Medical Device Playbook 2018, Canada’s premiere innovation and commercialization event for medical device professionals, is coming to the MaRS Discovery District on May 8, 2018. Industry speakers and panels from across North America discuss what it takes to Dream a Bigger Dream.
Network with industry veterans and learn 2018 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 2018 Toronto is co-hosted by StarFish Medical and OBIO. All net proceeds will go to OBIO for future medtech initiatives.
YING TAM, Managing Director, Health Venture Services MaRS
09:00 – 10:15
STAN LAPIDUS: Asking Better Questions
KEN GALL: The Ivory Tower?
10:15 – 10:45
Coffee/Tea & Networking
Paths to Success
BRIAN SHOEMAKER: Agile for Medical Devices – A New Day Dawns
HARI SREE: Acquisitions Due Diligence – What matters
DARREN KRAEMER: Commercialization at the cutting edge
12:30 – 13:15
Afternoon Welcome & Opening Remarks
GAIL GARLAND, President and CEO
Ontario Bioscience Innovation Organization
13:30 – 14:15
Getting the Product Right
JOSH TOLKOFF: How a gadget guy became a value proposition believer
14:15 – 15:00
Navigating the Regulatory Environment
VESNA JANIC: Preparing for ISO 13485:2016
JAMES JACKSON: Are you designing for the correct guidance regulations?
DAVID BELL: Do’s and Don’ts of Medical Electrical device certification and testing
15:00 – 15:30
LIANA DI MARCO: How to maximize your technology’s opportunity for system adoption
THOMAS MEIER: Commercializing innovative health technology across Europe
15:30 – 16:00
Coffee/Tea & Networking
16:00 – 16:50
SHERYL THINGVOLD: The Renaissance Approach
SCOTT PHILLIPS: Dream a Bigger Dream
16:50 – 17:00
SCOTT PHILLIPS: Closing Remarks
17:00 – 18:00
FREDERIC LEMAITRE AUGER: Reception Welcome
Reception sponsored by Accel-Rx Health Sciences Accelerator
Josh Tolkoff, Accelerator Executive at CIMIT - Boston
Co-Founder of Boston Scientific
Josh Tolkoff, MS has over 40 years of in-depth management experience in research, development, manufacturing, regulatory affairs, and general management of medical device companies. Currently an Accelerator Executive at CIMIT, Consortia for Improving Medicine with Innovation & Technology. 2005-2016, Mr. Tolkoff served as a Partner at Ironwood Equity Fund. He started and ran Seedling Enterprises, a successful incubator that spun off three companies. Prior to that, he started two companies, including ACT Medical, Inc. Mr. Tolkoff built the company to over $25 million in sales and sold it to a publicly traded company in 2000. He started his career as the VP of R&D at Medi-Tech which became Boston Scientific, and helped grow that company to over 500 employees. He is recognized as a leading figure in the medical device community and currently serves on the Board of numerous privately held start-ups, chaired MassMedic, and Chaired the Advisory Board of the Harvard-M.I.T. Health Science & Technology program. Mr. Tolkoff holds a B.A. from Harvard College and an M.S. in BioMechanics from The Massachusetts Institute of Technology.
How a gadget guy became a value proposition believer.
Stories from the early days of Boston Scientific. Find and study the significant needs and the technology will follow.
Stan Lapidus, Director of a number of public and private medical device and diagnostics companies - Denver
Founded and led two of the most successful (>$2Bn value) diagnostics companies of all time
Stan Lapidus has been active as a founder, CEO and board member of medical diagnostics and device companies for over 30 years. He founded and led two of the most successful diagnostics companies of all time. He founded and served as CEO of Cytyc Corp (NASDAQ:CYTC). He is the principal inventor of Cytyc’s ThinPrep Pap test which revolutionized screening for cervical cancer accounting for ~70% of the world market for cervical cancer screening. Cytyc was acquired by Hologic for $6.2 billion in 2007. Subsequently, he founded EXACT Sciences Corp. (NASDAQ:EXAS) and served as CEO and Chairman. EXACT pioneered high-accuracy non-invasive testing for early detection of colorectal cancer. Since commercial introduction of the company’s Cologuard test, EXACT has been the most rapidly growing company in the history of the diagnostics industry.
Stan holds 37 US patents and was elected as a Fellow of the American Institute of Medical and Biological Engineering in 2013 for his work on the early detection of cancer.
From to 2001 until 2017, he was an instructor at MIT.
He currently serves as a director of a number of public and private medical device and diagnostics companies.
Stan graduated from Cooper Union in New York City with a BS degree in electrical engineering.
My adventures as an inventor/entrepreneur in medical technology. How I identify unsolved, or poorly solved, problems and how asking new questions leads to the development of large businesses.
Brian Shoemaker, Principal Consultant at ShoeBar Associates - Boston
International Medical Device Software Consultant
Brian Shoemaker consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.
Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.
An Agile approach serves as discipline which medical device development teams can in fact follow, and results in products with higher quality and safety.
Hari Sree, Hardware Development Manager, Boston Scientific - Minneapolis
Multiple acquisition evaluations and integrations at Boston Scientific
Hari Sree, PhD, is currently a Senior Hardware Design Manager at Boston Scientific in its Rhythm Management Division. His responsibilities cover managing new product development and continuation engineering projects covering Electronic Medical Equipment for Rhythm Management and other divisions within Boston Scientific. His seventeen years at Boston Scientific spans design leadership in Diagnostic and Therapeutic complex Implantable Medical and Electronic Medical Equipment devices. Hari also has been engaged in multiple acquisition evaluation and integration activities for about 6 years. Hari graduated in 1995 with a Bachelor of Technology (honors) degree in Electrical Engineering from the Indian Institute of Technology in Kharagpur, India and subsequently earned his Ph.D in Electrical Engineering from University of Minnesota – Twin Cities, USA.
In the medical device space, acquisitions, more so than mergers, are common place events.
Learn key technology and product development maturity diligence aspects for potential acquisitions.
Darren Kraemer, Founder & President, Light Matter Interaction - Toronto
Darren Kraemer is the President and CTO of Light Matter Interaction Inc. a Toronto based company developing novel devices for laser surgery. The company was founded by the team behind Attodyne Lasers Inc., a successful brand of industrial picosecond lasers that Darren started while he was still completing his Ph.D. in Physical Chemistry. Having previously been involved with a wide variety of industrial and medical laser applications, Darren and the LMI team are currently focusing on bringing to market ophthalmology and biodiagnostic applications of a new laser technology. Darren has a masters in Chemistry and an undergraduate degree in Engineering Science from the University of Toronto.
Commercializing laser technology: New medical laser applications and instrumentation designed to provide surgeons with an unprecedented level of precision.
Ken Gall, Professor and Chair, Duke University
Founded five medical device start-up companies commercializing new university-based medical technologies
Ken Gall has been a professor for approximately 20 years at three different universities. Professor Gall’s technical expertise is in the structure and properties of materials, biomaterials, and the 3D printing of metals and polymers. His contributions to the scientific community are centered on the creation and understanding of new functional biomaterials, and he has over 230 publications that have been cited over 15,000 times. In addition to his research and teaching, he has consulted for various companies, the US Military and the US Intelligence Community, and served as an expert witness in multiple patent and product litigations in the medical device space. Finally, he is a passionate entrepreneur who has founded five medical device start-up companies. He is involved in all of his companies who are commercializing new university-based technologies in the medical device space. Two of his companies have experienced partial or full exits (MedShape to ConMed and Vertera to NuVasive), while the other three are all in early stages of development.
My experiences bringing advanced implant technologies out of universities and into the healthcare marketplace
Ying K. Tam, Managing Director of Health, MaRS Ventures
Seasoned entrepreneur and business executive, and has co-founded several start-up companies
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.
LIANA DI MARCO, Project Manager at MaRS EXCITE - Toronto
Medical device market expert
Liana Di Marco is the Project Manager for MaRS EXCITE. Liana is a Certified Clinical Research Professional and Trainer with 11 years of experience in corporate medical device, academia and laboratory/medical clinic settings. Throughout her career, Liana has worked with many global partners on the strategic development and implementation of pre- and post-market clinical studies incorporating health economic and outcomes research. She completed the post-graduate clinical research program at Humber Institute for Technology & Advanced Learning and was invited back as faculty to teach the Medical Devices in Clinical Research course. She has been a member of the Association of Clinical Research Professionals (ACRP) since 2008 and is a volunteer as President of the Canadian Chapter of ACRP.
Complex healthcare strategies and examples of EXCITE successes
Scott Phillips, CEO, StarFish Medical - Victoria
Creator Medical Device Playbook
Scott Phillips is CEO of StarFish Medical, Canada’s leading medical device development services company with offices in Toronto and Victoria. The company has been retained by leading companies such as Medtronic, Natus, Novadaq and Terumo as well as many startups over the past 18 years. In 2018 StarFish was a Western Finalist for the Deloitte Best Managed Companies in Canada awards. He holds a degree in engineering physics from the University of British Columbia and has been a professional in technology-based product development for 29 years. In a voluntary capacity he has served on various boards including Life Science BC, Victoria Advanced Technology and Entrepreneurship Council. BC Medtech Industry Association, Advisory boards for biomedical engineering at UBC and the University of Victoria, and Entrepreneurs’ Organization. He has also served on various startup company boards. He was the 2017 winner of the Ernst and Young Entrepreneur of the Year for technology in British Columbia. Scott is married with 3 children and lives in Victoria, British Columbia.
