Thomas says he’s hoping someone will make it so he can hoist a bottle of beer. 🙂 Introduces Megan Moynahan, who’s here from Case Western in Ohio.
Story: In ’97, there was a thing launched into the market called NeuroControl Freehand. It started in ’86. They eventually did dozens of patients and created a product that really did allow people to pick up a bottle of beer … and their sales were matching things like cochlear implants. But the investors were expecting more sales, so the project ended and NeuroControl went out of business. It’s used as a case study now for what not to do.
What went wrong? Hospitals took a loss on every implant — as much as $25k. There was a slow uptake of technology, tho’ that should have been anticipated. There was always turnover in leadership — multiple CEOs over a few years.
There’s a guy in Germany who had one of these things implanted who used it every day for 20 years before it failed, and was able to get a new one in 2006 — but that’s unusual. When a company fails, it’s the customers who get screwed. Some have described this being like getting paralyzed all over again.
So where is this thing today? The Institute for Functional Restoration at Case Western is building out a new product that (I think?) is called the Networked Neuroprothesis. It’s being prepared for a clinical trial now. She’s got a slide up that’s about all the things that have to happen in order to get a medical device onto a commercial market. The left-most column has R and D, Intellectual Property, Business Development, Regulatory, Marketing, Manufacture and Production, and Coverage and Reimbursement.
And each one of those lines has its own path to its own endpoint, which means that the ongoing set of handoffs is ridiculously complex. What that means is that — in a small market like ours — all kinds of anticipating of the hand off is going to be an absolute necessity.
They have a strategy for commercialization that takes all this into account. They don’t look like a research org right now — they look like a small business doing device manufacturing, except they’re doing it completely with grants and philanthropic money.
Because investors must get return on their dollars. It’s their job. That’s why the promising neural stem cell trials we just heard about got the axe — because they were funded by investors.
It’s challenging, though. There’s not an unlimited supply of grant/philanthropy dough to make this happen.
So why do they have confidence in this project? Still no cure. Huge need for something that works. Some things have changed … they’ve learned a ton from earlier trials and products. These devices can function for decades — they already have functioned for decades. They’ve moved way past the hoist a beer goal, too. Trunk control. Bladder control. And others.
What should advocates be doing? Make our voices heard at the FDA. They’ve got a program that invites patient participation. Patient preferences need to be baked into the clinical trials process at the outset, not the end. The Michael J Fox foundation partnership shaped statistical analysis of clinical trials to reduce the risk that an effective therapy might be rejected. One place this can happen is in the size of the required sample.
Summary: they want to commercialize their product. They’re directly addressing business lessons learned from the past. They’re using grants an d philanthropy. They’re working with patient groups. That’s US.
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