Human Capital

Marketing Medical Devices

Developing products that will improve diagnostics and treatment for patients is a multibillion dollar business internationally. Health care providers depend on these companies to provide the tools that will advance longevity and quality of life for people world-wide. But, developing new technologies is an arduous process that can take years to perfect and get ready for the consumer. So, when the time finally arrives to gain final approval and reap the rewards of labor, an expert in marketing medical devices is essential.

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.

What is Human Capital Development?

The medical device industry is a multibillion dollar international business. A need for health care solutions will always be needed. Research is responsible for the latest innovations in medical diagnostics and treatment. But, in order to be competitive in a challenging field, knowing the answer to the following question is vital: what is human capital development?

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.

The Need For a Medical Device Company

When individuals go to the doctor and need a series of tests and treatments, no one probably takes the time to consider all of the technology involved in making a right diagnosis. While some of the medical equipment is seen, yet taken for granted, there is even more technology behind the scenes required to improve health care and give patients a better chance of returning to health. Few understand the need for a medical device company.

From Start to Finish

A medical device company is there to back up the inception of a medical concept that will aid both doctors and patients. A lone inventor may come up with the idea, but someone is needed to take the idea, develop it for testing, and determine whether it is a feasible solution for a medical problem.

In most cases, the medical device company employees the experts to develop new and innovative ideas that will improve diagnosis and care. Medical changes do not happen overnight. It can take years to come up with the technology that will really make a difference for a lot of people seeking medical care.

Then, it needs to be determined whether the product will actually be used by the medical community and the patients. As with any product or service, market testing needs to be done, in order to determine whether developing the product for sale will be a financial boom or bust. Although altruistic motives may be an underlying motivation, no company can stay in business; unless they can realize a profit and go on to create more medical devices.

Once a device is invented, it is developed for testing purposes. Like drug trials for new prescriptions, medical technology cannot go to market, until sufficient data has been compiled to ensure the overall safety of the patients and health care providers. As with any innovation, the risks and benefits should be clearly stated.

Going to Market

After the trial period, the product needs to be marketed to the medical community. Again, this step in the process takes professionals trained in the sale and distribution of new and innovative medical devices. For example, imagine an employee trying to sell a new mammogram machine, without knowing how it works and why the hospitals should invest in this equipment.

With medical expenses going up for health care providers and facilities, an individual needs to understand the benefits of a new device inside and out. In truth, it all comes down to money and the bottom line. Consumers want to be 100% sure the new device will improve care, increase profits, and not leave anyone open for a lawsuit down the road.

Taking the Risks

A medical device company that is successful has awesome annual revenue, but it is definitely earned. The business takes the risks to develop potentially lifesaving technology. It takes a lot of people in the forefront, and behind the scenes, to bring one device to market. Not every piece of medical equipment developed is successful. Yet a company will keep striving to present the next medical miracle that will improve early diagnosis and treatment.

The Future

Medical device companies are growing around the world. The industry is generating more and more profits. However, one bad device can destroy a company. Coupled with the costs of innovation and development, lawsuits can put even the most profitable medical device company out of business.

So, the stakes are high. In order to be a successful competitor in the market, excellence is the key ingredient. From the president of the company to the janitor that cleans up vital areas of research and development, everyone working to create medical devices must be the best at what they do. The best of the best is what it takes to turn a fledgling business into a billion dollar company.

In short, for health care workers and medical facilities that are looking for innovative technology to improve patient care and profitability, a medical device company is essential. Partners in health care, the company develops the technology that will improve the time and need of invasive procedures to diagnosis health concerns. With the latest in medical technology, patients are more likely to be sent to the facilities that have the best medical devices available. As a result, it does not take long for hospitals, doctors, and other health care facilities to gain the reputation for being the best in the business. In turn, for a medical device company providing that one piece of equipment that makes all of the difference, the future is very bright.