I do not have any experience with clinical trials, but I think you raise a very important issue. Does over-regulation lead to a decrease in innovation? I believe that it definitely does, and there is a very delicate balance between sufficient regulation to ensure products released to the market are safe and too much regulation that prevents products with high potential clinical benefit from ever reaching the market because of all the regulatory hurdles. I think that in the future there will be an effort to streamline the regulatory path, because it has reached a point where it had become very burdensome to get a product to market.

I can understand where you are coming from and do see conducting clinical trials as an expensive, long, and risky investment. The problem is that I do not see an alternative to testing these devices. One thing that can be possibly done is to make the regulatory path more efficient as srg36 mentioned above. But aside from that, clinical trials are extremely important in assuring that the product is safe for human use. I worked as a research assistant at Rutgers Brain Institute where we were testing the effects of several pharmaceutical drugs on the locus coeruleus of rats. I learned that although the process is long and tedious, it really is important because several issues can arise. And it is through clinical trials that we are able to assure the quality and effectiveness of a certain product.

I completely agree with you. This does have a restriction on engineers, creating new innovative ideas. Medical devices basically have to be pre-existing. This week in the lecture we learned about CDRH. The goal of CDRH is to bring innovative technologies to market, by insuring that the medical devices out in the market will advance and continue to be safe and effective. Therefore, regulation does put a cap on the new innovative ideas which is very unfortunate. I believe this is due to safety. The FDA wants to make sure all devices out in the market are safe for the public. I think companies do this so they don’t face legal actions from the customers. Another issue is time and the amount of research needed for new ideas. This could take years before it could go out in the market.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/default.htm

Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in the medical device industry are essential and necessary since anyone could potentially create a harmful device. Without these stringent rules, it would be much easier to get a product out without keeping the patient's safety in mind. Clinical trials are necessary as well. I believe the FDA should look into optimizing the process which I believe they are trying to so that products can be released much quicker while satisfying the requirements. The trials are able to give valuable information regarding the future success of that product so yes it is costly and tedious but essential if the company truly cares about their patients and wants to produce great science.

I agree with the discussion above mentioned by srg36 and Parth D.Patel. Clinical trial are very expensive. we need clinical trial for a new innovation or a new design. For the device that are already existing in the market will not require a clinical trial. FDA wants to make sure the device are safe for patient use, before they are market. For the safety of patient we have to follow the regulation required.

I agree with the sentiments stated above as well. Overall you want to put a product out in the market that will in no way harm the patient and that can only be down through clinical or animal testing. There was just so much done in the past in regards to uninformed consent (Tuskegee syphilis study) or unjust clinical trials (Nuremberg trials) to not have stringent regulation over these trials. I do not believe these regulations will become any less strict anytime soon due to our history and the overall ethics of doing our due diligence as a society to ensure not only ensure the safety of the patients that will use these products but the current patients that partake in the clinical trials. That being said, I feel that if there is a need for it in the market, the proper funding will generally find its way to the right organization to make strides in innovation. This can be said for tragic diseases or cancers such as diabetes, pancreatic cancer, etc. There are numerous charitable organizations on the forefront of finding cures for these diseases through innovative technologies.

While it is easy to say make regulations elastic to do everything they intended to do without hindering innovation, practically insuring that everything is done to prevent a critical failure once on the market and deregulating as a means of sanctioning progress is almost impossible with a regulation that affects such a broad range of things from inter-aortic balloon pumps to bandages. Reducing the size of this umbrella may make the process seem easier but then time and man power become a greater issue. In this case, being all inclusive of potentially harmfully devices far out-weighs the fact that some genius ideas may have been hacked in the process. I agree than some innovations are shot down because of this but there is no way around testing an artery made of a manufactured biomaterial in a patient before putting it on the market. Reacting to an outbreak is much harder to contain than preventing it in the first place through controlled environments. And if it critically fails, at least the damage was minimized, and the spread fully monitored/understood.
One solution would be for the government to create program, like shark tank but for innovative medical devices, that allows companies, individuals, and organizations to submit their ideas on a periodic basis and the company(s) that can show the medical significance and the impact factor of their innovation is worth the investment and feasible, the government would help fund the trials/testing. Note that this would have to be under something unassociated with the FDA to ensure that the same scrutiny is used when the product is finalized, and the results are released.
Requesting an FDA analyst, on the FDA payroll, (a made-up position atm) to visit the requestee be it an institution, company, or organization and after signing a confidentiality agreement if need be for certain proprietary aspects of the material being viewed, the company can present certain innovative ideas to the analyst who will then make a report to the FDA regarding the idea. The response to the report will determine any assistance the government will be providing as well as what needs to be done on the companies half as well as accountability and revenue splitting should the product be successfully launched. The revenue made will be used to fund that portion of the FDA, self-sustaining hopefully after the initial investments, used for further investments, and health grants to pay for medical treatments for patients who would otherwise not be able to get life-saving treatment because of lack of insurance of the fact that the treatment is not covered.
Potentially making changes to the clinical trials(CT) process itself may also help even though this is completely dissociated with the regulations in place requiring CT, if the CTs cost can be optimized and components of the trial be broken down to the minimum requirements to ensure the efficacy of the study then with less aversion to CTs, companies may begin investing in themselves and their own innovative ideas.

aij5, I agree with you completely but I think that the issue doesn't always fall in the funding since many of the ideas are killed in their embryonic stages before there is anything worthy of funding to show. Ideas are shot down in fear of clinical trials so the investment needed to even test the viability of the idea is never given and the ideas die.

Responding to one of bnb6's questions, I feel clinical trials (depending on the product and its intended market) are very expensive and can be very time consuming, but are critical in proving the quality of the product. I don't believe that clinical trials should affect product innovation. Innovation provides the ability to advance the technology and practices in the medical industry. After innovating, then the product is weighed on its risks and benefits for the company and the market before even being considered for clinical trials. I don't think clinical trials should be viewed as restricting creative ideas, but as the process required to prove the product's safety in its intended use. If it's a new product to the market where it'll require a Pre-market Approval (PMA), clinical trials should be very stringent to satisfy all regulatory requirements. If the company has already launched a similar product into the market, having previous data and traceability of equivalency, clinical trial requirements are decreased, but not by any means relaxed. The clinical trial tasks are based on the product's class, its amount of risk, and its quality management. From what I have experienced in the industry, for a basic glucose meter design, a clinical trial timeframe is minimally 5 months. The trail site needs 1 month to set up the equipment, train the healthcare professionals and recruit participants. To run the actual trial takes 3 months and then to analyze the data and write the report, used in regulatory submissions, takes another month. This isn't with the consideration that before committing to the clinical trial, months of reliability tests are initially done with the first batch of pre-production meters. Then pre-clinical trials are conducted ensuring the product being used for clinical trials will guarantee high quality results. Then after the clinical trials are completed, the regulatory submission time for the FDA is 7-9 months, for Canada Healthcare approval is 3-4 months, and for Europe's CE-mark submission it takes 2-3 months.