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.
Hi Mark - thank you for your comment and feedback. I appreciate your insights.
Part of the challenge, I think, is that we are doing it to ourselves! By that what I mean is that we are creating an army of "internal regulators" whose job seems to say "we can't do that". This is the real reason for slow innovation and poor performance. What we need is people to say "we can't do it this way, but here are 10 other ways of achieving the same result which is also compliant". We are not seeing that in the industry.
I love the notion of "setting the net just beyond the regulator". In doing so, we aren't really thinking about the patient and doctors.
I do hope that a new focus on risk management beyond compliance will be helpful.
The Twin Cities where I live is a who's-who of the medical device industry. I did a longish consult with one of the primaries regarding thinking differently when it comes to implantables and how data is gathered. A perfect example of how the firm was focused on proprietary mechanisms for data collection when the larger industry has largely sorted out best practices for securing information, telemetry of data, and likely data analytics. The profound angst was loss of IP if we partner. This is the same thing that drove the extinction of AOL. A walled-garden works in a slow-innovation business but can collapse quickly in a business on a learning curve. It is very hard to change as you well know. I spent some time in the Light-Water Nuclear business earlier in my career. The business NEVER got on a learning curve, regulatory structure was part ot blame for essentially no innovation for nearly 40 years. People gnash their teeth nowadays and wonder why we stopped building fission reactors. It was a simple choice purely based on regulatory structure, economics and ROI.
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.
Hi Mark - thank you for your comment and feedback. I appreciate your insights.
Part of the challenge, I think, is that we are doing it to ourselves! By that what I mean is that we are creating an army of "internal regulators" whose job seems to say "we can't do that". This is the real reason for slow innovation and poor performance. What we need is people to say "we can't do it this way, but here are 10 other ways of achieving the same result which is also compliant". We are not seeing that in the industry.
I love the notion of "setting the net just beyond the regulator". In doing so, we aren't really thinking about the patient and doctors.
I do hope that a new focus on risk management beyond compliance will be helpful.
The Twin Cities where I live is a who's-who of the medical device industry. I did a longish consult with one of the primaries regarding thinking differently when it comes to implantables and how data is gathered. A perfect example of how the firm was focused on proprietary mechanisms for data collection when the larger industry has largely sorted out best practices for securing information, telemetry of data, and likely data analytics. The profound angst was loss of IP if we partner. This is the same thing that drove the extinction of AOL. A walled-garden works in a slow-innovation business but can collapse quickly in a business on a learning curve. It is very hard to change as you well know. I spent some time in the Light-Water Nuclear business earlier in my career. The business NEVER got on a learning curve, regulatory structure was part ot blame for essentially no innovation for nearly 40 years. People gnash their teeth nowadays and wonder why we stopped building fission reactors. It was a simple choice purely based on regulatory structure, economics and ROI.
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.
Thank you Ed. It is exciting to see the much-needed focus on patient safety and FDA making the right moves!