2 DAY WORKSHOPS.
Our 2 Day Workshops are ideally suited to managers, executives, CEOs, COOs, etc. They focus on higher level strategies and are condensed down to two days to fit with busy schedules and travel.
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- Brief overview of medical device development. Regulatory overview, implications of different regulatory bodies, their needs and effect on clinical strategy. Should include differences between 510k, PMA, CE and notified bodies. New focuses from MDR over MDD…..
- Regulatory strategies and how to navigate them based on commercial/business drivers (classifications, time, clinical strategy, etc). Run through some examples of different technologies and what risk they add to the pathway – or what the pathway adds to them.
- Product development – outsourcing or internal team. How to manage the QMS in these different models. Mock examples of different technologies and the implications on development risk – what areas to focus on and de-risk early. MVP discussions could be in this area.
- Making sure that the development is aligned with regulatory and commercial strategies. This is where the MVP fits in. Making sure that all areas of the program align and focus on funding strategy, path to market, etc.
- Contracts – vendors, suppliers, supply chain requirements throughout the lifecycle… how the burden changes through the lifecycle, etc.
- Could also include a bit on IP strategy. I don’t have deep expertise but certainly know concepts and approaches, especially for how to navigate and learn from existing IP. I think as this evolves I would bring in experts to give more input into generating new IP.