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.

What is a Consultant

A medical consultant is best known as the consummate problem solver. The well-trained expert deals with all of the issues related to the regulatory agencies, getting the product to market and selling it to the consumer. In short, the consultant is basically a jack-of-all-trades.

An industry consultant must have a working knowledge of the product as well. Without understanding, it would be impossible to submit the necessary requests and paperwork to the FDA, test the product, or convince the consumers that the product will truly improve diagnostics or treatment of illnesses or diseases.

Clinic Trials

Many companies in the medical industry leave the clinical trials to a medical consultant through outsourcing. The expert does not have any direct ties to the company, and gets paid, regardless of the outcome of the tests. Therefore, it lends a greater element of objectivity to the clinical studies.

The consultant is also well-trained in what the FDA is looking for, concerning the trial data, in order to fairly determine whether the product is both safe and effective for its intended use. Thus, it is easier to determine how many participants are required to give the product a good and credible test. Also, how many studies need to be conducted, before the FDA has the required data?

Whether the product is new or has been revamped for another purpose, the trials must be conducted. Also, the testing must be totally unbiased, without any chance of being skewed in one direction or the other. A consultant is paid to be objective, foreseeing any problems, and getting the product closer to the marketplace as quickly as possible.

The Paperwork

Medical consulting requires a lot of paperwork. Everything must be documented, down to the last detail. Many companies find this process both frustrating and time consuming. While a consultant deals with the paperwork and all the rules and regulations for putting a medical device on the market, the company can go back to creating the next modern miracle that will help both patients and doctors in the future.

Once the marketing is outsourced, the consultant must apply for and IDE with the FDA, for the products that are tested, before being cleared to reach the hands of health care providers. The investigative device exemption allows medical consulting companies to find the necessary participants to use the product and determine if it is safe and effective for the general public.

After all of the testing and documentation is completed, the consultant must file a pre-market application. Complete with data gather during creation and testing, the application allows officials in the FDA to determine whether clearance is earned or should be denied, until the product is improved or changed in some way.

Training

Especially because many of the medical devices have life and death implications, every step of the marketing process is meticulously handled. Medical consulting firms train their employees to pay attention to every detail and be prepared to deal with any assortment of problems that occur along the way.

Medical Consulting is a very important job that requires people to have the ability to work on their own and solve a myriad of challenges that may arise. Multibillion dollar companies count on these individuals to traverse the somewhat difficult path to market. Rather than go through the tedious process, executives hire consultants to be their expert problem solvers, in order to expedite the marketing process. Then, the product is able to advance healthcare, the company can realize profits, and reinvestments enable the industry to move on to the next medical miracle.

In short, professionals in the medical industry depend on medical consulting firms to provide well-trained experts in every area of the marketing process for those medical devices that will advance medicine and improve medical care. Consultants are very familiar with what the FDA requires, in the form of documentation and testing, before a medical product has a chance of receiving clearance for marketing to health care providers. Their expertise takes some pressure off of company executives, so they can concentrate on the next medical device that will benefit mankind.

Specialty

A medical recruiter may actually have a specialty. For example, the medical industry develops devices for orthopedics, cardiovascular, neuroscience, and more. So, some recruiters place medical devices specialists that are dedicated to orthopedic devices with a company that only creates advancements in that area of medicine.

Alternatively, a medical recruiter may have many resources, including potential employees from around the world, of human capital that involve all areas of the medical industry. In either case, executives can locate the perfect individual for an open position in the company.

Experience

Finding an employee that is qualified to work in the medical industry is a difficult task. The employment opportunities do not generally include on-the-job training. In fact, workers have a college degree and the equivalent of 10-15 years experience in the field, or one that is closely related.

The qualifications are specific, because jobs in the company are very detailed. An employee should be able to work well alone as well as with other experienced personnel. Because the product may have life and death implications, workers must be dedicated to excellence. When it concerns devices to improve medical diagnosis and treatment, there is no room for careless errors.

The FDA will likely refuse clearance for a medical device, and the company is sent back to the drawing board to discover the problem, or forced to move on to the next great idea. Mistakes are financially costly to the company. But, if the device is a class III product, like a pacemaker, carelessness may cost lives. Then, subsequent lawsuits can literally put a potentially multibillion dollar enterprise out of business.

