For starters we should realize the number one difficulty would be the capital required to develop this tool. While regulation and keeping up with current technology money to forego the project will constantly be a thorn in the side of the physician. So the best way to overcome this obstacle with out going into to unsurmountable debt would be to apply for grants and gain investors who believe in the project. The next challenge would be developing a product that is in compliance with the FDA's regulation, once they are registered to the FDA they must be able to pass clinical trials. The best way to navigate that challenge is to decide which class the device will be before hands and study the registration process before hand to ensure that it will get approved. There are numerous other challenges that a physician or anyone else will face once trying to develop medical devices, generally speaking these are the most common. 

Like Marvin said, I think some of the main challenges surround securing funding and navigating the regulatory landscape. Additionally, I think the physician might encounter challenges in the development and manufacturing of the device. In the event that the device is in to be used in the physician’s area of specialty, managing bias and or conflicts of interest in the development, manufacturing, and commercialization of the device might be another challenge to contend with.

Contingent on the physician securing sufficient funding, I think all the other challenges mentioned can be addressed through the contracting of specialists in each of the areas mentioned.

Hi Marvin, I agree that there are a number of challenges that the physician might face while trying to develop a medical device. I also agree that the cost and regulatory considerations are chief challenges among the others.

What about the development process itself?  Do physicians tend to know anything about Design Controls, for example, which we will talk about later in the course?

As a personal anecdote, I work with a great many MD and have been on the Morehouse School of Medicine or Emory School of Medicine campus on a weekly basis since 2012. I consider physicians to be a skilled group of people who have a passion for health care delivery or a passion to make money...or maybe both...

In our society, I believe, we place MD into a protected class of highly intelligent people who personify sheer genius. However, I regard MD as highly skilled as Engineers, Computer Scientists, etc... Therefore, if an MD wanted to transition a idea from concept to product, this person would need to undergo extensive training as offered by this course, and customer discovery courses as offered by Georgia Tech's ATDC.

Challenges to the MD:

• Research foundation
• Understanding the customer
• Patenting (domestically and internationally)
• Raising capital
• Monetization
• Comercialization

First and foremost the physician would have a lot of trouble in financing the project. Apart from this the time taken to complete the project could be vast. Knowledge of design controls would be highly essential as mentioned, so that all the standards and specifications of the device are within a safe range for use on humans. It is also important to understand if the medical device solves any problem and meets customer needs in order to receive funding after the completion of the project. Seeing to it that the device meets with the regulatory standards of the FDA is very important and understand the class of the device. This problem could be solved if the project is good enough and is funded by a company. 

For the physician to realize his or her goal of creating a medical device, he or she would need to surround himself with others who are knowledgeable and experienced in product development, process development, quality control, and regulatory affairs. While the physician can provide an expert opinion on clinical affairs and may have come up with the product idea, they remaining roles in the product development process would need to be filled with other experienced individuals. One way to accomplish this is for the physician to create a start-up company with other investors and hire a team to develop the product. As the product develops and begins to look more promising, selling the start-up to a larger company will open the door for even more resources and experienced individuals. It may be easier to conduct clinical trials and develop a working relationship with the FDA if he is working with a large medical device company that is already experienced in both aspects. However, the physician would likely keep a larger share of the profits as a major stakeholder in the start-up company.  

In my opinion, the first difficulty the doctor will encounter is the shortage of funds. The best way to solve this problem is to find one or more investors who believe in the project to fund the doctor. Then, the medical device needs FDA approval. The response to this challenge is to determine the level of medical equipment and to study registration before starting the project to ensure FDA approval.

Yes, In my experience as a Sales and Service engineer I have met a few Doctor's who build their own device out of curiosity as well as to earn a little extra from the sales.
The challenges that the doctors face is they are not engineer's so though the device does the job that is required there are a lot of design improvements that needs to be done so hiring someone for design improvements would be ideal.
They don't have the time to market their devices, the only way they can do that is through the sales and service engineers visiting the doctor's clinic.

In my opinion, a major challenge the physician would face is navigating through the FDA process without the assistance of a person specialized in regulatory affairs. For instance, in the first lecture, Dr. Simon mentioned the high demand there is in companies for a well-qualified regulatory affairs specialist. This goes to show the valuable role they play in helping to assure the progression of the project to the point of obtaining FDA approval. Correspondingly, the job of a regulatory affairs specialist continues post-market as it is necessary to monitor labeling and address any future concerns the FDA may have. As a result, I believe a physician can surmount or ease some of these obstacles by focusing on the development of a medical device with a predicate that dates before 1976, so that the medical device can be classified as a Class 2 medical device. Despite this, it still may be beneficial and necessary to obtain experienced advice or consultation if this is the first medical device whose development they have worked on. Furthermore, since the medical device industry is highly regulated, a physician may face obstacles due to a lack of knowledge on the required Design Controls. As a result, another possible path for the physician would be to approach a company with their proposed medical device and use their personal experience to advocate for its importance.

Though many people have pointed out the issue of funding, I think a bigger problem would be that physicians may not have an adequate understanding of FDA regulations for product development. A physician may take regulatory courses or certification programs to learn the ins and outs of regulation, it may be a better option to hire a regulatory consultant to overcome this obstacle. The use of a consultant may be especially useful if the physician does not intend to create many new products, so having the knowledge of regulations may no longer be necessary after the development of their new idea. 

This is a great question.
From reading the FDA regulatory articles provided the main concern of any medical device is two things
1) Is it safe, 2) Is it effective.
From business startup prospective I think the challenges is to assess if there are actual customers who need and want this product.
Additionally, from inception to actual delivery of a medical device could take many years.

So once there is an assessment of the rewards based on potential customer the doctor could assess the money and time they are willing to invest

So I think the major obstacle would be money,
lack of business knowledge in general,
lack of engineering skill in general,
misunderstanding of patent laws
and then lack of FDA regulatory understanding in particular.
 
I think one simple way to surmount these challenges would be to solicit services from a company which assembles all these skills in one place like https://starfishmedical.com/about/ This is a company that specializes in bring medical devices to market.

In my opinion the practitioner would first require  funds if he wishes to reach out his product on large scale. Being a practitioner he would need to hire someone to help him with the engineering design of biomedical device and someone who would check it before he can approach for FDA approval

There can be lots of problem with this which can be hard to fix when you are trying to develop a medication by oneself. One is that gigantic pharmaceutical companies have big labs and big research team to test and formulate drugs. Completing with them will be hard since developing drugs require great amount of time and resources.  In addition, the physician by practice are not chemist has a deep understanding of chemistry required to formulate drugs hence they might not cover all the bases compared to large companies. In addition, the FDA would require extensive studies done during Pre-clinical and clinical phase of the drug development which requires a lot of human and animal subjects. However, new technology have develope and is keep developing where scientist or doctors can use AI to reduce the time required to develop drugs. Do you guys think that the government should decrease the strictness of FDA regulation required for individual physicians to combine drugs for giving it to patients?