Julie Omohundro I had so many reactions to this question, I had to give it some thought.

As far as a straightforward answer goes, mine is no. I have looked, not exhaustively, but more than casually, and not found one. There is a design conference in Minneapolis that includes the usual suspects. From my perspective, it doesn't even address the "geekier side of design, much less development.

I think this is an admirable question for a portfolio manager to ask.

When it comes to understanding why this industry struggles so much with "innovation," this is a question that need only be asked.

I thought it was interesting that you used the term "medical device development." That is a term I brought with me from pharma, but which I rarely hear used within the medical device industry. I don't think the industry as whole engages in medical device development.

This raises another interesting question...what might be considered as the "non-geekier" side of medical device development?

Jean Bigoney, RAC, CQE That is indeed an interesting question. I'm also not aware of any conferences that take such a holistic approach. As different as medical devices can be, I would think that the only aspect they would have in common would be the regulatory environment. What if you were to abstract it and remove the medical device component? It seems to me that you would have more of a straight-up Quality Function Deployment problem and would be able to find conferences (or at least sessions) from the Quality Management perspective - like this one.
http://www.qfdi.org/symposium.html

There may even be some interesting cross-talk between different regulated industries (ie aerospace, automotive).

Julie Omohundro I'm very interested in putting together a comprehensive list of TBDs for device development. I would add risk analysis, human factors, process validation, and reimbursement to the "geeky" list.

Is user needs assessment something different than the process of developing design inputs? That is, is there a reason for listing it separately for design controls?

I don't think of quality systems or quality management (or risk management) as being part of the development process, because during development, there is nothing yet to manage.

I think process validation during the development phase provides a basis for quality management, but I'd be interested to hear other perspectives on this.

I would include risk analysis as the starting point for post-market risk management.

Barbara Ressler Thanks for the comments, Julie and Jean. I posted this question months ago, possibly even a year ago--must have taken a while for it to get through the queue. I did attend a "compliance" meeting in San Diego that looked promising on paper but wasn't terribly helpful. I also attended a small portfolio management workshop in November that did have some "geekier" elements to it. If either of you are interested I can look up the information again on those meetings.

I'm not a pure quality engineer--I like the term "design assurance engineer", which puts me at the interface between the design team, the quality/regulatory team, and the marketing team. There is always something to manage during development, otherwise you never make it to the end.

Julie Omohundro Barbara, it never occurred to me to look for a portfolio management conference, so I'd be interested in knowing more about it.

Barbara Ressler - I am the campaign manager responsible for the 2017 software design for medical devices conference taking place in Munich in February with industry attendance from Philips, Siemens, Medtronic, Sivantos and many more. It comprehensively covers most of the key aspects you mentioned with regards to quality and the FDA regulations. Let me know if this may be something that you're interested in.

Chad Johnson Hello Group. I am the Vice-President of APIS North America, LLC. As experts in the field of Functional Safety and FMEA, I realize that this is the medical world and it may seem a stretch for some, but I strongly urge that you all look to what's happening in the world of the automotive industry with regards to your concerns. I don't think any can argue that this industry is currently undergoing one of the biggest changes since the beginning of the mass-produced automobile. The design challenges for the autonomous cars are incredibly complex...and lives are at stake just like in medical devices. Reach out to the networks of American Society of Quality (ASQ), Society of Automotive Engineers (SAE), the Automotive Industry Action Group (AIAG), or the European equivalent VDA for what's happening in FMEAs. For that matter, check out what we're doing at APIS. We offer the most effective software, methodology, and training in the world for FMEAs using graphical functional modeling.

Marcelo Antunes The main problem, in my opinion, is that very conference focus on "design controls"as if it was the main focus. It's not. Design controls are only that - "controls"that you put into your design and development process (and where they will be put really depends on the type of deign process you have). Unfortunately, from my experience, a lot of medical device manufacturers have no idea on how to design a product, they simply create a "process" to create design controls (which makes no sense as design controls are not a process). The design process from a medical device is not different from the design and development process from other types of products (but it does have some particularities), so a solution would be to find conferences about product design and development processes. You can also check good product design and development books such as Pugh's Total Design: Integrated Methods for Successful Product Engineering or Pahl's Engineering Design: A Systematic Approach.

Marcelo Antunes Unfortunately most books on medical device design also focus on design controls, but there's at least one (Medical Device Design: Innovation from Concept to Market by Peter J Ogrodnik) that really deals with the D&D process, including making it clear the distinction between D&D process and design controls. However, I would take care with other approaches of that book (for example, as is the case of all book that I know that mentions medical device risk management, it does not get the ISO 14971 risk process in the correct way).

