A good stong postmarket surveillance system is how we make sure our medical devices are performing as designed and cleared by the regulatory agencies. In Europe, the MDR and IVDR both have revised their postmarket systems to become stronger and give early signals of problems. In the US FDA has long had systems in place and knows that they are not receiving all the information FDA needs to make sure the regulatory systems are functioning as designed.
However, more important is that the devices we design and sell provide the expected benefit to the patient and do not harm anyone, especially the patient, but also anyone that comes in contact with the device or its byproducts.
Two standards, ISO 13485:2016 Clause 8 and ISO 14971:2020 Clause 10, that both were developed from the same root, the GHTF CAPA guidance SG3:N18:2010, have requirements to provide postmarket information to regulatory agencies derived from the surveillance systems the manufacturer has actively collected, processed, and responded to the signals from the information.
As is pointed out in Naveen's article, the industry needs to improve our capabilities in monitoring, analyzing, and taking action on the postmarket information. Just this week, FDA posted another Warning Letter (Olympus) to a company that has clearly failed in its responsibilities. If you do not file based on clear signals in your data, yo might find your self in the same place as Olympus. Their reputation is besmirched and patients have been harmed because the company did not adequately review the data they had and take required action.
FDA will issue Warning Letters if you don't have a procedure for postmarket reporting that shows up during an investigation of your foreign facility. If your procedure is inadequate and results in poor reporting of incidents for any facility, that could probably lead to a Warning Letter.
Your customers will learn of a Warning Letter issued to your company from your competitor's sales force "faster than a speeding bullet" as the TV series used to say. You will have a hard time digging out of the reputation damage.
The product liability attorneys will be filing court cases that are very costly, and they will subpoena your risk management file and your design files as well as your production files. It will cost lots of money, time, and effort. A lot more money, time and effort than if you had done it right in the first place.
Pay attention to this article and improve your postmarket surveillance systems and use them to improve products, especially product safety!
Hi Ed - thank you so much for sharing your insights. I feel that FDA has not had much success in motivating manufacturers to develop robust post-market surveillance systems. Complaint handling and MDR reporting is not post-market surveillance. Companies spend too much time and resources in complaints handling, yet they are not meeting FDA's expectations. I think part of it is due to an excessive focus on regulatory compliance and part due to the fact the patients as a whole do not have visibility to adverse events. MAUDE is notoriously difficult to navigate even for experts, and in addition, it suffers from high variability in reporting. As a result, you cannot compare rates of adverse events accurately.
I am hopeful that the changing regulatory requirements in the EU, and expectations in the US will drive the much needed action. But honestly, I am not very optimistic about it. Our industry does not have a good track record in taking proactive steps to improve quality processes.
I do see 3 trends that may drive action, but it may take a while. I wrote about it in my article here
This article is brilliant. It will be fascinating to see how much quality activity is driven by customer demand, irrespective of regulator oversight. Kudos!
Great to discover your writing. I will share your writing with old friends who work in medical device sector. I enjoyed the reference to Donald Rumsfeld! I wrote about it in a light-hearted fashion a while ago but I think he was an example of a system thinker. Medical devices have transformed our lives but the right (and smart) level of oversight needs to be leveraged. I spent a significant part of my career in a heavily regulated marketplace. It was industry sharing, whistleblowers, and openness that transcended IP protection that helped the industry mature.
Naveen, excellent article. I especially love the statement: "Leaders who lament that post-market surveillance is a non-value added activity to be done to satisfy the regulators, need to take another look at the changing industry and regulatory environment. "
Again, the regulatory environment is REFOCUSING! We are not adding additional requirements. We are attempting to get back to the intent of the post market surveillance requirements. It was never supposed to be a non-value added activity done for the sake of compliance.
Thanks for sharing your insights Jacob. I think that FDA's position on post-market surveillance is a little ambiguous which leads many to believe that it is an optional, nice to have process. Complaints Handling is not post-market surveillance. The EU-MDR is a lot more prescriptive. It will be interesting to see how FDA's thinking evolves on this topic and if they decide to emphasize this when they harmonize the QSR with ISO 13485.
Unfortunately, many see the delay in the date of application of EU MDR as a reason to delay the expected improvements that you cite here. The need is now, the requirement to be compliant is still a few years away. If not a paradox, certainly a quandary.
Our industry, unfortunately, tends to be reactive. It was only after a massive recall nearly 15 years ago that drove a significant change in my prior organization. They decided to create a new Quality function with technically trained people and I was among the first 4 to be recruited. I had no idea about regulatory requirements, I was just a R&D guy. We were able to build a very efficient, highly effective PMS process that helped us to detect safety signals much earlier. We were also able to drive changes in the process and product to not only fix issues, but also to improve customer experience through better quality.
So, I know it can be done. Sometimes, we just need the right trigger.
Unfortunately, EU-MDR could never be that trigger!
Regulatory and quality voices are typically muted inputs in the business review meetings, business ROI for PMS is a real input for the companies and industries that do this well, as you cited the examples from the automotive industry. Recognizing the liability pushed these innovations.
Indeed Jacob - that is where I see an opportunity for us in the Quality/Regulatory functions. I believe that aspiring leaders in our field have a huge opportunity to make a significant impact. The bar is quite low!
