In Dr. Simon's Week 2 Lecture, there are mentions of caution and avoidance of creating new devices that require a PMA. A PMA (Premarket Approval Application) does not allow a new device to use the substantially equivalent claim and clinical trials would need to be conducted. This pathway for a medical device would require years and years along with millions being spent on development. It is mentioned in his lecture that big companies like J&J are "not nimble enough" to handle such a process. Regulatory and project management staff would not expect any return in profit for several years and the people originally working on the project could already be at another job. Startup companies however are more eager to go through a PMA for their new project since their primary purpose would be that new medical product. If the startup company succeeds in the creation of the product, they can choose whether to be bought out by a bigger company or to try their efforts in more medical products.
That being said, do you think that this common practice limits the creation and innovation of better products in the medical field? Please explain why.
Also, would you rather work for a big company where they are unlikely to make a product that needs a PMA, or would you want to try and work for a startup company?
Yes, common practice can sometimes limit the creation and innovation of better medical products for several reasons:
1)Premarket Approval (PMA) must undergo rigorous clinical trials and regulatory reviews, which can take years and cost millions of dollars. This discourages companies from developing entirely new products and pushes them toward modifying existing devices to qualify for the faster 510(k) pathway. PMA for a class III device can be managed well by proper planning, clinical trials from the initial stage, and early engagement with the FDA, which can help with later rejections.
2) Instead of focusing on groundbreaking advancements, big companies refine existing products to ensure a quicker return on investment. This can slow the development of transformative medical technologies.
3) When fewer companies pursue high-risk, high-reward innovations, patients miss out on potentially life-changing treatments. Even when new devices reach the market, the high development costs often make them expensive and less accessible.
4) While startups are more willing to navigate the PMA process, many face financial struggles and regulatory delays.
5) Apart from common practice, other factors limit innovation in the medical field. Even if an innovative device is approved, healthcare professionals may hesitate to adopt it due to lack of training, uncertainty about insurance coverage, or preference for traditional methods. Even patients hesitate to participate in a clinical trial to develop a new device or drug. The cost of the new device is often higher than a traditional one. For example, a power toothbrush costs more than a manual one. So, not everyone has access to it.
Also, there needs to be a balance between innovation and wellness. Medical device failures and malfunctions invariably harm people’s well-being because they are often deployed on the frontline of patient care and in users’ homes. The main aim should be the patient's health and well-being. We cannot risk any human lives at the cost of innovation.
I prefer to work in a startup because it allows me to contribute to cutting-edge innovations while having greater flexibility in research and creative freedom. I can be involved in every project stage in a startup, from planning and design to execution and decision-making. This hands-on approach allows for faster adaptation to new ideas and a more dynamic work environment. However, as the saying goes, "With great power comes great responsibility." I would always prioritize patient safety and regulatory compliance to ensure that innovation does not come at the cost of public health and well-being.
Avoiding PMA in medical device development can slow down innovation. Since PMA takes a long time and costs a lot, many companies choose to improve existing devices instead of creating entirely new ones. This helps them get products to market faster but limits major breakthroughs in healthcare.
However, innovation isn’t just about regulations. Careful planning, early communication with the FDA, and well-designed clinical trials can help manage PMA challenges. Startups and big companies can also work together—startups bring new ideas, while big companies have the resources to get products approved and distributed.
I would prefer working at a startup because it allows me to be involved in new and exciting projects. Startups encourage creative thinking and problem-solving, making them a great place to learn and grow. However, innovation should always be balanced with safety to ensure new medical devices truly benefit patients
Some responses already demonstrate how extensively a product that must meet Class III requirements can deter big companies from pursuing new medical treatment methods. However, the FDA does have a program called the "Breakthrough Devices Program," which was created in 2024 to try to mitigate that issue. The program allows companies to reduce the most impactful obstacles in a regular PMA process, such as increased interaction with FDA experts, priority review, and allowing some data to be collected after the product is on the market. This gives companies more incentive to innovate with more communication and a less costly method of filing a PMA.
I would prefer to work for a big company at first for some stability, but then consider startups for more exciting and challenging opportunities. Startups are a way to gain more adaptability and experience regarding project management, and would be beneficial to have that experience in my career.
@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation was being limited because of a PMA. Now reading up on this program definitely gives hope in the medical field for innovations to reach the market in a more timely fashion. This program is designated for products that provide more effective treatment or a diagnosis of life threatening disease and or chronic conditions. It seems the FDA decided to create a very similar program for products that have less but still important impact on those that are affected by disease and or medical conditions. This program is the Safer Technologies Program (STeP). Again, it offers the same opportunities as the Breakthrough Devices Program by giving the development team better avenues to interact with FDA personnel. The FDA can give feedback in a more timely fashion which will definitely expedite the development process. I am glad the FDA took initiative on this. It appears they recognized the problem of innovation being limited by certain aspects of the developmental process to satisfy a PMA.
I think this common practice clearly limits the potential for innovation in the medical field. The most obvious reasons to me are rooted in financial capacity and resources. Innovation and new devices and treatments are essential to the medical field since there are still a massive variety of conditions and diseases without cures or treatments, and this common practice puts the burden of discovery and invention on small companies. However, without billions of dollars and a powerhouse of a quality department, these small companies are at a severe disadvantage and take massive risks by investing into new treatments or devices. Clearly, a multi-billion-dollar company with a more than well-equipped legal department and excess of manpower is in a better position to spend millions of dollars and take on the FDA than a small start-up. If these larger companies invested more freely in startups or bought them in their earlier stages, taking on that risk, then there would be many more breakthroughs within the medical industry. Unfortunately, the current state of the industry and money-driven mentality of the majority of large companies hinders innovation and perpetuates a cycle of untreated medical conditions and suffering of patients worldwide.
As for where I would rather work, I would prefer to work for a startup. I am much more interested in innovation and have a desire to create something that can positively affect the lives of people around the world. There is a seemingly endless list of injuries, diseases, or other conditions that can need better treatments than those currently available and I would rather play a role in creating that than settling for subpar treatment simply because it is just what we have.
While the long and challenging process for a PMA make it so that companies are discouraged at innovating new medical devices, it is necessary for a PMA to be rigourous so that the effectiveness is determined to comply with pateint safety. However, I do agree that companies see this as a barrier to pursue innovation instead of a measure placed to ensure that medical devices are screened to meet standards.
Bigger companies do have the resources to pursue innovation (such as more money, employees, research facilities, resources to conduct clinical trials, etc.), but choose to play it safe an improve products already on the market because they get approved faster and therefore become profitable faster. Newer products take a lot of time and money and may not even get approved in the end. Startups are more innovative despite having limited resources. Usually what happens is that after a newer medical device is lauched, bigger companies will buy out start-ups.
I think that what should happen istead is a partnership where the bigger company can provide its resources and the startup can come up with the idea. This powerhuose can create more innovative treatments and get them approved faster.
With that being said, I like the idea of start-ups because while they have a limited scope, they put more of a focus on research and development. However, bigger companies provide stability and often are able to provide a larger impact overall. I would like to find a company that's in between where I can find both.
