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.

Profitable Assets

In order to start and maintain any business venture, capital is a necessary asset. Money is invested in the venture, in order to have the resources to make a profit. Large companies usually have multiple investors. In addition, it also means investing in people. In order to be successful, it takes well-trained employees to efficiently meet goals and create a profitable business. Human capital development is an investment in the successful future of any business, especially when the enterprise deals with medical device development.

Outsourcing Assets

In the field of biotechnology, human capital is expensive and can greatly reduce the company overhead. Although the medical device industry is very lucrative, keeping certain employees on the payroll year around is simply not cost effective. For example, it often takes years to develop a new device for the purpose of improving medical care. So, it does not make sense to keep an approval expert in house. When it is time to use the services of a medical device consultant, outsourcing is a cost-effective option.

Resources and Recruitment

Long before medical device companies look for the expert in health care solutions, businesses are growing human capital resources and recruiting people to join the medical industry. However, finding the individuals with the energy and dedication that the job requires is only the beginning.

Creating the best in human resources for medical device companies involves education in sales and performance management. Executives are also coached in the resources and information needed to ultimately increase development and the bottom line. The training is intense and any individual that successfully completes the courses will have expertise in multiple areas of the medical industry, whether it is related to cosmetics, cardiovascular, or Neuroscience.

The Problem Solver

Medical Device companies look to human capital for a problem solver. The product has been developed and shows great promise for improving medical diagnosis and care. But, it is a complicated process to actually get the device into the hands of medical care professionals. If anything goes wrong along the way, it can seriously delay its use and the company profits. It is time to outsource the duties to an expert who knows about the relevant issues like:

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

Regulatory issues ensure that a medical device will provide health benefits for the patient, with a minimal amount of risk. Otherwise, products would not be properly tested for safety and effectiveness, before being presented to the consumer. Of course the entire process requires strategic planning. What should be done, in the most expedient manner, to meet medical regulations and get the product to market?

Clinical trials are essential to government approval of a medical device, whether it is a simple tongue depressor or a pediatric ventilator. Here, the services of a medical device consultant are invaluable. Without a vested interest in the product, clinical trials are set up to gain unbiased and fair results regarding the benefits and risks of the new device.

Once the data is compiled, it is time to get all of the paperwork together, in order to achieve FDA approval and bring the device to market. Filing out the data, including all of the results from the clinical trials, and making sure the regulatory agency has the best information to review the product can be daunting because the FDA says:

“Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, 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”.

Thus, the services of a medical device consultant are essential, and human capital development should be of importance to all companies that provide the products that improve health care. Profits are realized only after a product proves safe and useful, making it to market. Outsourced experts in traversing the approval process help increase the reputation and profitability of a company dedicated to developing medical devices.