Jon Speer, Founder and VP of QA/RA at Greenlight Guru07.27.20
Between 6,500 medical device manufacturers in the United States and another 27,000 in the EU, the number of medical devices in development and already on the market is almost impossible to count. Throughout the entire design process and even after completing a go-to-market strategy, it’s important for professionals to continue seeking best practices to implement for maintaining the success of their medical device.
Finding success through the entire device lifecycle is more important now than ever before. The medical device industry is playing a critical role in the battle against COVID-19 as various organizations rush to create the next best innovation and obtain an Emergency Use Authorization (EUA) or another method for market access through FDA.
While the speed of this pursuit may seem daunting and challenging, working together to focus on True Quality and shared knowledge will alleviate some of this pressure. At Greenlight Guru, our team is working closely with customers actively involved in this fight, alongside other MedTech experts by leveraging our specialized areas of industry expertise and medical device QMS (MDQMS) platform.
To help leaders work through today’s challenges and achieve success throughout the entire device lifecycle, I spoke with three other industry experts to break down the issues that device makers are faced with and share best practices when using quality management tools and other resources. Here’s a deeper look at those conversations:
Medical Device Mishaps
Wrong turns can easily be made at any stage of the device lifecycle, especially when attempting to innovate at an accelerated speed. Throughout my 20+ years of experience, one of the primary issues I’ve seen arise is when companies neglect to focus on risk management processes. Risk management is intended to identify, analyze, evaluate, and mitigate any potential device issues.
During my first day as a medical device product development engineer, an important theme emerged from my training exercises. The medical devices I would be creating could potentially be used on one of my friends or family members, or even myself. This hit home for me. Patients accept a level of risk when using the devices we as medical device professionals create, which is why an effective risk management system is so important.
Risk Management is just one part of the product lifecycle, which is why manufacturers must take a holistic approach to establishing sound processes throughout their entire quality system. However, this doesn’t always happen as it should. According to Keith Drake, vice president of business development at Galen Data, many companies fail to consider critical components like device connectivity. Drake stated, "Recognizing device connectivity is no longer a ‘nice to have,’ but rather a ‘need to have’ for commercial success. 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.”
Isabella Schmitt, CRO at Proxima Clinical Research, claims another major issue she comes across is developers getting themselves caught in engineering silos and neglecting proper testing which often leads to unforeseen device issues.
"The best way to avoid this is to follow design controls as soon as you've decided this product is something marketable,” Schmitt says, “this means you'll be establishing your minimum viable product and designing towards that."
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 that a common mistake he often sees early in the development process is entering formal design controls without truly understanding the implications of doing so.
Gibson emphasized 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."
These are a few of the most common mishaps that we’ve seen companies make, all of which seem to be centered around a central theme of neglecting key processes. So, how do you prevent and solve these issues? Let’s take a look at some best practices that can help address these common mishaps and ensure successful outcomes for your medical device.
Ensuring Total Product Lifecycle Success
At the end of 2019, we released our original research findings in the State of Medical Device Product Development & Quality Management Report 2020, which found 80% of organizations ask their quality and engineering teams to "make do" with legacy tools.
Common issues, such as the ones described earlier in this article can be traced back to using a legacy system approach that treats quality like a checkbox activity. In order to be successful, industry professionals must abandon this traditional mindset and shift their focus to building a culture of quality that’s instilled within every process throughout the product lifecycle.
Make quality a focus from the start, while also considering the end-point success of the device’s design to support business needs. Chad Gibson echoed this advice by sharing, “Early interaction with regulators to align on grey areas of regulation and compliance can reduce over-design or under-shooting regulator expectations. 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." Before you even begin building out your quality system processes, it’s critical to define user, business and regulatory needs.
Keith Drake shared similar sentiments around this idea, suggesting the need to design for success from the start. "In addition to focusing on the implementation of your medical technology, consider issues such as connectivity, regulatory and usability. 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 this global health crisis evolves, medical device leaders must continually search for ways to steer excellence by participating in good business practices that place emphasis on quality processes to ensure the safety and efficacy of their devices for optimal patient outcomes. Tapping into other industry leaders’ proven methods and best practices is a great place to start and, according to the experts above, adopting a mindset of quality can position your company and medical device for lasting success.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru a medical device quality management MDQMS software & a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
Finding success through the entire device lifecycle is more important now than ever before. The medical device industry is playing a critical role in the battle against COVID-19 as various organizations rush to create the next best innovation and obtain an Emergency Use Authorization (EUA) or another method for market access through FDA.
