Brandon Henning, VP of Product at Greenlight Guru07.01.21
The balance between quality and speed when developing medical devices has always been difficult to find. For diagnostic test developers, COVID-19 raised the stakes of that struggle: a sudden, tremendous spike in demand for high quality testing kits to rapidly test for infection added incredible pressure to manufacturers throughout the supply chain. In a race to meet demand, quality sometimes took a back seat in favor of rapidly pushing tests to the public.
As the pandemic raged on, FDA released statements warning labs and hospitals about certain serological and rapid antigen testing kits that had faulty products or failed to properly secure an emergency use authorization (EUA). Tests had been released speedily but hadn’t gone through the necessary quality checkpoints to ensure safety and effectiveness. By not putting quality at the forefront, companies were unable to market these products as well as recoup any development and manufacturing expenses—all at the expense of the public’s health.
While the pandemic has taught the healthcare industry many lessons, it falls upon manufacturers to learn from them and improve. Speed remains a critical factor in any go-to-market endeavor; however, quality has proven to be equally as important. Leveraging technology, like a QMS specialized for medical devices (MDQMS), can both accelerate speed to market and create sustainable processes, while reducing the cost of quality each step of the way.
Manage Change Faster
Relying solely on humans to run change management using legacy quality systems allows for gaps to form and be filled by human errors or unseen issues. Change management is challenging enough for medical devices with long development cycles, but diagnostic device development can happen at a relatively breakneck pace. Legacy systems are not built with the infrastructure to keep pace with rapid changes, as these tools require frequent manual reconfiguration.
Device companies using a MDQMS can produce a comprehensive trail of change orders and other relevant documentation in a matter of minutes. A modernized quality system facilitates immediate communication between multiple teams and stakeholders, securely storing documents and records as supporting evidence. It removes much of the burden from humans who, using legacy systems, would not otherwise be able to keep up with a high volume of changes occurring at such a rapid pace.
In addition, antiquated quality systems can’t keep up with the pace and complex nature of the change control process for diagnostics. These companies need a change control solution that simplifies this experience, which is exactly what a modern QMS solution that’s powered by AI is built to do. This type of quality engine comes equipped with predictive intelligence and data-driven recommendations that simplify the overall experience for companies, allowing teams to quickly and easily understand the impact of changes and control all related processes at machine speed.
What’s more, demonstrating closed-loop traceability (CLT) through the development cycle is still a challenge for many companies, but it’s increasingly important to regulators that they can do so. For example, FDA includes traceability as a requirement in its quality system regulation. Still, our own industry benchmark survey found only 28% of medical device companies can update CLT in real-time, and 31% said it takes two or more days to update their traceability matrix. As development cycles speed up, it becomes more important to use a well-equipped MDQMS that supports this need for speed while maintaining quality standards.
Manage EUAs and Approvals More Efficiently
The EUA program from FDA saw a resurgence as a result of the need for speed in delivering COVID-19 tests to the public. While authorization is only granted on a temporary basis, this FDA program is designed to allow diagnostic tests to enter the market at an accelerated pace in order to address a public health crisis.
But speed cannot supersede quality — amid a flurry of low-quality EUA applications, FDA issued a warning to manufacturers that proper development and design control provisions were not optional, and that companies must continue to follow quality best practices. Authorization can be granted in a matter of days, but only if the necessary information submitted is in order and properly filed with FDA.
Companies using an MDQMS can effortlessly track this key data with a click of a button and ensure they’re following quality best practices throughout the development process. By having the means to demonstrate traceability, manufacturers can more quickly produce and submit their EUA applications with the right information easily accessible to FDA for faster review times. Shaving off this waiting time means tests get to market faster and save more lives.
Innovate Faster with Post-Market Intelligence
Compliance is table stakes — quality matters now and will matter even more in the future. Today, the pandemic continues, and the public still needs quality tests fast. Even though the rush to market has begun trending down for the time being, the need for accurate testing never will. Diagnostic companies must be able to have the means to innovate faster and accurately track how their products are performing post-market.
Manufacturers should already be conducting post-market surveillance of product efficacy in compliance with regulations like 21 CFR 820, 822 and ISO 13485. A MDQMS can help facilitate this, as it can collect information from a variety of sources, like customer feedback and adverse events, CAPA documents, service reports and literature reviews. Beyond compliance, however, teams can use this valuable data to find opportunities for process and quality improvements. They can discover where to streamline operations and help drive innovation faster when the next set of tests need to be developed.
The pandemic has taught companies important lessons about striking the right balance between speed and quality. Most critical is that market leaders do not have to trade one for the other. By using technology with quality built into its core, manufacturers can produce and deliver quality tests to market quicker than before while also developing a sustainable pipeline through effective change management. The stakes may be high, but a MDQMS solution ensures you’re working smartly and efficiently every step of the way.
