The New Year brings reflection and desire to improve. We asked our designers, engineers, manufacturing, supply chain and regulatory experts to consider projects finished in 2017 and think about things they could have done better or wish they had considered.
Here is their list of 2018 resolutions and smart things to do that would speed medical device commercialization in 2018:
Consider users even earlier in your product development. Rather than going often and imagining the whole device and then trying to figure out whether or not its compatible with the users and the use environment, turn it around and consider the users first and use that to help drive what the product needs to be rather than just as an evaluative tool to see if you’ve got it right.
Resolve the technical issues before starting to phase one. Understand the core technology before you can get too far down the road. Similar to DFM (design for manufacture), if you don’t do it early it’s going to cost you a lot more later on in time as well as money. When things go wrong later on, if you have not invested time in the core technology, you can’t understand where the costs are coming from. Just because it worked once, doesn’t mean it’s going to work many times. Don’t let money raising or investor milestones suddenly deviate your development path and take it away from refining and resolving technical possibilities.
Use a disciplined gate process and don’t allow people to talk about Beta manufacturing transferability issues. Recognize that Design Transfer is a separate phase. Many novices think that when you finish the design, you can start manufacturing. It’s not the case. Be prepared for a delay if you cut corners during the Design transfer phase. You’ll pay for it later in design changes. Design Transfer takes a lot of time and effort to make those changes from beta units to manufacturing while following protocols. If additional marketing changes are made at the last minute, they are going to take a lot of days and lot of manpower.
Consider all the right guidance documents early. Look at the FDA website, they have a search engine for the guidance documents, it takes a bit of work to dig through but at least if you look in there your chances of being surprised are reduced. Same with the medical device directive, they list a whole lot of normative and collateral standards you need to follow, it’s not enough to just go and say hey we are 60601 compliant and will be great, because there are other standards that nobody ever mentions and takes a little bit of effort to find. They are kind of a gotcha at the end of the game if you suddenly realize there was already a standard for the very same thing that you are making but you just didn’t know about it until you thought you were done.
Assign a primary QA regulatory resource for every device. The assigned QA Regulatory personnel will be aware of project intent, activities and regulatory implications regardless of whether a regulatory strategy is defined. They will conduct appropriate regulatory searches and make sure everyone is aware of all standards that apply to the device. They will read all the DHF documents that are mandatory for QA to review and participate in different project meetings, risk analysis, design reviews, and gate reviews, etc.
Get serious about testing. Conduct formative testing before you do summative testing. It’s a good year to look at post market design changes, post launch design changes in order to keep your DHF up to date and revisit your risk analysis. If you look at FDA warning letter records, there are a lot of findings relating to people dropping the ball on DHF and risk analysis.
Comply with the IEC 62304 software standard. The two big things for people to look at this year are MDSAP (Medical Device Single Audit Program) and EU MDR (Medical Device Regulation). It is going to be first time FDA aligns with the international regulatory frameworks. This will possibly allow companies to avoid the FDA audit. This the year to look at it seriously, so that’s the MDSAP. MDR is whole new framework that Europe is bringing in and it’s important to get familiar with it. The MDR challenge is that they are revising about 80 or 90 guidance documents around the MDR and how it needs to implemented and they have not published a single one yet. For a lot of MDR requirements there is little clarity on how they will be implemented, I really hope they start publishing these additional guidances soon because otherwise we are kind of in the dark. We are going to have lots of bedtime reading in 2018, so maybe no books are needed for Christmas.
Book your inspection now and update your documents otherwise you may lose your certification to ISO 13485:2016. The ISO 13485:2016 deadline is next year. It will be implemented in January 2019, but registrars are doing the audits in 2018. Our registrar Intertek sent an email stating they are cutting off companies in November 2018.
Clearly communicate your tactical needs and desires to consulting partners. If you need a working prototype to take to trials or show to KOLs, let your contractors and consultants know that so they can tell you what the process is to reach that end goal rather than asking for a portion of your needs i.e. “we need google screens”, etc. By sharing why you need a specific deliverable, your development partner can tell you what is required to get to your end goal of tactical requirements.
Establish critical components and critical suppliers through a defined risk management process. The new COC (certificate of compliance) standard has requirements for using the risk management in assessing the critical suppliers. Even if you were doing so already, it’s now going to be a part of the formal process based on the strict criteria for who is (and who is not) a critical supplier.
To understand the impact of the new requirement, ask whether your standard risk analysis process is appropriate. If it is complex, you will want to simplify it. If there are many parts to your device, you will have to conduct the process for every part. A simple guideline is to consider if a part affects safety and effectiveness, if it does then it is critical, if doesn’t then it’s not critical.
Get connected. There has been a lot of hype around Digital Health. It is becoming more and more clear that any medical device you don’t connect will be missing out on a vast opportunity to create value for yourself and your users as well as a whole bunch of post market surveillance capabilities. This is the year when it starts becoming much more real for more people. Connected medical devices are gaining popularity in hospitals. Devices are more complicated, they are generating more data. Two examples of connected data impact are:
- Manufacturers that let data just disappear into the void are not aware of what’s going on with their product until somebody complains. If you don’t have the ability to support your product by monitoring it actively post launch, you are going to be in trouble.
- Monitoring performance of the caregiver side; How can being connected can help with device conformance? Get serious about being connected to achieve everything.
You’ve seen our resolutions. What are your improvement plans for 2018? We’d love to hear and share them.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.