Medical Device Playbook, Canada’s premiere event for medical device professionals, is returning to the Vancouver Terminal City Club on May 23, 2018.
Industry speakers and panels from British Columbia and across North America will discuss what it takes to achieve this year’s theme: Dream a Bigger Dream. Network and learn 2018 trends, opportunities, and strategies. Entrepreneur Case Studies, Human Factors and Design, and Clinical/Regulatory advice from industry veterans.
Event includes Lunch, Breaks, and Networking Reception. All net proceeds will go to LifeSciences BC for future medtech initiatives.
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.
MITCH LEVINSON, Co-Founder, President and CEO at Cerebrotech - San Francisco
Serial Medtech entrepreneur and inventor of over 40 issued and numerous pending U.S. patents
Mitchell E. Levinson is currently President and Chief Executive Officer of Cerebrotech Medical Systems, a start-up medical device company he co-founded in 2010 focusing on noninvasive neuro-monitoring for early detection of stroke, cerebral bleeding and edema. Prior to 2010, Mr. Levinson was the start-up CEO for Zeltiq Aesthetics Inc. (the CoolSculpting company) when he became its first employee in 2005, and served as its president and its chief executive officer from September 2005 until September 2009. He continued with Zeltiq as Chief Scientific Officer from September 2009 through December 2010 to help transition the company. From March 2000 to September 2005 he served as Vice President of Research and Development of Thermage, Inc. (IPO, then acquired by Valiant), a company engaged in cosmetic tissue tightening devices. He held a similar position at BioSurgical Corp, a surgical sealant applicator company which was acquired by Baxter. Prior to that he held engineering and management positions at Nellcor, Baxter and HP. Mr. Levinson is the inventor of over 40 issued and numerous pending U.S. patents. Mr. Levinson earned his BS in Mechanical Engineering from University of California at San Diego and holds an M.S in Computer Systems from the University of Phoenix. Mr. Levinson has been a member of the board of directors at Pulse Biosciences (IPO 2016) and CryOSA, both companies focused on non-invasive tissue ablation.
Cerebrotech: A company “designed” to survive an unforgiving financing environment
Learn how I used an engineering approach to “design” my fledgling startup to survive.
MICHAEL HOEY, Co-Founder & Chief Technology Officer, NxThera - Minneapolis
Expert in thermotherapy with 72 patents granted and 94 patents pending
Michael started as an academician who taught and performed research in several departments at the University of Minnesota: Physiology, Urologic Surgery, Engineering, and Management. He also taught in the department of Biological Sciences at Hamline University in St. Paul, Minnesota. Michael is an expert in thermal energy-tissue interaction, and a prolific inventor with over 80 patents granted and more than 90 patents pending, the majority in the medical device field. Michael’s inventions include platform technologies which are the foundation for products being sold or in development for cardiac surgery, oncology, orthopaedics, pulmonology, general surgery, urology, gynecology, and vascular surgery applications. Michael has been a founder/principal/inventor for several medical products companies, which combined have raised over $500 million of capital. Two of these companies, Vessix Vascular and recently NxThera sold to Boston Scientific, and Salient Surgical sold to Medtronic. He also sold a musical products company Ontek Inc. to Kyser, and reached a distribution deal with an agricultural diagnostic’s company, ASI, to one of the largest dairy products manufactures, GEA in Germany. Two other medical device companies, Aegea and Uptake, are commercializing product. Michael is also a general partner in Solas Bio-Ventures, a venture capital fund that makes investments in early stage biotech, medical device, and pharmaceutical businesses.
Case study: Applying orthopaedics technology to urology
VIRGINIA A. LANG, President and Chief Scientist, HirLan, Inc. and HirLan International SA - Carlsbad CA
Human Factors Pioneer
Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to working at Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.
In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.
Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.
Human Factors is good business -- not an obstacle!
Jens U. Quistgaard, President and CEO Mirabilis Medica
Veteran Medtech CEO specialized in Ultrasound diagnostic and therapeutic devices
Jens U. Quistgaard is currently President and CEO of Mirabilis Medical (an approved product for non-invasive treatment of uterine fibroids) and NaviSonics (developing a guidance system for neurosurgery). Among other roles, he was formerly President and CEO of LipoSonix, Inc. (acquired by Medicis Pharmaceutical Corporation) and was a founder of SonoSite, Inc. (acquired by FujiFilm Corporation). During his career of over 25 years in medical devices, Mr. Quistgaard has raised a quite large pile of capital, and companies where he played a senior leadership role have achieved exits comprising a substantially larger pile thereof.
Mr. Quistgaard holds a BS degree in Mathematics and Computational Sciences from Stanford University, and MS and PhD degrees in Electrical Engineering from the University of Washington. He is a Director and member of the Executive Committee of Life Science Washington, Vice Chairman of the Washington State Medical Device Innovation Partnership Zone, and a member of the Electrical Engineering Advisory Board and College of Engineering Visiting Committee at the University of Washington.
Important aspects of medical device development and commercialization with the theme of risk reduction at every step of development. Topics include vetting of ideas, product and clinical development, regulatory, manufacturing, and product launch. Practical examples will be drawn throughout from the presenter’s checkered past.
KEVIN STRANGE, President and CEO at Biolux Research
20 Year veteran of Vancouver Medical Device Start-ups
BASc (1992) and MASc (1996) from Simon Fraser University, School of Engineering Science
1996 - 1998 SFU / Neurostream (Vancouver, private co) – implantable devices for stimulating and recording peripheral nerves
1998 – 2005 VSM MedTech (Vancouver, public co) - vital signs monitors and functional brain imaging
2005 – 2008 StarFish Medical (Victoria, private co) - contract medical device design and manufacturing
2008 – current Biolux Research (Vancouver, private co) - light accelerated products for dentistry – www.bioluxresearch.com
My 20 years of Medical Device Start-ups in Vancouver
All my ventures were excellent ideas / tech with great promise for improving patient’s lives. Each also had challenges common to start-ups.
