Assets Defined

So, how are medical consultants such valuable assets to the medical community? What services do they provide that make them so indispensible to multibillion dollar companies? To the executives, medical consultants are the gurus of problem solving. The process of taking a medical device from development to distribution among consumers is an arduous ordeal. A mistake anywhere along the way can mean losing a lot of money, taking a device back to the drawing board and starting all over again. In essence, medical consultants are masters of the medical details that will get a medical device to market in the most expedient manner possible.

Expert Multitaskers

Medical consultants are experts at taking care of the details and often thinking of various future tasks at the same time. When companies outsource to these experts in the medical industry, they count on them to deal with:

• Regulatory compliance
• Strategic planning
• Clinical trials
• Comprehensive data paperwork
• FDA approval
• Distribution

Understandably, there are a lot of rules and regulations to follow, in the effort to create medical advancements that will aid both doctors and patients in diagnostics and treatment. Rather than worry that some detail will be neglected that will result in the denial to market the medical device, well-established and fledgling companies alike will hire medical consultants to expedite the journey to marketing success.

A True Talent

The job of medical device consultants requires true talent. Some people do well to follow instructions to the letter and do their jobs superbly. But, consultants have to be self-starters and capable of knowing their tasks and getting them done in the most efficient means possible. They are innovative problem solvers and strategists. Knowing what needs to be done, in order to make sure the medical device is ready for FDA approval and distribution to the public. No every individual is suited for this high pressure position. It takes a special person to pay attention to every little detail.

Proof Positive

The major responsibility of medical consultants is to provide the FDA with proof positive that medical devices will truly advance medical care and benefit most patients. But, in order to give the FDA all of the necessary information needed to make a determination, consultants must first conduct clinical trials, making sure that any potential risks are minimal, and the device meets its intended purpose.

Part of the challenged is making sure all of the tests are not skewed one way or the other. The FDA will not approve a product that is not accompanied by fair and balanced trial results. Also, the consultants must determine the number of trials necessary to provide sufficient data. The regulatory agency will not approve a device that has not been adequately tested, before being used to provide better medical care to unsuspecting patients.

Compiling Data

After the clinical trials are complete, and deemed a success, it is time for medical consultants to compile the data and fill out the paperwork required by the FDA for medical device approval. Again, the paperwork must be meticulously correct. An error in the calculations or representation of the data, and a device will be denied for sale and distribution among the medical community. As defined by the FDA, “A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA)”.

In short, medical consultants are multi-talented experts trained in the process of the approval and marketing of medical devices that will ultimately improve patient diagnosis and care. With expertise and attention to detail, these people are perfectionists, when it comes to their duties. Although unknowingly, patients depend on their skills, to make sure medical devices are safe and dependable for diagnostics and care of potentially life-threatening illness and disease. After all, that is what the medical industry is all about.

Expertise

Marketing a medical device is often a difficult and time consuming process. Rather than stress over the details and deal with the inevitable issues that arise to put a monkey wrench into the process, executives hire a medical consultant that is specifically trained to get the medical device to market. While others move on to the next innovative device, a consultant deals with the issues related to:

• Regulatory compliance
• Strategic planning
• Clinical trials
• Comprehensive data paperwork
• FDA approval
• Distribution

Although an asset in many areas of the marketing process, the medical consultant’s claim to fame is the ability to recognize and solve problems that delay acceptance and sale of medical products.

Objectivity

Outsourcing the marketing process to a medical consultant is actually great for the medical industry. Because the expert does not have any real vested interest in any particular company, it lends to a greater degree of objectivity. As with pharmaceuticals or any other area of advancements in medicine, clinical trials and data collection is essential.

However, no company wants to be accused of skewing the data. In addition, it is important to view the product for what it is, rather than what it is meant to be. Company personnel that have literally worked for years to see a device enter into the medical marketplace are less likely to recognize problems that might result in a future lawsuit. But, a consultant is trained to look for problems that might prevent FDA approval or cause issues in the future.

Commitment

As part of the training in sales, performance, and healthcare management, consultants are also schooled in the commitment to excellence. When it comes to the devices that improve health care and have the potential to save lives, attention to every little detail is paramount. Consultants are responsible for making sure a medical product is really ready for FDA approval and distribution to the public. Essentially, a consultant is a perfectionist, because the price of negligence can cost more than medical industry profits.

Awareness

A medical device consultant is also an asset in awareness. He/she knows that the results of a clinical trial can make or break the sale of an excellent product that will no doubt improve medical care in the future. But, if the trials are not totally objective, detailed, and a fair test of the medical miracle, the FDA is likely to deny the marketing of the device.

Therefore, a medical consultant will set up the clinical trials and determine how they will be carried out, to ensure the best data possible. How will the device be tested and tried? How will the information gathered be recorded? How many trials will have to be conducted, in order to make sure the product is ready for consumer use?

Patience

One of the greatest benefits of a medical consultant is simply patience. After years of development, the process of getting the device into the hands of doctors and health care providers requires a lot of patience. The regulatory requirements, the paperwork, and dealing with the FDA can be a daunting process. So, rather than enduring an exercise in frustration, and worrying about the little details that might result in denial of the product, executives benefit from outsourcing the job to a exceptional problem solver with the patience to run the gauntlet of marketing.

In short, a medical consultant is an asset to any company in the medical industry. Start-up companies generally outsource the job of getting the product to market. Some of the bigger conglomerations actually have a separate department to deal with the issues and details related to this arduous process. Either way, it takes a specially trained individual to know how to circumvent the hurdles that will delay getting the medical advancement into the health care community. The medical device industry is a multibillion dollar business that loses profits, the longer it takes to get a product to market. But, the real losers are the patients that will benefit from the medical advancements that improve care, or have the potential to help save lives.

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.

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.