| 12:00pm |
Solutions Wheel
Play the “wheel” and join a series of rapid-fire, one-on-one meetings with leading
solution providers. Runs concurrently with:
Drivers of Change for Healthcare Technologies
Greg Kovacs, MD, PhD., Professor of Electrical Engineering and of
Medicine, Stanford University
What drives change in healthcare technologies? Clear need pulls, demographics,
and trends toward decentralized care are obviously key forces. However, many of
the real game-changers have percolated up from molecular biology, information
sciences, electronics, fundamental biology and other basic science and
engineering areas. Importantly, breakthrough devices have often emerged from
the overlaps between traditional disciplines, and this remains the largest
opportunity space.
Key Take-Aways: - Examples of interdisciplinary ideas and humble extrapolations through the next few years
- Insight into how breakthroughs will be born from monitoring basic science and engineering developments with an interdisciplinary, market-facing mindset
- Significant advantages will be realized by broadly-skilled personnel positioned to align market needs with these technology opportunities
|
| 2:00pm | INTERACTIVE Breakout Sessions: Create, Communicate & Connect Participant-driven discussions focusing on your key challenges
and concerns.
Choose one of the following: MS1. Success Factors for New Healthcare Delivery: Mobile, @Home and
Decentralized
FACILITATOR:
Stewart Fox, Head of Critical Care, Sagentia
THOUGHT LEADER PANELISTS INCLUDE: Linda Trevenen, Director, Marketing Excellence Programs, Philips Respironics Jim Peterson, Vice President, Dialysis Equipment R&D, Fresenius Medical Care Bonnie Norman, Executive Director, Quality Assurance & Regulatory Affairs,
Care Innovations Christopher Bergstrom, Chief Strategy & Commercial Officer, WellDoc The momentum to recreate healthcare as a concept from something that occurs in
a fixed clinical place, i.e. hospital, to a home/mobile/decentralized state is building:
driven by technology enablement, cost pressures, evidence of better patient
outcomes, and increasingly empowered patients who want their healthcare needs
to be met where they are. This transition from hospital-nurtured to self-
empowered patient is not straightforward and we will discuss how companies can
tailor their products and services to provide the best therapy, minimize patient
risks and maximize the value of the service to patient and provider in this dynamic
field. Key Take-Aways: - Best practices in designing devices for the mobile, at home and decentralized healthcare environments
- Strategies to maximize the benefit of a self-care service offering
- Important lessons learned from industry professionals who have succeeded in this field
MS2. Optimizing Innovation with Resource Allocation Tools
FACILITATOR:
Jeff Kavanaugh, Partner, Product Innovation, Infosys
THOUGHT LEADER PANELISTS INCLUDE:
Don DeLauder, Executive Director of Corporate Innovation, MEDRAD Jeff Kelley, Director, R&D - Hematology, Abbott Labs
Georgette Belair, Vice President - Program Management, CareFusion Steve Wilkowski, New Business Market Development Leader, Dow Corning
Innovation is on the tip of everyone’s tongue, but most of the talk is about ideas
and business models, with the actual machinery all but ignored. If strategy is
about resource allocation, then it stands to reason that medical device innovation
also depends on optimal resource allocation, and the tools to make it happen. This
interactive session will address how resource allocation tools can improve the
innovation process for medical devices: listen to leading practitioners bring to life
real-world examples from their product innovation areas, and contribute your own
stories to the dialogue. Key Take-Aways: - Relate the issue of resource management and allocation to the innovation process
- Highlight the leading tools for resource allocation, with pros and cons for each
- Framework for selecting a resource allocation tool, along with innovation metrics for resource management
- Product innovation transformation examples, with lessons learned and some leading practices
MS3. Clinical Development Strategy Under the Cloud of FDA Uncertainty
FACILITATOR:
Glenda Guest, Vice President, Norwich Clinical Research Associates
The Premarket Notification Process [510(k)] is the pathway to market for 90% of
medical devices in the US. The FDA’s CDRH 510(k) Working Group report
(8/2010) and the independent investigation by The Institute of Medicine (due mid-
2011) are causing concerns and uncertainty for device manufacturers. Panel
members will share recent experiences, discuss what changes we should expect
and identify actions you can take to successfully navigate the changing premarket
notification landscape. Key Take-Aways: - Examples of recent 510(k) denials that appear to reflect a change in interpretation/application of existing regulations and guidance
- Guide to defining indications for use versus intended use and how this may affect identification of appropriate predicate devices
- Insight on strategies to consider for preemptively defending against or responding to a denial of substantial equivalence by the FDA
|
| 4:00pm | Interview with an Industry Trailblazer
on
Advanced Technology Scenarios: Visionary Insight into The Future of Medical
Technologies
Joshua Makower, MD, MBA, Chief Executive Officer & Founder,
ExploraMed Development, LLC
Joshua Makower has dedicated his life to the creation of medical technologies
which improve the quality of life for patients. He is the CEO and Founder of
ExploraMed Development, a medical device incubator based on the west coast, a
Venture Partner with New Enterprise Associates, a Consulting Associate Professor
of Medicine at Stanford University Medical School and co-founder of Stanford’s
Biodesign Innovation Program. Josh has founded several companies through the ExploraMed incubator which
have achieved successful M&A transactions and holds over five dozen patents for
various medical devices in the fields of Orthopedics, ENT, Cardiology, General
surgery, Drug Delivery and Urology. Up until 1995, Josh was Founder and
Manager of Pfizer’s Strategic Innovation Group; he holds an M.B.A. from Columbia
University, an M.D. from the NYU School of Medicine, and an S.B. in Mechanical
engineering from MIT. |
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