technology unless they see clear improvements in efficiency and quality.

In the short term, the consumer is the end payer, so all products need to be geared toward consumers. To reduce costs in the healthcare system, companies should focus on the 1-5% of the population who cost the most and ensure that those patients are working to improve their own health. Change will be initiated by consumers with their increasing technological expectations and by clinicians who are aware of the technologies and devices becoming available.

TAKE-AWAY

The efforts of the FDA and other regulatory authorities affect companies’ abilities to bring new, innovative products to market. Today, research and trials that used to occur in the US are happening overseas.

BEST PRACTICES

In order for US companies to maintain a competitive edge, the FDA needs to cooperate in providing clear standards for submission and approval. Additionally, session participants said, the FDA needs to develop systems to handle the accelerating advancement of medical technology.


While changes on the part of regulators are necessary, companies also have a role to play. Businesses need dedicated regulatory affairs professionals with winning strategies. They can no longer rely on a person with a role split among regulatory issues, quality control, and other duties.

As the FDA works on making changes, Europe is also calling for an overhaul of its entire regulatory system in order to eliminate the gap between what consumers want and the products that companies are approved to provide.

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Many companies are conducting trials outside the US, as it is much easier to get a product approved in foreign markets. Likewise, a lot of manufacturing has been offshored because of cost considerations. However, technical support still needs to be local. People want to talk with someone nearby.

TAKE-AWAY

The country may see another soft recession in 2015-2016, Glitman said. By 2020, he predicted there will be about 15 major hospitals in the country with which all other organizations will be aligned.

BEST PRACTICES

In this environment, smaller companies need to refine their strategies for competing with larger organizations. Smaller firms should look for the areas the big companies are not serving in the hopes that they can contract with those organizations.

Medical device companies fear working together in industry groups because they worry that they would lose the advantage and end up developing products for their competitor. However, transformative mergers and acquisitions can help companies reduce costs and achieve their goals.


Companies should assess their core competencies and make sure they are creating products or offering services of value that are unique to their business. To handle the things outside of those core competencies, organizations can partner strategically with other companies around similar goals.

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Connected Health: Innovating a Holistic Interoperable Solution to Meet Your Customer’s Needs

FACILITATOR William Betten, Vice President of Business Solutions, Logic PD

TIME


SESSION ABSTRACT

Today’s technology connects us to the things about which we care. In the world of connected health, we’re witnessing an explosion of health and wellness devices, apps, and “quantized self” advocates catering to consumers and medical personnel alike. These applications and devices, coupled with consumer technology, are affecting the user’s expectations for more traditional medical devices.

How can traditional medical companies and new entrants adjust their approach to develop connected medical devices that meet both the government’s and the user’s expectations and create real value in this world of “big data”? This interactive session led by Logic PD’s William Betten explored approaches for developing a cohesive vision for your connected health products.

During the session, participants split into groups to answer a series of questions about how medical technology companies can adjust their approach to the needs of today:

What do we mean by interoperability?

What are the barriers to interoperability?

What are the connected health drivers?

How are consumers influencing medical devices?

Will consumer electronics or medicine set the tone for the new technology? Who’s going to win?

How and why will data repositories come into play?

How can technology connect repositories?

What are the implications of the “Internet of things”?

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TAKE-AWAY

Interoperability is the ability of the system or product to work with other systems or products, without special effort from the customer.

In today’s changing medical technology world there are growing questions about the interoperability of systems and devices. Information is becoming more important for healthcare, so medical technology companies must find ways to help providers collect, share, and use that information. Companies are facing a big question in regards to the data they’re looking to begin to utilize and just how useful it could be across various interfaces and current systems of record.

BEST PRACTICES

Medical technology comapnies need to look into the major challenges around interoperability for medical devices. Opportunities are available to try and mitigate those barriers.

The barriers to interoperability described by session participants included:

1. Competition and conflict between standardization and differentiation

2. Conflict and lack of cooperation among different vendors

3. Privacy and security issues

4. Increased costs, a lack of resources, and competing priorities

5. Government rules around meaningful use of health technology

6. A lack of standards and external driving forces to change systems


Companies must find ways to address all those issues. There are large cost benefits that can be achieved by providing a streamlined, unilateral system of data to hospitals.

The participant groups came up with some steps that can be taken to prove the value of greater connectivity:

Provide the big picture view of the whole care continuum.

Understand the daily impact of care on people’s lives and how this affects stakeholders.