Brandon Henning, VP of Product at Greenlight Guru, leads all product management efforts for the medical device QMS software company. He has been involved in life science manufacturing for over twenty years and has run an industry leading technology business focused on delivering quality and manufacturing solutions to the life science industry.
As the pandemic raged on, FDA released statements warning labs and hospitals about certain serological and rapid antigen testing kits that had faulty products or failed to properly secure an emergency use authorization (EUA). Tests had been released speedily but hadn’t gone through the necessary quality checkpoints to ensure safety and effectiveness. By not putting quality at the forefront, companies were unable to market these products as well as recoup any development and manufacturing expenses—all at the expense of the public’s health.
While the pandemic has taught the healthcare industry many lessons, it falls upon manufacturers to learn from them and improve. Speed remains a critical factor in any go-to-market endeavor; however, quality has proven to be equally as important. Leveraging technology, like a QMS specialized for medical devices (MDQMS), can both accelerate speed to market and create sustainable processes, while reducing the cost of quality each step of the way.
Manage Change Faster
Relying solely on humans to run change management using legacy quality systems allows for gaps to form and be filled by human errors or unseen issues. Change management is challenging enough for medical devices with long development cycles, but diagnostic device development can happen at a relatively breakneck pace. Legacy systems are not built with the infrastructure to keep pace with rapid changes, as these tools require frequent manual reconfiguration.
Device companies using a MDQMS can produce a comprehensive trail of change orders and other relevant documentation in a matter of minutes. A modernized quality system facilitates immediate communication between multiple teams and stakeholders, securely storing documents and records as supporting evidence. It removes much of the burden from humans who, using legacy systems, would not otherwise be able to keep up with a high volume of changes occurring at such a rapid pace.
In addition, antiquated quality systems can’t keep up with the pace and complex nature of the change control process for diagnostics. These companies need a change control solution that simplifies this experience, which is exactly what a modern QMS solution that’s powered by AI is built to do. This type of quality engine comes equipped with predictive intelligence and data-driven recommendations that simplify the overall experience for companies, allowing teams to quickly and easily understand the impact of changes and control all related processes at machine speed.
What’s more, demonstrating closed-loop traceability (CLT) through the development cycle is still a challenge for many companies, but it’s increasingly important to regulators that they can do so. For example, FDA includes traceability as a requirement in its quality system regulation. Still, our own industry benchmark survey found only 28% of medical device companies can update CLT in real-time, and 31% said it takes two or more days to update their traceability matrix. As development cycles speed up, it becomes more important to use a well-equipped MDQMS that supports this need for speed while maintaining quality standards.
Manage EUAs and Approvals More Efficiently
The EUA program from FDA saw a resurgence as a result of the need for speed in delivering COVID-19 tests to the public. While authorization is only granted on a temporary basis, this FDA program is designed to allow diagnostic tests to enter the market at an accelerated pace in order to address a public health crisis.
But speed cannot supersede quality — amid a flurry of low-quality EUA applications, FDA issued a warning to manufacturers that proper development and design control provisions were not optional, and that companies must continue to follow quality best practices. Authorization can be granted in a matter of days, but only if the necessary information submitted is in order and properly filed with FDA.
Companies using an MDQMS can effortlessly track this key data with a click of a button and ensure they’re following quality best practices throughout the development process. By having the means to demonstrate traceability, manufacturers can more quickly produce and submit their EUA applications with the right information easily accessible to FDA for faster review times. Shaving off this waiting time means tests get to market faster and save more lives.
Innovate Faster with Post-Market Intelligence
Compliance is table stakes — quality matters now and will matter even more in the future. Today, the pandemic continues, and the public still needs quality tests fast. Even though the rush to market has begun trending down for the time being, the need for accurate testing never will. Diagnostic companies must be able to have the means to innovate faster and accurately track how their products are performing post-market.
Manufacturers should already be conducting post-market surveillance of product efficacy in compliance with regulations like 21 CFR 820, 822 and ISO 13485. A MDQMS can help facilitate this, as it can collect information from a variety of sources, like customer feedback and adverse events, CAPA documents, service reports and literature reviews. Beyond compliance, however, teams can use this valuable data to find opportunities for process and quality improvements. They can discover where to streamline operations and help drive innovation faster when the next set of tests need to be developed.
The pandemic has taught companies important lessons about striking the right balance between speed and quality. Most critical is that market leaders do not have to trade one for the other. By using technology with quality built into its core, manufacturers can produce and deliver quality tests to market quicker than before while also developing a sustainable pipeline through effective change management. The stakes may be high, but a MDQMS solution ensures you’re working smartly and efficiently every step of the way.
Brandon Henning, VP of Product at Greenlight Guru, leads all product management efforts for the medical device QMS software company. He has been involved in life science manufacturing for over twenty years and has run an industry leading technology business focused on delivering quality and manufacturing solutions to the life science industry.
