There will be a lot of hurdles coming on the way to develop a medical device. The most primary one will be the approach to the FDA approval and the classification of the devices and then funding will also be a major constraint. He/She will also need to approach sales and marketing person afterwards to make it on the consumer side.
Physician has to know how the device will work and what it will take to build the device. After the physician has secured people who will be able to make the device then physician has to think about regulatory affairs which he might know is one of the main thing required to release the device in market because he is a physician. He has to classify the device as CDER, CBER, or CDRH and then choose a class for it if it is not the bio device which means higher the class more work physician has to do if he is willing to devote his time and money behind this device. Best thing to go around regulatory part is to higher a regulatory consultant.
Once the physician has an idea, they must determine which class their device falls into. The next concern would be the presentation of the idea to the FDA. They would need to submit an Investigational device exemption if the device falls into class 2 or 3. This allows the device to be used in clinical trials.
For a class 2 device, a predicate device, a previously existing device that the new proposed medical device is based upon, must exist. If there is no predicate device and a novel device is being proposed, it is considered a class 3 device and a pre market approval application (PMA) must be sought after. A PMA is a mandatory requirement for any medical device that claims to be life-supporting or life-sustaining. If the device has a patient-base of less than 4,000 patients per year, a Humanitarian Device Exemption can be applied for.
Medical devices are usually regulated by CDRH, however, if the product can be considered a combination device, it may be regulated by CBER, the regulatory body for drugs, or by CDER, the regulatory body for biologics. It is important to have someone well-versed in the regulatory process on your team. They will likely communicate with the FDA through the entire process to ensure the device meets all standards.
Having already lived this experience, while being outside of the academic health setting, there are several things that I know now, but didn't know then. One of my first moves would be to gather an advisory board of experts, consisting of physicians, clinician-researchers and biomedical engineers. Second, I would reassess and deconstruct my product design then redevelop it based on my new knowledge. In my third step, I would initiate the intellectual property process with patenting and/or trademarking. Fourth, I would begin pursuing funding, a combination of grants like the SBIR or R21 exploratory grants, plus seeking angel investor groups with a solid track record of supporting successful commercial healthcare ventures. With the successful procurement of funding, the fifth step would be the actual product development, clinical trial and commercialization phases. However, I would cultivate an ongoing relationship with the FDA, scientific journal editors and content experts outside of my advisory board, because I have learned that networking within our fraternity of medical device/biotech industry stakeholders is a vital means for facilitating funding, regulatory approvals and optimal commercialization.
Having an idea to create anything is much easier than actualizing that idea and making it come to life. A physician having such idea, is mostly due to been around patients with different kinds of health issues and diseases and in other to do more to help improve such health issues, they are prone to having ideas on how they want or feel a medical device should look like without the having the knowledge on how to create a medical device and what it entails. There are lots of challenges that can arise from this noble idea.
As mention above by almost everyone, funding is a major problem because without funds you can not actualize the ideas that you have. Also, funds are needed in getting all the right resources and materials for the project.
In the pre market phase, where all information are been gather and also, to determine what device will be created and what should go into it, can lead to scope creeps giving continuous or uncontrolled input since it's a one man entrepreneur idea and project.
Also, getting the best team together is also a problem because you have to sort for the best that can actually put your ideas into reality and create a quality device.
Timing is also another problem because there isn't enough time to monitor the progress of this device, make research when needed, follow up with all the regulatory requirement and proper documentation needed by the FDA according to the class of the medical device been created.
In other to surmount these challenges, the project needs to be outsourced to a company who has the right team and resources needed to take on the project. The physician been the main stakeholder who had the whole idea takes the larger percentage profit of what was actualized after the whole project becomes a success. So, it is a win win on both side-the physician who brought the idea and the company who created and brought that idea to life.
I think innovation can be conducted especially with physicians and health care providers, but thinking of the product life cycle of a medical device, starting with the idea generation all the way to support of an on market product, is not where the physician wants to be or can support with GMPs, quality and regulatory. I think the collaboration between physicians and medical device companies is a better model. This is very similar to drug development, where PhDs in academia and practicing physicians work in the early development stages and transition to clinical and commercialization with drug firms.
By the way, there is some interesting reading on product innovations such as Everett Rogers, Diffusion of Innovations and Eric von Hippel The Sources of Innovation that highlights end user participation with developing new products.
A physician would likely have a hard time developing their own medical device. The design, development, verification, and validation phases can prove to be very expensive. Depending on the completixity of the device, extra personnel would likely have to be haried to complete the process (engineers, regulatory, manufacturers, quality). A physician might also have a difficult time knowing the proper design controls, and channels to go through. Their best bet would be consulting with an engineering firm top have their product developed.
The major obstacle would be in the manufacturing capital and testing resources. Without a diverse team to help complete the project, this would take a long time, more faults and a lot more money if tried to be executed individually. Physicians may not have an adequate understanding of regulations for product development and validation in their country, this would not allow the product to enter the market even if does successfully get developed.