PAUL WEBER, President and Chief Executive Officer Perimeter Medical Imaging - Toronto
Medical Device Marketing, International Distribution, and Business Development Expert
Mr. Weber brings extensive marketing, commercialization and international business development experience with both large multinational and growth stage medical and technology companies. Prior to joining Perimeter Medical, he led Business Development and Marketing for Covalon Technologies. In this capacity he helped to transition the company from a technology focus to a commercially focused organization, building out OEM, domestic and international distribution channels. At Sentinelle he led Business Development and Marketing, growing the company from start-up revenues to greater than $18 million in sales in 2 ½ years. After being acquired by Hologic Inc. for $105 million, Mr. Weber led Marketing, integration, and OEM and International Distribution relationships. Mr. Weber has also had leadership roles in business development and product management capacities with Johnson and Johnson, Christie Digital and has consulted for numerous technology start-ups on growth strategies. He has developed and taught MBA courses in Marketing and Commercialization of Technology and holds a BA in Psychology and an MBA from Wilfrid Laurier University.
Critical partnering considerations with case study illustration
Hon. George Chow
Minister of State for Trade, British Columbia
George Chow was sworn in as British Columbia’s Minister of State for Trade on July 18, 2017, and was elected MLA for Vancouver-Fraserview on May 9, 2017.
The Minister of State for Trade is responsible for helping execute provincial trade initiatives and the delivery of trade programs in support of the mandate for the Ministry of Jobs, Trade and Technology. The Minister of State’s role includes aiding in the promotion of global opportunities for B.C. businesses, unlocking new markets, creating jobs for British Columbians, and ensuring the future prosperity of B.C.’s economy. The Minister of State’s portfolio includes strengthening the provincial economy through strategic partnerships. Additional priorities include expanding export opportunities in the manufacturing, agriculture, and value-added wood sectors; capacity building for trade promotion; promoting the tourism sector on trade missions; and advocating for trade deals in softwood lumber negotiations with the United States and Mexico that protect B.C.’s interests.
Minister of State Chow was born in China and completed primary school in Hong Kong prior to settling in Vancouver in 1965. He graduated from UBC in mechanical engineering in 1975 and had a 30-year career with BC Hydro in power generation before serving two terms on Vancouver City Council from 2005 to 2011.
He enjoys being very active within his community and has served on many community organizations as a volunteer.
The Minister of State is a member of the Association of Professional Engineers and Geoscientists of BC and a Fellow of Engineers Canada.
Doug Goertzen is the CEO of Kardium, a medical device company with a team of 120 developing an advanced ablation catheter for the treatment of atrial fibrillation. Doug has led the company since it was founded in 2007. Prior to Kardium, Doug held the position of General Manager, Proofing and Color at Eastman Kodak Company. Doug was responsible for the $55 million worldwide proofing and colour business and managed a 130 person team developing the proofing and colour product portfolio. He held senior positions in service, development and management during his 12 year tenure at Kodak and Creo Inc. (which was acquired by Kodak in 2005). Doug graduated with a B.A.Sc. in electrical engineering from Simon Fraser University.
Kardium – The journey of transforming a naïve idea into a commercial medical device
Exciting, frustrating, exhilarating, painful, and gratifying story of how the Kardium team created the most advanced therapeutic catheter ever.
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 17 years of experience in the R&D and QA fields, Vesna ensures that your StarFish project successfully meets and exceeds industry standards.
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.
What it takes to build a $100M Medical Device Product or Company
DR. LESLEY ESFORD, President & CEO, LifeSciences British Columbia
Academia, industry and government leader supporting the growth of the Life Sciences sector
Lesley received her PhD in Microbiology and Immunology from UBC and has spent many years in academia, industry and government in positions supporting the growth of the Life Sciences sector. Since 2006, she has worked as an ITA for NRC-IRAP, helping over 100 entrepreneurs developing a wide array of products and services, at every stage of the innovation process, from concept to commercialization. Lesley is a Kauffman Fellow, which is a Silicon Valley-based international leadership program for venture capitalists and innovators.
Ms. Wandler draws on over 20 years experience as a health sciences executive and as an entrepreneur in the role of Director, Partnerships and Programs for Accel-Rx Health Sciences Accelerator. Her background includes executive positions at Canadian biotech QLT Inc. as VP of Corporate Communications & Investor Relations and as VP of Business Development; and senior positions in market research, brand management and sales with the multinational Abbvie.
In addition to her corporate experience, Ms. Wandler has enjoyed success as an entrepreneur and business consultant. She built and ran a successful retail business for eight years that consistently ranked number 1 in consumer polls before being sold. As a consultant she provided business development, strategic planning, marketing and communications guidance to companies in a variety of sectors.
She received received her bachelor’s degree in sciences (biochemistry) from the University of Alberta and an MBA from the University of British Columbia.
JAMES JACKSON, Industrial Designer, StarFish Medical
Designed 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?
FDA Guidance Finder
Terminal City Club
837 W Hastings Street
Vancouver BC V6C 1B6
The 2017 events in Toronto and Vancouver were a hit with 450+ participants, speakers, and sponsors. Veteran speakers providing industry insights and experience joined rooms full of the medical device entrepreneurs to exchange ideas and business cards in a day-long event designed specifically for local medtech innovators.
92% would recommend the event to friends
“It is the only ‘conference’ of its type in Canada. I really enjoyed that it was all about the business and commercialization aspects of the health-tech industry and not heavily based on technology.”