by Thomas Maeder, Executive Director, AdvaMed-MTLI
The Medical Technology Learning Institute (MTLI) is the education department of AdvaMed, an association whose member companies produce nearly 90 percent of the medical devices, diagnostic products, and health information systems purchased annually in the US and more than 50 percent of those marketed worldwide.
That AdvaMed includes education as part of its activities-unlike the pharmaceutical and biotech associations-stems in part from the very different characteristics of the medical technology industry: device companies number in the tens of thousands, ranging in size from multinational corporations to mom and pop shops, producing everything from adhesive bandages, tongue depressors, wheelchairs and hospital beds, to implantable defibrillators, MRI machines, surgical lasers, and artificial joints. FDA's Center for Devices and Radiological Health (CDRH) also has jurisdiction over diagnostic tests, and, oddly, over such quirkish products as medicinal maggots and therapeutic leeches.
MTLI was founded in 2000 to satisfy the dual purpose of working with FDA to foster voluntary compliance by clarifying regulatory rules through education, and to help the diverse spectrum of medical technology companies share knowledge and best practices so that all might improve their procedures and work more efficiently and effectively. Unlike the highly competitive drug industry, where a relatively small number of companies make a fairly limited set of similar products, one can assemble a room full of medical device industry professionals who do not directly compete on product lines but who face similar regulatory, reimbursement, and other practical challenges, and who can benefit from one another's experience. It is a generous industry, which makes collaborative teaching and learning both possible and productive.
In nine years, MTLI has dramatically increased the number and scope of its educational programs, from six regulatory courses the first year to more than 35 in-person conferences and workshops per year today, plus audio conferences and webinars on narrowly focused topics such as specific new laws, regulations, guidance documents, or other timely issues. In addition to the original workshops on 510(k) submissions, FDA inspections, and specific aspects of the Quality System Regulation, MTLI now offers regulatory programs on such topics as statistics, medical device software, pediatric devices, clinical trials, combination products, supplier controls, molecular diagnostics, health hazard evaluation, risk management, recalls, standards, and advertising and promotion.
As the educational arm of the industry's largest association, MTLI's mission is to provide the programs most important to industry needs. New programs are developed and old ones are modified by working closely with industry leaders, key authorities from FDA and other government agencies, AdvaMed policy staff, and eminent outside consultants. Speakers are selected not only for their expertise in the core material, but for their skill in using case studies, breakout exercises and open discussions to help attendees apply abstract knowledge to practical working situations.
Alongside its comprehensive regulatory education, MTLI currently offers five distinct medical technology reimbursement programs, including conferences on global reimbursement strategy, evidence development, and its three-day Reimbursement Professionals Workshop, the industry's finest introduction to the concepts, strategies, and tactics for managing a product's myriad reimbursement issues throughout its life cycle. MTLI also offers programs on doing business overseas, particularly in China, Japan, and Europe, and various legal, business, and marketing programs addressing fraud and abuse, product liability, due diligence, outsourcing, sales force management, and the legal and ethical guidelines for responsible sales and marketing.
In addition to drawing upon FDA speakers for all of its regulatory workshops, a number of MTLI programs are formally co-sponsored with the Agency. For the past two years MTLI and FDA have co-sponsored the only conference specifically dedicated to medical device and diagnostics statistics. In December 2008, a high level group of regulatory, academic, and industry experts assembled for a joint conference on gender issues in cardiovascular device clinical trials, and MTLI has co-sponsored two risk management congresses with FDA and Virginia Tech. Most important, since 2005, MTLI, working with CDRH and FDA's Office of Regulatory Affairs, has organized three programs per year specifically aimed at small manufacturers. These "everything you ever wanted to know" primers grew out of a 2004 discussion with Thomas Gardine, then Director of FDA's Philadelphia District Office, who lamented the often tragic fate of many small companies with good potential products and wonderful intentions but a crippling lack of regulatory knowledge combined with a fear of FDA. These were companies founded by the innovators one wants to encourage, who devise the medical technologies of tomorrow, but who may not recognize that in becoming medical product manufacturers they have entered a new, highly regulated world. The two-day primers that resulted cover all FDA regulatory issues and provide an overview of reimbursement, legal, and ethical compliance issues, while offering companies the chance to meet and speak in a non-confrontational setting with the District Director, investigators, compliance officers, and representatives from CDRH and the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA). Over the past five years hundreds of companies have benefited from these programs in ten of FDA's twenty districts. In 2008, FDA honored the MTLI/ Agency team that devised this project with its Leveraging Collaboration Award.
MTLI continues to expand its repertoire of courses into new areas. As part of its ongoing effort to serve the medical technology industry, MTLI welcomes suggestions of all types of programs that can help companies not only understand and comply with the laws and regulations, but generally reduce risks, expand opportunities, and improve organizational effectiveness. Tell MTLI what you want, and they will try to comply, because they are doing it for you.
For more information on MTLI, its programs, and recordings of selected past workshops, or to sign up for the MTLI mailing list, go to www.advamedmtli.org.
Thomas Maeder is the Executive Director of the Medical Technology Learning Institute (MTLI), the education arm of AdvaMed, the world's largest trade association representing the medical device and diagnostics industries.
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