Interesting question. I hope folks have some ideas for you!

There are a lot of inexperienced people who have gotten involved in the medical device industry purely for financial gain,without the rerelevant knowledge to create truly sophisticated products that have warranted functionality. It has been very sad to see this decline in quality.

christophe dohen It is an excellent question. From my experience, I think there are several reasons:
- systems become more and more complex and I am not sure all engineers are able to integrate linux based real time system (for example)
- there is an increase of pressure on development teams with budget reduction and crazy time to market with at the end no time to take time
- From what I have seen, young engineers (I am not too old as well) are not as rigorous as older engineers I worked with
- I don't believe in new method of product development. Some companies hired huge amounts of engineers to develop theoretical model and simulate systems. Why not? The problem is that a model is still a perfect view not a reality. It is better having a different approach when designing a product. I usually prefer a good piece of paper, some good calculations to start but then, real tests on the bench. Of course, it can costs some money but I think it is worth it. And, how much costs ten engineers developping simulation full time on matalab?

This is an interesting question and your observation is right.

From my experience, one of the reason is that organisations / engineers are taking time to understand and adapt to the IEC 60601-1 updating along with Risk management requirements. Traditionally, those engineers were well versed with 2nd edition of IEC 60601-1 and the clear-cut requirements. 3rd edition is not so straightforward with many of the Pass / Fail criteria refers to Risk Management.

Another reason is that I have seen many Quality / Regulatory / Design engineers moving to Medical device domain from Automotive, Aerospace and purely Software background and they take time to understand the Medical device specific requirements and may not be following the standard practices followed by the experienced Medical device professionals. This leads to lot of design changes and updates. That in turn leaves out so many document update missing or not proper thus making the complete Technical file a mess!

One more thing to notice is that Medial device / systems are becoming complex in nature. That leaves lot of open issues in identifying and complying with many Directives / Standards / Guidance documents and the interaction between these requirements. When you consider Mobile Apps, Combination products etc. they are also adding additional burden to Medical device industry.

Having said that, I am quite optimistic that within next couple of years, organisations will (already, I guess) understand the importance of all the major changes and through training and updating of QMS processes (exclusive checklists, relationship references like Annex ZA, ZZ in Standards, Operation Documents etc. helps) will achieve success ultimately.

James (Jim) Dent, LSSBB, DTMx2 I don't know the real reason, however, what I've seen in several industries are engineering groups developing product with only the ISO standard compliance (I.e.: ISO 9001, ISO 13485, AS9100, etc. but not understanding the regulatory requirement (i.e. FAA, FDA, etc.) in addition to the basic ISO standards; and not involving quality or regulatory disciplines in the product launch phase.

David Lim, Ph.D. RAC, CQA Few root causes that I would state include, but are not limited to: 1). design with poor or lack of awareness/familiarity with the regulatory requirements; 2). even if a firm was aware of/familiar with the requirements, they (the requirements) have been progressively ignored or under-valued; 3).culture (management's, R/D's, etc.). Putting things under an adequate, regular check and exercising/enforcing an continuous improvement is one of the best ways to go while leaving one's ego at home before going to work!

Ee Bin Liew The increasing complexity (not in terms of leading edge technology, but alternative applications of the same technology) of devices today, not just stresses the engineers, but puts pressure on the vary standards and regulations as well. In terms of market access framework, for example, China and Korea are essentially the last countries to include type testing in addition to the usual technical/legal documentation review in their registration process. regardless of how you harmonise the GB and the KS standards with the international standards, there are still many differences, and with the abovementioned, they are also finding it tough to catch up with their own flavour of bureaucracy , thus causing engineers to perhaps become a bit 'reactive' in the sense that 'let's give it our best shot, see what they say, then fix it later'. not saying it is the case, but it is probable.

One solution to this is perhaps a faster feedback loop towards the standards and regulations themselves. we have to remember why these standards and regulations exist in the first place, other than having everyone harmonise to one expectation to meet. the bottom line is safety and efficacy of the medical device for the users, So standards and regulations must actively respond to the current wave of medical device technology so that its current state remains as relevant as possible to the vary devices they are trying to ensure compliance.