Julie Omohundro Chad, could you summarize what's happening in the auto industry for those of us who are hard-pressed to follow one industry, much less two?

Julie Omohundro Jean, I agree that the variability of devices inherently constrains the level of detail with which some of these topics can be usefully addressed. Nonetheless, you can find virtually all these topics addressed in various venues and in some detail. The challenge is to find a venue in which all of them are addressed. The bigger challenge would be to find a venue in which they are all addressed in an integrated manner, rather than simply as a series of topics.

Julie Omohundro Marcelo, just on a quick skim of the pages available in Amazon preview, I noted that it addresses FMEA (and fault tree and six sigma) under the heading of Quality in Design. Does that make sense to you? Why or why not?

Marcelo Antunes Julie, yes, surely it does. FMEA and fault trees are reliability tool/technique, and six sigma is a general process improvement tool (there's even book called Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness which is interesting). As tools/techniques, they can be used in varied solutions, but they historically have been linked to quality assurance and improvement.

Barbara Ressler Julie O.--the portfolio management workshop I went to was called the Medical Devices 3P forum and it was run by a group called EBCG. EBCG focuses primarily in the EU--I believe this was their first workshop in the U.S. What was nice was that many of the attendees were engineers or ex-engineers, so they've been through many of the development pain points themselves.

And Marcelo--I fully admit to the fact that I am NOT a design engineer, so I really was looking for workshops/discussions on design controls and I understand I wasn't going to learn how to design at these meetings. Creating good design is definitely a different beast with its own challenges and one that must be taught in a very different way. Although I think part of the industrial process is to discover legitimate new user needs and design to meet those needs. It sounds easy (just get out in the field and look/ask) but I don't think it is.

Julie Omohundro The other thing this helps me with is the (IMO) mis-use of the FMEA (fault-tree, whatever) for premarket clinical risk analysis. My gut has always told me that these tools were never really for that purpose, but what purpose, I didn't know. I keep thinking if I can figure that out, then maybe I will be better able to explain it to the engineers. It's hard to convince someone that they are mis-using a tool when you don't know what it is really intended to be used for.

Julie Omohundro Marcelo, thank you. This is very helpful to me personally, as the role of Quality in development is not something I've known much about until recently. I think it maybe helpful to others, too, because in trying to educate myself, I haven't found that many people who seemed to understand it much better than I do.

I think Quality tends to be translated into QS, QA and QC, which are really post-market functions. For this reason, as much as us Reg folk whine about not being brought into the design process, I think Quality is even more likely to be left out in the cold, until such time as Design is ready to "throw it over the fence." (Oh...that's why they call it a fence, right?)

I've sort of figured out that Quality's role in development is somehow involved with establishing the quality that will be managed, assured, and controlled post-market, and that this is probably related to process validation, but otherwise it's all still pretty murky to me. This adds clarification.

Julie Omohundro Barbara, thanks for the conference info. I will check it out.

If your interest is limited to design controls, you might try contacting one of the local biomedical engineering departments. They reportedly cover design controls in their programs. They might let you sit in. Otherwise...this is a topic I would like to teach myself; if I ever get one together, I'll let you know. Life has been getting in my way a lot the last few years, but it's pretty high on my to do list, so maybe it's time will come.

Marcelo Antunes Barbara, you really can't understand design controls (which, as I mentioned, are "controls"that you put in some parts of the design process) unless you understand the design process.

Marcelo Antunes Tools such as FMEA and FTAs are reliability engineering tools/techniques. FMEA was created in the 1940's to help lower failures in military systems (I remember reading in some old literatura that the first use was in reducing failures of landing gears in military planes). FTA was developed in the 1960s to evaluate control systems of ballistic missiles. As tools/techniques, they can be used for different purposes. Risk management is, in some ways, an advancement of the reliability engineering function. Originally reliability was focused only on component failures (this is clear as shown in the use of FMEA, FTA and several other tools), then it was noted that there should be a more systematic overview of the safety functions - when system safety was born. Risk management is part of the system safety engineering domain that woks with identifying, analyzing, evaluation and suggesting design solutions.

Edwin Bills, ASQ Fellow, RAC Julie, our book, Lifecycle Risk Management for Healthcare Products from Research Through Disposal" available from pda.org has a great chapter on research and design risk management written by a J and J design expert. I would recommend you look at it for some excellent information on the topic by the way four of the authors are/were members of the committee that authored ISO 14971.

