Medical Device Commercialization Playbook 2016

Medical Device Commercialization Playbook 2016: A full day of industry speakers and panels from across North America will discuss what it takes to Go from start-up to the first $50M. Network and learn 2016 trends and opportunities for scaling, regulatory issues, entrepreneurial strategy, and innovation design control from industry veterans.

Vancouver speakers:

• Robert Barry Co-Founder and CEO Stasys Medical Corp. Screening member WINGS
• Doug Evans PE, MBA CEO Lungpacer Medical Inc., formerly COO and board member of Kensey Nash Corporation
• John Walmsley VP of Product Development StarFish Medical
• Rick Sethi R&D Manager for Systems, Human Factors, and V&V at Covidien
• Robert McMaster Executive Director, VCH Research Institute
• Moses Zhao - Managing Director, Canada Branch Yonghua Capital
• Udi Daon CEO Navigate Surgical Technologies
• James Taylor Co-founder, CEO Precision NanoSystems, Inc.
• Vesna Janic Director of Quality Assurance/Regulatory Affairs StarFish Medical
• Sabina Bruehlmann Director Technology and Operations Zephyr Sleep Technologies
• Rene van de Zande, President & CEO at Emergo Group, Austin, TX
• Scott Phillips CEO StarFish Medical
• Zayna Khayat Lead of MaRS Health and Director of MaRS EXCITE
• Neil Fraser President, Medtronic Canada & Regional Vice President – Canada, Medtronic plc
• Joyce Drohan BC Healthcare Practice Leader for Pricewaterhouse Coopers

Event at a Glance

08:00 - 17:00 Registration, Coffee/Tea & Networking

08:30 - 08:40 Welcome & Opening Remarks

08:40 - 10:00 Entrepreneur Presentations

• Robert Barry “How we built Coaptus and Uptake Medical”
• Doug Evans “Building a Medical Device Company from Scratch - The Story of Kensey-Nash Corporation”

10:00 - 10:30 Coffee Break & Networking

10:30 - 12:00 Scaling Your Business

• John Walmsley "Managing innovation for rapid adoption"
• Rick Sethi "CardioDigital Story: Start-up to Acquisition"
• Robert McMaster "Working with Coastal Health to advance your innovation"
• Scaling Panel Discussion

12:00 - 13:00 Lunch

13:00 - 14:00 Financing your business

• Moses Zhao "Accessing the Chinese market"

• Financing Panel: "How have local medtech entrepreneurs raised capital recently?" Moderated by Kevin Wong, with panelists Udi Daon and James Taylor

14:00 - 15:00 Navigating the Regulatory Environment

• Vesna Janic and Sabina Bruehlmann Case Study: "Two tales of an FDA audit"

• Rene van de Zande "Major changes impact device regulations in Europe"

15:00 - 15:30 Coffee Break & Networking

15:30 - 16:45 Impacts on Innovation: Today & Beyond

• Scott Phillips "Major medtech trends in 2016"
• Zayna Khayat "Medtech innovation outlook"
• Neil Fraser "Summary of the Advisory Panel for Healthcare Innovation"
• Joyce Drohan "What's transforming healthcare and what you need to win in the new health economy"

16:45 - 17:00 Closing Comments & Thank You

17:00 - 18:30 Networking Reception

Speaker Biographies

Summary of the Advisory Panel for Healthcare Innovation

Neil Fraser President, Medtronic Canada & Regional Vice President – Canada, Medtronic plc Toronto, ON

Neil Fraser joined Medtronic Canada in 1984 and, following numerous commercial positions, was promoted to President in 2004. Under Neil’s leadership, Medtronic Canada has been a significant leader in business model innovation, market position, productivity and efficiency. He is proud of the high level of engagement among employees, faced with a challenging healthcare environment and one of the largest integrations in medical device history, following to acquisition of Covidien in 2015.

How we built CoAptus and Uptake Me

Robert Barry, Co-Founder and CEO Stasys Medical Corp. Screening member WINGS, Seattle WA

Robert Barry is CEO and Co-Founder of Stasys Medical. He has 25 years of experience in the medical device sector, previously having founded Uptake Medical and serving as their CEO. He was also Co-Founder of CoAptus Medical, Director of Product Development at Spiration, Senior Manager of R&D at Boston Scientific, and Product Development Engineer/Manager at Pfizer/NAMIC. He serves the UW as an Entrepreneur in Residence.

Building a Medical Device Company from Scratch - The story of Kensey Nash Corporation

Doug Evans, CEO at Lungpacer Medical Inc., Philadelphia PA

CEO Lungpacer Medical: LMI is developing a novel therapeutic solution for preserving the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation. Board Member Intact Vascular: Founded in 2011, Intact Vascular located in Wayne, PA is a privately held medical device company that develops minimally invasive peripheral vascular products. Former Chief Operating Officer of Kensey Nash Corporation (KNSY) based in Exton PA, which was recently acquired for $360M by Royal DSM a €9 Billion revenue global science-based company active in health, nutrition and materials.

Managing innovation for rapid adoption

John Walmsley, VP of Product Development StarFish Medical, Vancouver BC

John Walmsley is a Professional Physicist and holds a Master of Science in Optics from Queen’s University Belfast. His early career focused on high reliability optoelectronics development and manufacturing transfer. Since joining StarFish in 2005, John has managed projects as diverse as 3D ultrasound development, emergency medical devices, and laboratory automation. He now oversees all product development activities at StarFish with a team of 30 engineers and designers.

