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FDA's Regulation of Implantable and Wearable Sensors

By:
Dr. Thomas J. Webster, Department Chair and Professor of Chemical Engineering at Northeastern University
Coming soon.. Please contact customer care for new schedule

Course Description:

Sensors have begun to revolutionize human health due to their ability to provide real time health monitoring under a diverse set of conditions. For example, sensors can provide real time information such as heart rate, blood pressure, biomolecular concentrations, glucose levels, motion and exercise data, neural activity, and so much more. While wearable sensors have seen an explosion in use, the reliability of such data collected has been questioned. Moreover, very little has advanced in terms of implantable sensors, yet implantable sensor can provide much more in depth and variety of health data compared to wearable sensors. Implantable sensors also have the capability to reverse adverse health affects, whereas wearable sensors do not.

This tutorial will provide an historical context for the use of wearable as well as implantable sensors in medicine, where the field has been and where it is going. It will also provide a few examples of FDA approved sensors in medicine and what is needed for the field to progress. Currently, there is an ongoing debate in industry on how such sensors should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as medical devices, drugs or simply biologics.



Learning Objectives:

Upon completing this course participants should have an understanding of:

  • Fundamentals of sensors
    • What is all the excitement about
    • How to build sensors
    • Wearable versus implantable sensors
    • Incorporating cells and/or biological materials into sensors
    • Avoiding immune system clearance of sensors
    • Biological reactions to sensors
  • FDA regulatory approvals for sensors
    • Currently approved sensors in medicine
    • FDA guidance documents for sensors
    • Global approval of sensors
    • How the FDA regulates sensors
    • The medical device, drug and biological approval process
    • Sensors for both diagnostic and therapeutic purposes
    • How to design appropriate clinical trials
    • Applicable good manufacturing and good laboratory practices
    • Product labeling, marketing and advertising
    • FDA and other federal agency enforcement action
  • Future thoughts on approaches for the regulatory approval sensors
    • Remaining hurdles
    • Outlook for new technologies

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar



Who will Benefit:

This course is designed for professionals in wearable and implantable sensors such as for researchers, business personnel, start-up companies, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and private labelers
  • Contract manufacturers
  • Importers and custom agents
  • U.S. agents of foreign corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal professionals
  • Financial advisors and institutional investors
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs




Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  1. Fundamentals of wearable and implantable sensors
    1. Definitions
    2. What is all the excitement about
    3. How to design and fabricate sensors
    4. Example of sensors
    5. Incorporating cells and biological into sensors
    6. Understanding biological responses to sensors
    7. Avoiding immune system clearance of sensors
    8. Research examples pre-clinical approval
    9. Research examples post-clinical approval
  2. FDA regulatory approvals for the use of sensors in medicine
    1. Currently approved sensors in medicine
    2. FDA guidance documents for sensors
    3. Global approval of sensors
  1. FDA regulatory approvals for the use of sensors in medicine (continued)
    1. How the FDA regulates sensors
    2. The drug and biological approval process
    3. Medical device approval process
    4. How to design appropriate clinical trials
    5. Applicable good manufacturing and good laboratory practices
    6. Product labeling, marketing and advertising
    7. FDA and other federal agency enforcement action
  2. Future thoughts on the approaches for the regulatory approval of sensors
    1. Remaining hurdles
    2. Outlook for new technologies
    3. Strategies for commercializing sensors
  3. Questions




Meet Your Instructor

DR. Thomas J. Webster,
Department Chair and Professor of Chemical Engineering at Northeastern University

Dr. Thomas J. Webster’s degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. His research explores the use of nanotechnology in numerous applications. Specifically, his research addresses the design, synthesis, and evaluation of nanophase materials (that is, materials with fundamental length scales less than 100 nm) as more effective biomedical devices. He has completed extensive studies on the use of nanophase materials to regenerate tissues and has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. His research on nanomedicine has received attention in recent media publications including MSNBC (October 10, 2005), NBC Nightly News (May 14, 2007), PBS DragonFly TV (covered across the US during the winter, 2008), and ABC Nightly News via the Ivanhoe Medical Breakthrough Segment (covered across the US during the winters of 2008 and separate research segments in 2010 and 2011). His work has been on display at the London and Boston Science Museums. He is the founding editor-in-chief of the International Journal of Nanomedicine (the first international journal in nanomedicine which in five years has achieved an impact factor of 4.97), serves on the editorial board of 15 additional journals, has helped to organize 22 conferences emphasizing nanotechnology in medicine, and has organized over 53 symposia at numerous conferences emphasizing biological interactions with nanomaterials. He also recently chaired the 2011 Annual Biomedical Engineering Society (BMES) Conference and has organized numerous symposia for AIChE, IEEE, MRS and ASME Annual Meetings. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2003, Outstanding Young Investigator Award Purdue University College of Engineering; 2005, American Association of Nanomedicine Young Investigator Award Finalist; 2005, Coulter Foundation Young Investigator Award; 2006, Fellow, American Association of Nanomedicine; 2010, Distinguished Lecturer in Nanomedicine, University of South Florida; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering (AIMBE, representing the top 2% of all medical and biological engineers).





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