HOW WOULD YOU COMBINE RISK AND MEDICAL DEVICE PROJECTS? - Il project management … ·...

HOW WOULD YOU COMBINE RISK AND MEDICAL DEVICE PROJECTS?

PRESENTED BY FRANCESCO CARNABUCIENGINEERING MANAGER – R&D DISPOSABLE

12 June 2019

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SPEAKER SPOTLIGHT: FRANCESCO CARNABUCIENGINEERING MANAGER R&D DISPOSABLE, BELLCO – MEDTRONIC Aeronautical EngineerSix sigma green beltTechnical consultant at Modena CourtProfessional Project Manager

PMI Risk Management | 12 June 2019 | Confidential, for Internal Use Only

MEDICAL TECHNOLOGY IS WHAT WE DO. IT’S WHAT WE’VE ALWAYS DONE. You may know us as the pacemaker company, the diabetes pump maker, or deep-brain stimulation experts and we do so much more.

3 PMI Risk Management | 12 June 2019 | Confidential, for Internal Use Only

Since the late 1940s, we have been working with others to alleviate pain, restore health, and extend life.

FOUNDED ON INNOVATION AND COLLABORATION Surgeon

C. Walton Lilleheiin 1961, with a young patient wearing a Medtronic battery-operated pacemaker.

Our founder, Earl Bakken, who —together with his brother-in-law, Palmer Hermundslie —started Medtronic out of a small Midwestern garage in 1949.

PMI Risk Management | 12 June 2019 | Confidential, for Internal Use Only4

OUR RICH HISTORY OF INNOVATIONHOW WE’VE GROWN OVER THE YEARS

ACQUIRED COVIDIEN

19601949 1977 1983 1999 2001 2002 2015 2016

WROTE OUR MISSION

INTRODUCED PROSTHETIC HEART VALVE

EXPANDED INTO SPINAL CARE

MEDTRONICIS FOUNDED

EXPANDED INTO NEURO-STIMULATION

EXPANDEDINTO DIABETES CARE

INTRODUCEDFIRST REMOTE MONITORING SYSTEM

ACQUIRED BELLCO

INTRODUCED THE WORLD’S SMALLEST PACEMAKERAND THEFIRST HYBRIDCLOSED LOOP INSULIN DELIVERY SYSTEM

CREATED FIRST BATTERY-OPERATED, EXTERNAL PACEMAKER

1957

ESTABLISHED THE MEDTRONIC FOUNDATION

1979

Developed the first implantable pacemaker

2018

ACQUIRED CLEARUM

INTRODUCED THE WORLD'S SMALLEST IMPLANTABLE SPINAL CORD STIMULATOR


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OVERVIEW OF BELLCO COMPANYMEDTRONIC BUSINESS UNIT


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INTEGRATION STATUS POINT

Bellco – Medtronic integration period, previous status point according to the Risk Spectrum seems be defined:

from BAD to OKAY

Medtronic, current status point according to the Risk Spectrum seems be defined:

from GOOD to BEST


TODAY

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WE BELIEVE IN IMPROVING LIVES WITH THE POWER OF INTEGRATED APPROACHAll MEDTRONIC/BELLCO functions execute and participate in risk management activities from voice of customer to last product use.

Research and Development

Quality Assurance / Quality Control

Operations / Supply Chain

Medical and Safety Office

Sales / Servicing / Marketing


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HOW WOULD YOU COMBINE RISK AND MEDICAL DEVICE PROJECTS?LEVELS OF INTERVENTION

1. On top at Company level: Enterprise Risk Management

Enterprise risk management at Medtronic follows a collaborative and deeply integratedmethodology that provides a sustainable framework to proactively identify, assess,mitigate and report global strategy, financial and legal & compliance risks, bothexisting and emerging, in support to our core growth strategies and the MedtronicMission.

2. In the middle at Project level: Project Risk Management

Project risk management is part of an integrated development process workflow named Ideation to Market Release (ID2MR)

3. From down at Product level: Product Risk Management

Product risk management is part of Design Control process. Design Control is the formal methodology for conducting product development activities ensuring products meets established requirements. The purpose of Design Control is to, ensuring aneffective, repeatable, and compliant development process support the development of safe and effective medical devices


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PROJECT RISK MANAGEMENT PROCESSIDEATION TO MARKET RELEASE (ID2MR)


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Why is ID2MR?