While the speed of this pursuit may seem daunting and challenging, working together to focus on True Quality and shared knowledge will alleviate some of this pressure. At Greenlight Guru, our team is working closely with customers actively involved in this fight, alongside other MedTech experts by leveraging our specialized areas of industry expertise and medical device QMS (MDQMS) platform.
To help leaders work through today’s challenges and achieve success throughout the entire device lifecycle, I spoke with three other industry experts to break down the issues that device makers are faced with and share best practices when using quality management tools and other resources. Here’s a deeper look at those conversations:
Medical Device Mishaps
Wrong turns can easily be made at any stage of the device lifecycle, especially when attempting to innovate at an accelerated speed. Throughout my 20+ years of experience, one of the primary issues I’ve seen arise is when companies neglect to focus on risk management processes. Risk management is intended to identify, analyze, evaluate, and mitigate any potential device issues.
During my first day as a medical device product development engineer, an important theme emerged from my training exercises. The medical devices I would be creating could potentially be used on one of my friends or family members, or even myself. This hit home for me. Patients accept a level of risk when using the devices we as medical device professionals create, which is why an effective risk management system is so important.
Risk Management is just one part of the product lifecycle, which is why manufacturers must take a holistic approach to establishing sound processes throughout their entire quality system. However, this doesn’t always happen as it should. According to Keith Drake, vice president of business development at Galen Data, many companies fail to consider critical components like device connectivity. Drake stated, "Recognizing device connectivity is no longer a ‘nice to have,’ but rather a ‘need to have’ for commercial success. 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.”
Isabella Schmitt, CRO at Proxima Clinical Research, claims another major issue she comes across is developers getting themselves caught in engineering silos and neglecting proper testing which often leads to unforeseen device issues.
"The best way to avoid this is to follow design controls as soon as you've decided this product is something marketable,” Schmitt says, “this means you'll be establishing your minimum viable product and designing towards that."
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 that a common mistake he often sees early in the development process is entering formal design controls without truly understanding the implications of doing so.
Gibson emphasized 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."
These are a few of the most common mishaps that we’ve seen companies make, all of which seem to be centered around a central theme of neglecting key processes. So, how do you prevent and solve these issues? Let’s take a look at some best practices that can help address these common mishaps and ensure successful outcomes for your medical device.
Ensuring Total Product Lifecycle Success
At the end of 2019, we released our original research findings in the State of Medical Device Product Development & Quality Management Report 2020, which found 80% of organizations ask their quality and engineering teams to "make do" with legacy tools.
Common issues, such as the ones described earlier in this article can be traced back to using a legacy system approach that treats quality like a checkbox activity. In order to be successful, industry professionals must abandon this traditional mindset and shift their focus to building a culture of quality that’s instilled within every process throughout the product lifecycle.
Make quality a focus from the start, while also considering the end-point success of the device’s design to support business needs. Chad Gibson echoed this advice by sharing, “Early interaction with regulators to align on grey areas of regulation and compliance can reduce over-design or under-shooting regulator expectations. 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." Before you even begin building out your quality system processes, it’s critical to define user, business and regulatory needs.
Keith Drake shared similar sentiments around this idea, suggesting the need to design for success from the start. "In addition to focusing on the implementation of your medical technology, consider issues such as connectivity, regulatory and usability. 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 this global health crisis evolves, medical device leaders must continually search for ways to steer excellence by participating in good business practices that place emphasis on quality processes to ensure the safety and efficacy of their devices for optimal patient outcomes. Tapping into other industry leaders’ proven methods and best practices is a great place to start and, according to the experts above, adopting a mindset of quality can position your company and medical device for lasting success.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru a medical device quality management MDQMS software & a medical device guru with over 20 years of industry experience. Speer knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to achieve True Quality.
