Welcome to Medical Device
Commercialization Playbook 2017 TORONTO
Medical Device Commercialization Playbook 2017, Canada’s premiere innovation and commercialization event for medical device professionals, is coming to the MaRS Discovery District on March 30, 2017. A full day of industry speakers and panels from across North America discuss what it takes to Get The Product Right.
Network with industry veterans and learn 2017 Entrepreneurial Strategy for Innovation, Getting the Product Right, Deal-making, and Navigating the Clinical/Regulatory Environment.
Co-Founder and Chief Technology Architect HemoSonics, LLC, Director of Engineering Entrepreneurial Ventures at Duke University
Bill Walker founded HemoSonics to revolutionize the diagnosis of clotting dysfunction. To date we have raised over $9mm in grants and angel investment, built a series of prototypes, and evaluated the technology in over 270 human subjects.
Bringing ultrasound innovation to market – Hemosonics and Pocketsonics
CEO 2C Tech Corporation, CEO LensGen
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.
Going after the holy grail of ophthalmology – The Lensgen story
Chairman and CEO Claris Healthcare Inc.
Geof has more than 30 years of experience in the medical device field. He was part of the Vancouver-based team that built and tested the world’s first robot specifically designed to assist in surgery, then went on to develop a number of other medical technologies, including surgical tools for laparoscopic surgery, surgical limb positioning, blood sample handling equipment, apparatus for total knee arthroplasty and surgical drapes.
In 1997, Geof co-founded Neoteric Technology Ltd. Neoteric developed and commercialized technologies for ensuring the correct storage, tracking, handling and administration of blood for transfusion in hospitals. This technology, BloodTrack®, is now in daily use in hospitals in the UK, Canada, US, Australia and the EU. In 2009, Neoteric Technology Ltd. was sold to Haemonetics Corporation of Braintree Massachusetts (NYSE:HAE). Geof left Haemonetics in 2011 to co-found Claris Healthcare Inc. Claris provides Claris Companion, a communications hub that engages seniors in Internet communication and promotes aging in place.
Awni Ayoubi has over thirty years of engineering, management and product / business development experience. He is Principal Co-Founder and Co-Developer of Saturn Biomedical and the GlideScope® Video Laryngoscope (Acquired by Verathon – Jan. 2006). Mr. Ayoubi is Principal Co-Founder and Co-Developer of Rostrum Biomedical and the VQm® Enthalpy Monitor.
Rostrum Medical is a registered, privately held Canadian corporation, based in Vancouver. It commenced its operations in 2009 with a long-term goal to develop and commercialize unique solutions for patient care.
Ayoubi created Saturn in Saturn in 1998 and then successfully, in collaboration with a surgeon, developed and commercialized the GlideScope® Video Laryngoscope.
Breaking into a new market by creating a market niche – The story of Glidescope
CEO CellAegis Devices Inc.
Mr. Ganske joined CellAegis in December 2010 as the CEO after having participated on the CellAegis Board of Directors for a year. Mr. Ganske has over 30 years of both public and private company experience in the medical devices, diagnostics and life science fields, and has a broad background in management, operations, science and regulatory; blended with the disciplines of corporate processes, and successful entrepreneurial business ventures. Mr. Ganske has personally led multiple business and IP transactions with both Fortune 100 and Fortune 500 companies.
Prior to CDI, Mr. Ganske served as CEO of Axela, a university diagnostics startup focused on proteomic analysis. Mr. Ganske transitioned Axela to a full operating company, installing Axela’s platform technology in premier institutes in the US, EU and Asia Pacific. Mr. Ganske was instrumental in negotiating and closing significant patent in-licensing transaction with Fortune 100 companies for over 150 patents and applications and oversaw Axela’s acquisition of Xceed Molecular, a genomics diagnostic company.
How to use clinical trials to get your product right without spending a fortune
CEO of Elenza, Executive Chairman of Establishment Labs Holdings, Inc. (ELHI), Executive Chairman of OptiStent, Inc. and Executive Chairman of LAFORGE Optical, Inc.
Rudy A. Mazzocchi is an American entrepreneur and author. In 1989 he founded the firm Microvena, which he built into a company valued at over $170 million. After this he founded and then sold additional companies including Vascular Science, Inc., CytoGenesis, Inc. and Image-Guided Neurologics. He is currently the CEO of Elenza, Executive Chairman of Establishment Labs Holdings, Inc. (ELHI), Executive Chairman of OptiStent, Inc. and Executive Chairman of LAFORGE Optical, Inc. In 2012, published the award-winning novel Equity of Evil. He is the author of over 70 patents.
