Medical Device Daily National Editor

If you're old enough, you may have put together components for a great "hi-fi" system (that's high fidelity to you youngsters): tweeters and woofers and big speakers (or were the speakers the tweeters and woofers? – I don't remember), hitching these to some complicated electronics.

But then companies put all those pieces-parts together, so that listening to those big vinyl discs (records, to you youngsters) got a lot easier.

And that's very much what Texcel (East Longmeadow, Massachusetts) has done for medical device manufacturers making implantable stimulation devices.

Creating an integrated system for pushing forward the R&D of these technologies was the thinking of Texcel, a company that has worked in the medical device industry for 21 years, according to Keith Checca, and in the "active implantable devices industry" for more than 10 years.

Checca, director of business development for Texcel, tells Medical Device Daily that the company "had this idea for awhile. We were supplying kits and materials and customizing as we went for the last few years or so. And our customers would ask, 'Do you have something off the shelf?' We said, 'No, but we can get there.'"

And as a result of its experience in creating these component parts, Checca says, Texcel developed the StimX to give "quick data, data incredibly valuable to the companies we work with."

Calling the Stim X the "the industry's first truly programmable, implantable customizable platform" for early testing of implantable electronic therapies, the company designed the device to have a wide range of test abilities – based on the parameters of currently available devices in this arena, Checca says – but making it programmable, thus customizable, for the particular effects being tested.

"Most of the devices that are used in implantable neurostimulation are within a certain range of output and a certain voltage and a certain length of time," he says. "We looked at the general applications out there and picked something in the middle, and then it has the programmable ability to be able to use upper and lower edges of what that hardware can handle."

The device itself includes an implantable stimulator, a laptop and output customization program, wireless communication, and charging modules.

Looking somewhat like a pacemaker, the stimulator is implanted in the animal's body, with leads then directed to a nerve or muscle or other tissue to be stimulated. Because the animal then wakes and continues regular active moments, the research can measure that effect "over a period of time," Checca notes.

He says the combined research/business goal for the device – to cost in the range of $50,000, with the company issuing a cost sheet today, he said – is to free researchers "from the hours and dollars that they'd otherwise invest in designing and developing their own devices – and to literally re-allocate their resources back into their research.

"It builds data, provides the additional information to continue the research. For venture-funded companies, it gives the data they need to determine if they should spend the money to move forward."

Among the possible applications for the device, Texcel says, are direct nerve and brain stimulation, strategies used for devices to treat such conditions as epilepsy, Parkinson's disease and clinical depressions.

The system enables the testing of a specific simulating effect, Checca notes, though there may be cases – "rare," he says – in which both an implantable device under development and the StimX would both be implanted.

The StimX is not only a platform for research but offers what might be called a platform for Taxcel.

The device, he says, offers "a starting point – hopefully gets us connected with customers that we can do additional work for."

Plus, "There's good consideration that this isn't the only product we'll launch like this." And he says as the active implantable stimulation market moves forward, "there will be advances in some of the electronics and connections and all the other areas around these devices."

Thus, future StimX-type devices will be "updated, smaller, more powerful, more flexible ... and have the good ability to cover a wider range of parameters, and a wider range of testing options."

If companies want similar devices for human research, they won't be using the StimX in its current form, but something built on this platform and customized to human use, a strategy, Checca says, that "is what we do now."

He acknowledges that the market opportunity for the StimX isn't huge, but that the device would be highly useful in "several dozen" projects the company currently is involved with, as well as for newly launched companies each year in the dozen range, and opportunities in "university research and university hospital level, and doctors" looking to develop new products.

And Checca sees the active stimulation sector one in which Texcel finds an opportunistic fit.

"We've been kind of riding that wave when it wasn't even a wave, and now it's gaining some momentum," he says. "Because we can help [these companies] move in the right direction, we're committed to this space and involvement in this technology."