CardioDigital Story: Start-up to Acquisition

Rick Sethi, R&D Manager for Systems, Human Factors, and V&V at Covidien, Vancouver, BC

Mr. Sethi has worked at Covidien since 2008 as an R&D and Clinical Engineer Manager. He leads 3 groups at Covidien: Systems, Human Factors, and V&V, with teams in Colorado and India. Co-founder of CardioDigital, Rick holds a BEng Electrical, Honours and BS Biology from Dalhousie in Physiology research in cardiovascular and respiratory systems. Initially, he worked in fiber optics in RF technology, then biomedical. Previously Rick worked at Scientific Atlanta VSM MedTech, and Pyng.

Financing Panel Discussion

Udi Daon CEO Navigate Surgical Technologies

Since 2000, Udi has been at the forefront of 3D surgery, with great focus on the dental field. He founded Navigate Surgical Technologies to realize his experience and passion of providing the best product to create the best customer and patient experience.

James Taylor Co-founder CEO Precision NanoSystems, Inc.

James Taylor has a B.A.Sc. in engineering physics from UBC and a Ph.D. in genetics from the Institute for Systems Biology. James worked at the venture capital firm, Accelerator Corporation, and has nearly a decade of experience in microfluidics, nanotechnology and systems biology. James has been the leader of Precision NanoSystems’s technology and commercialization since the company’s formation.

Working with Coastal Health to advance your innovation

Robert McMaster Executive Director, VCH Research Institute,Vancouver BC

Robert McMaster is VP Research, Vancouver Coastal Health Authority, Interim Executive Associate Dean, Research, Faculty of Medicine, University of British Columbia, and Associate Dean Research, Faculty of Medicine, University of British Columbia.

Medtech innovation outlook

Zayna Khayat, Health System Innovation, MaRS Discovery District; Director, MaRS EXCITE, Toronto, ON

At MaRS, Zayna and her rockstar team help smooth the path to adoption of health innovation by healthcare systems in Ontario and around the world. She is also an adjunct faculty with the Rotman School of Management in the Health Sector Strategy stream. Prior to joining MaRS Discovery District, Dr. Khayat was a senior leader and adjunct faculty member with the International Centre for Health Innovation at the Ivey School of Business at Western University. Previously, Zayna was an associate partner with SECOR Consulting/KPMG Canada. There, Zayna worked with medium and large sized public and private health and life sciences organizations in Ontario and nationally on issues of strategy and management. Prior to joining SECOR-KPMG, Zayna was a Principal with the Toronto office of The Boston Consulting Group (BCG), a global management consulting firm.

What ‘s transforming healthcare and what you need to win in the new health economy

Joyce Drohan, BC Healthcare Practice Leader for Pricewaterhouse Coopers, Vancouver BC

Joyce Drohan is the BC Healthcare Practice Leader for Pricewaterhouse Coopers with 20 years of experience in end to end large-scale transformation across public and private sector. Joyce’s main areas of expertise include healthcare strategy, transformation, innovation, analytics, information management and process improvement where she works with clients locally and internationally. Joyce has held very senior roles in the UK government including Senior Advisor and Policy Director for Improvement and Efficiency at the Department of Health in England and at AstraZeneca (Canada and the UK).

Case Study: "Two tales of an FDA audit

Vesna Janic, Director of Quality Assurance/Regulatory Assurance, StarFish Medical, Victoria BC

Vesna Janic is the Director of Quality Assurance/Regulatory Assurance at StarFish Medical (medical device design development and manufacture) and ViVitro Labs (cardiovascular testing equipment and services). She has extensive experience and expertise in regulatory compliance and conformance with standards including cGMP, GLP, GCP, QSR, ISO 13485 and ISO 17025. Her Senior Management experience spans 4 organizations and 100+ products and services, including more than 5 years as QA/RA Director for medical devices. She served 9 years as a volunteer SCC GLP inspector.

Sabina Bruehlmann, Director Technology and Operations Zephyr Sleep Technologies, Calgary BC

Sabina Bruehlmann is Director Operations, Research & Development and co-founder of Zephyr Sleep Technologies, an innovative sleep medical device company. Leading the R&D team with 9 years of of research & medical device commercialization experience; Sabina's focus is on intellectual property strategy and new technology development in sleep medicine. Zephyr Sleep Technologies develops, manufactures and sells innovative, scientifically validated medical devices to improve sleep.

Major changes impact device regulations in Europe

Rene van de Zande, President & CEO at Emergo Group, Austin, TX

Rene van de Zande is responsible for all operations of Emergo Group (www.emergroup.com), which he founded in 1997 and as its CEO & President, and he has a consistent record of delivering results in growth, revenue, operational performance, and profitability. Today, he spearheads the international expansion of Emergo Group’s operations and service offerings, and provides guidance and support to Emergo Group offices in 24 countries to date. Between 1990 and 1997, René worked in the capital of Europe, Brussels, Belgium, on European internal market issues and Trans-Atlantic business relations.

Major medtech trends in 2016

Scott Phillips, President StarFish Medical, Victoria BC

Known for being an entrepreneur and for helping entrepreneurs, Scott Phillips is CEO of the StarFish group of companies, including StarFish Medical™ and ViVitro Labs Inc. Scott graduated in engineering physics from UBC in 1989 and has authored 17 patents. He speaks on medical device topics frequently around North America. His industry awards and service include President of Entrepreneurs Organization Victoria Chapter, 2011 Executive of the Year for the Vancouver Island Technology Association (VIATeC), 2012-2013 Vice-chair of the Viatec board and former board member of the BC Medical Technology Industry Association. Scott’s passions are being a Dad, solving design problems, outdoors adventures, and helping companies be successful.

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