The physician could be better off if he approached a company with the proposed medical device and used his personal experience to advocate for its importance and give inputs on how it the project needs to be implemented so that the final need is met.
Although the physician may face many challenges, the physician is in a very good position to know which medical devices are in need in the medical device industry and which medical devices need to be improved. This is a great starting point, since it is important to develop a medical device which will actually be used. In addition to the challenges mentioned previously on funding and not having enough background knowledge on regulations, I think a physician's work schedule may be particularly demanding and it may be difficult developing his or her own medical device just due to lack of time. One way to solve this is collaboration with a medical device company, which would help greatly in regulatory affairs, creating the device itself, and marketing the device.
Another interesting point is the concern over someone stealing the physician's ideas, as they gather information on device development from engineers, investors, or advisors. One way to overcome this challenge is to apply for a provisional patent before the physician starts asking others about the process. Source: https://www.medicaleconomics.com/view/how-doctors-can-create-medical-technology
As many others have said in this forum, one of the largest issues or difficulties that a doctor will face in trying to make a medical device is funding. Unless they can access or have a large amount of capital, it will be hard to design, prototype, test, and get such a device approved without significant financial support. Another issue would be the sheer man power needed to make and implement such a device. In all honesty, it would be incredibly difficult for a single person to make and get a device approved by the FDA alone. Especially if the person, such as a doctor, is not well acquainted with FDA regulations or how to get devices approved. I don't think its impossible, I just believe that, since there are usually multiple parts of companies involved in doing such, it would be a huge task for a single person to accomplish.
Ultimately, I think that the difficulty in making and getting such a device approved also depends on the nature of the device. If it is a type I device and poses a limited threat, it might be easier for a doctor to build, test and get such approved. If the device is labeled as a type III device, it may be almost impossible for a singular or small group of people with limited funding and organization to develop, test, and approve such a device.
There are many challenges that go into the creation of a medical device, whether that it be novel or a predicate device. During the pre-market lifecycle of the product, the physician must go about defining exactly what kind of medical device they want to make, what it's intended use is, how it works etc. This will most likely require some research and experimentation on if there is a need for this device, and it that need can be fulfilled with the solution proposed. A physician would probably be knowledge and most helpful during this phase of the product.
Moving into the product realization phase of the product lifecycle is probably where a physician may start to encounter some challenges. I say this because it is at the point where a regulatory body, such as the FDA, will be investigating the safety and efficacy of the proposed device. A physician would most likely not have much knowledge in this area and would require the help of someone with a regulatory background. A regulatory consultant, per say, would act as the liaison between the physician and their team and the FDA. If the device requires clinical trials, this is also another area to encounter possible challenges and would need additional expertise from, for instance, clinical trial or project managers.
If the device is deemed safe and the FDA gives the go ahead, it would then move into the post-market phase. By this time, there would most likely be a large team working with the physician on getting the product onto the market. Challenges that may arise during this time could be in regard to adhering to Good Manufacturing Practices, for example. Or possibly adding additional features to the device that require a revision to the PMA or NDA to be submitted to the FDA. It is therefore imperative that departments of this medical device company exist and work effectively, such as quality, regulatory, manufacturing, legal etc. Overall, this noble goal would be impossible to accomplish with the expertise of only one person, such as the physician, and requires knowledge from a team of experienced professionals with various backgrounds.
Initially, the physician will have to have an idea about the product that is what to make and how to make. Then make sure he/she has sufficient capital available for the product. Then after the design development phase, the validation and verification come into the picture. Further, the physician will have to see if the product is in compliance with the necessary specifications regarding the regulatory. They should match with the FDA regulations. Then after passing these hurdles the product will go into clinical trials. If passed successfully then it will go for further processes. It actually depends on the feasibility of the product and the complexities involved in designing it.
To begin with, the physician would have a difficult time raising funds for the research. Aside from that, the time required to finish the job might be considerable. As previously stated, knowledge of design controls is necessary to ensure that all of the device's standards and specifications are within a safe range for usage on people. In order to get financing when the project is completed, it's also crucial to know if the medical equipment addresses any problems and satisfies consumer demands. It is critical to ensure that the device complies with FDA regulatory criteria and to comprehend the device's class. If the idea is excellent enough and is financed by a corporation, this difficulty might be solved.
As many people have mentioned, funding could be an issue, but personally I don't think this is as big of an obstacle as many believe. Most doctors have many connections and could easily find a partner or investor. I think the greater issue is in the skillsets. While a doctor is experienced in the human body and what types of devices or instruments would help physicians in the field, what they lack is the engineering background to make the dream a reality. While some aspects could be desired in a device, it may not be feasible technically which an engineer could understand and convey. Steve Jobs had great technological ideas but was not the one to actually do most of the work, instead he worked with a team of qualified individuals who brought together their experiences to find the best route possible to the goal. A doctor can definitely educate himself in the areas of medical device development and design controls, but the time required to do so would not be the most effective way to do so. Finding an educated team with different skillsets would be the best as most work in the industry is done like this as well (made of teams of people from various parts of the product cycle).
