The Medical Device Innovation Consortium (MDIC)

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The Medical Device Innovation Consortium(MDIC)

• Michelle McMurry-Heath, MD, PhD,
• Associate Director for Science
• Center for Devices and Radiological Health,
• U.S. Food and Drug Administration

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THE MDIC Solution
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Overview

• Medical Device Innovation
• CDRHs Role
• Impact of Regulatory Science
• The role of novel public-private partnerships
• FAQs

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What we do

• CDRH is responsible for regulating firms who
  manufacture, repackage, re-label, and/or import
  medical devices sold in the United States.

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The Medical Device Industry is Critical to Our
Nations Health
Source 1CDC, National Hospital Discharge Survey
2009 table, Procedures by selected patient
characteristics - Number by procedure category
and age http//www.cdc.gov/nchs/data/nhds/4procedu
res/2009pro4_numberprocedureage.pdf
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And Critical to the Health of Our Nations
Economy
Employees Payroll
Sales (1,000s) ( billions) (
billions) Medical Technology Industry
Overall 422.8 24.6 136.1 Industry
Sector Surgical appliance and supplies
manufacturing 114.5 6.4 35.3 Surgical and
medical instrument manufacturing 109.3
6.2 33.6 Electromedical and electrotherapeutic
apparatus manufacturing 65.3
4.8 27.6 Dental laboratories 50.0
1.8 4.7 In vitro diagnostic substance
manufacturing 27.0 2.2 12.7 Ophthalmic goods
manufacturing 23.5 1.0 5.8 Irradiation
apparatus manufacturing 16.8
1.5 11.6 Dental equipment and supplies
manufacturing 16.3 0.8 4.7
State Economic Impact of the Medical Technology
Industry Figure 1, The Lewin Group- Commissioned
by AdvaMed, June 7, 2010
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But the Industry is a Challenged Resource
Medical Technology Industry Employment
State Economic Impact of the Medical Technology
Industry Figure 6, The Lewin Group- Commissioned
by AdvaMed, June 7, 2010
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CDRH Mission 2012
In our new Mission and Vision statements, CDRH
has crystallized our role in ensuring this vital
resource continues to serve patients and the
needs of the Nation

• The mission of the Center for Devices and
  Radiological Health (CDRH) is to protect and
  promote the public health.  We facilitate
  medical device innovation by advancing regulatory
  science, providing industry with predictable,
  consistent, transparent, and efficient regulatory
  pathways, and assuring consumer confidence in
  devices marketed in the U.S.

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CDRH Vision 2012

• Patients in the U.S. have access to
  high-quality, safe, and effective medical devices
  of public health importance first in the world.
  The U.S. is the worlds leader in regulatory
  science, medical device innovation and
  manufacturing, and radiation-emitting product
  safety.  U.S. post-market surveillance quickly
  identifies poorly performing devices, accurately
  characterizes real-world performance, and
  facilitates device approval or clearance. 
  Devices are legally marketed in the U.S. and
  remain safe, effective, and of high-quality. 
  Consumers, patients, their caregivers, and
  providers have access to understandable
  science-based information about medical devices
  and use this information to make health care
  decisions.  

Faster, Cheaper, Safer
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Medical Device Development
The Total Product Life Cycle
Faster, Cheaper, Safer
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Regulatory Science Can Make TPLC Faster,
Cheaper, Better

• Provides the tools, standards, and approaches
  needed to evaluate the safety, effectiveness,
  performance, and quality of medical products
• Benefits patients by speeding the rate of
  important technologies reaching market
• Reduces time and resources needed for device
  development, assessment, and review. For example
• Can lead to quicker, more efficient device
  approvals
• Can decrease the size and duration of pre-market
  clinical trials

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CDRH Regulatory Science Priorities

• Advancing medical device innovation, and
  evaluating new and emerging technologies
• Improving device quality and manufacturing
• Analyzing medical device performance
• Improving medical device safety
• Developing novel ways to use clinical data in
  evaluating medical devices
• Protecting against emerging infectious diseases
  and terrorism
• Improving the health of pediatric and other
  special populations

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Center for Devices and Radiological Health (CDRH)
Includes Substantial Research Divisions
Office of the Center Director (OCD)
Office of Compliance (OC)
Office of Surveillance Biometrics (OSB)
Office of Device Evaluation (ODE)
Office of In Vitro Diagnostics and Radiological
Health (OIR)
Office of Science Engineering Laboratories
(OSEL)
Office of Communication and Education (OCE)
Office of Management Operations (OMO)
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• But to get there we must pool our resources-
  people, knowledge, and information.
• Impactful regulatory science is big science-
  requiring collaboration, data sharing, and
  manpower.