I agree with Sonilal that it would take some time, but other than placing all the pressure on the engineers and industry, standards bodies and regulatory authorities need to strengthen that feedback loop to be more nimble and relevant.

a side note: between deciding what to and what not to regulate vs. having a true risk-based method in regulating all devices appropriately according to their intended use, personally I would opt for the latter.

In my observations of the delivery of medical care in general, I believe the underlying issue can be explained more simplistically: the onset of the incipient attitude that "close enough is good enough." Ready, fire, aim.

Even with the adoption of a plethora of quality standards, the standards aren't being followed rigorously, and those in charge of seeing that they are aren't doing their jobs either because they feel that their department's or company's performance is "close enough." The commitment to quality has to come from the top down, and there doesn't seem to be an incentive for quality anymore. I don't believe the fundamental issue is standards or engineering. It's the decaying beliefs and attitudes of leadership, which has led to the more immediate, practical issues pointed out by the other posters here.

Wim van Hoogdalem From personal experiences: if companies do not comply with quality standards, it is simply ignored when money is involved. And that happens all around the world!

Marco CATANOSSI The trend to import and relabel imported products manufactured and designed in countries where these aspect are not considered or claiming a too much low price on suppliers.
And also the tendency of vigilance agency to soften controls and avoid fines (justified sometimes with the economic crisis) unless an accident has happened.

Karl Schulmeisters I think David Lim is on the right track

>>1). design with poor or lack of awareness/familiarity with the regulatory requirements; <<

this is particularly true of folks getting into this field from the "smartphone" "smart tablet" and "Software As a Service" side

>>2). even if a firm was aware of/familiar with the requirements, they (the requirements) have been progressively ignored or under-valued; <<

This is often true when management doesn't understand the issue OR... as code work gets outsourced it simply doesn't get transmitted down the chain with proper emphasis.

>>3).culture (management's, R/D's, etc.). Putting things under an adequate, regular check and exercising/enforcing an continuous improvement is one of the best ways to go while leaving one's ego at home before going to work! <<

Again in the era of outsourcing and offshoring this is particularly a problem


In that context I would add "offshoring" as a significant issue. a lot of "offshoring" projects go to countries where not only the developers do not have an awareness of the requirements for quality validation and robustness required.

Even more so - in some cases there is a cultural approach of "meet the minimum that the spec says" so if the robustness and functionality requirements are not detailed to the last comma - they don't get done

For an electronic medical device, I know I have to meet IEC 60601. And I have no idea what this means. Despite having years of experience with medical device product development, I am not an expert in standards, such as IEC 60601.

Fortunately, there are experts such as MECA to help provide guidance.

As a project manager, I likely am trying to figure out the critical path and trying to determine what can be done in parallel. With the 3rd edition of IEC 60601, my "rules" as a project manager changed in some respects. Now there is a much higher emphasis on risk management and the requirement to address sooner rather than later. The "old" way meant I had to address risk too but might have done so a little later in the project.

Plus, from a CEO perspective, it is not always understood why I should do pre-screening / testing BEFORE going to the official testing. If I don't understand the value, I might forego the pre-screening activities and go straight to the official testing. Yet, I might not be ready for this.

Many view activities such as IEC 60601 compliance as necessary and gating activities. Few see that these activities should become part of the product development process.

Karl Schulmeisters Jon I think you are right as well. There is a broad move away from StageGated processes. Not only do you have to do pre-screening earlier in the process, you also need to start on reimbursement strategy earlier in the process, as well as anticipation of post approval followups.

Dr Terence Vardy Interesting to see the different defensive comments.
The honest truth is that it is all about money and directors/owners without experience in the medical field pushing for money making devices without taking the necessary time to research the true market needs and translate these into an effective technology.

Yes - there is increasing complexity in government requirements and the FDA is often seen as hindering medical progress rather than providing assistance guidance to medical device companies. This is however how much of government operates - building regulatory bureaucracy - to further political and career goals for individuals. This will not change so companies have to take this in their stride. The good aspect is that part of this complexity safeguards patients through gating.