Chad Johnson Barbara Ressler and Julie O., I appreciate the discussion you have kicked off. I suggested the auto industry community as a reference as it has shown a true perseverance and a true resurgence in its focus on safety & risk mitigation. The auto industry has been on the precipice of failure and lived to talk about it...and improve from it. GM is stronger and safer. Toyota isn't viewed as infallible. Product safety is happening. The products are mind-blowing. The rapid pace of the autonomous vehicle development is lighting a fire under the risk mitigation and functional safety fields. You won't find a one-stop-shop for conferences to cover "design controls, quality systems, FDA regulations, user need assessment, etc." Check out QFD Institute...I mean really check them out! Attend a Green Belt class from Glenn Mazur and attend the conference. Attend an ASQ Global conference. The topics you seek are being discussed actively!

Barbara -- re conferences, there is one in early May in Cincinnati that is sponsored by Xavier University and which collaborates heavily with FDAers and ex-FDAers in device development. The conference is called MedCon. I've only been to one, but I thought is was terrific both in content and attendees. Here's the link: http://xavierhealth.org/medical-device-industry/medcon/. Hope this helps!

Julie Omohundro Chad, what automotive products do you find mind-blowing?

Julie Omohundro I'm not in favor of industry collaborating with FDA/FDAers/ex-FDAers on device development.

Michael Zagorski MedCon is great, but covers more compliance than product development. AAMI has usually great training programs. I also just looked at MD&M West conference in Anaheim, CA and it seems to have a bunch of interesting sessions on device design

Ee Bin Liew hi Barbara - if you follow Marcelo's train of thought.. we should control what we design, and not design to what we can control.

the first distinction is to separate R&D from Design & Development - they are not the same.

Of all of the medical devices out there, one of the most intricate is software development (embedded, firmware, and standalone), and especially with the popularity of the Agile methodologies. Many have said that Agile cannot gel with design controls, but in actual fact it can (with some careful planning to ensure the paperwork is in sync).

very few conferences (if at all), gets all of these right.

hope it helps

Cheers,
Ee Bin

Chad Johnson Julie O., What automotive developments do I consider mind-blowing? I find everything fascinating...that's why I became an engineer in the first place. With the release of the movie, "Hidden Figures" (highly recommended) I am reminded of my awe with the fact that we sent people into space strapped to a huge rocket/bomb and brought them back home with no more computing power than a drug-store calculator! With the current automobile, most of what I find mind-blowing are things most folks probably don't even know exist in their car. Vehicle stability control automatically controls your brakes to keep your car from spinning out of control and/or flipping over. You don't realize it probably...until you turn it off on an icy road. We take for granted these things until they go wrong. I had a chance to sit in the driver's seat of an electric car (notice I didn't say "drive the car") because the car drove itself! It stayed in the lane around curves, stopped, started...mind-blowing!

I recommend the international symposium on human factors and ergonomics in health care. FTA human factors persons from both CDRH and CEDR will be speaking. https://www.hfes.org//Web/HFESMeetings/2017HealthCareSymposium.html

Barbara Ressler Hello, everyone. Thanks for all your input and suggestions. I have lots of things to look into now for attending this calendar year.

Marcelo Antunes I prefer to think that the medical device industry should know more about and try to mirror product design and development and related subjects (including system safety( from the aerospace industry, not the automotive industry.

Marcelo Antunes Another common misconception is that regulators know how to design and develop a device. Regulators know regulations, and should know how to verify them. Industry knows how to design and develop a device. So, unless a regulator worked as a device designer in the medical device industry, their knowledge of device design may be pretty limited (I encounter this problem a lot, when regulators try to verify a requirement in a way that does not make sense to a design process).

Julie Omohundro Chad, I decided my question was off-topic, so I will leave it here, but I will still thank you for satisfying my curiosity.

Julie Omohundro Marcelo, I got distracted looking at the Ogrodnik book and missed your previous comment, which I think is very insightful. I will confess to referring to design controls as a process, and will stop doing so immediately.

"Unfortunately, from my experience, a lot of medical device manufacturers have no idea on how to design a product" Yes, I'm afraid my first thought on a conference about the "geekier" side of device development was, "who would teach it?"

Julie Omohundro MZ, I looked at MD&M West and, at least for what I'm interested in, I agree, it looks great.

Canadian HealthCare Engineering Society (CHES) https://ches.org/ and Design Control, Process Verification & validation http://www.cbinet.com/conference/pi17136 look interesting

Barbara Ressler Here's a helpful list I just received.

http://blog.greenlight.guru/top-medical-device-conferences-2017