Based upon your comments and questions on another Newsletter I was sure I would enjoy this. The best writing makes me think and question. This post accomplished that. I look forward to examining your prior writing as I am sure I will learn a lot. Thanks.
The rest of my comment is based upon my experience with manufacturing processes and how businesses embrace continuous improvement. This is especially difficult in regulated industries where the cost of certification and papering the process can be major impediments to innovation. We regulate things we fear and do not understand (light-water reactors, medical devices, broad-based public education). In each case we invariably create structures which cannot get on a learning curve and deliver durable and consistent benefits. Risk management is one of the few leverage points where the story might change.
I think we can all become prisoners of our training and our perspective. An early career exposure to the Toyota Production System and its attention to encompassing the largest practical circles of impacted groups drove an inquisitive and recursive asking of why in order to not draw a system boundary too small. I believe the Medical Device Industry often sets its net just beyond where the regulator lies. The regulator lies, necessarily, just barely beyond public opinon and that changes rapidly in response to events. There are businesses that did the same as the fear of the regulator and its impact on shareholder value can cause uncertainty.
I did some work in the Medical Device business related to new product development as my community is likely the center of thought for this business. The conflicts of IP protection, pursuit of proprietary solutions, and fear of creating a framework for future competition all are drivers of what gets made, how it works, and the tendency to be inward looking. While far from an implantable device, the recent lessons of smart watch technology, options in the auditory market via some deregulation are examples of how companies that play it safe and focus on the FDA may be creating a competitive onslaught they could be unprepared to deal with.
I am sure parts of this are disjointed as I am just thinking about what I read and how it melds with my narrow experience. This post activated a lot of thought. Thanks.
Well written article Naveen. I always begin my training on medical device and combination product risk management with a focus on the patient, and ask the question, "What if you would be th first patient to use your device? How would you perform risk management? It always gets some reaction. I might also say that yes, FDA is increasing its focus on risk management and have already begun training in CDRH and ORA on ISO 14971 in conjunction with the preparation for the move to ISO 13485 to replace 21 CFR 820. There will no longer be the single reference in the regulation to 'risk analysis" as it is all over 13485 and will become much more important for industry, if they are not already in the EU MDR/IVDR space, where as you point out it is much more pervasive.
Based upon your comments and questions on another Newsletter I was sure I would enjoy this. The best writing makes me think and question. This post accomplished that. I look forward to examining your prior writing as I am sure I will learn a lot. Thanks.
The rest of my comment is based upon my experience with manufacturing processes and how businesses embrace continuous improvement. This is especially difficult in regulated industries where the cost of certification and papering the process can be major impediments to innovation. We regulate things we fear and do not understand (light-water reactors, medical devices, broad-based public education). In each case we invariably create structures which cannot get on a learning curve and deliver durable and consistent benefits. Risk management is one of the few leverage points where the story might change.
I think we can all become prisoners of our training and our perspective. An early career exposure to the Toyota Production System and its attention to encompassing the largest practical circles of impacted groups drove an inquisitive and recursive asking of why in order to not draw a system boundary too small. I believe the Medical Device Industry often sets its net just beyond where the regulator lies. The regulator lies, necessarily, just barely beyond public opinon and that changes rapidly in response to events. There are businesses that did the same as the fear of the regulator and its impact on shareholder value can cause uncertainty.
I did some work in the Medical Device business related to new product development as my community is likely the center of thought for this business. The conflicts of IP protection, pursuit of proprietary solutions, and fear of creating a framework for future competition all are drivers of what gets made, how it works, and the tendency to be inward looking. While far from an implantable device, the recent lessons of smart watch technology, options in the auditory market via some deregulation are examples of how companies that play it safe and focus on the FDA may be creating a competitive onslaught they could be unprepared to deal with.
I am sure parts of this are disjointed as I am just thinking about what I read and how it melds with my narrow experience. This post activated a lot of thought. Thanks.
Well written article Naveen. I always begin my training on medical device and combination product risk management with a focus on the patient, and ask the question, "What if you would be th first patient to use your device? How would you perform risk management? It always gets some reaction. I might also say that yes, FDA is increasing its focus on risk management and have already begun training in CDRH and ORA on ISO 14971 in conjunction with the preparation for the move to ISO 13485 to replace 21 CFR 820. There will no longer be the single reference in the regulation to 'risk analysis" as it is all over 13485 and will become much more important for industry, if they are not already in the EU MDR/IVDR space, where as you point out it is much more pervasive.