Aside from the financial struggles everyone else has mentioned, I believe another huge struggle for the physician when developing a medical device would be time. Physicians are working 24/7 as it is and developing a medical device is literally an entire other full-time profession. With that said, there's a specific skill set that comes with it that the physician might lack. To overcome this obstacle of time and skillset the physician would need to work with a team. As for funding he/she can apply for grants/loans. As for the actual development process, depending on the physician's background, they may or may not be able to pull it off. If the doctor has experience with CAD, biomechanics, and essentially the engineering behind the device they can probably put their expertise to the test and pull it off. Considering they do have the proper skills or team and they are able to develop the device, going through the FDA to get it approved is just another obstacle especially if it's a Class 3 device where they'll need a PMA. All in all, the physician would require an engineer-type skillset, proper funding, and a team to get the device across the finish line. Once passed the FDA as well the post-market cycle of the product can probably only go on with the continuing support of the team, again due to the physician's busy schedule.
Paradoxical as this idea and question seem to be if you take a moment to think about medical devices already on the market it is obvious medical doctors are innovators and developers of important medical devices. I am reminded of the artificial heart and its history. I will link a journal article below for your convenience. Reviewing this article there were several MDs as well as engineers, inventors, and medical students who all added their expertise at different time periods to the development of an artificial heart. It is a noble goal and a challenge to create a medical device that matriculates from conception into a viable product on the market that aids in patients’ overall quality of life. The challenges would be first material resources, funding, and time. The second set of challenges will be the FDA approval, marketing the device, and either starting a business collaborating to have it contracted out for production. One way to overcome these challenges is to be connected to a medical school-hospital that is research practicing hospital. There are opportunities for funding through grants by NIH, that could be seed money.
Khan, S., & Jehangir, W. (2014). Evolution of Artificial Hearts: An Overview and History. Cardiology research, 5(5), 121–125. https://doi.org/10.14740/cr354w
Perhaps in your career you will meet (or be) a physician who works in a hospital or private practice and wishes to create his or her own medical device. Though this is a noble goal, what challenges would that physician face and how could the physician surmount these obstacles?
Taking the risk and creating a medical device, there are a few things that could be possible challenges they may face. The team. It is imperative that the physician dedicate a healthy amount of time considering whom they will be working (manufacturing) and what people will be needed to help make the medical device successful. With 75% of medical device companies failing before their product makes it to the market, indicates that even though a person may have a great idea for a medical device, not having the proper team in place that helps to develop research processes, quality control and quality assurance needed could lead to a means of an end before the company even begins. Another challenge is ensuring the quality of the components used for their medical device. Have the components been properly assembled? Have they been tested? Or do they positively interact with the mechanisms of the medical device? Ensuring that they devices materials are quality and actually function properly with the device would be a way of overcoming this challenge.
These are just a few suggestions about the possible challenges the physician may face and ways to overcome them. Starting a company developing medical devices is challenging in itself, but ensuring that there are standard practices done to support the business will make it more likely to be successful.
@shavondraleak I think the networking aspect that you mentioned in your response is spot on! While there are many technical aspects of starting a medical device company, have a good network could be beneficial for the physician. One of the most important aspects of starting a medical device company is the team. Having a good network would allow the physician to make contact with people who may know what it takes to assemble a team and what members are the most vital to have at the start of the business. I would ask, what do you think is the most important step to take after committing to developing a medical device. Is it more important to start the assembling process or developing a team?
I think being a physician, you will face many challenges that you want to accomplish. Making medical devices can be a cumbersome task if not done the right way. Some of the biggest challenges a physician could face are money, legal resources, testing ability, and finding the right manufacturer depending on the type of device being created. When making a medical device, a lot has to go into what exactly needs to be done to be successful and the most cost-efficient. A physician needs to ensure he has a team that knows what they are doing. He needs to have a plan/budget for the amount of money that can be spent and if investors or outside help will be needed for funding. A proper team to handle the FDA processes that need to be followed for the device to use for humans and follow the proper channels to have the device tested as to not cause any harm.
I think the best way for the pysician to create a medical device is to design the device and pitch it to a company that could buy the rights to manufacture the device and get through regulatory and FDA approvals to take it to market. The physician would sell his idea for the device and possibly make themselves available as a consultant as the device goes through the necessary steps. Unless the physician wants to construct a medical device company surrounding his or her idea I believe outsourcing for selling the design to an already established company is the best way to ensure all of the necessary resources.
I will give an example of this from my own work. I am currently designing a handheld device to deliver drugs with hydrogels. We had an interview with surgeons for this and we tried to find out what kind of needs they had and we wanted to reflect this on our device. The common answer from the surgeons was that the device should be similar to the devices used in daily life or in the medical field. The reason for this is that the period of getting used to the use of the device is reduced to less and they feel more comfortable while using the device.
The challenges that a physician would face in trying to create a medical device is that they may not have experience with design controls, such as understanding how to develop design inputs, outputs, verification, and validation. Additionally, the physician may not have much experience with different regulatory bodies such as the FDA, ISO, and, if the device is going to be marketed globally, country-specific bodies. Funding could also be an obstacle if the physician is not working with an external company and is developing a start-up. The physician may have an idea of what they would like the device to accomplish, it would be difficult to achieve this goal independently. To surmount these obstacles, the physician should create a project team with individuals familiar with regulations, project management to help define timelines, manufacturing, design controls and risk management, and quality. Through forming this team, many functional areas of the device development process would be covered, and an assessment of the feasibility of the device can be conducted.
What is most important to address is that most physicians, while possessing an exceeding amount of knowledge in clinical practice, which may inspire their development of a medical device, they often lack the technical expertise necessary to create a medical device. For this, they must rely on the expertise of biomedical engineers and regulatory specialists. Regulatory specialists are essential to help the physicians guide a product through the market, especially as physicians do not generally deal with FDA requirements on a day-to-day basis. They also require specialists to help with intellectual property rights, market entry, and post-market surveillance. While doctors may have a great deal of expertise with patients, and may be able to test their product on their set of patients, this sample size is often too small, so the physicians will need to collaborate with other physicians and hospitals, which may be difficult due to concerns about competing products.
Yes, I agree that, as most have mentioned, funding is the first and foremost step to get started with the initial process. however, in my opinion, based on my small co-op experience working with a medical device manufacturing company, I learned that the company can also hire and partner with contract manufacturing organizations that specialize in precision medical devices. They can handle the bulk of scaling, ensuring that the devices meet all necessary standards and production regulations, which helps avoid production delays or defects. These organizations have skilled engineers who work in different departments like mechanics, R&D, quality, and machining.
