At least as early as the 1990s there were growing pressures to correct perceived problems in the patent system of the United States. The problems were said to relate to patent quality and the increase in patent litigation, its costs and its consequences, among others. Some considered it important to “harmonize” the US patent laws with those of foreign countries. Starting with Senate hearings in 2001 and followed by legislative bills in 2005, the process of revamping the U.S. patent system culminated in the Leahy-Smith America Invents Act (AIA) being signed into law on September 16, 2011. Read More
For many of us that work in the medical device area, the constant pursuit of the next product innovation is as natural as breathing air. The U.S. economic malaise and the rapidly escalating cost of healthcare, however, have some pundits suggesting that medical technology development must be curtailed or the country will go bankrupt. Read More
In this blog, I have made a big deal about the difference between needs and ideas. The reality is that for a need to be more than pointing out the obvious, it has to provide sufficient definition or a problem statement. Or, as the very successful Dr. Josh Makower, CEO of ExploraMed, says “decide what you want the end result to be before you invent it”.
Years ago I attended a unique conference in Jackson Hole, Wyoming for physicians and invited guests from the medical device industry. The conference’s theme was to expose the worst clinical case train-wrecks with the goal of catalyzing development of improved medical device tools that could avoid these mishaps. Since everyone was exposing his or her dirty laundry, there was a refreshing sense of openness and sharing. Read More
Big medtech companies have been criticized for their diminishing innovation record, especially from this blog. One of the few innovation strengths that large companies should exhibit is manufacturing. And, I’m not referring to advanced manufacturing in itself, but the synergy between manufacturing and R&D. Read More
How does a medical device company improve R&D productivity when most of the industry is in decline due to regulatory and reimbursement pressures? According to Ray Swanson (partner at TCG, LLC), the best performing companies place the customer at the helm of a market-driven innovation process. Read More
In October 2010, the FDA published the initiative “Advancing Regulatory Science for Public Health”, which has meaningful goals for developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulatory products. So, why am I struggling with the FDA considering regulatory a science?
As part of the Healing Innovation blog, we have been reaching out to physician inventors to learn how we can assist them in our tutorials and postings, connecting them with resources, as well as assessing their identified medical needs. In the process, we are realizing that many clinical innovators are more naïve than expected and don’t fully absorb the level of effort required to license a medical device idea to industry, never mind develop a medical device oneself. Read More
In the medical device innovation space, like other industries, there are many dreamers and much fewer doers. I have previously postulated that one of the key reasons doctors never get out of the starting blocks on their medical device ideas is fear of someone stealing their idea. Whatever the reason, there is inertia working against taking the first step in the inventive process. Read More
Although veterans of the medtech industry may lament the loss of R&D and product development at major medical device companies, the reality is that big companies are just not good at it, and getting worse. Read More