As we know that medical devices regulations and processing is more challenging, I would like to discuss some challenges that I thought of like Regulatory Compliance and Securing Funding. Firstly looking at the first challenge Regulator Compliance, as we know that FDA regulates all medical instruments before and after they reach a marketplace. Here the after bit is more important as by continuously using the instrument it would get affected that would inturn affect the pateints. As we know the classification of medical devices and we also got that Class 2 devices takes more time for affiliation and certification and eventually costs alot for the company that makes them do wrong by taking shortcuts and even there is waiting for 510(k) so I wish they should come out with the solution. This brings me to second problem that is Securing Funding, investors knowing that the medical device industry is risky, time consuming and things may also don't go as it was planned out they hesitate investing their money. So as the marketplace is getting more competetive and risky there should be some solution for security funding and regulatory compliance.
I agree that this is a major problem that is prevalent within the medical device industry. I had similarly posted in this forum (see "Clinical Trials" post) about how patients and engineers are effected because of the time/cost of the class 2 or class 3 process as well. I hope there will be a decrease in cost but that is a large issue within the whole medical field, and I don’t see it getting addressed any time in the near future.
I also do agree that stocks in the medical device industry are risky, but it is still heavily invested into. Large companies especially have been slowly and steadily increasing their net worth, which maintains the trust of all of the investors.
I believe that the Regulatory Compliance will remain the same and it will be a long and tedious process for the FDA to approve these medical devices. I also believe that it will be difficult to secure funding and that the cost will always remain high. The reason for this is as bnb6 mentioned, high cost is an issue in the medical field as a whole. It is up to the company to do everything properly through these issues and not take shortcuts. One thing that I believe can help speed up the process and help identify and find solutions for issues quicker is to connect top floors to shop floors. In my company, everyday at 9am-9:30am everyone in the office meets on the floor shop, whether you are from quality, manufacturing, and ect. We go through the scrap pile which are products that went through the process but were identified as unusable due to issues. This allows every person to get to know the process as well as common issues that come up. So if a medical device gets denied by the FDA, the company can work quicker to identify the issue and find a solution.
As has already been stated in the posts above, Regulatory Compliance is a tedious, expensive, and lengthy task which can prove to make the engineers' job full of obstacles and headaches in order to make sure that a new product is compliant with FDA standards, and that products already on the market remain compliant. With this task it is the engineer's job to provide proof that all product specifications are met and that designs are validated. However, when you focus only on the day to day items (and the obstacles that need to be overcome to demonstrate compliance), it is easy to lose sight of the reason the devices are so highly regulated in the first place: to ensure that when a product is used on a patient it will be made correctly, perform reliably, and overall help accomplish something that leaves the patient better off. If your product fails in the field, it could be disastrous for both the patient and your company.
The daily meeting that ala26 described is a good way to keep things in perspective for everyone in the company. It demonstrates the importance of quality control for catching the defects before the product was shipped, while also provides other departments with motivation to improve processes to avoid defects and make an overall safer product for the patient/end user.
My company recently conducted a company wide survey and one of the main feedback points was that the employees did not feel like what they were doing was connected to the end user. The company addressed this by publishing weekly "success stories" on the intranet page to demonstrate how one of the company's products save someone's life. They also have TVs in the lobby of the building that show the devices in use in places like operating rooms and in ambulances providing life saving support for the patients they are being used on. I think that this is a good way to remind employees that the challenges they face on a day to day basis, which could seem annoying, are all for the good of the patient in the end.
I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with their devices to get it approved by the FDA, this most certainly is even harder in smaller companies. When a really good idea is brainstormed, even if it will cost a lot to get approved by the FDA, a large corporation has the option to determine whether they see a return on investment and visualize this making a big impact in the healthcare community because of its larger budget. On the other hand, this seems like it would be harder on a smaller company with less funding. However, it seems like smaller companies, such as start ups, are often the ones driving innovation. Does anyone have any opinion on this or experience with this? In addition, does anyone know of any bias that may occur with a large well known company to a small unknown company when it comes to the FDA? Are these large well known companies given priority or is everything looked at on an even playing field and the order it comes in?
Sorry technical difficulties! Posted this out of order! This was meant to be after Ashley's post...
This is a really good addition to the conversation Ashley. It seems like more innovation is with start up companies, yet while the bigger, well established companies, whom have a larger medical product portfolio, have an assumed easier time getting FDA approval for class II and III devices. I actually read a linkedin post regarding this topic. The author, Stefan Lindegaard, mentions how there are limitations for both big and small companies. Smaller companies have more passion for innovation because they are just entering the market while larger companies focus more on performance, stable operations, and productivity/investment in corporate global growth. I think the environment in a start up company is different and eventually evolves as it grows larger, focusing on more prominent factors for the company's profit and growth compared to innovation. I have never really thought about the difference in the cultural environments between big and small companies and I think this is a great topic to open awareness for students thinking about entering the industry.
LinkedIn article: Innovation: 7 Key Differences Between Big and Small Companies by Stefan Lindegaard.
I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device Regulations (MDR) 2017/745 that will take effect in mid-2020, EU is now driving the requirements for Medical Devices in my opinion, and it will not take too long for the World to follow, including FDA. With the new MDR, the company clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. In addition, the company will have to increase post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports. All these activities will increase costs and funds necessary to market a medical device and keep it in the market. From a project management perspective, large companies surely have funds necessary to accommodate for these new MDR requirements, however small companies will definitely have to assess their budget to ensure they have the means to pursue development of the medical device.
While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU's transition to implement new regulations on medical devices to heighten scrutiny on clinical trials and post-market compliance is transforming the medical industry on the global stage. The transformation of the regulatory framework is to minimize risks of medical devices on the market, but, as a side effect, will substantially increase the prices to introduce new products to market. If the FDA implement new regulations, the process for a 510(k), de novo application, clinical trials, premarket approval, and postmarket reporting will only becomes less efficient and more expensive. Only well-established medical companies will be able to afford the costs of having a project team to introduce Class II/III products that meets the FDA requirements for clearance/approval. The costs are already very high that make it very difficult for startups to disrupt the industry as mentioned by Ashley. However, new medical breakthroughs can lead to startups that can amass funds from venture capitalists and resources provided by business incubators. The barrier to entry will continue to get higher as stricter regulations are introduced, which undoubtedly limits competition and innovation, but with the premise of transforming medical industry with a startup device, investors can enable startups to enter the competition.
