Medical Device Playbook 2019, Canada’s premiere innovation and commercialization event for medical device professionals, is coming to the MaRS Discovery District on May 9, 2019. Industry speakers and panels from across North America discuss Entrepreneurial Strategy for Innovation, Getting the Product Right, Deal-making, and Navigating the Clinical/Regulatory Environment.
Event includes Lunch, Breaks, and Networking Reception. Medical Device Playbook 2019 Toronto is co-hosted by StarFish Medical, MaRS, and OBIO.
Sameer Sabir is Co-Founder and President of SevenOaks Biosystems, a Cambridge MA based venture-backed lifesciences company developing novel and highly innovative solutions to address the major challenges associated with wound-healing. SevenOaks was acquired by Medline Industries, Inc in April 2017. Previously Mr. Sabir was Co-Founder & CEO of Momelan Technologies - a medical device company that developed Cellutome, a groundbreaking minimally invasive epidermal skin-grafting system. The company was acquired by Kinetic Concepts, Inc in November 2012.
Medical Technology Entrepreneur, Adjunct Professor, McGill University
Steven G Arless is a Canadian entrepreneur in the biomedical technology industry. He was the CEO of several medical device companies, including CryoCath Technologies, CardioInsight and Resonant Medical.
In 1971, Arless took a position with Smith & Nephew, a British medical equipment company, staying there for 17 years. He was CEO of the North American operations from 1986-1990.
Arless started his career path as a Medtech startup entrepreneur in 1996
when he started and built over 10 years CryoCath Technologies Inc, a cryoablation catheter balloon technology for AF (atrial fibrillation), which is now considered a clinical gold standard globally.
Arless relocated to Cleveland, Ohio in 2009 to become CEO of CardioInsight, a company marketing and advancing research in cardiovascular technology. Arless stepped down from his position at
CardioInsight in 2012.
Arless co-founded medical device company, Soundbite Medical Solutions, which fabricated wire devices to treat
occlusions caused by coronary and peripheral artery disease with shockwaves. Arless stepped down as CEO in 2017.
Arless is a Professor of Practice at McGill University.
Jay Caplan is Co-founder and President of Fractyl and has held leadership positions in the medical device field for more than twenty years.
Prior to founding Fractyl, Jay was the Chief Operating Officer of the Candela Corporation, a world leader in aesthetic devices. Previously, he was Chief Technology Officer and Vice President of Research and Development of InfraReDx, Inc. a venture-backed startup developing a novel cardiovascular imaging system to identify lipid-rich coronary plaques.
Prior to InfraReDx, Jay was Vice President Operations for Thermo Cardiosystems, where he led the team developing the HeartMate II left ventricular assist device. Jay holds a B.S. in electrical engineering from M.I.T. and an MBA from The Wharton School.
Lessons learned from experiences with Infraredx and Fractyl
Peter Van der Velden
Managing General Partner of Lumira Ventures
Peter Van der Velden is Managing General Partner of Lumira Ventures. Peter joined Lumira Capital in 2005 as President and CEO to oversee and manage the generational change resulting from the retirement of the founding CEO. Peter oversees the overall business operations of the firm and is a core part of the senior senior management team that is making new investments out of the recently closed Merck Lumira Biosciences Fund and Lumira Capital II funds as well as managing the legacy investments of Lumira Capital I. His investment focuses include growth equity, non-traditional and consumer oriented medicines, spin-outs, re-structurings and public companies. With 25 years of investment and operating experience, he has participated in building companies from start-up through to expansion and has been involved not only with companies in the life sciences sector, but also with companies in the information technology and consumer sectors.
Randy AuCoin is a seasoned clinical executive with broad experience in all aspects of medical device operations. He started his career developing software in a medical device start-up and quickly realized his love for early stage companies and medical devices. Randy’s career is reflective of his passion for growing early stage medical device companies and spans a broad range of operational and managerial roles. Prior to Exact Imaging, he was a key executive in three other early stage ventures, helping to grow the companies’ valuation resulting in four liquidity events including one company which was sold twice based on the fundamental technology which Randy helped to develop and commercialize.
Randy is President and CEO of Exact Imaging, responsible for the company’s strategic direction, key operations and overseeing the development and global commercialization of its ExactVu™ micro-ultrasound platform. He joined Imagistx (now Exact Imaging) in 2011 as COO. In 2013 he became President and CEO, successfully restructuring the company into a Canadian entity, driving the Company’s strategy and fundraising, and building the Company’s management and operational teams. He also architected and led the company’s multi-site clinical trial. Randy has also successfully raised over $50 million in financing.
Prior to Exact Imaging from 2003 – 2011, Randy was Vice President, Quality Assurance and Regulatory Affairs at VisualSonics (sold in 2010 to Sonosite (SONO: NASDAQ)) and was responsible for the development and execution of all quality assurance and control efforts as well as directing all regulatory affairs and clinical programs. He directed VisualSonics’ achievement of ISO 9001 quality certification within its first 2 years of operation. He also led all clinical investigations including the original efforts into successfully validating the Imagistx’s opportunity leveraging the VisualSonics technology for prostate imaging. He also contributed to the quality system that successfully delivered over 1,500 VisualSonics high resolution-ultrasound systems with an extremely high-level of quality and customer satisfaction.