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While the US Government Maintains a Strong
Investment in Basic Research
Source The National Science Board, Science and
Engineering Indicators, 2010 (The National
Science Foundation)
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US Federal Investments in Applied Research,
including Regulatory Science, Represents a
Smaller and Smaller Piece of the RD Pie
Source The National Science Board, Science and
Engineering Indicators, 2010 (The National
Science Foundation)
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And these Investments are Particularly Low in
Health Related Engineering
Source The National Science Board, Science and
Engineering Indicators, 2010 (The National
Science Foundation)
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And While Our RD investments Hold Steady Other
Countries are Increasing their Investments in RD
Source The National Science Board, Science and
Engineering Indicators, 2010 (The National
Science Foundation)
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Now is the time
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The Power of Collaboration

• The most effective way to advance medical device
  regulatory science is through collaboration.
• Regulatory science is big science. In the current
  fiscal climate, we need to pool people,
  resources, and ideas to drive breakthroughs.
• The Medical Device Innovation Consortium will
  promote these collaborations by establishing an
  independent non-profit that brings together
  industry, government, academia, and other
  stakeholders to this end.
• The MDIC will vastly expand our capacity for
  device-related regulatory science by creating a
  safe space for facile, creative, and ambitious
  medical device collaborations.

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Device Development
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THE MDIC Solution
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MDIC Progress
Nationwide rollout of MDIC on December 3, 2012 in
Washington, D.C.
Convene first meeting of the full Board-Feb 26,
2013
Memorandum of Understanding (MOU) submitted in
December 2011
Business plan created in October 2012
Respond to Membership Requests-December 2012
MDIC website launched on November 12, 2012
MDIC at LSA Conference on December 5, 2012
Articles of Incorporation filed in August 2012
Align Achieve Accelerate
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THE MDIC Origins and History
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MDIC Foundational Members
Align Achieve Accelerate
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THE MDIC Solution Structure
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Projects

• Computational Modeling and Simulation, Randy
  Schiestl
• Development
• Assessment
• Review
• Clinical Trial Reform, Rick Kuntz, MD
• Large Simple Trials
• Post Market Surveillance
• Data Transparency
• Clinical Trial Efficiency
• Patient Centeredness and Risk Management, Ross
  Jaffe, MD
• Validation strategies for measuring patient views
  on device benefits and risks
• Provide suggestions on how to utilize this data
  in the regulatory setting

Align Achieve Accelerate
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MDIC Current Steps
Align Achieve Accelerate
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CDRH Patients Preferences Survey for
Weight-Loss Devices

• Benefit-Risk Guidance CDRH will consider
  evidence relating to patients perspectives of
  what constitutes a meaningful benefit and a
  tolerable risk
• CDRH conducted a pilot survey to evaluate
  patients preferences and assess potential uses of
  such information in the Centers decision making
  process
• The survey was commissioned by CDRH
• The survey instrument was co-developed by CDRH
  reviewers to include relevant regulatory
  questions
• 645 obese subjects constituted a nationally
  representative US sample
• High quality data provided an unbiased picture of
  patients perspectives and captured preferences
  of heterogeneous subjects (risk averse and risk
  tolerant)
• The survey provided subjects preferences to help
  CDRH assess what would be the minimum meaningful
  weight loss for a given safety profile of a
  device
• Analysis of the survey results describe obese
  subjects preferences when comparing benefits and
  risks for devices with different features

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Device Features (Attributes) Evaluated in the
Survey
Device Attributes Levels
Average weight loss ( Total body weight) 5 to 30
Type of surgery Endoscopic, Laparoscopic, Open
Mortality risk 5 to 10
Diet restrictions Eat ¼ cup of food at a time Wait 4 hours between meals Cant eat sweets or foods that are hard to digest
Average duration of weight loss 6 months to 5 years
Average duration of side effects No side effects to 5 years
Chance of side effects requiring hospitalization None to 5 chance of going to hospital for surgery
Comorbidity Improvement Eliminates, 50, No change
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Example Survey Question
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Survey Demographics(Sample size 654 subjects)
Characteristics Study Sample General US Population
Mean BMI 38
Mean age 51 years 45 years
Female 57 51
White, non-Hispanic 73 63
Education Level Associate degree or higher 39 37
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Key Findings

• Amount of weight loss and duration of weight loss
  are the most important benefits
• Mortality associated with the device is the most
  feared risk
• Subjects value being able to eat sweets or hard
  to digest foods (e.g., pizza) but are not very
  averse to diet restrictions such as eating only
  ¼ cup of food at a time or waiting at least 4
  hours between meals
• Subjects with prior gastric procedures tolerate
  higher risk and value weight loss more than those
  who never had a gastric procedure
• Gender, race, and comorbidity type (Diabetes,
  high blood pressure, cardiovascular disease) do
  not influence the preferences
• Older subjects (gt 50 yrs. of age) are more risk
  averse in terms of mortality risk, duration of
  adverse events, and types of surgery than younger
  subjects

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Next Steps
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Question

• But FDA already has research partnerships. Why
  not stick with that approach?