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Emphasize how a more ubiquitous monitoring system will lower cost outside care facilities.

Focus on the increased need for a more connected world and the social need to have more information provided for a healthy controlled and connected technology ecosystem in healthcare.

Begin scalable population management and start to identify macro trends and provide better resources and research.

Emphasize the operational efficiency potential with new technologies.

Look at just how much new connectivity will lower patient care costs for hospitals.

New knowledge and collaboration in the technology world could produce some very real results with the combination of data and genomics.

TAKE-AWAY

Any successful product in the market today is driven by consumer influence. Companies must understand the deep impact this influence is going to have on new medical devices when utilizing data and interconnecting systems in the healthcare industry.

BEST PRACTICES

Participants listed three major considerations companies must take into account when it comes to the growing influence of consumer technology:

Demographics: As older generations begin to adopt high-tech devices, there is a huge market for new systems that patients can use to monitor their own health.

Chronic illness: New technology can enable people to interact with medical devices on a different level. The demand for data, lowering healthcare costs and high-tech systems is becoming increasingly prevalent in daily life.

Technology Awareness: More and more individuals are becoming technologically aware, and there are different levels of understanding among varying age groups.


Purpose should be the number one concentration for medical technology companies when looking into how to market a product to the consumer. Companies need to look at the various age groups, their preferences, and the technology platforms they use in

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order to see what the demands are for new medical technology and how people want to integrate those tools into their daily lives.

TAKE-AWAY

There is a debate among medical technology professionals over who will have the greatest influence as the market evolves: Will it be consumer electronics companies who drive the market, or will it be the healthcare industry?

BEST PRACTICES

The answer to that question is currently unclear. Medical technology companies, therefore, must begin to look into both avenues for the commercialization of their new products. Companies must also begin to look at how data will be stored and figure out the value chain in the use of integrated technology in the medical field.


Medical technology firms must evaluate utilizing consumer electronic networks to push new medical technology into the public sphere, but also utilize the vast benefit the medical industry has in using these products to lower cost of care. Look into data repositories for these new data-driven systems and decide how information can be stored and made available to different tools and systems. Access to this information can be created through standard wireless or wired connections, and medical technology companies need to look into how they’re going to create these connections.

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Understanding the Shift in the Mindsets of Global Regulators

FACILITATOR Amanda Pack, Staff Engineer/Lead Auditor/Lead Regional Lead Reviewer, UL

TIME


SESSION ABSTRACT

In the last year alone, we have witnessed several changes to the regulatory structure in China and Korea, and we will soon see the same in the EU. There have also been changes to how regulators work together, like the new Medical Device Single Audit Program (MDSAP), which includes four active regulatory agencies and one observer. Regulators have put these changes in place to move the pendulum toward stricter controls in some cases. This roundtable discussion led by Amanda Pack from UL looked at the impact these changes are having on companies’ regulatory strategies.

TAKE-AWAY

The discussion looked at some of the reasons there have been regulatory changes in the European Union. For example, some changes were made by regulatory authorities because several manufacturers were intentionally defrauding the system. The regulators began unannounced audits to try to combat this issue.

BEST PRACTICES

Participants talked about the effect of Notified Bodies reclassification or de-notification on device manufacturing. Reclassification may require manufacturers to change Notified Bodies. This would require labeling changes as well as lead to additional manufacturing expense.


Eventually the directives in place, such as the Medical Device Directive (MDD) and the In-Vitro Diagnostic Device Directive (IVDD) will become regulations. That will give the regulators more authority. Currently, each member state has to transpose the directive into national law, but that will no longer be the case once they are regulation.

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There is not a set implementation date or timeframe for the changes. Several different proposals have been discussed that would put those changes into effect immediately, in three years, or in five years.

For IVDs, a significant change will be the classification of devices. Currently, the majority of devices are self-declared by the manufacturer, but in the revised regulations, the majority will require Notified Body involvement.

Some observers see the audit processes and requirements as changing for regular assessments. However, it is actually a calibration process of bringing all of the competent authorities up to the same level.

What was seen in the EU is that some competent authorities had a different view from others on the requirements for Notified Bodies. So there is an emphasis on standardizing the competent authorities.

The changes also affect Notified Bodies. All are required to undergo a reclassification audit. Notified Bodies will also be required to have clinical experts on staff.

There are also significant changes in the EU for Own Brand Labeled (OBL) manufacturers. Audits will now be required for OBL manufacturers and they will be required to maintain a quality system equal to the quality system of the manufacturer that originally registered the product.

