Interested in your perspective on this, Michelle Lott , RAC.

Richard Bollinger interestingly enough, I have been at Xavier's MedCon this week where the FDA addressed this very topic. The mission of FDA's Case of Quality program is to promote a strong culture toward quality and drive a deeper understanding of how quality (not compliance) must be integrated throughout the company. Basically, quality is not just Quality's job. Companies who participate in the program and meet certain criteria can be considered for exemption from inspections and other benefits.

On a personal note, after working directly in the medical device industry for 15 years, I couldn't agree more with the reports conclusions. Too often I have seen the Quality department regarded as "the police" or "blockers" to meeting company financial goals. Companies focus on risk is to the P&L rather than the patient.

Hope you enjoyed the previous articles from 2016 we authored

Kris Kelly Hey Charlie Gragg - I'm really interested in your thoughts here....

Naveen Agarwal, Ph.D. Great article Richard love the idea of Risk Management Innovation!
Lately I have been fascinated by the recent failures and near-misses at Southwest. I bet the challenges you highlight are not limited to the #MedTech industry. I would love to collaborate with you as I have a lot of experience in integrated risk management using a lifecycle approach.

The human species doesn’t learn easily and has the propensity to repeat mistakes. I gathered that from studying the Challenger disaster and subsequently the Columbia as well.

Business as usual is what the species returns to soon after tightening the belt

With regard to risk management we have a loooooong way to go

Jason Partin Important info to consider,because regardless of exact numbers or methodology of studies, reducing risk helps patients. There's no reason not to incorporate continuous improvement into a risk management policy. The attached link is to an article describing how risk management led to safer products, innovation, & new markets, and summarizes the ISO standard for Risk Management, #ISO14971 :
https://www.linkedin.com/pulse/medical-device-risk-jason-partin

Adam F. Atherton, PE The article is spot on. At the manufacturer, I think the problem boils down to compliance vs commitment. Manufacturers are generally compliant with their SOPs. Practically, this means when "doing" risk management they are starting in the proper phase and they are finishing near the end of development. In my experience, most manufacturers lean HEAVILY on labeling when documenting mitigations. Of course, this is the least effective of the 3 types of 14971 mitigations. Why do they do this? Because of the timing of meaningful risk management activities, it is the only thing left that can be influenced - the design is already done. When committed to using risk to drive development, the risk team will dive in sooner and stay engaged throughout development and as a result be able to identify and implement more design and protective measures making the device more robust and reliable. Bottom line: Culture change is more difficult than developing devices or staying compliant to your QMS.

Good article. I find some Notified bodies don't track properly the risk management process. A lot of companies seem considered the risk management file as a output data done at the end of project and build by only one or two Project leaders. Obviously this behavior shows an misunderstanding of benefits/risk ratio during the life cycle of products.

Salvatore Domenic Morgera This article misses the point entirely. I have been involved in this industry for decades in research, design and verification and validation. Many companies are blinded by potential profits and putting devices on the market that reflect a lack of understanding of the fundamentals of the specific dysfunction. As I have said many times and seen too often in companies, there is not enough research done prior to development. I realize that research is costly, but it is vital. We will see more and more recalls of FDA approved devices in the future.

Christopher Paris Risk management consultants need to watch themselves. Consistently overpromising that they can fix everything will only ensure that they are blamed when things go wrong. Plus, it's just unseemly. Stop it already.

Keith DeBrunner 1/1 This article strikes me as more “risk management” confusion. Note this quote from the 2015 article:

“In correlation with the upward trending of device design recalls, medical device manufacturers have failed to consistently mitigate hazards associated with component design, labeling design, packaging design, process design, and software design.”

Yet the hazards created are not named. Note the table from the 2017 update of the Top 10 FDA Form 483 Device Observations for 2017. Failure of risk management to identify and mitigate risks leading to harm is not cited.

I don’t know the source data for the 2016 statistics provided, but if they are aligned with the 2017 FDA findings, risk management would not seem to the problem at all. It would appear to be a lack of quality assurance across many functions.

Keith DeBrunner 2. No effective risk assessment attempts to account for design errors, manufacturing errors, labeling errors, etc. It assumes the product is designed and implemented per requirements and procedures, manufactured per requirements and procedures, labeled per requirements and procedures, and so on throughout its aspects, and those requirements and procedures are adequate to ensure conformance to standards.

Errors are obviated not by risk management, but by rigor. That rigor is a matter of quality focus sponsored by management that recognizes it will succeed, or fail, because of its procedures, and the continuous improvement of the processes and procedures is not a matter of convenience. It is non-negotiable and driven into the culture.

Part of the solution has to lie in a formalised, systems-centric approach to development and maintenance, and adequate resourcing to allow designers to handle the appropriate portion of risk management at the appropriate levels in constant step with development. Any tendency for risk management to be palmed off by overwrought design teams and handed to the boring, nervous guy in the next office who'll "just deal with it for you" is toxic. You may be a great engineer, but if you're not doing your own risk management, you're not a medical devices engineer.

Mark Vornheder Terrence Callahan

Richard Bollinger Thanks for the good ideas, valuable advice and kind thoughts.

Darin, I did enjoy your 2016 article and the depth to which it made sense of the data.

We should recognize boiled frog syndrome. Throw a frog into hot water and it will jump out. Put it into cold water and raise the temperature and it will die.

I agree with many that the interests of patients are paramount.

Innovation to me is not a blind search. It starts with understanding, like getting the situation from the manufacturer point of view.

Telling your story will help where anger will not. This is why I am currently qualifying more volunteers to tell their stories for my research. Start with a survey for the dry stuff [] to keep all participation confidential. Be in the 100 that shape the diagnosis and receive a free gift that will start your journey to quality and improvement.

Valuable stories and goals like device reliability and patient safety should guide us.

Christopher Wood If risk management does not consider manufacturing, design and labeling errors, it's not risk management. It's risk lip service. It's lack of commitment to compliance and interest only in the appearance of compliance. Sounds systemic and endemic

Jason Partin Thanks for the post! Risk Management is important for patient safety, but also leads to innovation and expanded market access. This article on Risk gives examples, and explains main points behind #ISO14971, Risk Management.

https://www.jipbit.com/single-post/2018/03/18/Medical-Device-Risk

Richard Bollinger Why is it assumed that innovation has to always be big or disruptive? How about a way to expand risk management beyond lip service and beyond development? Don’t practical and tactical improvements count?

I will be attending the Michigan Growth Capital Symposium (www.michigan-gcs.com) this week. It is near Ann Arbor, home of the University of Michigan with its Center for Entrepreneurship (cfe.umich.edu). I will be getting the stories of the many medical device companies attending. Also at the MichBio Expo in October.

I will be giving out my method to combine FMEA, Fault Tree Analysis and Benefit-Risk Assessment into a world-class risk management innovation. The same paper is available to all members of this group. The first page of my survey above has the deal and contact info.

Innovations are experiments. Maybe you should give them a try. This one is free.

Richard Bollinger For example, many more members should get and try my innovation: a method that combines Failure Mode and Effects Analysis with Fault Tree Analysis into world-class risk management. I will make it very easy.

Don’t interview to get the PDF. Don't even complete a survey []. Just START the survey and submit your name and corporate email. The PDF will be sent to 100.

Requests will be considered in the order submitted. Answering more questions earns extra credit. Those doing FTA go to the front of the line. (Tell me the tool used.)

This paper is a first draft. I am happy to answer questions and feedback. For people that take it on I am willing to help you with pro bono support for my time via phone, email, Skype, or whatever.

Maybe tell your story in an interview after you have seen the invention.