Profit for profit's sake is not what medical devices and their development should be focused on. Create a good product at the right price and everyone benefits.

This does not preclude effective field testing as part of development R & D nor determining reimbursement levels. Unfortunately, reimbursement may lag behind acceptance, use and ascertaining the flow on benefits of the new technology to patients.

Julie Omohundro I can't say I see any defensive comments, but lots of good observations about the many factors that contribute to quality or the lack thereof. I agree with most of them, and have seen many of them, but I haven't noticed anything special about the past year. If you have only noticed them in the past year, it could be that you just need to get out more. :) Or maybe I am the one who needed to get out more, this past year. :) :)

What we have been hearing on the regulatory side for a number of years now is "What is the minimum we have to do?" I think there are two problems with this approach:

1) Things are not that clear cut, so if you shoot for what you think is "the minimum," you risk falling short.

2) Even if you meet the minimum that is required, this is not going to assure quality.

It is also reflective of a general "low bar" mindset, not limited to regulatory, that others here have commented on already.

Austin Walters I also think the volume of truly novel medtech innovations has increased of late, which results in a greater number of wrinkles to iron out, but also heralds promise for improved healthcare once they are.

Julie Omohundro I haven’t see much evidence of a significant increase in the volume of "truly" novel medical devices entering the US market of late, which is to say I have seen no significant increase in the volume of original PMAs approved (20 in 2010, 37 in 2011, 39 in 2012, 21 in 2013, 25 in 2014) or De novo petitions granted (72 decisions, 2010-14), although the latter may change with the advent of the new De novo process.

What I have seen is an ongoing increase in the volume of enthusiastic talk, about many innovative technologies that could eventually emerge as "truly" innovative medical devices. Perhaps what Brian and others have observed is the result of two worlds colliding...an increase in the development of innovative technologies, coupled with a decline in the ability to manufacture even not-so-innovative devices that don't break.

Rick Stockton How to wreck a medical device? How many ways can you pop a balloon?

Here are a few "balloon-poppers":

• We are trying so hard to Regulate products into success that we are constraining our own capability.

• We are taxing Industry. This is silly, since, in the end, we are really just taxing the Consumer, but being deceptive and sneaky about it. Good people don't have to be deceptive and sneaky.

• We try to do more with less by fiat, rather than by leading by example and creating new solutions. (This could be a separate article.)

• Sometimes, we are illogical. I was recently asked to quote a fixed design price, but the customer had no written timeline, no written cost targets, and no written product requirement.

• Sometimes, we do not see the opportunity to do good. I was caught off-guard by the previous potential client. But. next time, I'll offer the customer a separate project planning and specification service, and *then* quote to that.

• A lack of profit motive. Incentives always drive behavior. And the incentive for excellent work is the opportunity to make a profit on the next project. Profit should always be the primary incentive for the work of a moral person.

• Sometimes, we lack integrity and morality. An excellent profit motive, when combined with integrity, is a real winner. Without integrity? No so much. Or not at all.

The good news is that there is money to be earned by helping companies develop strategies to remove the effects of these problems, or to put solutions in place to deal with them.

Brian Biersach This discussion has had a wealth of great information - thank all of you.

After reading all of the comments, I did some research into projects that had delays and major noncompliances in the past (when there were far fewer of them). I discovered something interesting.

While there are exceptions, the majority of the companies having these problems have one or sometimes two people that are the design (and sometimes implementation) engineers. The engineers that I have dealt with are very bright and experienced, but with only one or maybe two people designing an entire medical device, the end product hasn't had the level of brainstorming or choices between different ways of making things work. This may be why the medical device companies who still have large experienced engineering teams are the ones who have few problems at the end.
Another fact that seems to support this is that a couple large medical device companies (not going to be specific) have moved their device design out of the company (sometimes out of the country), and now have major problems (in device functionality and compliance). They contracted to firms that don't seem to have the level of experience with the type of equipment that they're designing as the engineering teams within those companies did.