TAKE-AWAY

In addition to Europe, device manufacturers are also increasingly looking to developing markets to sell their products. Session participants talked about their strategies for approaching emerging markets.


The advice offered included:

Find local government representation.

Consider local holidays when releasing products to market or making regulatory submittals.

Have your own people on the ground. Don’t just use consultants.

Develop close working relationships with regulators. Have senior VP leadership from the US meet with regulators and discuss what is happening in other regions.

Have a close relationship with the manufacturing facility in the market.

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Understanding the culture of the region is critical.

Many markets have limited regulatory resources so checking credentials and ensuring loyalties of local staff in those areas is important.

Be selective about which markets you choose.

Be aware of language differences, including differences in regions and dialects within the same languages.

In India – one of the top emerging makers – regulations are straightforward but changing.

CE approval often increases your chances of approval in emerging markets.

Some markets like to see local clinical trials, while others will accept US trials.

One of the big lessons learned by participants in the discussion: Be very selective regarding the people and organizations you hire and partner with. Companies are still responsible under US law for their product and the actions taken by a sales rep or distributor.

TAKE-AWAY

Participants discussed the regulatory impact of the Medical Device Single Audit Program (MDSAP), which began as a pilot program through a partnership among the FDA and equivalent agencies in Canada, Brazil, and Australia. The goal is to come up with a single audit that will allow a device manufacturer to meet the requirements of all the participating bodies.

In theory, all IMDRF countries will join the program once the pilot is over. That would include the EU.

BEST PRACTICES

Several audience members involved in the discussion expressed concern about the implementation of the program, while others believe it is on the right track.

Some of the participants argued that companies should be part of the pilot because, they said, if you don’t play then you can’t have a say. Since this is a pilot program, there is feedback from each audit that is being looked at by the MDSAP for process improvements.

Those representatives recommended manufacturers use their smallest facility that would have the least amount of impact to the overall company for their first audit.

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FINAL THOUGHT

It is clear regulations continually evolve, but there is still a strong business need to innovate and sell more products in more markets. Companies need to constantly be aware of the proposed and planned changes that could affect their ability to sell products and also be aware of opportunities, such as the MDSAP pilot, that give manufacturers an opportunity to participate and provide feedback.

Part of the benefit of bringing a discussion group like this together was to share best practices with each other and learn from the experts who sit at the table with the regulators. Having a diverse group to network with allowed for discussion around what to be aware of in emerging markets and also leverage UL’s detailed knowledge of the MDSAP. Perhaps the final takeaway is to encourage manufacturers to participate in these types of MindXchanges as a way to effectively add value to their businesses.

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EXECUTIVE BULLETIN

Creating Value via 3D Printing

PRESENTER Stuart K. Williams, Ph.D., Executive and Scientific Director, Cardiovascular Innovation Institute

TIME

Tuesday, March 11, 2014, at 1:00 p.m.

SESSION ABSTRACT

It is now well recognized that the in vitro assessment of new drugs and devices and tissues created for implantation in patients must utilize tissues that exhibit three-dimensional structure. Bioprinting, the biological equivalent of computer-assisted design and computer-assisted manufacturing, is rapidly emerging as the method of choice to construct 3D micro-physiologic systems for pre-clinical and clinical applications. In this session, Stuart Williams of the Cardiovascular Innovation Institute talked about some of the new advances being made in this field and what it means to medical technology companies.

TAKE-AWAY

Bioprinting is on the forefront of 3D printing technology. It can revolutionize healthcare and alter the course of the medical industry by giving doctors tools to see exactly what they are facing in patients prior to surgery. Bioprinting may even be used in the future to create complete new organs for transplants in patients.

BEST PRACTICES

The concept of 3D printing has been around since 1859, Williams said, when Francois Willeme created the breakthrough imaging technique called photography. Charles Lindbergh and Alexis Carrel further explored the idea in the 1930s, as David M. Friedman’s The Immortalists discusses. In the 1980s, Chuck Hull patented stereolithography as a means of successively printing thin layers of an ultraviolet curable material, one on top of the other.

While the idea of printing biological material is still emerging, 3D printing has many uses in healthcare already. For example, use of bioprinting in pre-surgery and scaffolds reduces some of the expertise required to perform procedures and enables physicians to work with models of organs before opening up patients on the operating table.