Recent Experiences in Commercializing Emerging Medical Technology – The Exact Imaging Story
President, Principal at MAVEN Medical Device Strategies, Boston MA
Joel Weinstein is a serial entrepreneur and an industry-recognized marketing and strategy “guru”. He was a member of the founding management team of Hologic, Inc. and directed the strategies of that company’s first 12 years of meteoric growth. He has since served as a Founder of Assurance Medical, CEO of VueSonix Sensors, Andrew Technologies and Global Marketing and Sales Officer of women’s health pioneer BioSphere Medical. Since 2001, he has also served as Founder and President of MAVEN Medical Device Strategies – a firm that nurtures growth of early and growth stage medical device companies. In addition to his current engagement with Partners Healthcare incubator CIMIT, Joel has also served as two-term member of the Board of Directors of MassMEDIC and currently serves on the Boards of NovaScan, Rivanna Medical and Photonicare.
Co-Founder & Managing Director of Novateur Ventures
Ali Ardakani is the Co-Founder & Managing Director of Novateur Ventures, a premier global advisory group with over 100 senior life science advisors, and the current Senior Vice President Device & Business Development for AIT Therapeutics, a publicly traded company. He is also sits on multiple boards including LifeSciences BC (Vice Chair) and Altum Pharmaceuticals (Executive Board Member) and is Entrepreneur in Residence at Innovation Boulevard. He was the Co-Founder and COO of Niiki Pharma, which was acquired in 2013 by Intezyne Technologies, of which he became the Vice President as well as the Co-Founder & CEO of Lexi Pharma, which was acquired in 2018 by Altum Pharmaceuticals.
Director of Technology and co-founder of Zephyr Sleep Technologies
As Director of Technology and co-founder of Zephyr Sleep Technologies, Sabina is experienced in all aspects of early stage medical device commercialization. With over 20 years of research & medical device commercialization experience; Sabina’s focus at Zephyr is on intellectual property strategy and competitive positioning, new technology development and regulatory/quality/clinical affairs in the medical device industry. Recently, Sabina led the Zephyr team in successfully obtaining de novo clearance for the first auto-titration device for treatment of sleep apnea using oral appliance therapy. The innovative device utilizes AI powered algorithms in a cloud based home based sleep test to provide a personalized prescription for effective care.
Prior to starting Zephyr, Sabina worked with medical device start-ups in Calgary as well as Silicon Valley, and was a Director of Partnerships, Manager Licensing and Business Development at University Technologies International Inc. Sabina holds a BSc in Mechanical Engineering from Queen’s University and a PhD in Biomedical Engineering from the University of Calgary.
Successfully Navigating the De Novo pathway for FDA Clearance
Managing Director of Health for MaRS Ventures
Ying Tam is Managing Director of Health for MaRS Ventures, one of the world’s leading urban innovation hub. MaRS works with entrepreneurs to access customers, investors, corporates and partners, mentors, university and research institutions to develop and test their concepts and to create successful global businesses from sciences, technology, and social innovation. Ying works with entrepreneurs, corporate leaders, investors and technologists who are applying innovation and cutting-edge technologies to create health solutions that are positively impacting patients’ lives and improving the healthcare system.
Ying is a seasoned entrepreneur and business executive, and has co-founded several start-up companies, including Mindful Scientific, a medical device company addressing concussion diagnostics and management, abridean (acquired by nCipher PLC), a software company developing application provisioning and identity management solutions, and i-HRx (acquired by Healthconnex), a digital health company focused on chronic disease management. He has significant strategic and functional experience with operating roles in a wide range of organizations, from early stage companies to major multi-national corporations.
Gail Garland is the founder and CEO of OBIO®, a not-for-profit, membership-based organization championing the development of an integrated health innovation economy for Ontario.
Gail established OBIO in partnership with dozens of like-minded industry CEOs to advance the goal of making Ontario into a world-leading health innovation sector where health science companies will flourish, as well as a global leader in providing health technology products and services to the international marketplace.
Gail serves on the Dean’s Advisory Council, Faculty of Science, at Ryerson University; the Biotechnology Advisory Committee at Humber College; the Canadian Life Sciences Advisory Counsel for Springboard Enterprises; and the Advisory Board for the Centre for Bioengineering and Biotechnology, University of Waterloo. Gail is the Industry Chair of the OBIO MPP Health Sciences Caucus and serves on the Conference Board of Canada’s Council for Innovation Procurement in Healthcare. She has advocated for the future of the health science industry on national television (Business News Network) and has also written extensively on the topic, with numerous publications in both the national press (The Globe and Mail) and international industry publications (Biotechnology Focus).
Vesna Janic’s expertise in regulatory compliance and conformance standards provides StarFish Medical’s clients with invaluable guidance and assistance in understanding and complying with regulatory standards such as cGMP, GLP, GCP, ISO 13485 and ISO 17025. Drawing upon her certification by the SQA as a Registered QA Professional in GLP and more than 18 years of experience in the R&D and QA fields, Vesna ensures that your StarFish project successfully meets and exceeds industry standards.
Successfully Navigating the De Novo pathway for FDA Clearance
CEO and Founder of StarFish Medical
Scott Phillips is CEO and Founder of StarFish Medical. Scott holds a degree in Engineering Physics from the University of British Columbia. Prior to starting StarFish, he worked in diverse areas such as lithium battery development and manufacturing, UV spectroscopy instrumentation and hi-fi audio speakers. Under his leadership StarFish has grown into a diverse professional organization with clients around the world and 100% focus on medical devices. Scott is a Fellow of The Canadian Academy of Engineering, winner of the EY Entrepreneur Of The Year™ 2017 Pacific Awards Technology category, 2017 recipient of the VIATEC Technology Champion award, member of the LifeSciences British Columbia board, and volunteers with Junior Achievement, Entrepreneurs Organization, and University of British Columbia.
David Bell is an Account Executive at TUV SUD Canada. David guides med tech and other electronic device clients through hardware certifications. David’s main focus is EMC/Radio, Electrical safety and battery testing as well as requirements for international markets.