Dealing with 8 of the top 10 medical device manufacturers, as well as many start-ups and people building devices in their basements has provided a good balance of the full market. For the large device firms, hopefully they will learn that a good engineering TEAM can actually save them time and money in the long run. The start-ups have also had more problems recently, but have at least been good about getting help early on in the design process. The successful basement designers have actually gotten better, since they know that they don't know, and are getting help from companies like ours in the beginning of the design process.

christophe dohen From my experience Brian, I do not fully agree with you. I have seen small well experienced teams doing great job. Larger teams can sometimes lead to bad experience and from what some contributors said, it is also about how managers are, what consideration they have to regulatory affairs etc.... I am actually helping a small company developing their first medical device and I believe they can do a great job because:
- they understand how important it is to think about regulatory affairs, standards compliance at the start of the project
- they listen and learn quickly
Personnaly, I also think following standards, following ISO13485 process is good but not enough. Couple of years ago, I started building design rules based on MISRA C for example. These rules apply to electronic, software and mechanical design and they are based on good practice of engineering. I do believe it is a key point and apply them in my own company.

Brian Biersach Christophe, I don't think we're in disagreement.
We have also seen small teams do a great job. The small company that you referred to also understood the importance of this, which is why they have you helping, which is great to hear.

The biggest problem that we're dealing with (and got a bit lost in the discussion) is that many (almost a third) of the devices that we receive for compliance evaluation/testing don't functionally work (won't turn on or won't perform the intended use). We've started asking companies to please turn the device on, and check the functions before they ship. It seems obvious, but a last-minute software update, a swap/change to a PCB, or a missed connector in a quick assembly to get it out the door have been some of the causes identified.

Most of the compliance issues (many more in the last year) have been on complex medical devices, mostly patient monitors, patient warmers, and electrosurgical devices. This is where we've seen the issue of one engineer (a few times two) handling the whole design and building of prototypes. While this can be done, it usually takes much longer, especially when the engineer doesn't know all of the requirements in the base and applicable Particular standards. It's nearly impossible to design an ECG, and comply with IEC 60601-2-25 without using it in the design process. That said, I can't even count the number of times we've had an ECG submitted where the company (or design engineers) didn't even have a copy of the applicable standards.

Julie Omohundro Joanne, "Doing what's legally required' probably sounds better, but legal requirements are all shades of gray. You can do the minimum to meet legal requirements or you can aim a little or a lot higher than the, so I'm not sure how much the difference is meaningful, from a quality perspective. In any case, the downsides are the same...if you just aim to meet the legal requirements you can fall short, and meeting the legal requirements does not assure quality in your products.

Karl Schulmeisters Brian your point about inexperience is very important. The industry statistic is that if you have never gotten a medical device approved by the FDA, it will ON AVERAGE take you 5 submissions to get through the process. And the FDA - because of its regulatory role - can only do so much to aide you in the process. That's in fact where Ms. Carver (my CEO) got her idea for our https://ClearRoadmap.com product. While she was Entrepreneur in Residence at the CDRH working on streamlining the approval processes she realized that there was a crying need for guidance on how to get through the processes.

That's why we have put together free guides that we offer on our website (of course as a teaser for getting folks to subscribe to our more heavy duty process guidance and integrate/enhanced search capabilities :-) )

But the bottom line is that these are complex processes and even when you have been through them once before, if you are doing something new, you are going to make errors.

At one point in my career I was attending a software project management course and the statistic cited then (and I really don't think its changed) was that IF you had done a project like your current one at least once before - your schedule estimates ON AVERAGE were +/- 100% of actuals. If you had never done a project like that one it was closer to +/- 300%

And I think part of what you are seeing is this uncertainty as more and more devices have more and more complexity in them

Julie Omohundro Rick..

o We are trying so hard to Regulate products into success that we are constraining our own capability.

I agree, and I see the push for this coming entirely from industry, although many seem to think it comes from the regulators. Or perhaps it's really coming from the investors. I have started to appreciate more and more that much of what is presented on behalf of the industry, is not being presented by the industry, but by the investors, and often represents their interests, rather than those of the industry.

