Elizabeth Hofheinz, M.P.H., M.Ed.
In today’s tight climate, there is less room than ever for wasted effort. However, many medical device companies get lost along the product development path and run into brick walls…and sometimes that wall reads “FDA.”
There is a company in the Netherlands, however, that has proven adept at piloting startups through the labyrinth of company and product development and over many obstacles. Indeed, you might say that BAAT Medical Products is the Alpha and Omega when it comes to bringing medical innovations to market.
“In the days of old,” says Gert Nijenbanning, M.Sc., Ph.D., Managing Director of BAAT Medical, “a physician and an engineer would approach one of the companies with an idea. For the most part, those days are gone. Now, the big companies have largely stopped doing product development for themselves, which is good news for startups as there is substantially more opportunity for them in the marketplace.”
Great…so where is the problem?
“The majority of startups are laser-focused on their product and don’t widen the lens to address business-related issues,” states Nijenbanning, who grew BAAT Medical out of his alma mater, the University of Twente. “Typically, startups have no clear ideas about what a multinational company demands in the way of healthcare compliance, validation, manufacturing scalability, etc. And these smaller companies are ill prepared to contend with the demands of obtaining CE certification (CE Mark) or the challenges of going through the FDA approval process for medical devices.”
But the medical device engineers at BAAT specialize in chaperoning an idea from conception to the last FDA handshake. “Increasingly, big device companies are sourcing things out to reliable partners who take over the product and sell it in their own distribution chain. This is just one aspect of a multilayered, complex process.”
So how does BAAT Medical use its expertise for startups?
BAAT begins with the client’s idea…their concept. “We follow their lead and help make their vision a reality,” says Nijenbanning. “We start out with a validation plan, looking into the real costs involved in developing a given product—because it’s always more expensive than people think it’s going to be. We also ask, ‘What risks are actually associated with this product and how can we lower them?’”
“This is followed by a design phase (special for medical device design), where we begin with getting all potential objections on the table. For example, one concern raised about a particular 3D printed cage was, ‘You can’t clean it.’ However, we performed the appropriate tests and found that this was not true. Following this ‘objection roundtable,’ we define the manufacturing chain, clinical pathway and which tests are needed for validation.”
The must haves and the nice to haves
With a full 80% of funding going toward engineering validation, sates Nijenbanning, it is critical that this phase progresses smoothly. “Because we have put all of the production of the instruments and implants in place, the engineering validation process is a well-oiled machine. In this and other ways we save time for startups. Also, because of our extensive background with FDA submissions, BAAT Medical knows the right amount of information to provide them—not too much, not too little. This is an important and underappreciated skill for medical device consulting. At the same time, we can view the development process from the customer’s viewpoint…we know what needs to be done now and what can wait…we know what is necessary and what is ‘nice to have.’”
So that your idea and ultimate product will not be a flash in the pan, BAAT Medical puts each potential product through a “reframing” process. “Some products look promising in the short-term but won’t be relevant in the mid- or long-term period, which is perhaps 3-4 years out.”
During this two-month reframing process, says Nijenbanning, clients start out with one idea and typically see it evolve into something else.
“Reframing gives the client a way to choose where in the product you want to intervene. For example, we recently put a scoliosis brace through this process. The company was initially thinking about the brace in a conventional manner, but as it turned out, it was not the brace what matters but the way patients behave in it. During puberty, no one wants to wear a brace, so they need motivation. We had to think more along the lines of making it more comfortable. If you are just comparing the old one to the new one, then yes, your improved brace is nice. But, if yours is the first of its kind, then you still have a problem because that’s not enough. So we determined that any innovation couldn’t be at that point…we needed a brace together with a system that helps monitor patient results.”
BAAT Medical steps into the gulf between what big companies want and smaller companies need. “So often, startups don’t realize that once the development is done, it is very challenging to manufacture, solve the related issues, and deal with the FDA. They think that this process is, ‘Push a button and sales come out.’”
In using BAAT, startups don’t have to develop detailed systems, handle maintenance, contend with product liability issues, traceability, and ERP system, having a sterile environment, or warehousing. They only have to focus on selling.
“We know what J&J wants”
“Startups are essentially selling proof that their product works…they are selling their clinical data. The large companies take full control of a startup’s existing manufacturing. BAAT Medical will maintain a contract with a startup and scale up with them. The critical thing is that if the manufacturing process chain is not well validated then a large company won’t buy the startup. At BAAT, we know what the ‘J&Js’ expect, and we take that risk away from the smaller companies.”