WAMIII – Virtual Talk Series

WAMIII Virtual Talk Series

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us.

The WAMIII Virtual Talk Series is a critical educational and outreach program under the Clinical Health Workstream of the IEEE SA Healthcare and Life Science Practice.

Learn More About the WAMIII Program

Upcoming Sessions

2022 Webinars to be Announced.

Sessions On-Demand

Browse all of the recorded sessions for the WAMIIII Virtual Talk Series – or view by related topics. All of the sessions provide insight on the latest innovations from Industry experts either by presentations or a moderated panel. Register to gain access to all sessions for free.

View On-Demand Sessions

WAMIII Virtual Series – Session 25

Going Beyond Design in Connected MedTech Innovation: Navigating the Pitfalls of Liability and Policy in Garnering User Trust for Adoption

December 8, 2021 at 3:00 PM – 5:00 PM UTC | 11:00 AM – 12:00 PM ET

  • 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.

Maria Palombini

Director, Healthcare and Life Science Practice Leader, IEEE SA

Maria currently leads the IEEE SA Healthcare & Life Sciences Practice working with a global community of stakeholder volunteers who are committed to establishing trust and validation in tools and technologies that will change the approach to discover therapies, deliver care, and ultimately enable a sustainable and universal quality of care for ALL. Maria is the founder of DisruptiveRx, an information gateway addressing the critical need for pharmaceutical and life sciences executives to connect innovation with business strategy to re-think the process of the drug development and distribution value chain. She has extensive experience in building global media brands in multiple industry sectors. She holds a B.S. and B.A. from Rutgers College and an M.B.A. from Rutgers Graduate School of Business at Rutgers University.

Paul Kostek

IEEE Senior Member; Systems Engineer, Air Direct Solutions LLC

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.

Nick Leighton

Class Underwriter, AEGIS London

Nick began his underwriting career in 1982 with the J.S.Marsh Syndicate, writing all classes of E&O and joined AEGIS London in 2012. He has experience leading a wide range of PI classes and has led a number of market facilities for many years. Specialties include architects & engineers, insurance brokers and miscellaneous risks, focusing mainly, but not exclusively, in the US. As a binding authority specialist, he has written many facilities for specific affinity groups and industry associations and is used to creating bespoke solutions to address their needs.

Supporting Partners

Registration

Note: When you register for the Series you get access to the recorded sessions. You’ll receive a weekly email announcing new sessions for the week, links to ALL recorded sessions and you will receive reminder emails (24 hour and 30 minutes) prior to each session.

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us. Participation in these sessions includes the following:

  1. Hearing global expert perspectives (from every corner of the world) on the technical and regulatory challenges and viable clinical applications of wireless medical devices on, in around the patients.
  2. Learning, sharing ideas and building consensus for development of solutions to address challenges impeding trust and adoption of these technologies for diagnosing, monitoring and treating patients.
  3. Access to a platform without geographic bounds enabling a global community of progressive thinkers with common initiatives to harmonize recommendations and form collaboratives to drive solutions through the development of technical and data standards.
WAMIII - Virtual Talk Series

July 20 – December 1, 2021

On-Demand

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