It's not the job of the regulators to make products succeed, and I hope they haven't been lobbied to the point of thinking that it is. That would not be good for anybody. I actually can see where the investors might think it is in their best interest, but that won't work out, so I'm not going to spend time thinking about that.

Julie Omohundro Brian/Christophe,

Small teams or large is not the issue, I don't think. I think the issue is whether you are designing a contraption (a thing that meets specs) or a product (a medical device that you can market). If you are just designing a contraption, then a team of design engineers is just what you need. If you are designing a product, then a team, small or large, that is dominated by design engineers is inadequate, and the more "innovative" the product, the more inadequate it will be.

Brian Biersach Karl, that's really good information. I emailed for the free copy of the ClearRoadmap.

We've also been putting a lot of free tools together and making them available on our website (http://60601-1.com/download.html).
This is to help medical device companies get it right the first (or at least second) time. The tools cover guidance for the markings and manuals, to risk management requirements, to checklists for the requirements in the base standard (Edition 3.1 is almost done).

christophe dohen Karl, you are right. Finally, experience is important. And also, good to know that all these guides and roadmaps are available to customer

Rick Stockton Julie,
I agree. It is concerning that the FDA has gone beyond safety, and is trying to be the decider on efficacy also, and, in some instances, making determinations even on cost. Some would call this "Mission Creep". The market is equipped to evaluate efficacy and cost, but the FDA is not. This is categorical over-regulation, and it interferes, not enhances, the development of medical devices.

Julie Omohundro Rick, I think you misunderstood me. I said it's not the job of regulators to "make products succeed," as you put it. I don't think that has anything to do with deciding safety, efficacy, or cost. My impression is that there are those who would like FDA to play a role similar to that of an agricultural or industrial extension service.

I guess you could say that no one decides safety or efficacy. They are what they are. FDA just reviews (or at least it should) the evidence of safety and efficacy presented by the manufacturer to determine whether it shows that the ratio between the two is a net positive for efficacy. Since no product is inherently safe, if FDA takes efficacy out of the equation, then the ratio will always be a net negative for safety, and FDA would have to (or at least it should) reject every premarket application.

I can't speak to cost, as I have no expertise in reimbursement. (Don't want any, either. What a headache.) I probably confused things by referring to "regulators," when really I can speak only of FDA.

Rick Stockton Julie, you made me smile. I have not one concept of the FDA being helpful in any way! :-)
And, yes, they have weighed in on cost, which is beyond both ridiculousness — and their ken.

Ginger Cantor My experience is that it is a combination of inadequate team resources from design through regulatory and quality, and a launch it at a particular time to meet unrealistic business plans. Fail fast mentality is creeping into med devices from consumer electronics. First to market, first to fail lsometimes. Might be ok in the consumer goods arena but definitely NOT IMHO in the medical space.

Julie Omohundro Rick, I have found FDA helpful at times, but I don't see this as their mission. I have no idea why FDA might want to wade into cost issues, but if they do, I hope they bring their water wings.

May be the the development lead time is beeing pressioned to be reduced. Cost reazons? Market launch time?
.

Rick Stockton Thanks, Julie. Extremely helpful is the right Regulatory and Quality consultant. The right Regulatory consultants can be extremely helpful focusing documentation efforts on necessary tasks. The time redeemed can be used to make the device more competitive, effective, and reliable.

I'd like to add my two cents in a different perspective - As the years past, regulatory requirements have changed. A lot. At the same time, most of the medical innovation is driven by companies and people who have been in the industry for years (if not decades).
They started working in the medical industry when regulation and compliance were simple and easy. The devices and inventions got approved quickly, without an in depth inspection or analysis of the nature of the device and its application.
Now, the same people who once got their devices approved in a snap think that it is still the way it used to be 10-20 years ago. They do not realize times have changed, and that regulatory requirements keep changing.

I realized this fact when i attended a medical trade fair. It seems that the medical device companies (and especially "low tech" devices) are owned by people who are now in their late 50 or early 60s. When there will be a new generation with young blood running the industry we will see better compliance with the changing standards.