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Commercial bioprinting systems print guides for implantation of appliances into the mouth. Bioprinting 3D models will allow physicians to examine and practice on mock-ups prior to cutting into a patient. Those guides allow PAs to perform work that used to fall on dentists, such as drilling. The ability to reduce risk during procedures through the use of 3D-printed models can be applied in a variety of situations, including cardiovascular surgery and neurovascular separation of conjoined twins.

Medical technology companies need to explore these areas to see just how well it can be used for physicians in all areas of healthcare. Companies can also look at how bioprinting can be applied to other new medical technology in the future.


Williams said medical technology companies should collaborate with doctors who have adopted bioprinting and see what can be done to better facilitate this revolutionary technology. Information pulled from various industries within healthcare can be used to help advance the use of 3D printing.

Bioprinting will also lead to the development of other new technologies, and likewise, other technologies will need to be developed to allow for effective use of bioprinting. For example, there’s a need for technology to help with the input of medical information into a computer to be used as a script for printing organs. Medical technology companies should be looking into this so they can begin to develop new products to meet those needs.

The ability to bioprint human organs is emerging. One such example is the Total Bioficial Heart™ the Cardiovascular Innovation Institute is developing. For further advancement, companies must partner with those in the medical profession to grow their knowledge. In order to successfully bioprint and implant human organs, technology companies need to know a lot about biology and the glue that holds structures together.

FINAL THOUGHT

Bioprinting is becoming a reality as doctors and scientists are tirelessly working to create a feasible system in the healthcare industry for this new technology. Medical technology companies should explore ideas around how the information and technology they currently have and will produce in the future could be applied to this process.

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VISIONARY INSIGHT

The Healthcare Industry: Disrupt, Collapse and Transform

PRESENTER Greg Caressi, Senior Vice President, Healthcare & Life Sciences, Frost & Sullivan

TIME


SESSION ABSTRACT

Key trends are playing a distinct and personalized role in destroying/reshaping industries and enabling others as we push toward 2020. Whilst some sit back and allow new technology and business models to converge into them, others understand the key role they will play in enabling disproportionate growth for clients and customers, internal and external. This discussion, led by Frost & Sullivan’s Greg Caressi, tackled the key disruptive forces in several critical areas to analyze which will have the greatest impact and precisely what should be done about them.

TAKE-AWAY

All companies need to change in order to stay on top of innovation and remain competitive in the market today, Caressi said.

Medical technology companies must examine new developments in the healthcare industry, along with other industries like telecommunications, to see how everything is moving forward in the market. Analyzing these changes will allow medical technology companies to see how other developments can be applied toward their industry.

Some of the technologies to keep an eye on include:

Health and wellness tools

New medical devices and imaging technology, including surgical robots and interventional radiology

Advanced manufacturing and automation technology, including 3D printing and micromanufacturing

Advanced materials and coatings

Microelectronics

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Sensors and controls, including nanosensors and ubiquitous wireless sensors

New information and communication technology, including cloud computing and data analysis

BEST PRACTICES

Companies need to look to new means of innovation and monitor trends going on in the telecommunication world and other emerging players in the healthcare industry. Look at how these new opportunities can be incorporated into current and developing technology in the medical industry to better serve the healthcare industry and to capitalize on an ever changing market.

Specifically, Caressi said companies should look for opportunities around technology designed to:

Reduce the cost of care overtime

Better manage diseases

Reduce hospital readmissions

Reduce individuals’ needs for chronic care

Prevent disease in the future

Bring data together to increase efficiency and improve outcomes

TAKE-AWAY

Caressi listed the top 10 disruptors on the horizon for the medical technology industry:

Frugal innovation – Companies must develop lower-cost products with a wide range of applications

Cloud computing

Big data

The impact of ecommerce on the way we do business with hospitals

Increasing consumer power

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Aging in place – 65-90% of baby boomers prefer to live at home

Regenerative technologies

3D printing

Private labeling – Expect to see branded disposable products

Optimized delivery – It’s no longer just about the technology of the device itself, but also about trying to reduce the combined cost of creating the device and getting it to the consumer

Last decade, Caressi said, technologies were geared toward extending life, and companies focused on advancing the standard of care. Currently, technology aims to improve outcomes and mitigate risk, while companies strive to make treatments safer and easier. In the future, integrated platforms will be necessary to provide a comprehensive continuum of care with a focus on quality of life, and companies will need to understand consumer behavior, needs, and pain points.

