In Hollywood films inventors are often portrayed as mad-eyed, wild-haired eccentrics doomed to years of glorious failure. Thankfully the reality tends to be more prosaic, particularly within the medical devices industry.
Usually, it will be the hard-working dedicated clinicians who have spent years working on the patient frontline or engineers and academics grafting away unsung in a lab who suddenly get struck by a moment of inspiration.
That is precisely what happened to Oz Harmanli, director of urogynecology and pelvic surgery at Baystate Medical Center in Springfield, Massachusetts, US, who in 2008 came up with an idea for an innovative device to treat women who have problems with pelvic floor support or have a herniation through the vagina.
“Often clinicians come up with ideas when they are treating patients,” says Harmanli. “Essentially, what I have developed is a pessary – a device to keep the bulge in place – but it is a much more user-friendly device.
“I started off simply by drawing a picture of the device and how it might look and work. I knew there was a need for such a device on the market.”
After the innovation
In many respects having the idea is the easy bit. The next challenge is getting it to market. This is a process that can be fraught with difficulties, including obtaining finance, with securing funding to make a prototype the first hurdle to be approached. Then there will be the need to ensure the device is fit for purpose, the grind of taking it through clinical trials and securing regulatory approval, along with the stress of further funding rounds and negotiations to secure investment and contracts for the manufacture, production or distribution of the product.
Unless you are extremely lucky or well-connected, the one thing you can be almost certain of is that developing a new medical device will not be a fast track to automatic riches. This is why securing the right contract service provider can be such a vital part of the process of getting a device to market.
A good contract service provider can take over the technical manufacture of the prototype, provide access to funding, business expertise or an understanding of the targeted medical market.
“The key thing to look for is simply capability,” says Steve McCarthy, co-director of the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and University of Massachusetts Worcester. “Can the contract service provider do what it says it can do? One thing that sets us apart is that we can call on the expertise of a large academic team. So, with medical devices, many of which will use specialised technology, we can reach out to professors who have the right expertise in that area. Not everyone has that ability to match the expertise to the inventor.
“If you are a small contract service provider employing, say, three people, as the inventor you are going to have to be very lucky to find that one of them has the expertise to match your product. What you want to avoid is having a contract service provider that is learning the process or the technology as it goes along.”
It was to M2D2 that Harmanli turned to start getting the momentum going to bring his (as yet still unnamed) product to market.
“Because I work in a university hospital my contract says that if I have an idea I need to go and speak to them about it,” he says. “They were interested in it and could see it had potential and so wanted to become my partner, which was great. They liked it and we filed a patent, back in 2008, which is still working through.”
Finance and prototypes
The first challenge was securing funding. Harmanli decided to apply for a state grant for start-ups, but he did not get it. Then he developed a relationship with UML and the M2D2 programme.
“I had some meetings with them and they found me some alternate funding through a number of foundations,” he says.
“Having an organisation like M2D2 behind me has made a big difference. I did not really know where to start and my hospital is not a hub for new innovation – it is a big community hospital and so does not necessarily have that much experience when it comes to developing and marketing new products.”
M2D2 brought in PhD students to start designing a few prototypes and they now have a prototype that is very close to completion. They also helped Harmanli with presenting the project to potential investors.
“They know all kinds of people who might be interested in particular products,” explains Harmanli.
M2D2 and Harmanli are in negotiations with Cooper Surgical, which is the largest pessary maker in US, with a 66% share of the market about the possibility of Cooper Surgical licensing the product.
“Until we started the relationship with M2D2 we really did not know what we were doing,” says Harmanli.
Business and marketing expertise
The fact that M2D2 was also able to link Harmanli with potential investors was hugely important, as was the way it helped with the development of prototypes and sourcing funding.
“When it comes to funding, if a product is very high risk, yet is also likely to satisfy a high need, then we tend to try and help the inventor access government funding, for which there are quite a few specific programmes available,” says M2D2’s McCarthy. “If it is a product that has a lower level of risk then what we try to do is use our academic staff to develop prototypes that can then be taken to potential venture capitalist investors.”
M2D2 will make a scan of the marketplace to check there are not other inventors working on, or already on the market with, similar products and inventions. Similarly, it can look to check that the market is not already overcrowded with similar products or that there are not patents overlapping which may create a headache when further down the line.
“Ideally you need to have three different types of expertise: business and marketing expertise, medical expertise (to know whether it will be accepted by doctors) and engineering knowledge, so to know how actually to make or develop that product,” says McCarthy. “Often as an inventor you might have one or even two of these, but normally at least one of them will be missing. So that is what you need a contract service provider to do, to meet that demand for expertise.
“We have a lot of doctors who come to us who have identified a product and a need but have no idea how to produce it, make it functional and legal or how market it. We also get engineers who know the product inside out, but have no idea whether it will be acceptable to doctors. So it is really about accessing those three areas of expertise.”
Good working relationship
One of the most important elements in the relationship is the mutual understanding both sides have. At its most basic there will be a gut feeling, a recognition that these people understand the inventor and the invention, understand where that person is coming from and what their expectations and ambitions will be.
“The relationship you have is absolutely vital,” says Harmanli. “The working relationship I have with Steve, for example, is very important.”
There were probably other places I could have gone to – a lot of law firms, for example, can help with the entire process. But the relationship I have developed with my contract service provider has been so important. I met M2D2 two years ago and, if I had not, then I don’t think I would be where I am today.”