A good stong postmarket surveillance system is how we make sure our medical devices are performing as designed and cleared by the regulatory agencies. In Europe, the MDR and IVDR both have revised their postmarket systems to become stronger and give early signals of problems. In the US FDA has long had systems in place and knows that they are not receiving all the information FDA needs to make sure the regulatory systems are functioning as designed.
However, more important is that the devices we design and sell provide the expected benefit to the patient and do not harm anyone, especially the patient, but also anyone that comes in contact with the device or its byproducts.
Two standards, ISO 13485:2016 Clause 8 and ISO 14971:2020 Clause 10, that both were developed from the same root, the GHTF CAPA guidance SG3:N18:2010, have requirements to provide postmarket information to regulatory agencies derived from the surveillance systems the manufacturer has actively collected, processed, and responded to the signals from the information.
As is pointed out in Naveen's article, the industry needs to improve our capabilities in monitoring, analyzing, and taking action on the postmarket information. Just this week, FDA posted another Warning Letter (Olympus) to a company that has clearly failed in its responsibilities. If you do not file based on clear signals in your data, yo might find your self in the same place as Olympus. Their reputation is besmirched and patients have been harmed because the company did not adequately review the data they had and take required action.
FDA will issue Warning Letters if you don't have a procedure for postmarket reporting that shows up during an investigation of your foreign facility. If your procedure is inadequate and results in poor reporting of incidents for any facility, that could probably lead to a Warning Letter.
Your customers will learn of a Warning Letter issued to your company from your competitor's sales force "faster than a speeding bullet" as the TV series used to say. You will have a hard time digging out of the reputation damage.
The product liability attorneys will be filing court cases that are very costly, and they will subpoena your risk management file and your design files as well as your production files. It will cost lots of money, time, and effort. A lot more money, time and effort than if you had done it right in the first place.
Pay attention to this article and improve your postmarket surveillance systems and use them to improve products, especially product safety!
Hi Ed - thank you so much for sharing your insights. I feel that FDA has not had much success in motivating manufacturers to develop robust post-market surveillance systems. Complaint handling and MDR reporting is not post-market surveillance. Companies spend too much time and resources in complaints handling, yet they are not meeting FDA's expectations. I think part of it is due to an excessive focus on regulatory compliance and part due to the fact the patients as a whole do not have visibility to adverse events. MAUDE is notoriously difficult to navigate even for experts, and in addition, it suffers from high variability in reporting. As a result, you cannot compare rates of adverse events accurately.
I am hopeful that the changing regulatory requirements in the EU, and expectations in the US will drive the much needed action. But honestly, I am not very optimistic about it. Our industry does not have a good track record in taking proactive steps to improve quality processes.
I do see 3 trends that may drive action, but it may take a while. I wrote about it in my article here
https://naveenagarwalphd.substack.com/p/why-we-need-a-stronger-focus-on-medical
Naveen,
This article is brilliant. It will be fascinating to see how much quality activity is driven by customer demand, irrespective of regulator oversight. Kudos!
Steve
Thank you Steve!
Thanks for publishing this synopsis, Naveen. It's a valuable tool to understand recent FDA regulatory actions.
Great to discover your writing. I will share your writing with old friends who work in medical device sector. I enjoyed the reference to Donald Rumsfeld! I wrote about it in a light-hearted fashion a while ago but I think he was an example of a system thinker. Medical devices have transformed our lives but the right (and smart) level of oversight needs to be leveraged. I spent a significant part of my career in a heavily regulated marketplace. It was industry sharing, whistleblowers, and openness that transcended IP protection that helped the industry mature.
Thank you Mark for your kind words. I appreciate your support.
Naveen, excellent article. I especially love the statement: "Leaders who lament that post-market surveillance is a non-value added activity to be done to satisfy the regulators, need to take another look at the changing industry and regulatory environment. "
Again, the regulatory environment is REFOCUSING! We are not adding additional requirements. We are attempting to get back to the intent of the post market surveillance requirements. It was never supposed to be a non-value added activity done for the sake of compliance.
Thanks for sharing your insights Jacob. I think that FDA's position on post-market surveillance is a little ambiguous which leads many to believe that it is an optional, nice to have process. Complaints Handling is not post-market surveillance. The EU-MDR is a lot more prescriptive. It will be interesting to see how FDA's thinking evolves on this topic and if they decide to emphasize this when they harmonize the QSR with ISO 13485.
Unfortunately, many see the delay in the date of application of EU MDR as a reason to delay the expected improvements that you cite here. The need is now, the requirement to be compliant is still a few years away. If not a paradox, certainly a quandary.
Our industry, unfortunately, tends to be reactive. It was only after a massive recall nearly 15 years ago that drove a significant change in my prior organization. They decided to create a new Quality function with technically trained people and I was among the first 4 to be recruited. I had no idea about regulatory requirements, I was just a R&D guy. We were able to build a very efficient, highly effective PMS process that helped us to detect safety signals much earlier. We were also able to drive changes in the process and product to not only fix issues, but also to improve customer experience through better quality.
So, I know it can be done. Sometimes, we just need the right trigger.
Unfortunately, EU-MDR could never be that trigger!
Regulatory and quality voices are typically muted inputs in the business review meetings, business ROI for PMS is a real input for the companies and industries that do this well, as you cited the examples from the automotive industry. Recognizing the liability pushed these innovations.
Indeed Jacob - that is where I see an opportunity for us in the Quality/Regulatory functions. I believe that aspiring leaders in our field have a huge opportunity to make a significant impact. The bar is quite low!