Good, Bad and Ugly: Product commercialization twists from my 6 medtech start-ups
Co-Founder & Chief Technology Officer, NxThera
Michael co-founded NxThera in 2008 to develop and commercialize the urology applications of the vapor platform technology that he invented. Michael has been a director and chief technology officer since NxThera’s inception. Prior to becoming an entrepreneur, Michael taught in several departments and performed research at the University of Minnesota, including the Department of Physiology, the Department of Urologic Surgery in the School of Medicine, the Institute of Technology, and the Carlson School of Management. Professor Hoey also taught in the department of Biological Sciences at Hamline University in St. Paul, Minnesota. Michael is an expert in the interaction of thermotherapy and tissue and a prolific inventor, with 72 patents granted and 94 patents pending, the majority of which are in the medical device field.
Michael’s inventions include platform technologies, which are the foundation for products being sold, or in development for a variety of cardiac surgery, oncology, orthopaedics, pulmonology, general surgery, urology, gynecology, and vascular surgery applications. Michael has been a consultant to, as well as a founder/principal of, several medical products companies, which combined have raised over $250 million of capital.
Are you limiting your platform's potential? Applying orthopaedics technology to urology
Former Senior Policy Advisor at FDA/CDRH/Office of Compliance FDA/Center for Devices/Office of Compliance
David Kalins served as senior regulatory advisor, internal consultant as an experienced contributor in the 200-person Office of Compliance. Support the OC Director, Center for Devices and Radiological Health in carrying out diverse responsibilities related to implementation, compliance and enforcement of Agency's highly complex laws, regulations, policies, procedures and programs supporting the safety and effectiveness of marketed medical devices.
Executive Director, Scientific Affairs, Late Phase and Clinical Diagnostic Services, PRA Health Sciences
Kathleen Mandziuk, MPH, RN, Executive Director, Scientific Affairs, Late Phase Services, has a professional research career almost exclusively in late phase development and observational research. Following her nursing training, Ms Mandziuk joined the pharmaceutical industry as a clinical data coordinator and enjoyed a variety of management positions in the late phase group of another large CRO. In these roles, she managed the data aspects of several large global post-approval and biomarker/diagnostic projects from planning to analysis. Her responsibilities included overall strategic planning, daily operational supervision, upper management communications, and mentoring activities to several departments/units. Following her success in data management, Ms Mandziuk transitioned into a project manager position and was responsible for the overall management of post-approval projects, specializing in large national and international post-marketing and registry programs. She managed several programs ranging in size from 60 to 18,000 patients in a number of countries (US, Canada, Europe, Central/South America, and Asia) and therapeutic areas (CNS, oncology, dermatology, gastroenterology, women’s health, ophthalmology, and men’s health).
The New Finish Line: Case studies in designing clinical trials for both clinical and marketing impact
President and Chief Executive Officer Perimeter Medical Imaging
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.
Founder and CEO, StarFish Medical, Creator Medical Device Commercialization Playbook
Scott Phillips is CEO of the StarFish group of companies, including StarFish Medical and ViVitro Labs Inc. Known for being an entrepreneur and for helping entrepreneurs, Scott graduated in engineering physics from the University of British Columbia and holds 17 patents. StarFish Medical is Canada's largest medical device development services provider a 2014/2015 Profit 500 ranked fastest growing company, and winner of the 2016 Business Excellence Technology Business of the Year and 2016 VIATEC Team of the Year award.
Daryl oversees operations and consulting for Emergo offices in Canada. He has more than 20 years of experience in the medical device industry, with expertise in Medical Device Licensing in Canada and 510(k) submissions. s consulting position. He has been Partner of Wisdahl Consulting Group, and Director of RA/QA of Urodynamix Technologies Ltd., where he was a senior manager with responsibility for setting up the quality system, and clinical research as well as regulatory strategy for the Non-Invasive Urodynamics (NIU) system.
Panel: The impact of the next ISO13485:2016 standard
Director of QA/RA StarFish Medical
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.
Panel: The impact of the next ISO13485:2016 standard
President, IPD Inc.
Joel Ironstone is the president of IPD, a medical device consulting firm that helps its customers commercialize new health care products. Joel is a medical device development expert. He has brought several complex medical and healthcare products from concept to commercialization including over 25 successful FDA, Health Canada, and CE Applications. He is a prolific inventor in the fields of women’s health, minimally invasive surgery, pain management, and hospital products with dozens of issued and pending patents including multiple successful licences and technology acquisitions. He has held positons as CEO, Lead Engineer, VP Product Development, Direct of Operations, as well as VP Clinical and Regulatory Affairs for a variety of small and medium sized medical device companies
Panel: The impact of the next ISO13485:2016 standard
MARS Discover District
MaRS Centre, South Tower
101 College Street, Suite 100
Toronto, ON M5G 1L7
Last year’s events in Toronto and Vancouver were a hit with 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.
From a post-event survey:
91% of Medical Device company attendees found the event Extremely Useful
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.”