What it takes to build a $100M Medical Device Product or Company
Gail Garland, President and CEO of the Ontario Bioscience Innovation Organization (OBIO)
Established OBIO in 2009 in partnership with dozens of like-minded industry CEOs
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, Director of QA/RA StarFish Medical - Victoria
QA/RA responsible for 30+ concurrent medical devices and companies
Vesna’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.
James Jackson, Industrial Designer, StarFish Medical
Category leading products for Logitech, Olympus, Medtronic, Welch Allyn, Covidien, and Hollister
James Jackson is an industrial designer at StarFish Medical. He utilizes a multidisciplinary approach to managing client projects. By successfully balancing industrial design, mechanical engineering and human factors with medical science and regulatory ISO 13485 design control and documentation, Jackson has designed and developed category leading products for Logitech, Olympus, Medtronic, Welch Allyn, Covidien, Hollister, St. James’s Hospital and The Helen Hamlyn Center London. A graduate of Trinity College Dublin and The National College of Art and Design (MSc., Medical Device Design) and National College of Art and Design (BDes., Industrial Design), Jackson has generated almost thirty patents from first principles. He is currently composing a paper on Novel insight into the Pathogenesis of Calcific Aortic Valve Disease.
Are you designing for the correct guidance regulations?
Introduction to new Guidance Document App
David Bell, CITP David Bell, CITP Account Executive, TÜV SÜD Canada
Created largest EMC lab in Canada
David Bell has been an Account Executive at TUV SUD Canada for 6 years. David’s main role in the company is guiding 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.
Do’s and Don’ts of Medical Electrical device certification and testing
Thomas Meier, Founder of you-can.biz - Switzerland
International Launch Expert
Thomas was raised and studied in Basel / Switzerland, one of the world’s most important centres of gravity of Life Sciences. He’s an open personality and an economist focused on internationalisation and foreign trade. Different assignments took him through various industries such as financial, automotive, food, life science and medical technology. Fluency in five languages. He lived in Laval/Montréal and builds solid bridges and runs businesses for and with Canadians and Europeans running in both directions.
Based on his previous global responsibilities and many durable friendships Thomas created you-can.biz which is his company and network since 2007. Thomas and his team provide access to a global network, creativity and know-how by assisting innovative companies in the course of their market validation, (pre-)commercialization, business development and they do create long-lasting customer retention. Most accounts of you-can.biz are doing business in health, medical, sports and nutrition and a few other industries as well. Thomas is an advisor and executive coach with different health technology hubs in Europe and USA. Thomas had been resident in Canada as an expat on behalf of Roche Diagnostics until 12 years ago. His leisure time is filled by practicing rowing, mountain biking and climbing.
Commercializing innovative health technology across Europe
The Commercial Launch of ONE product in ONE continent means 44 countries and 44 healthcare systems. There are plenty of options for new technologies to be sold and used, but limited homogeneity among these national healthcare systems.
FREDERIC LEMAITRE AUGER Senior Director Investments, Accel-Rx Health Sciences Accelerator
Health sciences venture capital expertise
Mr. Lemaître-Auger is currently head of investments at Accel-Rx Health Sciences Accelerator. He brings extensive health sciences venture capital expertise to this role through his prior involvement with Desjardins Venture Capital and CDP Capital – Technology Venture (Sofinov) where he was involved in both biopharmaceutical and medical device deals. At Sofinov, he was involved in investments such as NuVasive, Inhibitex, IntraLuminal Therapeutics, Acurian, and TransMedics. While at Desjardins, he showed significant leadership in the creation and management of a profitable early-stage health sciences investment portfolio that included, amongst others, BioAxone Therapeutics, Enobia Pharma, and Tranzyme. In recent years, Frédéric was involved in project-based investments, as well as developing licensing and spin-off opportunities at MSBi Valorisation (now Aligo Innovation). He has served on the board of directors of many health sciences company and has been involved on organizing committees of conferences such as MedTech North and Advamed.
Sheryl Thingvold Senior Advisor Medical Devices, MaRS
Start-up enthusiast with an engineering and business background
As senior advisor of Health Venture Services, Sheryl Thingvold supports the medical device and diagnostics companies that work with MaRS.
Sheryl has extensive experience in the medical device field, including experience working with magnetic resonance imaging (MRI) at the National Research Council Canada in Winnipeg. She joined Toronto’s startup community with a position at Sentinelle Medical, where she developed radiofrequency coils for MRI breast imaging and biopsy applications, and assisted in scaling operations in advance of the sale of the company to Hologic. Most recently, Sheryl was one of the founding team members at Synaptive Medical, a company focused on developing and commercializing medical devices to support neurosurgery. After working on the product side, she later undertook marketing and strategy functions for the company.
Sheryl has a bachelor of science in electrical engineering from the University of Manitoba and studied antenna theory for her master’s degree in electrical engineering. She also has a master of management sciences from the University of Waterloo, where she graduated summa cum laude.