1. National Medical Device Curriculum Francis Kalush, Ph.D. Senior Science Health Advisor Office of Center Director Center for Devices and Radiological Health Food and Drug Administration BME-IDEA September 25, 2013. Seattle, WA

2. 2 National Medical Device Curriculum Program Overview  Purpose: To encourage development of innovative medical devices by enhancing academic knowledge and experience with medical devices regulatory processes  Vision: Series of case studies that use hands-on exercises to teach students about regulatory concepts. Case studies to be available at FDA website in the format of a Harvard Business Review case study  Target audience: Entrepreneurs; engineering, medical, science, regulatory science and public health students; undergraduate and graduate, enrolled in a certificate or degree program

3. 3 Background  The health care challenges of the 21st century require innovative solutions through collaboration between Federal agencies and academia by harnessing the best ideas from a broad range of stakeholders.  Two Medical Device Technology Innovation Partnership (MD-TIP) forums in collaboration with UVA, JH, UPEN, UMD, Howard U. Discuss “Innovation, Technology Transfer and Scientific Interchange” Leveraging Academic and FDA Collaborations to Resolve Unmet Public Health Needs Only 10% of technology transfer activities involve medical devices Barriers for moving a device out of the research lab into clinic are navigating FDA and lack of faculty knowledge/experience with the regulatory process National medical device curriculum development

4. 4 Opinion Leaders input  Conference calls with champions and opinion leaders: Stanford, JH, Kauffman Foundation, MIT, UVA, Wharton, UPEN, Case Western, RAPS, USC, Duke, BME-IDEA and others Share learning experiences with medical device regulatory curriculum, assess unmet needs on how to train and stimulate next generation of innovators Develop widespread availability of educational programs in device development and assessment. Enhance academic knowledge and experience with regulatory process leading to increase in academic activities for development of innovative medical devices Disseminate and Adopt- future steps

5. 5 Content discussion  A general case compendium or library would have flexibility for instructors to tailor their programs to either undergrad or graduate students develop and share rationale for using certain cases, case notes, lesson plans,  One size curriculum does not fit all, programs should have flexibility to adjust based on local dynamics build adjacent competencies into existing programs students must learn to synthesize and solve problems before product in the market (consider design controls, quality system) give enough education so students can interface, team work curriculum in engineering programs have finite credits and set requirements include basic elements, more a floor than a ceiling

6. What is the National Medical Device Curriculum  It is a series of case studies that use hand on exercises to teach regulatory processes & concepts.  The case studies format is of a Harvard Biz Review Case Study. It is the first of a kind at FDA. The case study tells a story. It conveys the regulatory concepts the students will learn through the case study.  Students have assignments before class, read the case study and click on the web links and videos  The instructor's guide, helps the instructor gain the knowledge and provides ideas for group exercises and discussion in class. 6

7. Criteria for selecting case study topic  Public information available (voice of stakeholders: regulators, users, industry)  Involves multiple regulatory concepts identified on interviews representing common issues to classes of devices  Center expertise 7

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9. Case Study Pilot- Internal and External  The first case study developed "Regulatory Pathways for Medical Devices: Choosing the right one" describes a fledgling company working to bring its first infusion pump to market. The case study was successfully piloted internally and externally at 2 Universities: Internally,  Piloted by a ODE group of 7 new Ph.D and MSc engineers’ reviewers (1-3 months at FDA). Externally,  Piloted by 20 graduate students (Pharmacology, Public Health, Regulatory Science, Radiology, IRB experts,etc) at Georgetown University (under the CERSI umbrella)  Piloted by 90 undergrad students (freshmen-seniors) at John Hopkins University- Biomedical Engineering School. 9

10. Feedback from Pilots External-undergrad 1- How did the case study assist your understanding of FDA’s medical device regulations? By actual case example- 60% By watching the videos online- 12% By discussion in class- 3% By going deeper into the process- 15% Other (eg, simple language not legal language)- 10% 2-In which way, did the case study help you to decide upon the best regulatory path for your project? Help navigate FDA website Importance of planning the regulatory strategy ahead Use of specific examples with actual people to understand real life example Example clarifies regulatory process Easy to read and understand regulatory pathway in a story Understand and show the thought process required 3- Describe the main concepts learned and components of exercise which were the most useful: Navigate through FDA Website Using website step by step Having people in the case study walking your through the process Learning from past mistakes Learning steps in order rather than categories Putting process in simple language rather than in legal language External-grad 1- Describe how the case study helps you to identify the best regulatory pathway for a new medical device? Clearly helped define steps needed to categorize a device, from device class type to market approval/clearance Case study was a great simple example to help identify reg. pathway and follow up of a marketed device Helps identify predicate devices and business strategy Explains risk determination 2- Describe the component of the case study exercise that was the most useful? Defining terminology, simplicity and clarity of case study FDA website and FDA online search Presenting the case from the perspective of the inventor/innovator Group discussion exercise Planning with the group how to achieve clearance 3- Describe the main concepts learned? How regulations are key to business plan Database of devices- wealth of information it holds Classification of devices based on risk Definition of a medical device Regulatory pathways and process Regulations governing medical devices Approving a medical device through FDA

11. Next Steps  Finalize Case Studies #3 (PMA) and# 4 (510(K)).  Extend pilot to other institutions  Partner with academic champions to develop additional case studies  Curriculum Adoption-promote & disseminate 11

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