There are more than 6,500 medical device companies in the United States alone. Each of these organizations is constantly developing new devices, not to mention upgrading those already on the market, which is why many industry professionals are frequently seeking ways to ensure success throughout the entire medical device lifecycle.
This idea is especially true given the current state of the world with the medical device industry playing a key role in the fight against COVID-19. Many companies are working tirelessly to bring new devices to market as quickly as possible in order to meet growing global demand. But to truly find success and maximize efficiency, true quality best practices must be kept at the forefront and exercised throughout the entire device lifecycle. True quality is the highest level of standard to which medical device professionals, processes, and technologies are measured and serves as the driving force for the industry’s shared mission to improve and save lives. A true quality mindset becomes the heartbeat of your company, leading to reduced costs, increased profits, and higher customer and employee satisfaction. By making the switch to true quality, the status quo of treating compliance as a checkbox activity disappears and medical device leaders emerge.
If the medical device industry works collectively through shared knowledge, innovation, and resources, the tasks at hand can become seemingly less daunting. In my current role, I am experiencing this firsthand as I consult with not only the Greenlight Guru team to provide specialized support through our MDQMS software and services, but also our customers and industry partners as well. While the news around COVID-19 continues to be fast-paced and shifts almost daily, our industry is rising to the occasion and acting as part of the solution.
To help companies navigate this time of uncertainty with confidence and continue to produce innovative devices that go beyond baseline compliance and achieve true quality at every stage, I enlisted three leading medical device experts to provide their valuable insights on the topic, common mistakes and tips for avoiding them, and how manufacturers can use quality management tools to ensure lasting success of their devices.
Following are their perspectives.
Common Mistakes throughout Medical Device Lifecycle Stages
In my opinion, one of the biggest, most frequently made mistakes of companies is neglecting to establish a risk management process. The regulatory landscape is constantly changing with recent updates to both EU MDR and ISO 14971:2019, and this shift can often pull the focus away from efficiently managing the risk of a medical device.
I remember my first day on the job as a medical device product development engineer. As part of my training I was shown a company video with a salient theme: the devices I was helping to develop could someday be used on a friend, family member, or even myself. Imagine this realization from the perspective of someone awaiting any medical procedure. The patient likely has given little consideration to all of the risks associated with the device they will be interfaced with, unknowingly accepting the risks based on the medical recommendation given by their healthcare provider. This example illustrates why it is so critical for the medical device industry to exercise strong risk management practices.
Manufacturers should consider and fully grasp all facets of their medical device; unfortunately, this isn’t always the case. For instance, Keith Drake, vice president of business development at Galen Data, sees many industry players failing to consider device connectivity.
"Recognizing device connectivity is no longer a ‘nice to have,’ but rather a ‘need to have’ for commercial success,” Drake told me. “Cloud connectivity platforms receiving patient information, such as vital signs and treatment status and device data like battery level, must be able to communicate back to the device in a compliant manner.”
Another area that can fall through the cracks is ensuring a firm grasp on formal design controls. Chad Gibson, managing partner at CMD MedTech, shared his feelings on a common mistake that occurs early in the development process by implementing formal design controls without truly understanding the implications it will have on other system processes.
Gibson also said that “controlling the design too early can result in additional burden and overhead when unforeseen or deferred technical challenges arise. In addition to technical risk reduction, early diligence in program management and systems engineering will result in a less costly and more predictable design process."
According to Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, one of the major issues she often sees is manufacturers trapping themselves in an engineering silo, which has a propensity to hinder adequate verification/validation testing and overlook user needs considerations.
"The best way to avoid this is to follow design controls as soon as you've decided this product is something marketable,” she told me. “This means you'll be establishing your minimum viable product and designing towards that."
A common theme that causes many to fail in these regards is a lack of focus on establishing a strong risk management and design controls connection. How can you mitigate these potential issues so you can avoid falling into the common pitfalls altogether? Here are a few best practices to consider.
Ensuring Success During Every Stage of the Product Lifecycle
What I tell every manufacturer is to make quality a priority from the start. This means everything from your internal culture to the tools you use should be built on a foundation of true quality. Start by providing your teams with the best tools available to make their jobs easier.
Data-driven insights from our 2020 industry benchmark survey of over 500 medical device professionals worldwide found that 80% of organizations ask their quality and engineering teams to "make do" with legacy tools. This outdated approach of treating quality as a checkbox activity, reinforced by these legacy systems, must be forgotten. A cultural mindset shift must be made in order to keep quality as the heartbeat of a company and its medical device practices.
When making this mindset shift, also consider designing the device to support business needs with end-point success in mind. One of the medtech experts featured earlier, Chad Gibson, offered some valuable advice to further this point. He believes that before you even open your CAD software, you must define and refine your user and business needs, including those of regulators.
“Early interaction with regulators to align on grey areas of regulation and compliance can reduce over-design or under-shooting regulator expectations,” he said. “Similarly, having a firm understanding of users' "must-haves" and "nice-to-haves" along with development risks, costs, and timelines provide a solid basis to enter design controls."
Keith Drake also stated that a mindset shift is critical in that you must design for success from the beginning.
"In addition to focusing on the implementation of your medical technology, consider issues such as connectivity, regulatory, and usability,” he said. “Devices designed for collection and analysis of data developed with certified design controls and created from the end user's viewpoint enhance the probability of commercial success."
As the healthcare needs around the world continue to evolve, there are endless opportunities for innovation to meet demand and deliver quality outcomes as you do. Tapping into the proven techniques and methodologies of other successful industry professionals is a great place to start and, according to the experts above, adopting a mindset that ensures quality at every stage of your medical device puts you in the driver's seat on the road to success.