BEST PRACTICES

Medical technology companies must invest not only in development, Caressi said, but also into the strategy and business model. It’s important to look toward the need being served, rather than the technology itself. Ultimately, the focus must be on how the solution will lead to better healthcare.

Frugal innovation and tiered product markets are also important as the focus on the cost of care and releasing products to emerging markets increases.

Caressi also stressed the importance of partnering with other organizations for business model and product innovation, and of looking to groups outside of the core customer base.


One critical factor for success will be how well medical technology companies meet evolving customer expectations. New technologies must engage patients to participate in their own care. As shown by the consumer electronics industry, those end users have several key demands when it comes to technology:

Convenience – Consumers prefer that the diagnosis, testing, and treatment be moved into the home to break down the brick-and-mortar approach to healthcare.

Engagement – Shared decision-making and storing all collected data in one

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accessible location will help keep consumers actively engaged in their healthcare.

Personalization – Consumers want care that is based on their preferences.

TAKE-AWAY

One of the key areas in which medical technology companies must innovate, according to Caressi: Finding ways to analyze the vast amounts of health data available in order to create value for patients, the healthcare industry, and other stakeholders.

BEST PRACTICES

Clinicians need to be able to use data that is acquired, Caressi said. Successful technologies provide multiple ways to create value for multiple stakeholders.

Data should be sifted from the amount that is collected down to what is useful for clinicians: data collected through individual devices that capture metrics and the EMR system becomes information, which is analyzed to create knowledge, which is then clinically integrated.

Value for stakeholders can be created through outcomes, satisfaction/experience, service, individual empowerment, data/information, efficiency, costs/risks, and time savings.

Systems need to take data from mere collection through analysis to convert it to useful clinical information. The biggest gap to be breached is not in creating more data and analytics, but in transforming the process data goes through once it is collected.

FINAL THOUGHT

Medical technology companies must plan for change in the healthcare industry. New approaches to investment and innovation must be a priority for medical technology companies when looking to move into different realms of data and information for better healthcare. Companies must look toward frugal innovation, data management and analysis, and ways to engage customers in their daily lives.

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Disrupt, Collapse, and Transform: Using Trends to Focus Your Growth

FACILITATORS Greg Caressi, Senior Vice President, Healthcare & Life Sciences, Frost & Sullivan

Reenita Das, Partner, Frost & Sullivan

Venkat Rajan, Industry Manager, Medical Devices, Frost & Sullivan

Charlie Whelan, Director of Consulting, Healthcare & Life Sciences, Frost & Sullivan

TIME


SESSION ABSTRACT

This interactive session looked at how medical technology companies think about growth by exploring the mid- to long-term issues that can be integrated into planning today. Participants discussed what healthcare could look like in the future, what opportunities will come from that changing environment, and what threats and challenges companies will face.

TAKE-AWAY

Participants agreed that patients of the future would want shared decision-making support based on evidence and up-to-date, authoritative information. Convenience and ease of use will also be critical to meet changing consumer demands.

BEST PRACTICES

Scenario modeling could help patients make informed decisions about their potential diagnoses. Patients want to be empowered to take care of themselves, participants said, and they will look for healthcare systems that allow them to do so.

Companies should start to look into how they can provide consumers better access to their medical history and health information through new technologies that provide actionable data and useful and convenient tools to acquire said data.

In addition, as mobile technology becomes more popular, apps will feature more prominently in a patient’s monitoring of his or her individual healthcare. That software must be designed for ease of use and patient engagement.

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Android- and iPhone-based platforms need to be developed. App-based data collection will allow for the personalization of medical treatment. For example, when a patient is sensitive to certain behaviors, he or she can feed that information into the system, which will offer incentives to change those behaviors.

Mobile health tools will need to move beyond their current isolation and be able to communicate with each other across common platforms. Apps should ask behavioral questions and offer medical tests.

The information patients receive should not come from their providers but instead should be from an objective third party. All the important information patients need in order to manage their healthcare should be in one convenient place so it can be shared among patients and all of their healthcare providers.

Interoperability will be a key to success for new medical technologies. Companies must develop ways to incorporate vast amounts of data currently available. Look to see how current interfaces can begin to be integrated into the new potential systems. See what roadblocks may be in place to limit the streamlined transfer of data across all platforms in the healthcare industry. Look to integrated technologies like Bluetooth, iPhones and other technology as a means to link interoperability, and develop new integrated systems for electronic health records.