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Ongoing Regulatory Science Partnerships with FDA
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Each Partnership Required 6-24 Months to
Formally Establish
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Question

• Who are the foundational members?

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MDIC Members
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Questions? Comments.

• Michelle McMurry-Heath, CDRH Associate Director
  for Science
• Michelle.mcmurry-heath_at_fda.hhs.gov
• Nancy Pluhowski, Director CDRH External Expertise
  and Partnership Program
• Nancy.Pluhowski_at_fda.hhs.gov
• Rochelle Fink, CDRH Technology Transfer Lead
• Rochelle.Fink_at_fda.hhs.gov

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Extra Slides
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The Case for Regulatory Science The Example of
Refining Test Methods

• Comprehensive evaluation of a marketing
  application for a therapeutic medical device
  typically includes the review of data gathered
  from four types of models animal, bench,
  computational, and human.

• Each model has its strengths and limitations for
  predicting clinical outcomes.
• CDRH believes that, when applicable, the most
  effective evaluation strategy includes data from
  all four models.

And, that computational modeling and simulation
is the key to advance and speed device design and
evaluation.
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Models Used for Assurance of Device Safety and
Effectiveness
  Human Trial Animal Model In Vitro Model (phantom) Computer Model
cost very high moderate low low (after development)
time long moderate short short
ability to vary parameters not easy limited limited high (good learning tool)
testing involving harm no, unethical restricted yes yes
simplifying assumptions none none many and always always (limiting)
relevance direct variable (species) limited variable (depends on validation)
testing of disease state yes difficult simplified states yes
experimental control difficult good high high
interpretation of data and ability to predict not easy yes limited Yes can predict device and drug interactions
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Current Uses of Computational Modeling in Medical
Device Regulatory Submissions

• Modeling is mainly considered a development and
  design optimization tool, rather than a method by
  which physical performance of final devices can
  be demonstrated.
• Mainly the modeling studies are supplemental
  information (to complement mechanical bench
  testing) for
• 510(k) class II devices
• Pre-Market Approval class III devices
• Investigational Device Exemption Clinical
  Studies

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Current Uses of Computational Modeling in Medical
Device Regulatory Submissions

• Computational Solid Mechanics
• Stents / Heart Valve Frames / Occluders / Vena
  Cava Filters / Annuloplasty Rings / Dental
  Implants / Spine Joint Implants / Surgical
  Tools
• Determine the implant size
• Evaluate the effect of manufacturing tolerances
• Predicate Comparison
• Evaluate next generation devices with minor
  modification
• Computational Fluid Dynamics
• Ventricular Assist Devices / Blood pumps / Heart
  Valves /
• Endovascular Grafts / Drug Eluting Devices
• Identify regions of high shear stress, wall shear
  stress
• Identify areas of low flow or flow stagnation
• Determine blood damage and thrombosis

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Current Uses of Computational Modeling in Medical
Device Regulatory Submissions

• Computational Electromagnetism
• Metallic Implants / Deep Brain Stimulators /
  Electrophysiological recording devices /
  MR-guided Interventional Devices
• Simulate the worst-case magnetic resonance
  imaging (MRI) conditions
• Radiofrequency-induced currents and heating of
  (external) devices for electrophysiological
  recordings
• Computational Thermal Mapping
• Metallic implants / Ablation Devices
• Determine the thermal field distributions
  generated by tissue ablation devices (e.g., High
  Intensity Ultrasound)
• E.g., organs, tumors, fibroids
• Radiofrequency heating analysis of metallic
  implants

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Challenges with the Current Uses of Computational
Modeling

• Reports typically lack sufficient details because
  there are no reporting standards for
  computational modeling
• Lack of sensitivity and uncertainty analyses for
  crucial input parameters
• E.g., geometry, physical properties, boundary
  conditions
• Lack of adequate validation
• Not well defined (yet) for the medical device
  community
• Lack of complete understanding of physiological
  loads and variations in patient populations
• Important for bench and computational studies

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FDA Is Working to Make More of These Models
Regulatory Grade

• Develop computer models using radiological
  imaging data from healthy and diseased anatomy
• Integrate with these models physiological,
  clinical and engineering data to promote
  development of complete physiological models and
  simulations that can be used in the development
  and evaluation of medical devices and,
• create an open-source library of validated
  computer models and data easily accessible to
  industry developers, clinicians, and researchers.

Virtual Physiological Patient Initiative
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Library of Models Public compendium of anatomic
and physiologic data A shared point of
reference may improve understanding of the model
attributes and limitations and will allow the
model to evolve as data grows. Discrete
computer models and simulations validated for
regulatory evaluation Selective use of high
value models will improve predictability and
consistency in the regulatory review process.
Peer-reviewed by experts in academia,
government and industry Ensure robust
verification and validation, including periodic
assessment.
Virtual Physiological Patient Initiative