🔥 Find me at MedicalDevicesGroup.net 🔥
5 min reading time
As originally asked by Brian Biersach.
In the past year, I’ve seen something that I haven’t seen in my whole career of medical device compliance work. Devices that don’t work (software and hardware problems), serious compliance issues with performance (especially requirements from particular standards), and major delays addressing risk management requirements.
* 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 developing simulation full time on matalab?
From my experience, one of the reason is that organiZations / 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, organizations 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.
Jim Dent, LSSBB, DTM
David Lim, Ph.D. RAC, CQA
Ee Bin Liew
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.
Pamela V. Falk
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
>>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.
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.
Dr Terence Vardy
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.
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.
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.
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.
* they listen and learn quickly
Personally, 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.
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.
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.
We’ve also been putting a lot of free tools together and making them available on our website (http://60601-1.com/download.html).
Sammy Roger Ewald
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).
Dr Terence Vardy
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.
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.
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?
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.
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.
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.
Jitendra (G2) Pongurlekar
David Lim, Ph.D. RAC, CQA
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”.
Marked as spam