Time Savers

A medical recruiter is a valuable asset to the medical industry. Not only does the individual solve the problem of matching executives with the perfect employee, but they can save the company a lot of time and trouble. In the time it takes to advertise a position and hire the best person for the job, a recruiter can make a good match and have the employee already contributing to the success of the company. In the medical industry, time is money. In addition, the sooner an innovated medical device can begin benefiting patients, the better.

In short, executives in the medical industry benefit from the services of a medical recruiter. The frustration of finding the right employee to fill a position is gone. Potential employers simply post their requirements, and the recruiter will match the need, using a database of medical device experts that are looking for the perfect job. Thus, it is a win-win situation for all concerned.

In the Beginning

A new medical device is usually developed in answer to a need. For example, patients die when their hearts develop an irregular rhythm or stop unexpectedly. Since resuscitation equipment and CPR is not always readily available, people expire before medical help arrives. So, someone has the bright idea to invent a pacemaker that gives the heart a little jolt, if regular beats cease.

Today, this small device implanted near the heart is responsible for saving many lives and improving quality of life. Maybe doctors went to the medical industry and asked for something that would solve the problem of electrical shorts in the heart. Maybe someone in the industry took on the problem and began searching for a solution. Either way, in the beginning, ideas for medical advancement are born from the need for better diagnostics and treatment.

Development

Unfortunately, a great idea is often years in the making. Through a series of trials and errors, someone or a group of innovative engineers and scientists work on making the perfect device to improve medical diagnostics or treatment solutions. In order to make sure the device is both safe and effective; a device is constantly tested and modified, until it is just right.

While no device is 100% perfect, the benefits must ultimately far outweigh any potential risks. While some devices, like tongue depressors, have little to no risk to the patient, if it is not perfect, other devices like the pacemaker can be the difference between life and death. The pressure to develop the best device possible means not rushing a good idea. It is vital to get it right before marketing it to the public.

Pre-Marketing

The device is as perfect as humanly possible. But, the medical industry cannot simply advertise the product and put it on the market. A lot of pre-marketing requirements must be met, before it actually gets into the hands of the medical community to help patients.

When the device is potentially responsible for a major consequence to life, the company must obtain an IDE, which is an Investigative device exemption. Without this important document, people dedicated to the medical industry cannot set up the clinical trials needed to prove safety and effectiveness of the product. Once the exemption is obtained, participants are often required to test the device. Sometimes, in order to collect the necessary data, these trials may last years. For instance, no one wants to undergo implantation of something like a pacemaker, unless it has been proven to last a significant length of time, before it begins to fail or needs replacing.

In addition, enough volunteers have to be available, in order to provide a measurable ratio of success and failure of a device. If only two people are willing to undergo the trials, a 100% success is no big deal. The results have to show an objective and realistic view of the potential for improving health care.

Gaining Clearance

After all of the tests have been run, and the data has been recorded, life and death types of medical devices must be approved by the FDA, before they can be marketed to the public. It is time to fill out a pre-market application to gain clearance for sale. The document must be meticulously accurate, and accompanied by all of the test results, so the regulatory agency can make a proper determination and decide whether the device is worthy of helping the patient, or the medical company must go back to the drawing board.

In short, a great idea for medical advancement may be years, and even decades in the making. After creating the device, medical trials are often required, in order to prove the product is both safe and effective for its intended purpose. Trials commence only after the FDA has issued an exemption to test the medical device. But, even after the tests are complete, there are still some more steps to follow, before the device is distributed and the company sees any profit. In the end, the whole arduous process is well worth the effort, because advancements in diagnostics and treatment have the potential of saving countless lives.

Development

The process of creating medical devices that improve diagnostics and treatment begin with an innovative idea. Members of the medical community may voice concerns, hoping the industry will come up with a solution. In addition, medical scientists may have a brilliant idea and decide to make it a reality.

Long before it ever helps to improve patient care, years of trial and error may go into making the next medical miracle. In truth, nameless individuals work tirelessly to provide health care solutions, with no credit for their efforts. The company name goes on the medical devices.

Marketing

Unfortunately, the lengthy development of medical devices is only half of the arduous process of helping needy patients. Getting the product to market is difficult, especially if it is a class III device. According to the FDA, this type of medical miracle has life and death consequences.

