Each year, millions of patients benefit from innovative therapeutic and diagnostic tools that enhance medical care, extend lives and improve the quality of people's lives. Collaboration and interaction between medical technology companies and health care providers are essential to developing and advancing these new diagnostics, treatments and cures, as well as to their safe and effective use. Taking a reasonable approach to avoiding potential conflicts of interest, in accordance with AdvaMed's Code-of-Ethics, helps preserve the opportunity for innovation while ensuring that decisions relating to medical treatment are always based on the best interests of patients.
Whether in a medical office, hospital or other health care setting, physicians and other health care professionals spend each day caring for patients, and medtech companies seek their unique and valuable insights about how individual patients may benefit from therapeutic and diagnostic devices. Experiences by clinicians in the field can help inspire and inform research and development by industry, and provide essential data for product refinement and commercialization efforts.
Physicians often are also inventors of new technologies themselves, seeking to partner with established medical device companies to help advance their ideas through the development, marketing approval and distribution process. Such licensing arrangements often involve continuing interactions between the companies and physicians to facilitate the development process.
Once an area of clinical need has been identified, either through clinical experience or emerging data, development of potential solutions can begin.
During this phase, physicians and other health care professionals provide important perspectives on the design and use of potential new therapies and diagnostics, including providing input on user requirements; assisting in designing bench tests; participating in usability studies; and helping perform validation testing.
This process is often iterative, with many cycles of refinement before a device prototype can move on to further testing, including possible clinical trials.
New medical technologies often must be tested extensively through clinical trials before they are approved by regulators for commercial marketing. This helps examine how well potential new treatments and diagnostics may work for patients. Trials sponsored by medtech companies have led to life-saving breakthroughs for some of the most challenging diseases and conditions.
Physician participation is integral to the success of these trials: Physicians review and help design clinical trials; conduct the research; track patient progress; and help to ensure the product is safe and effective. Physicians also may report the research at medical meetings and in peer-reviewed journals, which helps educate health care professionals worldwide on use of new technologies.
Once an advanced medical technology has received regulatory clearance or approval, the product is ready to be commercially marketed. Because the successful use of medical technologies often depends on the skill and training of the clinician using them, manufacturers have a responsibility to provide health care practitioners with education and training on the safe and effective use of their products.
Training facilitated by medtech companies can include hands-on, in-person training courses as well as online refreshers. Health care providers also play a key role in teaching and training their peers – other physicians, nurses and health care professionals.
During the post-launch feedback stage, medical technology manufacturers proactively seek input from physicians and other health care professionals who use their products in real-world settings, through market research, postmarket studies and other means.
Based on the feedback received, the innovation process can continue with potential improvements on existing technologies or even development of future designs.
In this era of rapid advancement in the life sciences, medical expertise from physicians who are working with patients and products every day is crucial to continued medical progress that will provide the life-saving and life-enhancing treatments and cures of tomorrow.