4 DAY WORKSHOPS.

Our 4 Day Workshops are ideally suited to managers, executives, CEOs, COOs, etc. They focus on higher level strategies. These workshops are a longer program that goes into more detail across four or five days.

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  • As the two day program starts, go into the overview of medical device development. How it has evolved and the implications of getting new technology to market. This leads well into MVP discussion and effective ways to get to market. Work through some examples.
  • Discuss regulatory as per two day workshop. But also add some work examples.
  • Discuss product development models. Internal teams, outsourcing. Risks, pros/cons. Way to manage external vendors and contracts. I think the RFP suggestions you made fit well into this. This is a critical part of the process.
  • Then spend some dedicated days working through parts of product development with examples:
  • QMS – when to start. How to start. Impact of different regulatory pathways on how the QMS should be setup and when. Look at some examples and work through a few different scenarios and examples from the group. I also agree that “what is a DHF/DMR/DHR” is critical. I just found out that one of my clients were led down the wrong path on that by a reg “expert” and started working on a DMR when they are in initial prototyping phase. 😯
  • Review some products/technology. Carry out high level risk assessment brainstorm on whiteboard and discuss areas to focus on. Work through how this should be managed as part of the development process. Get some examples from group and work through ways to manage this.
  • Spend some time on software development. Regulations and what they mean (62304). Efficient ways to progress with medical device software development. Ways to reduce regulatory burden with architectural choices. Integration and working with hardware teams. A quick discussion on software in manufacturing – programming devices in manufacturing, releasing to manufacture, software versioning control, etc.
  • Designing to standards and the regulations. Pitfalls and lessons learnt. Models to follow to reduce risk through this process. EMC, 60601 safety. How specific and collateral standards fit into this. I have tree diagram that shows how this is broken down.
  • In-line with your designing for strategic partners suggestion I think working through examples of feeding into companies product roadmaps. Aligning with these for licensing, acquisition or just supplying your device as an OEM supplier. How to work with that company and dealing with integrating any parts of their existing products (software, etc) into your product. Impact of integrating with certified products or incorporating certified components into the device.
  • Transfer to manufacture. When, what to do through the process. Who does what? Risks and issues with who does what and defining the split. Work through a worked example. This is a good time to bring the DHF/DMR discussions into practice to show the differences. Outsourcing model vs setting up internal manufacturing.