To address historic project outcomes• Lack of Predictability

• Time: Schedule error = 38%• Budget: Forecasting error = 69%

• Lengthy Development Cycles• Platform Projects = 23 months (goal ≤ 18)• Derivative Projects = 14 months (goal ≤ 9)

• Poor Launch Outcomes• Field Corrective Actions = 12 in FY16-17

• Employee Engagement Score• "Getting work done around here is easy"• "Employees are encouraged to try new ways of working"


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Project Risk AssessmentThe objective is to identify the project risks that prevent theteam from committing to a ±10% launch window and±10% budget at the end of Phase 4. Those risks areidentified in Phase 2, and mitigation activities for Phase 3are planned and approved. These "project" risks includetechnology, manufacturing process, supplier selection andcapability, inspection, clinical, service and repair,component end of life, product risks (identified in a riskassessment), etc.


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Product Risk Burn-downThe intent is NOT to burn down all project risk; just thehigh-risk items that could result in major project delaysin Phases 5-6 if not resolved earlier



PRODUCT RISK MANAGEMENT PROCESSAN INTEGRATED APPROACHProduct Risk Management Process in compliance to the Essential Requirements of the European Directive 93/42/EEC on Medical Devices and to ISO 14971 consists of the following basic elements:

Risk Analysis

Identifying the hazardous situations and severity of the harms associated with the hazardous situations, taking into account the intended use and reasonably foreseeable misuse of the product,

Estimating the individual risks taking into account the severity and the probability of occurrence of the harms,

Risk Evaluation

Evaluating the individual risks against established acceptability criteria.

Risk Control

Controlling the risks to ensure that they do not exceed acceptable limits,

Implementing risk control measures and evaluating risks arising from these additional measures,

Evaluating the residual risks to assess whether additional risk control measures are needed,

Production and Post-production information

Monitoring the internal and field commercial performance of the product to assess the effectiveness of the original risk management activities and the need for additional risk controls.

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PRODUCT RISK MANAGEMENT PROCESSAN INTEGRATED APPROACH

How the risk management process steps are applied throughout the product lifecycle?

Risk Management Plan (RMP)

Preliminary Hazard Analysis (PHA)

Failure Mode Effect and Analysis (FMEA)

Risk Analysis Chart (RAC)

Combined PHA and RAC

Risk Management Report (RMR)

Post-Market Surveillance Report

Project Tasks / Deliverables

Project Phases

Risk Management Plan Concept / Feasibility

Preliminary Hazard Analysis

Design Development

Applicable FMEA(s) Design Development

Process FMEA Design Evaluation

Risk Analysis Chart or combined PHA & RAC

Design Development

Risk Management Report

Design Evaluation

Post-Market Surveillance Report

Post Market


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PRODUCT RISK MANAGEMENT PROCESSAN INTEGRATED APPROACH

There are multiple factors in the determination of the Probability ofOccurrence of Harm. The first factor is the probability of the hazardoussituation occurring (P1), the second factor is the probability of thehazardous Situation leading to harm (P2), and the final is the probabilityof occurrence of harm (P1 cross P2):

ScoreSeverity of Harm

Definition

5 Catastrophic Results in patients death, or catastrophic property or environmental damage

4 Critical Results in permanent impairment or life threatening injury, or critical property or environmental damage

3 MajorResults in injury or impairment requiring major professional medical intervention, or serious property or environmental damage

2 MinorTemporary injury or impairment that requires minor professional medical intervention, or minor property or environmental damage

1 NegligibleResults in temporary injury or impairment that does not require professional medical intervention; inconvenience

Severity (SEV) table ranking

Severity of HarmCatastrophic

(5) Critical(4)

Major(3)

Minor(2)

Negligible(1)

Prob

ability of H

arm

(P1 x P2

)

Frequent(5) 3 3 3 2 2

Probable(4) 3 3 2 2 1

Occasional(3) 3 3 2 1 1

Remote(2) 3 2 2 1 1

Improbable(1) 2 2 1 1 1

Risk Zone Structure


FURTHER, TOGETHERCASE STUDYNEW HIGH FLUX DIALYZER PROJECT

PROJECT RISK MANAGEMENT: NEW HIGH FLUX DIALYZER PROJECTNEW HIGH FLUX DIALYZER PROJECT


Project Scope: release of a new MDD - CE marked high-flux dialyzersfamily based on a new membrane manufactured.

RISK MANAGEMENT STRATEGY:Perform regular project risk assessments on project levelOnce a month bring 5 top risks to the Project Risk Assessmentmeeting (separate meeting). Present the risks, their ranks, ownersand the proposed mitigations.


