Innovative Medical Device Design
Health care solutions depend on people that are in the business of innovative medical device design. Without those individuals behind the scenes, patients would not be using something as simple as a tongue depressor or living longer thanks to a pacemaker that keeps an irregular heartbeat in rhythm. Biotechnology is a multibillion dollar business, because the creations approved by the regulatory agencies make simple heath care tasks easier or provide lifesaving advancements to help mankind around the world.
Easier Said than Done
Unfortunately, medical device design is generally a long and arduous process. Innovative ideas become reality with a lot of trial and error. The pressure to fulfill a medical need, especially those that deal with life and death solutions can be immense. Even under the best of circumstances, the entire process from inception to sales and distribution usually takes years. Regulatory agencies like the FDA have a lot of guidelines and classifications that require compliance before a medical device reaches the skilled hands of a doctor to improve health care for patients.
Classification
Every new medical device design fits one of three categories or classifications. According to the FDA:
- Class I devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.
- Class II devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards.
- Class III devices sustain or support life, so that their failure is life threatening.
Approval
Knowing the product classification is only a small segment of the approval process. The paperwork for a pre-market approval is a meticulous requirement. One error in the submission of the paperwork can delay the legal right to sell the product to the heath community.
Filing a 501(k) clearance is essential for getting a medical device design to the marketplace. The paperwork may include clinic trials and other information necessary for the regulatory agency to make a right judgment. Even if a product has been changed or altered in any way, after receiving clearance, the approval process must start all over again. According to the U.S. Food and Drug Administration:
Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
Any medical device is strictly regulated. The purpose is to protect the health of the patient and prevent issues that might result in malpractice lawsuits for doctors or people in the medical industry.
Clinical Studies
As part of the development process, medical devices have to undergo clinical studies, in order to collect data that the FDA will need to fairly determine whether the product is ready for distribution. However, people in the medical industry cannot arbitrarily decide to run tests on human subjects. Everything is regulated to provide the safest environment for all concerned, from the development of the design until the product is being successfully used in the medical community.
Manufacturers need to obtain an IDE. An investigational device exemption allows companies the ability to perform tests on a new design. The purpose is to determine effectiveness and safety of the device. Of course, participants know the device is basically in the experimental stage. Although tests have been conducted in the lab, and the outcome is fairly certain, subjects of the study are well aware that they are essentially allowing themselves to be guinea pigs for the betterment of diagnostic and treatment of patients in the future.
The Consultant
By the time a device is ready to be judged fit for distribution in the medical community; companies dedicated to the medical industry have already been working with a particular product for months or years. Thus, when it comes to all of the legal issues associated with classification, clinical studies, and the approval process, it is generally more expedient to hire an expertly trained consult ant to deal with all of the relevant marketing issues.
In short, medical device design is a lot more involved than developing a great idea, for improved diagnostics and treatment, into a product that will be used by doctors and patients. The data needed to receive approval from regulatory agencies must be gathered and documented in an objective manner. Then, once the innovative medical device design receives clearance, it can actually benefit patients.
Tags: Biotechnology, FDA, Medical Device Design, Pre-Market Approval