Posted by Joe Civiello on Fri, May 21, 2010
Speculation in the medical device industry continues to build as the industry waits for the FDA to unveil changes to its premarket notification submission process, also referred to as the 510(k) process.
Transparency, consistency, and predictability seem to be a few of the FDA buzz words mentioned when describing what is hoped to be the result of positive changes to the FDA submission process. Over the last couple of years, the 510(k) review process has been under scrutiny by the Senate and House and critics within the FDA. Growing concerns cite that the priority to ensure public safety and efficacy of approved medical devices has been minimized in the name of innovation, and device approval fast-track processes have been without enough comparisons to their substantial equivalents or predicate devices.
In an effort to strengthen its approval standards and scientific review rigor, the FDA has commissioned the Institute of Medicine (IOM) to conduct an independent review of the 510(k) program and recommend changes as they see fit. The IOM findings and report is due out early 2011.
In the meantime, the FDA has also opened an internal audit through its own medical devices arm-Center for Devices and Radiological Health (CDRH). The CDRH has established a working group whose efforts kicked off with public meetings held earlier this year in February entitled, "Strengthening the Center for Device and Radiological Health's 510(k) Review Process." These meetings focused on strengthening the 510(k) program in four specific areas:
- Issues related to predicate devices (device creep/redefining substantial equivalence/indications versus intended use)
- New technologies and scientific evidence
- CDRH handling of increased volumes of 510(k) submissions
- Post-market surveillance and new information about marketed devices
Just recently CDRH director, Jeffery Shuren M.D., addressed one of these areas (CDRH handling of 510(k) submissions) by announcing changes in the process for its Medical Device Advisory Committee. The function of this committee serves as a technical panel to discuss and review data for medical devices under premarket review.
Previously, panel members were FDA employees, but effective May 1, 2010, panel members will now be independent professionals from the private sector. These new reviewers will provide expertise and technical assistance from their related field specific to the appropriate medical device that is under review. "These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts," said CDRH Director Jeffrey Shuren.
So what might these changes mean for medical device companies moving forward? It may be too early to tell or understand. It is thought that the current FDA environment has gone too far with a current zero risk tolerance policy in order to satisfy reviewers. New reviewers have little experience with the 510(k) process, which has left medical device companies feeling the pain of a lengthy review process and unpredictable requests and submission guidelines.
Longer approval times and unclear submission requirements can result in costly development overruns. This is a concern for not only the medical device community but for the investment community as well. Recently Massachusetts Medical Device Journal (MassDevice) surveyed a group of New England med-tech investors and found that the FDA changes were the primary concern for investors when considering investment into the med tech sector.
Transparency, consistency, and predictability...These attributes are needed and necessary, but will the additional requirements to see these attributes through result in an improved process? Changes are coming and it will be interesting to see how the 510(k) process evolves.
Posted by Matt Harkins on Mon, Mar 01, 2010
Due to the buzz surrounding social media, it seems people have shifted their focus away from traditional networking events. While social media and online networking provide added value, you cannot abandon the traditional networking events that foster growth, collaboration, and innovation in the medical device community. I'm a business development manager here at Farm and can testify to the benefits received from attending medical device networking events. Networking has not only contributed directly to top-line growth by bringing in new projects and prospects, it has also helped us build brand recognition as a leader in medical product development.
The New England region has a number of valuable medical device specialty interest groups that are great venues for networking with industry professionals and promoting your services to prospects. It would be overwhelming to attend them all, so it is important to identify the meetings where you can add the most value and gain access to the right group of prospects. Here are some groups in the medical device industry that I have found to be valuable:
Medical Development Group (MDG)
MDG holds networking meetings in Waltham, MA on the first Wednesday of each month. MDG combines networking meetings with a forum session where industry experts are brought together to discuss different topics of interest in the medical device industry. Past topics have included healthcare reform and its affect on medical technology usage, the emergence of drug delivery and combination products, future trends in women's health products, trends in medical devices, and why devices fail and how to prevent it from happening. Farm has been an MDG sponsor for five years now. We have gained excellent visibility and brand recognition due to our affiliation with its networking sessions and forum meetings.
MassMEDIC
MassMEDIC provides a number of different networking opportunities throughout the year. In addition to its annual Investors Conference in the fall, MassMEDIC hosts smaller networking sessions with a range of relevant topics from the Massachusetts Gift Ban Law to best practices in the 510K process. MassMEDIC has also started MedTechIGNITE to help foster medical device companies through their early stages of conceptualization, formation, and product development. MedTechIGNITE offers its own networking sessions geared toward medical device startups and entrepreneurs seeking advice in Massachusetts.
Merrimack Valley Venture Forum (MVVF)
MVVF provides a variety of valuable events for the technology and scientific industries. It is important to identify the meetings that fit with your networking needs. The MVVF provides multiple sessions for medical device startups to pitch their business plans to an audience of potential investors, service providers, and business partners. In the past these events have attracted a number of startups from the orthopedics, urology, women's health, cardiology, and biotech markets.
Tradeshows
In addition to networking groups, tradeshows offer another great venue for networking with industry professionals. Throughout the year Farm exhibits at a number of tradeshows that are geared specifically to the medical device design and manufacturing community. We recently exhibited at MD&M West in Anaheim, CA. It was our first time exhibiting on the west coast and we were overwhelmed by the positive response we received. In addition to meeting new prospects in need of development services, we were able to reconnect with a number of former colleagues. Exhibiting at the show served as a powerful reminder of how important it is to get out and promote our services to our target audience.
It is important to remember that you won't walk away from every networking event with an opportunity. Networking is a cumulative effort where persistence pays off. You'll benefit from being a regular attendee and finding additional ways to get involved. Establishing more visibility in your industry will help you build brand recognition and increase the chance that your prospects will know of you when you reach out to them.
Posted by Marc Dubreuil on Wed, Jan 06, 2010
For those of us who make our living in the world of medical product development, the future seems very uncertain based on current economic and political trends.
The struggling economy is forcing venture capitalists (VCs) to find and fund products and opportunities that are less risky and farther down the development and commercialization path. VCs are moving away from early-stage medical devices to later stage and energy investments, where returns may be lower but the exit is visible and predictable.
The FDA is undergoing a culture shift and is trying to get a better handle on the appropriate level of clinical data to support safety and efficacy. Recent news suggests that the 510k process will remain largely unchanged; but anyone who's been waiting on 510k decisions knows that it has become a much more arduous process over the last 18 months.
And what effect will the pending Health Care reform have on the ability of the medical device industry to innovate and introduce new products? In a well researched, documented, and written book by T.R. Reid, titled The Healing of America, the subject takes a page from the experiences in Japan. Japan uses a single national fee schedule that sets fixed prices for all procedures. For example, an MRI in the US costs $1,000 to $1,400. The fixed price for an MRI in Japan is $105. So the Japanese service providers turned to the MRI manufacturers and demanded lower cost equipment. The manufacturers responded with machines with more advanced features that cost about one-tenth the cost of US units. Most of the product innovation in Japan comes from small hospitals associated with large medical schools while medical companies are focused on cost out.
As we start to move more plan participants to public options, will Medicare and Medicaid face the same regulated price limitations? Will the development of new life-saving Health Care technologies be strangled by the system? Will our new product development be driven by cost and not effectiveness? Time will tell.