Medical Device Commercialization Playbook 2015

Medical Device Commercialization Playbook is a half day seminar for Vancouver medical device company leaders who want to learn from experts and peers across North America. Spend an afternoon at the Terminal City Club in downtown Vancouver sharing expertise, learning, and collaborating to foster innovation.

Michael Baker, Ramgopal Rao, Steve Arless, Awni Ayoubi, Paul Geyer and Scott Phillips share experiences and topics critical to success in 2015. From attributes of successful spin-out companies to secrets from industry veterans, attendees will gain practical advice, current trends, and real examples from Southern California, Montreal, Seattle, and Vancouver.

The free half day seminar is designed for Vancouver medical device company leaders who want to learn from experts and peers across North America. BCIT, Emergo Group, Innovation Boulevard, and LSBC are supporting sponsor organizations.

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Planned Speakers

• Steve Arless Medius International, MONTREAL QC
• Awni Ayoubi President & CEO Rostrum Medical & MTI Systems, Vancouver BC
• Michael Baker Managing Partner Baker Group, CEO Otoharmonics Corporation, Co-Founder Applied Exergy, Inc., Founder Home Dialysis Plus, Ltd., Portland OR
• Paul Geyer CEO & Chairman of the Board LightIntegra Technology, Chairman of the Board Neovasc, Vancouver BC
• Scott Phillips President StarFish Medical, Victoria BC
• Ramgopal Rao CEO 2C Tech Corporation, CEO LensGen, Irvine CA
• Larry Spears Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations
• John Walmsley VP of Product Development StarFish Medical, Vancouver BC

Event at a Glance

13:00 - 13:30 Registration

13:30 - 15:00 Opening Remarks and Presentations

• How to reduce vulnerability to an FDA audit
• Overview: The Playbook of medical device development in 2015
• THE SKETCH TO LAUNCH PROCESS - Navigating the Path to Commercialization

15:00 - 15:15 Coffee Break

15:15 - 17:00 Presentations and Panel Discussion

• Entrepreneurship and Incubation - A Journey
• What I learned from building and selling two medical device startups for over $500M
• Panel Discussion: Success secrets of medical device executives

17:00 - 18:00 Networking Reception and LifeSciences BC Award Presentation

• Presentation to: Kardium Inc., winner of the 17th Annual LifeSciences BC Award for Medical Technology Company of the Year. Kardium Inc. is a medical device company located in Vancouver, B.C., working on a revolutionary treatment for a heart rhythm disorder called atrial fibrillation.

Planned Sessions

How to reduce vulnerability to an FDA audit

Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

Mr. Spears brings 30 years of experience with the Food and Drug Administration (FDA) as an investigator, compliance officer, compliance manager and director. He gained considerable experience in inspection outcome management, regulatory case management, and recall evaluation/classification during his over 20 years at FDA's Center for Devices and Radiological Health. Mr. Spears served as a Director in Deloitte & Touche LLP's Health Sciences practice providing his FDA insights to assist clients in developing quality and risk strategies in areas such as regulatory governance, contract manufacturing, and validation prior to joining Certified Compliance Solutions, Inc as a Principal Consultant.

Introduction: The Playbook of medical device development in 2015

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.

THE SKETCH TO LAUNCH PROCESS - Navigating the Path to Commercialization

Michael Baker, Managing Partner Baker Group, CEO Otoharmonics Corporation, Co-Founder Applied Exergy, Inc., Founder Home Dialysis Plus, Ltd., Portland OR

From his early years as a PA in emergency medicine to senior executive roles with companies including Lockheed Martin, GE and Philips Medical, innovation has been at the core of Michael Baker's career. Mr. Baker leveraged education and experience in international business, mergers and acquisitions, technology transfer and corporate contracts to create the Baker Group LLP, a technology advancement company focused on bringing new products to market the medical device, informatics and advanced energy sectors. As Managing Partner, he leads a multi-disciplinary of team of top professionals. Collectively his team has advanced 42 products over the course of their careers… and they’re still counting.

Entrepreneurship and Incubation - A Journey

Ramgopal Rao, CEO 2C Tech Corporation, CEO LensGen, Irvine CA

Mr. Rao is a successful entrepreneur in ophthalmology in both device and pharmaceutical areas. He is the inventor and founder of LensGen, Inc. and is also leading 2C Tech Corporation, a nanotechnology based device for the treatment of AMD and RP. Mr. Rao co-developed an innovative corneal implant device for presbyopia and co-founded Acufocus, Inc. Prior to that Mr. Rao founded Tomey Technologies Inc., that pioneered the corneal topography imaging technology that is now a standard of care in ophthalmology. Mr. Rao was President of Ophthalmic Group at Premier Laser, Inc.; a publicly held company. He also held various executive positions at Biorad Laboratories.

What I learned from building and selling two medical device startups for over $500M

Steve Arless, Medius International, MONTREAL QC

Mr. Arless served CryoCath Technologies Inc. as President and Chief Executive Officer from a start-up in April 1996 to July 2006. CryoCath gained worldwide recognition as the leading technology company developing therapeutic catheter ablation solutions for atrial fibrillation, a pervasive cardiac arrhythmia. Supported by aggressive financing strategies including a record IPO of $45 MM in October 2000, worldwide sales grew to over $40 MM, with over 65% coming from the USA. Recently, Medtronic Inc. of Minneapolis, Minnesota, announced the acquisition of CryoCath, listed and traded on the TSE, for $400 million.

Mr. Arless has accumulated more than 35 years of extensive Canadian and international experience in the development, marketing and sales of medical devices products, including 17 years at Smith & Nephew Inc., where he served as President for close to five years. His experience includes extensive involvement in technology transfer and strategic acquisition projects across the United States and Canada and numerous international marketing mandates in the areas of orthotics, prosthetics, orthopaedics, wound care and durable medical equipment.

Panel Discussion: Success secrets of medical device executives

Panelists: Steve Arless, Awni Ayoubi, Michael Baker, Paul Geyer and Ramgopal Rao

Panel Chaired by 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.

Awni Ayoubi, President & CEO Rostrum Medical & MTI Systems, Vancouver BC

Awni is the founder of Rostrum Medical Innovations Inc. and is the co-developer of the VQm System. Awni has over twenty-five years of engineering, management and product/business development experience. Most notably, Awni was the Principal Co-Founder and Co-Developer of Saturn Biomedical and the GlideScope® Video Laryngoscope which was acquired by Verathon in January 2006. In addition, he is a Professional Engineer with the British Columbia and Ontario Professional Engineer Associations.

Paul Geyer CEO, Chairman of the Board LightIntegra Technology, Chairman of the Board Neovasc, Vancouver BC

Paul Geyer, a successful Medtech Entrepreneur and experienced Board member. Over the past 20 years Paul founded and led two companies through their growth phase, in one case to a successful private exit and in the other case through growth as a public company with numerous acquisitions. Both companies have grown to be anchor medical device companies in the Vancouver area, employing more than 350 people. Paul is currently the CEO of LightIntegra Technology Inc., a spin-off from Canadian Blood Services which has developed the ThromboLux technology, used to determine platelet quality for blood transfusions.

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