Posted by Beth Loring on Tue, Mar 30, 2010
A couple of weeks ago, I attended the Human Factors Committee meeting of the Association for the Advancement of Medical Instrumentation (AAMI) in Nashville, TN. If you aren't already familiar, AAMI is "a nonprofit organization comprised of nearly 6,000 members from around the world with a variety of different backgrounds unified by their commitment to increasing the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications."
The Human Factors Committee convenes several times a year, and its members are responsible for writing the Human Factors standards that are adopted by AAMI and ANSI (the American National Standards Institute) and become best practices that the U.S. FDA expects device manufacturers to follow. This committee worked long and hard to develop the forthcoming ANSI/AAMI HE75:2010, "Human Factors Engineering-Design of Medical Devices." This nearly 500-page document will provide detailed Human Factors engineering design guidance, examples, checklists, and case studies. There is a delay in publication due to the fact that the publisher needs to obtain permissions for some of the figures it contains. It should be available for purchase shortly, but because it's so big, you won't be able to download it.
Another important development to be aware of is the FDA has officially endorsed the international standard IEC/ISO 62366:2007, "Medical Devices-Application of Usability Engineering to Medical Devices." IEC/ISO 62366:2007 calls for manufacturers to follow good Human Factors processes when designing medical devices, but does not provide detailed design guidance. Interestingly, Annex D in 62366 is almost a direct replica of ANSI/AAMI HE74, the document developed by this committee.
The meeting ended with discussions of diverse topics, such as post-market surveillance, user interface design for medical software, and guidelines for observational field research. The group is deciding which initiatives to pursue next.
In addition to hearing about these developments, it was a great opportunity to get a behind-the-scenes glimpse at the work that goes into creating, editing, and approving Human Factors standards. It was an insightful experience and a pleasure to finally meet some of the members that make up this influential group of thought leaders. I highly recommend attending if you're interested in Human Factors standards.
Posted by Tristan Sedgwick on Mon, Mar 15, 2010
Achieving ISO certification is a tedious, time consuming, often difficult and complex process BUT there are a multitude of reasons why you're doing it.
Farm has been going through the lengthy process and although we are not "required" to be ISO certified since we are a medical product development consultancy, we know that our business can benefit dramatically by obtaining ISO certification and so can our clients.
If you're in the process of becoming ISO 13485 certified and you're starting to rip your hair out - keep the following in mind...
- You are doing this because you want to offer your clients a high level of customer satisfaction. A certified quality system establishes your company's credibility and commitment to quality, helping you earn your client's trust and confidence.
- You want to comply with statutory and regulatory requirements to assure clients that you are committed to developing products that are safe and effective.
- You want to unlock doors that were previously closed since many medical device companies won't even speak to a development company that is not certified.
- You want to experience financial growth by gaining access to a larger market share that operates in a highly regulated medical sector.
- You want to motivate your staff and increase productivity. This is achieved through proper training, a documented, straightforward communication of the quality management system and evaluation process in order to create a work environment that embraces accountability.
- You realize the importance of mitigating risks in all stages of the product development process in order to detect and prevent errors in all stages of a product's lifecycle.
- You want the ability to identify when processes are obsolete or inefficient so you can reassess and correct them.
The process of achieving ISO 13485 certification shouldn't be feared, it should be embraced. It's a chance for a company to create a quality management system that works for them, not against them. It's an opportunity to develop a system that will offer a competitive advantage and help your business be the best that it can be.
If you reach your goal in obtaining ISO certification and are thanking your lucky stars that it's finally over - you're missing the point! Certification and the process in and of itself NEVER ends. Your quality system must continue to be audited and improved, tracked and reviewed, trained and understood by everyone in your business. It's not a course you've completed and will soon forget but instead a promise you've made to your business, employees, clients, suppliers and industry liaisons. If you want to be successful as a business, you must realize there is always room for performance improvement and by changing your perception you will not just raise the bar but go above it.
Posted by Marc Dubreuil on Fri, Mar 05, 2010
"Cautiously optimistic" is what one person is calling the outlook for venture capital funding. It's not news to anyone that this industry has fallen on hard times, and it will likely remain troubled for a few years. It is hard to believe how much money was flowing into the VC world when, just two years ago, it was actually considered to be an "asset class." At a recent conference the speaker suggested it was always a niche investment instrument and it will return to that category until the next predicted cycle (roughly ten years) brings the money back to the excitement and heroic returns that drove the IPO markets.
The good news from PriceWaterhouseCoopers indicates that the last quarter of 2009 saw significant funding gains over the prior quarters and over 2008, and Life Sciences funding is leading that comeback. Although the funding is still at its lowest point in six years, the good news for us in the product development business is that the population is aging and we will demand more diagnostics, therapeutics, and procedures/devices.
We heard about two big strategy shifts with investors last year.
In this brave new world everyone involved in start-up funding is practicing "capital efficiency." We used to call it belt tightening, but it's more about higher ROI on your early investment rounds. For us in the product development outsourcing business, it means becoming smarter, more nimble, and more effective at bringing safe and competent solutions much earlier in the game. We use analysis, prototyping, and testing in quick iterative steps to confirm our concepts and ideas, but the pressure is on to get to animal, cadaver, and human trials as major milestones in the validation of products and investments.
Another major speculation was regarding the shift from early-stage investment to later stage opportunities. The prognosticators were suggesting that later stage investments may compromise equity positions, but they also reduced risk and shortened the time to an exit event. Interestingly enough early stage funding grew to $1 billion in the fourth quarter of 2009 vs $649 million in the same quarter of 2008 while late stage funding declined over the same period in almost identical numbers.
The best news probably came from reports and blogs from the annual JP Morgan event recently held in San Francisco. The news is that private investors are getting back into the game and that VCs are back to raising funds. It all sounds so hopeful, and then you read about the FDA overhauling the 510K process. Just when we thought the money was coming back and the healthcare reform bill was dying to give us a hint of hope, the FDA turns on the warning lights to all of us in Life Sciences product development. Stay tuned.
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.