Our design is finally done going to be released to the market. It's exciting. But before we hand off our design and move on to the next thing, there's something you need to consider: do we have a good plan in place to capture data about the device, post-market? In other words, do we have a good post market surveillance plan? Let's talk about this more after this brief introduction.
Hello and welcome to Quality During Design, the place to use quality thinking to create products, others love for less. My name is Dianna. I'm a senior level quality professional and engineer with over 20 years of experience in manufacturing and design. Listen in, and then join the conversation at qualityduringdesign.com.
Designers have great input into the design of a post market surveillance plan for their products. You have been involved in usability engineering, performance tests, and risk management throughout the design process and you know your product inside an out. Now, linking post market surveillance to things like risk management and product performance is not a new concept. Continuous improvement cycles like Plan, Do, Study, Act have been around for many years. And if using a cycle for product design, part of those cycles is taking field data and feeding it back into the requirements or specs. However, I'm seeing it become highly regulated in the medical device industry, in as much as what's being reported, how often it's reported, and the level of third party oversight has increased. In the European Union, the sale of medical devices requires a CE-mark and getting a CE-mark means compliance to the Medical Device Regulations. There was a Medical Devices Directive which was released in 1993, but it was repealed and replaced by the Medical Device Regulations, which was released in 2017. And the transition period for medical device manufacturers to comply with this new MDR ends at the end of May, 2021.
Now, regulations are laws and laws require compliance, which in the product device world means third party audits, mandatory reporting and other oversights. If you don't comply, you can't sell your products in the EU. The MDR put the medical device manufacturing community into a bit of a tailspin because of the increased post market surveillance (really it's the reporting requirements for postmarket surveillance). Companies needed to change their internal policies and procedures in order to meet the demands of MDR. When we get into business systems, there is no one-size-fits-all fix, and policies and procedures depend on the company's existing structure, the types of products they sell, their markets, and their users, and even their company culture. Because of the changes introduced by the MDR, companies had to redo the way that they've been doing business.
So, what is a post market surveillance system? It's really an engine of information and it's information that leaders need to use to make decisions about the acceptability of their products in the field. How does this engine work? It's a lot like a Plan, Do, Study, Act cycle (or the Deming wheel, that continuous improvement cycle) so much so, I don't really see a need to make up something new for it. If we visualize a wheel with four spokes and each spoke has a different letter designation, one of the spokes is P for plan, D for do, S for study and A for act.
- In our post market surveillance engine scenario, planning is the design of the product and its risks. Planning is associated with the product design performance, or the claims of what the design can do: the expected performance we've learned from doing verification and validation and usability engineering. Planning is also managing risks: identifying them, estimating their effects, putting controls into place, and making an acceptability decision.
- On the second spoke of the wheel is Do, which is releasing our product of the field.
- The third spoke of our wheel is Study, which is the actual post market surveillance activities.
- And the last spoke of our wheel is Act. This has to do with the responsibility of the company to evaluate the post market surveillance data and make a decision about the product. Is it performing the way we intended it to? Are people using it as directed? Is there a problem that we need to recall it in this model?
Product designers affect the planning stage the most.
The most obvious effect that a designer has on the planning part of this engine is the design performance. What are the performance claims we're making about the product and can it deliver? In other words, is it reliable and dependable?
Usability engineering is also a big part of this: usability engineering started early in the design as an input and it's part of the design process and includes studies with user groups. It answers questions like can the design be used? Can the user carry out the task? Is it intuitive? Where are places of possible misuse and can it be prevented? Do they understand how to use the device safely? Do they understand the instructions of the product's use, maintenance and proper disposal? Are the instructions accessible? And do users require training before they use a device?
Risk management is also part of the planning phase of our post market surveillance engine. It is started early in the design as an input as well. It's also part of the design process, and features analysis, risk controls, and drives action items for improvement. Risk management is an iterative system. It's never really finished, and the analysis can be considered a ‘living analysis’. It answers questions like: What can go wrong? How bad would it be if it did go wrong? How often would this bad thing happen? What are we doing to prevent this from happening? What are we checking to make sure it doesn't happen? And what are we telling our users about it and what are we expecting them to do? After all those questions finally, given all that we know about the risk of our product failing or doing harm to people or environment, is it worth manufacturing and selling? Does the benefit of our product outweigh the risks it introduces? Risk management also interfaces with the design, performance and usability engineering efforts, so it affects the design and test methods.
Back to our post market surveillance engine: We are now at the Do part where we are releasing our product to the market. After the release to the market, we can move on to Study and this is where our post market surveillance planning comes into effect, where we're collecting information about what's happening in the field and we're asking questions like: How does it compare with our product performance? How successful is the design? Does it perform as advertised? How does it compare with our usability engineering file? How is it being used? Is it being used for something other than what's intended? Are there use related issues that were not captured in the usability engineering process and we can compare to our risk analysis? Are there unexpected failures occurring? Is their affect worse than we estimated? Is our occurrence more often than we thought?
Finally, in our post market surveillance engine, we get to act what Actions are we taking based on our study of post market surveillance information? In other words, what are we going to do with what we've learned? We need a cross functional team to review this information, just like design inputs include other experts like field ops, quality engineering, reliability engineering, quality assurance, and marketing. Medical device manufacturers have the additional responsibility to decide if their therapy is as good or better than other therapies out there, available for patients. They need to investigate other devices and therapies used to treat the same illness. What have been their failures and how many issues are there? How does their product compare with the use of our product? And they need to make a decision on if the therapy they're selling is really the best option for the patient. And they need to decide: should they continue to sell it? For some businesses, this would be a huge shift in business focus, wouldn't it?
So, what's today's insight to action?
Well, first we can acknowledge that a great post market surveillance plan will include more than monitoring for complaints. Consider case studies, published reviews, surveys, and other field assessments of our product. But we need to base it on our particular design and market.
Another thing we can do today is to understand that because of our role as designers in product development, we have great input into the planning for post market surveillance of our products. We've been involved in performance tests, usability engineering and risk management throughout the design process, and we know our product inside and out. So, before there's a release to market, we can take another look at the product performance results during development, the usability engineering file, and the risk management file. And we study these so that we can pull out what's really important to monitor in the field for this product. We can consider what a team would need to monitor to ensure the product is worthy of customers to use. We can use all that work that we did during design development to help make a meaningful plan for post market surveillance.
I'd like to hear from you, now. What are some examples of post market surveillance activities for products you've been involved with? Please reach out to me on LinkedIn (I'm Dianna Deeney) or you can leave me a voicemail at 484-341-0238. I get all the messages and I might include yours in an upcomin
