Crowd Source in Medical Devices?

Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known example), but other examples are appearing more frequently, including in the medical device industry.

The first example in my mind is Kickstarter, a community funding website. We have heard often, especially considering the volatile regulatory risk in funding medical device companies, that companies are struggling to secure funding in light of the relative reluctance of venture capital, angel, or other funding investors in this sector. What happens? Many companies, medical device or not, turn to Kickstarter and have the public fund the company from the outset. The public funds the products / technologies it wants and, in return, the companies have the money to launch the product. (UPDATE: Speaking of crowd funding, check out this interesting article from the Pittsburgh Business Times)

The next example is the crowd sourced project most obvious to many people - Wikipedia. Sure, the site has moderators so it may not be 100% crowd sourced anymore. But its development, use, and growth has been fueled by the process of people uploading their knowledge to a common database. It isn't much different from crowd sourced software - our company used a collaborative version of a documentation software in our infancy - or even engineering projects. I've worked with a few engineers that have been using crowd sourced projects to successfully build "3D Printers" for prototyping.

With the benefits and recent increase in frequency of crowd sourcing, isn't it time that we see its use more in the medical device industry? We may already have, but not in the way you'd expect. I think there is an opportunity for a company (or many companies for that matter) to co-ordinate open source projects and, when at an appropriate stage, freeze the design and begin clearance / manufacturing activities. What is already occurring, though, is regulatory and statutory body crowd sourcing. The FDA, Therapeutic Goods Administration ("TGA" - Australia), Brazilian Health Surveillance Agency ("ANVISA") and Canadian Health Products and Food Branch ("HPFB") are seeking a "crowd sourced" type of regulatory oversight - though, in this case, the "crowd" is limited to these organizations and not the public or other regulatory bodies.

Truly, the optimistic side of me is excited. It would be great to harmonize the structure of regulatory oversight into a common pathway with similar if not identical requirements. In fact, it would have made the last two months much easier as I was juggling three submissions and two external audits from three different regulatory bodies in 2 months. If this program somehow finds a way to harmonize anything in the regulatory framework, I'd be thrilled.

However, the realistic side of me (or some may call it the pessimistic side - moot point) won't hold my breath. I'm typically not much of a pessimist, but there is precedence for failure in international harmonization. Look at the recently disbanded Global Harmonization Task Force ("GHTF") which attempted to encourage international harmonization since its inception in 1992. I can't say they've been useless - a few of their guidance documents are nice - but regulation is still complex and fragmented. The GHTF has been replaced by the IMDRF, but that organization may only solve part of the problem as industry is not represented in that organization. Furthermore, implication of further fragmentation (such as a potential diversion of ISO 13485 and the European Medical Device Directive), leaves me less encouraged.

Crowd sourcing is an incredibly powerful tool if wielded properly. Potentially, in an industry now financially challenged in the US by the Medical Device Excise Tax and national price controls, it may provide an option for developing products in a cost-effective or cost-saving manner. It seems regulators see the value in it as well. I can only hope that both regulators and industry participants can make it a success.

- RTK

Image Credit: James Cridland on Flikr