If you thought getting your technology ready for clinical testing or through Standards compliance was a challenge….the best is yet to come! The route to market for Medical technologies involves understanding and navigating complex pathways for regulatory, reimbursement and health technology assessment, in pursuit of coding, coverage and payment.
For countries such as Israel, Switzerland, and Canada, the home market is so small that the focus must be on export to the US, EU, Asia and developing markets. Unfortunately, if your home market is not a leading adopter of innovation, that makes the challenge even more difficult. In addition, traditionally relaxed EU is becoming more stringent, and the historically complex US has become even more complex!
This talk outlines these challenges in addressing complex international market access pathways, as well as some evolving tools and reason for optimism, especially in Ontario. Some of the topics discussed will include, the typical path to market for Medtech products, variations across markets and why selecting the right market is critical, Increasing use of HTA, the “punitive gate to reimbursement”, MaRS EXCITE, and its innovative approach in Ontario and Optimism in Ontario: OBI, OHIC and Innovation Procurement changing how the health system pursues innovation.
John Soloninka has over 24 years of experience in medical technology consulting and company formation, growth and management. He graduated from Queen’s University in engineering physics in 1981 and worked several years in aerospace engineering before earning an MBA, with distinction, from the University of London in England in 1986. Over his career, he has led major projects in health system transformation, biopharma/device development and regulation, health IT, disease management, clinical trials, clinical genomics and venture capital for Price Waterhouse, Soloninka and Associates and IBM. Mr. Soloninka was a founder, senior executive and leader in startup companies in oncology, radiology and electronic medical records (EMR) and clinical trials that were variously sold to US firms Varian Medical Systems, Merge Technologies and Assistmed. He came to HTX from his role as Healthcare Practice Lead for IBM Global Business Services in Ontario. He was appointed President and CEO of HTX in July 2010 and is currently a director and advisory board member of CIMTEC (the Centre for Imaging Technology and Commercialization), the Ontario Brain Institute (OBI), HTX, EXCITE, CHWP (Connected Health and Wellness Project), DFATD Life Sciences, Baycrest Centre and Baycrest Research Advisory Committee (RAC).