WAMIII Virtual Series – Session 25
8 December 2021 3:00 PM – 5:00 PM UTC | 11:00 AM – 12:00 PM ET
Going Beyond Design in Connected MedTech Innovation: Navigating the Pitfalls of Liability and Policy in Garnering User Trust for Adoption
- Moderator: Maria Palombini, Director, Healthcare and Life Science Practice Leader, IEEE SA
- Paul Kostek, IEEE Senior Member; Systems Engineer, Air Direct Solutions LLC
- Nick Leighton, Class Underwriter, AEGIS London
As an engineer or software/hardware developer of a connected medical device (ingestible, implantable, wearable or otherwise), it usually begins and ends with innovation. As an entrepreneur or a lead engineer in an established medical device organization, there are many critical considerations beyond verifying “does the technology work?” These could include considerations of feasibility, safety, security, privacy and more, all of which may impede market acceptance or adoption of your cutting-edge medical technology. Ensuring patient safety is vital and of utmost priority, however minimizing risk and exposure to your start-up or current organization should be top of mind. Tune into this special session to get a better understanding of hidden risks and pitfalls and tactical strategies that may better protect the personal and organizational brand, while reassuring users of commitment to responsible business conduct.
Key questions discussed in this session include:
What are some of the challenges with policy in this genre of connected medical devices and downstream impact on the overall market entrance of this product?
What is holding back liability underwriters when it comes to product coverage of in-body connected wireless medical devices?
What are the overall risks to tech start-ups or lead engineers (in larger organizations) developing new in or on-body technologies for healthcare diagnosis, monitoring or research?
What are the implications of physician and patient trust and usability when devices are too far ahead of the curve?
Where do limitations begin and end for software developers with the right to protect privacy if information collected for healthcare can be mandated for disclosure in criminal and civil litigations?
Where can global technical standards development alleviate some of these challenges?
This session will feature experts in regulatory, insurance and healthcare fields to explain the many challenges impeding trust in adoption of the latest cutting-edge devices and some potential solutions that will begin to open the pathways for all developers.
If you are currently in the design or development process and/or about to release a connected medical device/application into the healthcare market, this is one session you may want to tune in to stay ahead of the bumpy curve ahead. Sign up for this free session at https://ieeesa.io/wamiiisessions.
+ Read Paul J. Kostek's Bio
Paul J Kostek is a Systems Engineer with Air Direct Solutions LLC, a consulting firm in Seattle, Washington. He works with companies in the aerospace, defense, medical device/healthcare, commercial space and ground transportation industries. Paul is experienced in requirements development/management, architecture, risk management, interface definition, verification, MBSE and project planning. This includes defining user needs, system/subsystem requirements, system architecture, risk analysis, interface control documents and verification and validation planning.
He is a member of the IEEE Humanitarian Activities Committee and chairs the Education Committee. Paul supports the IEEE Visibility activities with interviews and articles on aerospace, commercial space, UAVs and medical devices/healthcare for IEEE and other general news publications.
In 1999 Paul was the President of IEEE-USA, and a member of the IEEE Board of Directors. He served as President of the IEEE Aerospace & Electronics Systems Society in 2000-2001 and was a candidate for IEEE President-Elect in 2001. He Chaired the American Association of Engineering Societies in 2003. And served as VP Conferences for the IEEE Intelligent Transportation Systems Society. He was the Secretary for the P1616 WG revising the Motor Vehicle Event Data Recorder Standard.
He was General Chair of the 2004 IEEE Intelligent Transportation Systems Conference, Chaired the 2006 IEEE/AIAA Digital Avionics Systems Conference and was the Chair of the 2011 and 2012 IEEE Global Humanitarian Technology Conference.
Paul is a Senior Member of the IEEE, an Associate Fellow of the American Institute of Aeronautics and Astronautics and a member of the International Council on Systems Engineering, SAE, and the Project Management Institute. He is an adjunct professor at Seattle University and received his BS from the University of Massachusetts, Dartmouth.