Asked a medical device supply chain expert about the ventilator shortage problem. Can companies like Tesla or GM help?
Here's what they said.
1) Firstly, med device companies need to share their blueprint so the companies with supply chains locally can replicate those parts.
Here's what they said.
1) Firstly, med device companies need to share their blueprint so the companies with supply chains locally can replicate those parts.
2) They would need some kind of assurance for the sake of their lawyers that this access to blueprints would be temporary, and wouldn't impact their business long-term.
3) The FDA would need to come up with a new set of guidelines, which potentially relax the rules while ensuring patient safety/efficacy of the product.
4) The key would then be to access the important parts from different suppliers. The vent companies would need to say what they need, whether it's tooling, plastics or metals. Someone needs to coordinate that so testing/QA still goes through the med device companies.
5) The end result isn't ventilators that are just basic pumps with fans. You still need the feedback loops and the control systems, or medical personnel won't know how to use them.
6) If done right, this expert thinks that a lot could get done in two weeks. But the med device companies and the regulators would need to start thinking about this today.
7) That's all. Bear in mind it's one person's perspective. But I found it helpful talking to someone with a decade of experience in medical device supply chains, so passing along.