* No intention to underestimate anyone's achievements or age. All these people have done an awesome job to make the medical industry a lot better. But they are stuck in the past (at least in my opinion).

christophe dohen Barak,
I don't really agree with you. Again, some seniors are aware of changes and some not. What we all agree is that people make the difference.

Julie Omohundro While I think we can all agree with Christophe, that one size seldom fits all, I have also seen a good bit of what Barak describes. I think it may vary a bit from sector to sector, and perhaps geographically as well. I think there is probably a significant link between those who are keeping up with innovative technologies and those who are keeping up with regulatory requirements.

From a regulatory perspective, I'm watching to see which companies eagerly jump on the new De novo bus, and which ones prefer to stick with the security of the old "me too" path. And which companies have adopted a strategy of acquiring new products from other companies, rather than developing new products themselves.

I would put outsourcing as a component of the increasing trend. Economic and regulatory pressures are driving growth in outsourcing. This often leads to problems with visibility and accountability. Add more cooks to the kitchen with their own procedures and processes and sometimes interpretations of requirements and a development project becomes exponentially more difficult to manage.

Add regulatory and legislative changes and its not hard to mess up the recipe.

Devices need proper visibility and constant measurement of KPI's from birth till death which isn't prevalent in the culture of this industry from what I've observed.

Dr Terence Vardy Great to see such robust discussion. While everyone has a different map of the world each commentator has added to my knowledge of the situation. All involved are certainly doing their best to make the development of 'good' medical devices as efficient as it can be given the different circumstances that exist with each company and the development and management team coupled with financial considerations. Let's hope that mission creep does not unnecessarily accelerate in respect of the FDA. Also that a reasonable balance is achieved with the desire for profit and the achievement of same, the development of effective and reliable medical devices and the maintenance of sensible regulatory requirements.

David Schoon Interesting question. Could you point us towards some data supporting that there has been in increasing trend in denials? I've come across some reports that have indicated that Additional Information Requests on 510k submissions have increased pretty dramatically (more than doubled) in the last ~15 years so it doesn't seem that out of the question that the amount of denials has increased at a rate larger than the growth of the industry itself. Given what we know about the collective intelligence of society as a whole (Flynn Effect), I'd say that talent of those that are innovating and implementing is the least likely culprit.

One thing that I have observed is a shift in how innovation is now incubated and invested in. Whereas years ago, innovation in medical devices were being developed by large vertically integrated OEM's this seems to be less and less the case. Innovation is now primarily coming fresh out of academia and other entrepreneurial forums where investors are providing seed funding and mentoring agile and horizontally integrated practices. I don't want to sound cynical, but sometimes I wonder if it is all to maximize ROI and not for the social impact a technology could have. The large OEM's on the other hand, being the institutions they are, are able to sit back and watch the dust settle and acquire the technologies that rise to the top.

If I had to paint with broad strokes I would say that money and time are probably the biggest reason why you are seeing more noncompliance in more devices.

Brian Biersach David - I don't have any indication that there has been an increase in denials (regulatory). All of the devices that we handle do get through the evaluation/testing process, so they can submit to the regulatory agencies for the markets that they will be selling into.

The change that we've seen is that many of the devices now require a considerable amount of redesign to function properly and to meet the requirements. As many pointed out, there are many new requirements in Edition 3.1 as well as most of the Particular standards. This is one of the main causes.

Hopefully the engineers and managers will realize that learning these requirements is important, if they want to reduce their time to market. Right now, it seems to be more of a "design by compliance" approach, where we identify a problem and they fix it, repeat, repeat, etc. There has always been some of this in the compliance process (meeting the required standards), but in the last year it has increased significantly.

Julie Omohundro JoAnne (et al), what I'm not sure about is how often those who jump in for financial gain find they get what they came for, and how often they come to regret it. Over the long haul, it seems that eventually a lack of knowledgeable management leads to an unhappy ending, but when it does, I'm not sure how many people ultimately connect the dots.

