The story of most medical devices begins with a problem more than a product. Someone close to a clinical procedure notices an unresolved issue and sees a way to fix it. They sketch it. Maybe they can build a rough version. And now what?
This is the story of one idea and how Turner MedTech guided it on the journey from a bench prototype to a production-ready medical device. The company and product remain in stealth mode until launch, but here is the process, presented as a loose case study that demonstrates how Turner adapted to the specific needs of this Inventor and his idea.
Let’s start at ‘Alpha’
The Inventor arrived at Turner MedTech with exactly what Turner expected. “When he brought the idea to us, he already had what I would call an alpha prototype,” says Charles Jensen, Turner MedTech’s vice president and general manager. “A proof of concept.”
An alpha shows how the idea might work. Of course, it does not prove the idea can be built to scale, sold, or trusted in a clinical setting.
Putting the Product Before the Regulatory Path
Rather than just build a better prototype, Turner had a few significant ideas on how that should come together. The Inventor believed the device was simple enough to sit outside the FDA’s reach. Turner’s regulatory review saw it differently. Because the device instructs a patient during a procedure, it is part of that procedure — it is, in Turner’s words, “telling the patient what to do, when to do it” — and a product like that is generally regulated as a medical device.
Rather than a roadblock, Turner saw a design input. Its advice was to build the device to Class I standards from the start — the documentation, design controls, and testing that prove a device does what it claims. Because most Class I devices are exempt from premarket review, building to the standard costs little, and it leaves registration as a business decision the Inventor can make when the market calls for it, rather than a costly redesign after the fact.
“All of the things that would be required for the FDA, we’re doing all of those, including the verification and validation,” Jensen says. The device is being built to pass if it is ever submitted, ready either way.
Quality, Cost, or Schedule — Pick Two
Early on, every project runs into the same triple constraint: quality, cost, and schedule — you can have any two, but rarely all three. This inventor wanted speed without cutting corners on quality, which left one place to give: cost. “You can throw more resources at it to do it faster,” Jensen says, “but the cost goes up to compress the schedule.” In this case, Turner and the Inventor answered the questions and backed up their accelerated goals by adding resources. “Basically, the right solution was to hire another engineer to make this go faster,” Jensen says, “And with our position in the contract manufacturing world, we were able to do so efficiently.”
Making It Twice
That next stage — the beta build — is where the real puzzle starts, and most of it comes down to components and complexity. “It’s fairly simple to build something once,” Jensen notes. “Making it repeatable for manufacturing is part of this next step.”
An alpha can lean on off-the-shelf parts. A production device often cannot. For example, in this device, “we needed to design an electronics board that is custom,” Jensen says.
“It is all about requirements,” he says. A project is defined early by what the user — and, in many cases, the regulatory agencies — require. Those translate into design requirements that are built into the device. The final stage, verification and validation, tests the design to ensure that all requirements are met.
Ready On Every Level
By the time you read this article, the product will be on its way to commercialization. In fact, the Inventor is already doing marketing and pre-sales work.
What began as a rough sketch on a workbench now has a solid foundation. The requirements have been met, components sourced, and the manufacturing process is in place to repeatably build this device to spec for the current market and, if need be, for the FDA, whenever the business calls for it.
As CEO, Clark Turner puts it, the partnership “really allows him to focus on invention, and figuring out the next thing, and selling.”