DeviceTalks Minnesota 2019 Agenda
*Timing and session topics are subject to change
Day 1
09 Sep 2019
Day 2
10 Sep 2019
9:00 am-9:45 am
How We Built This: Abbott
R&D leaders at Abbott will walk attendees through the company’s device development process.
Kevin Bourque
10:00 am-10:45 am
Inside Mayo Clinic’s Engineering Efforts
The historical context of engineering at Mayo will be used to describe how Mayo Clinic engineers and physicians collaborate. A case study of a novel 3D-printed titanium orthopedic implant will demonstrate how computational modeling, virtual implants, and cadaveric testing of 3D printed parts can each be used appropriately and effectively to allow for the rapid development of novel devices.
Mark Wehde
10:00 am-10:45 am
Innovation in Neurostimulation
A live interview with SPR Therapeutics’ CEO Maria Bennett. The company’s Sprint percutaneous peripheral nerve stimulation system is FDA-cleared to treat chronic and acute pain.
Maria Bennett
10:45 am-11:00 am
11:00 am-12:00 pm
Keynote: Jerry Mattys – CEO, Tactile Medical
Tactile Medical CEO Jerry Mattys will give attendees a glimpse at what’s ahead for the company and its at-home therapy devices. This interview will be conducted by Medical Alley president & CEO Shaye Mandle.
Gerald R. Mattys
12:00 pm-1:30 pm
1:30 pm-2:15 pm
Ensuring Patient Safety with Reusable Medical Devices
For reusable medical devices, ensuring patient safety is a shared responsibility. The ability to render devices safe for re-use is subject to the demands of device design and function, clinical application, and reprocessing execution. Further, increased regulatory scrutiny, including the EU-MDR, mandates a robust and thoughtful approach for safe and effective reprocessing validations. This talk will provide an overview on the conduct of successful reprocessing validations with an emphasis on current regulatory requirements. Sponsored by:
Michael Brady
1:30 pm-2:15 pm
Protecting the Connected Hospital from Ransomware and Malware
Healthcare budgets are straining under the cost of implementing new layers of cybersecurity technology to mitigate the flaws of weak network security, outdated unpatched systems, and unsecured medical devices. In our presentation we propose a simpler approach that is cheaper, more effective, and more efficient. Leveraging a trusted foundation to build your infrastructure. Use that trusted foundation to segregate your untrusted functions from your trusted functions. Allow the users to interact with each of these functions without the vulnerabilities of one having the ability to compromise the others.
Martin Nappi
2:15 pm-3:00 pm
Rightsizing Your Development Strategy
What is a Minimally Viable Product (MVP)? How does it apply in the Medtech space? Is your goal to secure funding, gain clinical evidence, or update an existing product? Not all paths to commercialization look the same. This interactive session with experts in product development and innovation will cover how structuring a tailored development strategy for your device can help you gain critical insights early, spend limited development budget wisely and accelerate time to market. We will discuss several different real-world development programs and how the approaches varied to optimize quality, time and cost.
Janis Skujins
David Hawks
Javier de Ana, Ph.D.
2:15 pm-3:00 pm
Fireside Chat: How EU MDR is Rolling Out for Notified Bodies and Industry
Have lingering EU MDR questions? Are you sure you will have everything necessary implemented by May of 2020? In this exclusive discussion, hear exactly how the EU MDR is rolling out from both notified body and industry perspectives. With the limited time frame in mind, Ibim and Julie will share stories and best practices designed to help companies cross the finish line ahead of the May 2020 deadline. The conversation will include advice on how the new regulations impact your QMS and implementing the new role of the person responsible for regulatory compliance. Wherever your organization is in the EU... Read More
Julie Maes
Ibim Tariah
Juli Denny
3:00 pm-3:30 pm
3:30 pm-4:15 pm
Using Agile Methodology to Navigate the 510(k) Approval Process
Learn about how Pops! Diabetes Care and MentorMate’s use of an agile rather than waterfall methodology in the development and approval process allowed for more flexibility and speed when navigating the 510(K) approval process.
Eve Poeschl
Lonny Stormo
Hot Topics: M&A, IP, and Products Liability Trends Impacting MedTech
M&A trends from the perspective of both acquirer and seller IP protection is key to a successful exit Products liability litigation – what every medtech company needs to know
Jamie Ackley
Kenneth Karanja
Marcella Ducca
Stephen Baird
David Dykeman
4:15 pm-5:00 pm
Keynote: Sheri Dodd – VP & GM, Medtronic
A live interview with medtech veteran Sheri Dodd. Sheri will discuss how to execute on the vision of value-based healthcare, as well as share her experience leading two divisions at the medtech titan, Medtronic.
Sheri Dodd
5:00 pm-6:30 pm
8:00 am-9:00 am
9:00 am-9:45 am
Keynote: Sumant Ramachandra – Chief Science & Technology Officer, Baxter
Baxter’s chief science and technology officer Sumant Ramachandra will give attendees a glimpse at how his company is working to solve the problems faced by clinicians in today’s healthcare system. Ramachandra will share his perspective on redefining innovation in medtech.
Sumant Ramachandra
9:45 am-10:15 am
10:15 am-11:00 am
A Medtech Insider’s Walk through the Medical System
As a long-time medical product development engineer and executive, Bill Betten has been involved in product developments ranging from medical imaging to surgical instruments to wearable devices. However, a brain tumor diagnosis earlier this year led him on a journey through that same medical system as a patient. Join us for an insider’s view of the medical system, ranging from diagnostics, insurance/financials, surgeon/hospital selection, 7 hours of surgery, ICU care, monitoring, pain management, and recovery. Finally, we’ll discuss how the trip though the system has impacted his view of “person-centric” product development.
Bill Betten
11:00 am-12:00 pm
How We Built This: Cardiva Medical
Executives from Cardiva Medical will share the end-to-end device development process for its latest vascular closure device. The company’s leaders will discuss topics such as identifying a clinical need, designing clinical trials with end-claims in mind and commercial messaging.
Roger Owens
Justin Ballotta
John Russell
11:00 am-12:30 pm
FDA Workshop
Hear from and meet with key FDA officials and staff who lead all medical device inspectional and compliance activities covering eighteen states from Florida to Minnesota. This interactive FDA session will cover a myriad of compliance and regulatory issues critical to the medtech industry, as well as Q&A and discussion. Hot Topics: Key FDA priorities & Initiatives This section will cover program alignment, FDARA, transparency, nonbinding 483 feedback, experiential learning and regulatory convergence/ISO. Speaker – Blake Bevill, Division Director, Office of Medical Device & Radiological Health Operations, FDA Med Device Compliance & Enforcement This section will cover device inspectional issues,... Read More
Meredith M. Andress
Joshua Silvestri
Blake Bevill
12:30 pm-1:30 pm
1:30 pm-2:15 pm
Keynote: Sameer Kumar – CEO, HabitAware
HabitAware co-founder & CEO Sameer Kumar will discuss the company’s inception and unique technology – a smart bracelet designed to help “retrain the brain” away from detrimental behaviors like hair pulling and nail-biting.
Sameer Kumar
2:30 pm-3:15 pm
Stepping into the Shoes of an R&D Lead at a Startup
A look at the device development process at FlexDex Surgical from the company’s lead R&D engineer, Deepak Sharma.
Deepak Sharma
3:15 pm-4:00 pm
