MedVentions Core Seminar:Clinical Needs Finding 101

Brian Courtney

• Co-founder, director and officer of Conavi Medical Inc., an intravascular and intracardiac imaging startup company.

• Several patents• Research interest in the field.

Disclosures

Overview

• What is “Needs finding”?• Why is it important?• Multiple perspectives of “Needs”• Key considerations and approaches• Resources• Next step: Needs Screening• Discussion

The Beauty and Challenges of MedicineHealthcare is abundant with needs• Better outcomes• Lower costs• Improved emotional profile (better

comfort, less stress)• Time savings• Improved knowledge

The “Needs Clients”• Patients• Healthcare workers

• Physicians, nurses, technologists, staff

• Payors• Providers (Hospitals, clinics, EMS,

homecare services, long term facilities)

Needs Finding

Process of identifying how to improve the delivery of healthcare.Defining a need can be broad initially, but can be refined considerably over time

• Gain insights over time• Incorporate multiple viewpoints / perspectives• Narrow down on the pain points and opportunities and

to have focus• Broaden in some dimensions to capture larger audience• Consider candidate solutions (preferably at later stages)

Elements of a Need Statement

• Core problem• Population being served• Desired OutcomeExamples:

• Address bleeding rates in patients undergoing cardiac surgery to reduce length of stay, transfusion requirements and complications (death, redo surgery)

• Address the need for urgent administration of resuscitative medications in patients experiencing cardiac arrest out of hospital to improve survival rates.

• Note: The proposed solution is not part of the needs statement.

Importance• The needs identified will be the nucleus of considerable

downstream efforts• An addressable need of significance will

• Motivate you• Motivate others• Provide the necessary “pull” to inspire thousands of hours of effort and

significant resources

• Settling on a need has an opportunity cost• Choose a need that has will provide best value to you, your team,

future stakeholders and the “Needs Clients”

• Building a new medical technology can be an expensive proposition – a well chosen need provides the fuel for the fire

Approach: Asking someone for a need

• Let other people do the work by latching on to someone else’s identified need

• Might be attractive / easy initially, but• Predicated on them knowing more than you

• You need to become the expert / master of your domain• Why aren’t they trying to solve the need themselves? Are

they willing to join your team in the solution?• ? Multiple failures for this need in the past?• Skips the whole process of choosing the most important need

amongst a list of many• Can be added to your list of candidate needs, but continue

the search and use as a benchmark against other needs you identify

Approach: Looking up a need

• Read a marketing report or review academic papers to find your needs

• Needs identified in literature might be well supported, and might benefit from being popularized or characterized, but

• Authors are often removed from the sites of direct activity

• By virtue of being published, they are out there for everyone else to see – diminishes the unique trait of the needs

Approach: Copycat Need Finding

• “The market for xyz devices is hot – let’s go there”• This is a common approach• But has several disadvantages:

• Loss of first mover advantage• Might not be based on your own data collection and

influenced by data generated and / or presented by others to advance their agenda

• Very different from finding a need, pursuing it for 2-3 years, only to find another unexpected competitor

Approach: Be your own “Need Client”

• Examples:• Physician that wants a better way to complete a procedure• Nurse that wants an easier way to get iv access.• Administrator that wants to cut costs, improve reportable

outcomes• Patient that wants better access to their health records and

best support for decision-making

• These are highly motivated situations, but• Typically only one or two needs get considered, rather than a

broader search for best opportunity• Takes a very long time or unfortunate circumstances to

become a Need Client

Approach: Direct observation

• Watch procedures• In person - primary• Live cases – secondary (conferences, web – VuMedi, TCT)

• (but be careful of bias introduced, as live cases often sponsored)

• Observe patients in clinic• Read associated literature

• To get baseline sense of problems, understand the language and find areas of opportunity / prior failures

• Speak with stakeholders• Physicians, nurses, students, residents, admin, purchasing,

patients, referring physicians, billing specialists

Direct observation

• Take notes• Chart times• Draw out workflows

• Identify when emotions and / or attention shifts• When is a pause for thought happening? Is more info

needed? Is the decision of next steps not clear? Is their a stressful situation?

• Identify failure points• “Play” with the equipment / instruments on the

benchtop to understand what current practice is, how the devices currently used interact with each other and how they fail in meeting the clinical need.

