Something is killing medical technology innovation—or at least slowing it unnecessarily. That basic argument has been repeated ad nauseum in recent years. As for exactly who or what is to blame, that is more of a contentious matter. But there is widespread agreement that the state of med-tech innovation is dire. Frequently, the U.S. regulatory climate is blamed in this context. For instance, a recent survey of medtech CEOs in Minnesota found that many respondents blamed an "unpredictable” and “unresponsive” FDA for stifling their ability to innovate. MD+DI recently ran a piece that asked whether politicians should share some of the blame for "killing medtech innovation."
Upcoming Conference Tackles Medtech Outsourcing Challenges
MD+DI is organizing a conference designed to provide industry professionals with the tactical tools and strategies to achieve the transition from procurement to partnership in the development of medical devices. Scheduled for August 22–23, 2012 in Boston, the MedTech Supplier Partnerships conference will provide a forum for industry experts to share practical guidance on how to get the most value out of buyer/supplier relationships, protect quality standards and innovation, and speed regulatory compliance. More details are available from the link above or by calling +1 310/996-9435.
Although the terms "innovation" and "invention" are freqently used in similar contexts, the two words have distinct meanings, as regulatory consultant George Samaras points out:
A product can't truly be innovative unless it can be commercialized successfully. And, today, that requires not only getting a medical device to market that is safe and effective; the end product needs to provide better patient outcomes at a lower cost than competing products.
Complicating matters further is that innovation is sometimes confused with iteration, which is an integral part of product development, says Bob Lathrop, owner of Lathrop Engineering (San Jose). Innovation requires "a clear vision of what it is that you are trying to achieve," Lathrop says. This requires a solid understanding of the problem you are targetting as well as the path to market and other factors such as price point and intellectual property. Developing a product that is best able to meet these various needs requires an open mind and the willingness to take on some degree of risk, Lathrop says. "You don’t necessarily have to take on a high amount of risk, but you have to be willing to open up new possibilities."
That willingness to be open, to really investigte the problem your problem is targetting, usually comes at a cost. That is, coming up with novel ideas can take time, as the phrase goes, equals money. But the investment is worth it: if your firm wants to maintain market position, it has to be innovative. So in the end, there has to be authorization to be innovative and a willingness to invest in that, Lathrop says. And in the present economic climate, finding that funding can be tough. Most investors are looking to de-risk their assets, so projects that do find funding are rarely game changing devices. "Everybody seems to be trying to minimize risk to maximize their return on investment," Lathrop says. "And I think it is [affecting innovation in life sciences] more than anything else." But developing truly innovative products usually requires a long-term view, he adds.
In meeting these objectives, it is hard to overestimate the importance of solid teamwork, which begins with an assessment of your team's strengths and weakness. As for what they are, they tend to differ dramatically for startups as opposed to their larger brethren. But, in any case, if the weaknesses are difficult to address internally, outsourcing of some sort becomes a necessity.
In making that leap, it is important to find a consultant or outsourcer who will truly work with your firm as a partner. You don't want to work with somebody that only wants a vendor/customer relationship, says Bill Betten, medical technology director at UBM TechInsights (Ottawa, ON). Your company and the outsourcer should form a solid partnership, which can be developed and refined over time. “It sounds trite,” Betten acknowledges. But that doesn’t mean it happens as often as it should.
Another factor to consider is the importance of continuing to keep critical aspects of production in house. "You don’t want to outsource your crown jewels," Betten says.
|In this video with Thomas Grasty, co-founder of Stroome explains that innovation and invention are often conflated and poorly understood.|
|Brian Buntz is the San Francisco-based editor-at-large at UBM Canon's medical group. He covers a range of topics including regulatory issues, the future of healthcare, and the cardiovascular device market Follow him on Twitter at @brian_buntz.|