I have wondered if "investors are risk averse!" is another way of saying they have been once burned in recent years, and are now twice shy, or if it is perhaps an effort by the defenders of the status quo to discourage the type of risk-taking that is necessary for meaningful innovation, in both product and process.

David Schoon Brian - As someone that works in the design consulting services I certainly know all to well that sometimes development programs may only have one to a few engineers working on them. A term that has made it's way from software development, which rightly or wrongly, is now being tossed about in the hardware field is MVP (minimally viable product) which essentially is the characterization of doing quick spins of a product with limited capability and being able to recognize what worked and what didn't work so well before doing the next spin. I think that this approach is somewhat tolerable with software development, but it is at best risky and at worst dangerous when developing hardware, let alone a medical device.

All I can elaborate to is the qualitative data that I've been observing, but the trend I am seeing out in the Boston area is that most innovation is coming from smaller new technology medical start-ups which are being mentored and built in a fashion where device development is built across horizontally integrated satellite teams. Why that is, I'm not totally sure. I think early stage investor risk adverseness and hedging may be part of it. But that's neither here nor there.

I do think that this trend and your current observations point towards an evolving market need and provides a great opportunity for companies such as yours. Bringing specialized skills, a 'teachable moment', and being part of the collaboration process for teams that either don't have or don't know that they need to have a certain capability burned into their process is a great selling point. For clients such as the ones we are working with, they need to be exposed to regulatory, compliance, and testing standards as early as possible so they understand why it is valuable and necessary. This is why we have a great partner that is able to collaborate alongside us and our clients to be the expert in the compliance, regulatory, and testing domain, but this probably isn't always the case with all engineering/product development firms.

At what point in the development process does MECA generally become engaged with their customers? Does your involvement come pre-Alpha, Alpha, Beta/Pilot? Do you think that some of the observed non-compliance or failed results in testing would have been different if you had been involved in some of the earlier design and development phases?

Julie Omohundro Brian, would you expand on "smaller new technology medical start-ups which are being mentored and built in a fashion where device development is built across horizontally integrated satellite teams"? Sounds intriguing, but I'm not sure I quite understand how this works. Who are the mentors? How are the horizontally integrated teams integrated? And what are they satellites of?

I think there is a form of "MVP" that can work quite well for start-ups, which is to get a version of the product through FDA that is going to be easy to develop and to get through FDA, and then bring along a later version that might push the regulatory envelope a little more than the first. The main advantage to this approach is that you can generate some revenues to fund additional development of the more challenging/innovative version, rather than be all burn. (But I wonder if I'm wrong about this in some way I don't see, because start-ups never seem to want to do this, where to me it seems like the best of all paths to take.)

The other advantage is that it gives FDA an opportunity to get comfortable with the "lite" version of the product before reviewing the more innovative version, which I think can help smooth the way for the latter. However, in this case, the MVP should be a good, well-designed, well-tested product in its own right, not just a quick spin to see what works and what doesn't, or you run the risk of tainting your main product with a bad rep before it ever gets to the market.

Jerry Twomey Applying a consumer product design mentality to medical devices has been happening for sure. Consumer product quality is highly variable and frequently marginal.

Brian Biersach David - We're typically involved in the early design process with the companies that have been through it before. Those are the ones who have continued to get throught he process quickly, with few problems.
Others contact us when they're either done, or when their managers tell them that the "testing needs to start now". Those are the ones that have a lot of problems.

Unfortunately, it's hard to convince a company that doing some of the compliance review work early in the process is worth the cost (even if there's no additional cost, just having to pay for the first step earlier).

Since our job is to get the device/system through the evaluation/testing/document review process as quickly as possible, I'm looking for ways to address this problem.

There have been a lot of great posts about all of the problems companies are facing, so now I need to find if there's a way that we (MECA) can help address them. Many of the posted problems can't be addressed by us, but some can.

David Schoon Julie - To preface, this is merely qualitative and only reflects my experiences in the niche that is the ~Boston area.

Essentially, I've seen that most medical innovation is being developed and incubated outside of the traditional larger business institutions (i.e. your Boston Scientific's, Medtronic, etc.). I'd define these are being generally vertically integrated companies that own/run much of their supply chain.

