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.

While it may not be expedient to keep an expert on the payroll, medical device companies generally outsource the complicated process to a medical device consultant. Basically a jack-of-all-trades related to the medical industry, this individual is well-trained in the areas of:

• Regulatory Issues
• Strategic planning
• Clinical trials
• Comprehensive data paperwork
• FDA approval

Essentially, a consultant is the expert problem solver. As a result, the product is more likely to traverse the approval process in the most expedient manner, which gets the product in the hands of the consumer faster, and increases profits for companies dedicated to improving medical care with innovative devices.

Qualifying Medical Device

Before any new medical device can be sold to the public, it must comply with all of the regulations. For example, it must first meet the FDA definition of a medical device:

"…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Based on the lengthy and edited definition alone, it is easier to understand why the services of a medical device consultant are so vital to business success. Imagine all of the regulations that must be understood and met, before a product gets to market.

What Next

A medical device consultant is paid to know what to do next, and circumvent any problems that might crop up to prevent expedient approval of the product. For example, companies are naturally concerned about the clinical trials that are necessary to prove the device will be so beneficial to mankind that any risks are minimal in comparison.

Clinical trials are vital to the success of a product. Yet, the FDA should never see any data that can be construed as biased in any way. The results are scientifically gathered, without the data becoming skewed. So, a consultant sets up the trials. As an outsourced resource, the consultant has no vested interest in the product itself. A major responsibility of the job is to determine whether the medical device is ready for the market.

The Paperwork

Even when people love the work they do on a daily basis, most do not like the resulting paperwork. However, the proper documentation can make or break a company dedicated to the development of medical devices. If the product is not approved by the FDA, it means scrapping years of work and going back to the drawing board.

Thankfully, a medical device consultant has been well-trained to know exactly what is required of the medical industry to gain authorization, and be able to distribute the product to consumers world-wide. One of the most important skills of the consultant is to know what it takes for pre-market approval. A 501(k) that includes all of the research data and other required information is so important because according to the FDA: “PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses”.

In short, marketing medical devices is an arduous process that can be daunting to many companies dedicated to the invention and development of devices that vastly improve medical care. So, it is essential for companies to outsource, or have a separate division for, the job of marketing like a medical device consultant that has the expertise necessary to get the product in the hands of the consumer in the most expedient manner possible.