FINAL THOUGHT

Participants agreed that medical device technology would have to evolve to keep up with consumer trends in order to engage patients in their own healthcare. An increase in available information and data will create more informed consumers who feel empowered to make educated decisions based on evidence and predicted outcomes.

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INTERACTIVE

Inspiration to Implementation: Developing Your Day-to-Day Action Plan

FACILITATORS Michael Waldman, Director of Growth Implementation Solutions, US East, Frost & Sullivan

Kunle Malomo, Director of Growth Implementation Solutions, US West, Frost & Sullivan

TIME


SESSION ABSTRACT

Whether acquiring companies, expanding geographically, or launching visionary new products, implementing innovative strategies is complex, risky, time-consuming, and expensive. This is further complicated by limited internal resources and senior executive bandwidth, dedicated team member skill constraints, and aggressive project timelines. In this interactive session led by Frost & Sullivan’s Michael Waldman and Kunle Malomo, participants explored the challenges and best practices associated with implementation planning.

TAKE-AWAY

According to participants, implementation planning requires building actionable work plans, including all impacted business units, and integrating plans into a consolidated view.

BEST PRACTICES

Participants shared some steps companies can take for a successful implementation plan:

Clearly document the who, what, and when for all parts of the process as well as all dependencies, and deliverables.

Consider affected business units, which can include engineering, manufacturing, operations, marketing, sales, finance, regulatory and compliance, distribution, IT, and HR.

Identify resource efficiencies and critical paths.

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Promote risk mitigation by differentiating issues vs. risks, prioritizing top areas for immediate focus, creating mitigation plans with owners and dates, and tracking and reporting status.

Measure, monitor, and report success throughout the implementation. Track performance by time, cost, requirement and scope, resources, and risks.

TAKE-AWAY

One of the key obstacles in successful implementation of medical technology strategies, according to participants, is communication among different members of the team and the time commitment required to put new strategies into effect.

BEST PRACTICES

Executive commitment and clear direction with documentation are essential for team members to understand and implement new processes.

Because employees on product development teams also have other, non-project-related tasks on their plates, vice presidents and general managers should help project managers determine priorities and what percentages of time should be devoted to different aspects of the project.


Many companies should be spending more time planning before they rush into a project so that communication is clear and team members know what is expected of them. It’s important to spend the proper amount time and money on market research prior to implementing a project. Otherwise, a misunderstanding of market needs may prove costly later on.

Rather than expecting people new to the project to be able to jump in and lead, companies should provide training on how to be a functional manager. Similarly, teams need to be trained so that they understand the needs and requirements of their functional manager. Train and retrain as needed, participants stressed, and keep in mind that people learn in a variety of different ways. While one person – such as the department vice president – should make decisions regarding priority of tasks within a project, project managers need to be enabled to motivate their teams.

TAKE-AWAY

Another big challenge for the discussion participants is getting the right products to market in a timely fashion.

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BEST PRACTICES

Some recommendations for how to overcome that challenge:

Establish a clear baseline early even if it is not completely correct – it’s important to have somewhere to start.

Monitor projects and be willing to adapt as they continue to develop.

Reduce cost barriers to production.

Be mindful of regulatory pressure that may prohibit a product from getting to market.


Companies can also try to simplify products to diminish the likelihood that they will meet regulatory hang-ups and continually assess if a product is still viable.

It’s important to review processes to recommend changes and to ensure that the consequences of said changes are understood. Establish clear targets as you progress – after all, as the saying goes, “If you don’t measure, you can’t manage it.”

Participants also recommended companies hire interns to lower costs over a short period of time, keep quality people on retainer as needed, and outsource manufacturing to decrease the length of time it takes to get a product to market.

FINAL THOUGHT

Participants agreed that perhaps the biggest factor influencing the successful implementation of new processes and product development is communication. That includes communication inside the development team itself, between the development team and other departments and executives within the company, and between the company and outside regulatory agencies and the market.

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The Executive MindXchange Chronicles: Medical Technologies 2014discusses key insights and take-aways from Medical Technologies 2014:A Frost & Sullivan Executive MindXchange, held March 9–11, 2014, atthe Loews Coronado Bay Resort and Spa in San Diego, CA. Frost &Sullivan makes every effort to ensure the quality of individual sessionChronicles; however, the summaries presented in the articles are theexpert opinion of the writers, and inclusion/exclusion of specificmaterial is at the discretion of each speaker. For more details, visitwww.frost.com/chronicles. Frost & Sullivan is not responsible for theloss of original context or the accuracy of the information presentedby the participating companies.

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