So, clinical trials are necessary to ensure that the product is safe and works efficiently for its intended purpose. Depending on the medical devices tested, trials can take weeks or years. For example, an artificial heart valve may take years to test. The medical community needs to know the longevity of the device, as well as the success and failure rates. Only after the device is proven to potentially benefit the patient, to a far greater degree than the risks, will the FDA give clearance for the devices to be marketed to the medical community for patient use.

In Writing

In order to receive clearance for sales of medical devices, regulatory agencies require documentation, including the minute details. Everything must be in writing. Applications for permission to test new medical devices are called IDEs. The Investigative device exemption allows medical consultants to conduct trials in order to collect the data needed to eventually receive permission to market the product.

Of course, if the product poses no threat to the patient, like a tongue depressor, trials are not required. But, if it is something like a new and improved hip implant, the FDA will want to be assured that the device will not fail shortly after undergoing such a serious surgical procedure. Probable longevity of the device must be determined, so patients understand both the risks and benefits of the device.

In summary, advancing care with medical devices is a growing business around the world. Providing health care solutions benefits all of mankind, improving the quality of life, as well as life expectancy. Devices help doctors make quicker diagnoses, so care can begin before it is too late, and patients can have hope for a future.

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.

Without a Thought

When people go to the doctor, they have a reasonable expectation that their Healthcare providers will diagnose the problem and prescribe the right course of treatment to regain good health. Rarely, does anyone consider devices like that little microscope with the light that the doctor sticks in the ear.

Who made that device? How many years did it take to develop? How many prototypes had to be scrapped, before the current medical device is approved by the FDA? By the way, what is the process for getting a device or standard of treatment approved by the regulatory agency? What reams of paperwork are presented to the powers that be, before a potentially lifesaving device actually gets into the hands of the doctor, so that a patient receives better care.

Most people go to the doctor, without any thought for the countless individuals they will never know, that have dedicated their lives to developing devices for better Healthcare solutions. The general public, and probably some Healthcare providers, simply take all of the wonderful advancements in medicine for granted.

Pausing to Appreciate

Before leaving the doctor’s office after the next visit, take time to thank the Healthcare providers. The doctors, nurses, and office personnel have spent years studying, working and learning to ensure that patients have good Healthcare. For example, doctors go to school for at least eight years, probably more, before they ever reap the true benefits of their education.

But, do not let the appreciation stop there. Pay attention and look around the room. Notice all of the devices, down to the tongue depressors, and think about the people that may spend years developing a Healthcare device that improves diagnosis and/or treatment. The process is not easy. Knowing a device is perfect, and should be implemented in Healthcare solutions tomorrow, is not enough. With all of the regulatory rules and regulations, companies often wait years to reap the rewards of labor.

Expertise

When coupling the words medical and expertise, the first thing most people consider is the doctor. But, the expertise begins years ago, with scientists and the medical device consultants that implement a variety of talents to actually get Healthcare solutions into the hands of doctors and other Healthcare providers. The duties include:

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

Most people understand that any new device must be tested and tried, before it can be distributed for use in patient care. The process can take months or years. So, it is important to have a professional dedicated solely to navigating the path from creation to consumer.

Tested and Tried

In order to facilitate Healthcare solutions as quickly as possible, a medical device consultant should set up trials, to determine if the product is ready for the consumer. Although no medical device is absolutely perfect, the benefits must far outweigh the risks.

So, medical device consultants set up clinical trials that will yield objective results. Depending on the product, this part of the process can take years. Thus, the data must be irrefutable, when presented to the FDA for approval. The regulatory agency provides help for companies new to the requirements. Services include:

• CDRH learn-an innovative educational tool
• Guidance Information
• Making a device
• Requirements post-market
• Important and exporting regulations
• International information
• Classification information
• Bioresearch monitoring
• eSubmitter
• Dispute resolution

But, with the services of a medical device consultant that has already been expertly trained, companies also have a great resource, to make sure that a device makes it through the necessary channels in an expedient manner. However, if issues do come up, the consultant is also a confident problem solver.

In short, Healthcare solutions should not be taken for granted. Before medical devices ever reach the public, a lot of unseen people are behind the scenes developing, testing, approving and marketing the latest in medical advancement. The newest technology that provides for earlier detection, better diagnosis and treatment is the product of years of innovative research and hard work. Thanks to the companies and workers that have the insight to create better Healthcare solutions, people are living longer and more productive lives.