PROJECT RISK MANAGEMENT: NEW HIGH FLUX DIALYZER PROJECTNEW HIGH FLUX DIALYZER PROJECT

N. Risk description Action Grade Trend Owner

1 Product Clinical-related Safety may stop the projectMitigate: clinical safety related test early started and done: no concern

Low stable SA

2

Manufacturing Line Improvement delay impacts heavily on project due date. Potential causes:•External supplier delay - SINTECO•Process Validation delay

Mitigate: •set recurrent meeting with SINTECO•early start PV activities to anticipate potential issues

Medium stable MFE

3Steam Sterilization with observed performance data variability may lead to high lot-lot variability during DVT

Mitigate: lot-lot performance variability evaluation in DVT with testing methods fine tuned to lower test method variability

Low stable R&D

4

Clearum HF11: mold D32PP has to be adjusted, impact and timings are still under evaluation; in the best case PQ samples will be available in mid July (2 months beyond other models availability) with the current MFE activity pipeline high impacts may lead to further delay HF11 samples availability and release

Avoided: keep-on with models starting from filtering surfaces 1.3 to 2.2. Introduction of 1.1 to be planned in other stream upon dedicated MKT business case release.

High N/A

MFE / external supplier

CGM / MKT

5 Shelf life of the supplier is 2 yy, while shelf life of dialyzers are 3yy additional: this might lead to potential specs deviation

Avoid: plan for product verification at the specs limits

High decrease R&D

CURRENT TOP FIVE HIGH-LEVEL PROJECT RISKS

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PROJECT RISK MANAGEMENT: TOOLS TO USE

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Do not re-invent the weel!

Project Risk Ranking is the same for the product and project.


NEW HIGH FLUX DIALYZER PROJECT

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PROJECT RISK MANAGEMENT: TOOLS TO USE

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Project Risk Model


Negligible Minor Serious Critical Catastrophic

Improb

able

Remote

Occasiona

lProb

able

Freq

uent

Consequence Impact

Occ

urre

nce

prob

abili

ty

4

8

12

8 12

16

24

24

32

32

36

16

16

20

20

40

40

48

48

60

60

80

8064

100

2

2

Project Risk ID.2:Manufacturing Line Improvement delay impacts heavily on project due date. Potential causes:•External supplier delay - SINTECO•Process Validation delay

PROJECT RISK CATEGORIES: 1. RESOURCE RISKS1. Organization COMMITMENT

Are project resources sufficient? (Management, testers, QA, etc.)

Are there well-determined processes for R&D and Manufacturing engineering and project management?

Does the project team have authority to complete project work? Does it have influence to secure all inputs?

2. Financing BUDGET

Are the fundings adequate and sufficient to complete project?

Are the fundings secured?

Are there fundings allocated for training?

Are project costs assessed accurately?

3. People ENGAGEMENT

Are there enough employees available in the project?

Do these employees have appropriate skills and experience?

Have the employees worked together before?

Do the employees believe in project succeeding and take measures to strengthen it?

Have customers and user representatives participated in product reviews?

Do crucial experts participate in the project?

Is project schedule realistic?

Is the delivery date critical?


PROJECT RISK CATEGORIES: 2. BUSINESS RISKS

Business FORECASTING

Are there potential consequences on the project (scope, funding, existence) if a competitor reaches the market first?

Is projected cost worth projected product value?

Are key suppliers secured?

Are stakeholders expectations still valid?

Are there any legal risks (contracts, regulatory obligations, etc.)?


PROJECT RISK CATEGORIES: 3. TECHNICAL RISKS1. Scope Risks PROJECT SCOPE

Are requirements properly designed and well understood by staff?

Is project scope stable or does it keep expanding?

Are there tools/processes to measure project progress and success?

2. Technological Risks KNOW HOW

Have technology been proven?

Are there challenging technical requirements with which the project team is unfamiliar?

Does the project success depend on new, untried, or unproven technologies, HW, SW, or techniques?

Are there external dependencies to other systems including those outside the organization?

Are product users experienced and skilled?

Is product system complexity manageable?

3. External Dependency Risks CROSS-FUNCTIONAL

Does the project depend on parallel project development?

Does the project success depends on externally-developed components?

Do integration of development tools (design tools, compilers, etc.) and implementation technologies (OS, databases, communication mechanisms, etc.) have an impact to the project success?

Does the project have a back-up plan for completing without mentioned technologies?


CONCLUSIONS

Risk management is not only a process but also a mindset.

Risk is a potential probability to suffer loss, We want to minimize the probability to suffer loss !

Enterprise, project and product risk management is expression of organization maturity level.

Address risks early in a project is the winner strategy to reduce costs and development time

The integrated approach, especially in the medical device field, is the alone way to conduct well a project.

A complete integration of a small/medium company in a worldwide company needs a passage across a structured process to conduct project and address risks.


Q&A

THANKS FOR YOUR ATTENTION AND FOR THIS GREAT OPPORTUNITY

Francesco CarnabucI

[email protected]

3484412524

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