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.