In recent years there has been a pretty radical increase in such things as business accelerator development (Mass Challenge), pitch competitions (both at the university and post grad levels), and social micro-financing/internet entrepreneurial campaign tools (Kickstarter, Indiegogo, Quirky to name a few) that people have access to. This along with the dumbing down of software and relative ease of making cheaper prototypes with development boards (arduino, rasberrypi) and additive manufacturing have been powerful enabling tools and made the barrier of entry into creating new products or businesses far easier than ever before.

It really is great that now probably more than ever before, a person with a decent idea has the ability to get some seed funding and get a business going along with the help and guidance of industry, academic, and investment experts and mentors. My comment about "horizontally integrated satellite teams" alludes to the fact that many of these medical device start-ups are essentially teams of people that understand their core technology very well but they will outsource some of the device development to EE/ME/ID/Regulatory/Research/Optical/Materials.... etc. firms because it is difficult and expensive to build up an internal team. So their business structure is 'horizontal' and the teams that they collaborate with are not developing under one roof aka 'satellite development'. $2M of seed funding, high investor expectations, and aggressive scheduling is incredibly constraining.

Christine Zomorodian Great discussion everyone! Laura Wilbur I think you would enjoy reading this.

Julie Omohundro David, Got it. I think a lot of business activity may be evolving toward the use of horizontally integrated satellite teams.

I tend to be a bit skeptical of government-industry-investor consortiums. Too many agendas in the stew. Plus it seems that, when it comes to fostering innovation, they often have the same limitations as the industry they are trying to support...a lot of focus on the money and the technology, not so much on regulatory, quality, or clinical. The product developers pitch innovative products, but the investors still seem to gravitate towards the products that represent the lowest risk.

The "campaign" tools are aptly named, having their roots in the Howard Dean campaign for the Democratic presidential nomination in 2004. Not sure if that means anything. Hmmm. Anyway, they are definitely an interesting development, and I'm looking forward to seeing how they evolve, too.

As reflected in the comments above, there are many contributors. Most of the issues raised above appear to be results. Approaching this from a Root Cause Angle, I believe the problem can be summed up in organizational efforts focusing on “Documenting Compliance,” not “Achieving Compliance”. The Quality Mindset needs to be focused on activities that provide “Real Value” in fulfilling “Compliance Intent” not merely “Documenting Compliance Activities” to satisfy audit requirements. “Real Compliance” (to the intent) is much more than “Paper Compliance” (to the letter).

All of us encounter compliance situations everyday. To simply follow a checklist of activities without taking them in the context of their intent is of little to no value. Conducting the right activities for the right reasons, right the first time, ensures that resources are used efficiently and that services and products exceed organizational goals and customer satisfaction.

I think it boil down to Testing, Testing and Testing. There are companies with separate quality departments to test the product and there are companies where engineers will develop test cases and test them. Also finding balance between innovation, Agile development and quality is a tough task. Companies lack promoting compliance as quality assurance to customer compare to bureaucracy.

My answer is that people rush to the market with their device. They will not test the device enough because they are afraid of losing market share. This is the case in special with wearables where the market is dynamic and competitive. They prefer to be the first on the market, even with a bad design rather than after one year with a good device.

Julie Omohundro "You can't test quality into a device."

David Lim, Ph.D. RAC, CQA Brian, there are many reasons for the cause! Sometimes, it should be viewed on a case by case. Above all, what I think is critical is "we should be ready, willing and able to SEE, BELIEVE and ACT upon the problems." I have been working hard to increase industry's adequate awareness as a way to identify signals and prevent the problems, accordingly!

I can't say that I have seen more device problems over the last year however It appears to me that the FDA is stiffening its audits of design controls and risk analysis.

I general, competitive pressures continue to push organizations to do more, faster with less. This can be disastrous for companies with weak quality or product development processes. I have seen the biggest problems with companies that are led by CEO's new to medical devices or entrepreneurs. Worst I've seen: "Do the least necessary to be in compliance with regulations".