Direct observation and Primary data

• Interviews• Open ended questions• Get a story from your interviewee

• Attend rounds• Ward / ICU rounds• Complex case review rounds• Quality assurance rounds / M&M rounds (if accessible)

• Look up complications• MAUDE database• Institute of Medicine reports, QBP reports

Direct Observation / Primary Data

• Walk through the various stockrooms• Follow “team on call” – night time is often the best

time in acute care to get real sense of pain points• Seek range of experience levels

• Young residents may be more apprehensive about real problems than more experienced staff physicians.

• Physicians in their “prime” make most of the decisions about new programs and direction

• Very senior physicians may have more time and experience to share their career-long findings

Understand the environment

• What is the disease?• What are the medications used, and how do they

support and / or limit other therapy, such as procedures?

• E.g. Bleeding vs clotting paradox in cardiology• Are their subpopulations that are more difficult

than others to treat?• E.g. co-morbidities, such as renal disease, diabetes

• How are complications managed• What is the training like?

Clinical Needs Findings

Observation

Background Learning

First hand familiarization /

simulation

Synthesis / Distilling

Commitment and Execution

The ideal “Needs Finder”

• Open minded – adequately naïve to be creative and observant

• Thoughtful listener and observer. Empathetic.• Organized, takes notes, communicates well• Reflective• Good at personal interactions, getting information and

working in team setting• Understands how things work (and fail)• Inquisitive, resourceful• Has time committed to the task. Cannot be rushed.• Pleasantly persistent / resilient

The Ideal Needs Finding Team

• Communicates well• Divides and conquers• Mix of clinical, technological and industrial

backgrounds• Can speak enough of the language and know the basics of the

clinical context while not being overly biased by existing background

• Can see broad scale market trends, barriers and opportunities

• Willing to stick together in the long term, recognize each others contributions and avoid fractionation, motivated by clinical impact.

Additional thoughts• Beware of biases

• Self-reporting• No physician ever has complications, except sometimes they do.• Ask them about specific instances or occurences (“last case” rather

than “typical” case) • Case selection

• Some sites only do the easy cases, avoiding the complex with co-morbidities

• Academic vs Community care setting• 60-80% of care is outside of the academic care setting• Needs / resources are very different

• Our way is the only way• Except that the doctor down the hall does it another way, which is

different from the doctor down the street, which is very different from the doctor in another country

Biases (cont’d)

• Land of unchallenged assumptions• Many KOLs are very engaged and knowledgeable• Conflicts of interest are abundant• Some ‘leaders’ may be too removed from the day to day clinical

activities• Observer bias

• The behavior of the healthcare team may change purely as a result of your presence. What happens when you’re not there? What happens when the patient’s family is nearby / observing?

• Animation bias• Animations / illustrations are helpful for explaining a concept.• They are designed to make procedures look easy and can grossly

over-simplify a technology or problem relative to anatomic variations.

Early Screen

• The goal is to be open-minded, so don’t screen out ideas too early (Formal “Needs Screening” is the next step), but you have to be pragmatic

• The need should be• Significant ($1B market ? – or at least have the size of the

problem match the likely size of resources that will be needed to concur the problem)

• Appreciable and preferably measurable impact• Not specific to one physician or one site, but broadly relevant• Motivating• Satisfiable with a solution that

• Has viable path to regulatory approval and reimbursement• Has viable adoption / training / acceptance pathways• Saves system money (or at least does not add cost)

NEEDS FINDINGS & SCREENINGTHE FOUNDATION OF THE INNOVATION PROCESS

“I find out what the world needs. Then, I go ahead and invent it”(Thomas Edison)

The essential task is to identify the real clinical challenges and problems that impose a significant medical burden

Needs Finding “Snorkeling” Strategic FocusObservationProblem IdentificationNeed Statement Development

Needs Screening“Deep Dive”Disease state fundamentalsTreatment optionsStakeholder analysisMarket analysisNeeds filtering

NEED CRITERIANEEDS & RISKS

Trends

• Ignore the trends initially when doing needs finding• Will overly bias your initial process of searching

• Pay close attention to them when entering the next stage -> Needs Screening

Summary

• Needs Finding• An important step in the innovation process• A tremendous learning opportunity• Focuses your efforts towards provision of value• Done well, can have a huge influence on likelihood of

success and magnitude of impact