Where do medical device development professionals go for answers?

Everyone has a “go-to” resource when they get stuck with a question or challenge they have not encountered before. StarFish employees specialize in designing and developing novel medical devices. We asked them for their favorite medical device development resources and tips:

Research Sources

ResearchGate and ScienceDirect have a lot of general and technical information relevant to microfluidic projects. The only downside is a fee for every journal you download. Enter a topic or keyword that you want to research – for example, a biocompatible adhesive – into ResearchGate and, “Bingo!”, you can see research conducted in different industries and publications.

PubMed is produced by the US government. It’s a great resource for health-based research papers, biotech, etc. There are lots of research papers and, of course, with paywalls, depending on the journal. The papers cost money, but of course you’ve got to pay academics too.

Regulatory Sources

Guidances for human factors and usability engineering are my first go-to resource. For the States, that includes the FDA’s guidance. HE75 is another human factors guidance and IEC 62366. I do a quick skim through those in PDF form to see if I can find what I’m looking for. If not, there’s a forum called the ELSMAR Cove Quality Forum with a human factors engineering forum which is super helpful if you have a specific question. You can look to see if someone else has asked your question, and if you’re a member, you can post your questions and see who answers.

FDA databases are another good resource because they publish the 510k and de novo summaries. You can learn a lot about different types of medical devices that have already been cleared or approved. Another great site is the ClinicalTrials.gov site. It gives information about ongoing clinical trials. Interested in what clinical trials your competitors are up to? You can find that information as well. The site uses key words, but quite often with the FDA, you need a fair bit of information, so often it’s easier to find the FDA databases by Googling “FDA cleared 510k” and the type of technology you’re investigating. That will bring you to relevant FDA databases.

Regulatory Affairs Professionals Society (RAPS) have a forum that’s really good for regulatory interpretation of problems which often can be interpreted many different ways. It’s really useful to read different experiences on addressing problems. You need to be a member, but membership also brings lots of other benefits such as publications, books and downloadable papers, plus free webinars.

General Sources

I use YouTube to study about the topics in the projects that I’m new to, and want a better understanding of a device or topic. I generally search on training, study guides, and product reviews for the topic or device. I just click the video with the most views. For example, when looking into ECG monitors, I found a lot of nurses and doctors sharing their study guides and how they studied ECG monitors in their universities.

I also like YouTube for looking up procedure workflows for certain surgical procedures or whatever is being considered at the time. There are endless videos for all sorts of procedures uploaded by doctors. This helps a lot.

I like to read patents and look at where the leaders of other companies are in this space. I look for what’s assigned to the companies or other people using the United States Patent and Trademark Office USPTO. Often quite a lot of their foundational patents are written in a different context by a university professor or an industry liaison office for the university. They may disclose quite a lot of context for the industry and their strategies that we wouldn’t pick up in other places. I add Google Patents as a similar resource as it searches outside the US as well.

Software is a bit of a different beast because we’re almost always trying to pull Lego pieces out of a box to put together and make an algorithm or fill in an algorithm to solve a specific problem. Sometimes papers have some good, baseline things to work from. I recently found a good paper with an algorithm to measure eye redness through Googling rather than trawling through citations on papers to find one that was publicly available. Bonus tip: Especially in physics, you can usually email the first author asking for a copy of the paper, and they’ll happily give it to you because they don’t get any money from journal reads or journal purchases.

Sharing Knowledge and Resources

I’m pretty new to the company. I just ask people if I get stuck on something.

Another avenue is word of mouth. Talking to folks and picking up leads that kind of spider webs into other development veins. For example, talking to vendors that are doing a similar capability will talk about examples that they have worked on, but with a different element or spin. We onboard that information and can work out our solution that way.

I reference a previous design. We have a reference design compilation on the StarFish Wiki. With our database we can say, “This has been done in the past for a different type of device, why not use it for this kind of project.”

The Mechanical Engineering team have a wall of physical components from lots of vendors that really help when you’re thinking of how to connect parts or buttons for PCB attachments, et cetera. When pictures on the computer aren’t conclusive, we can take the physical parts to our desk and think of how to integrate them or use them.

For Human Factors, a lot of the information we collect for a project can be transferrable. When we do our preliminary research and analysis, we’re getting contextual information about who our users are and what our environment is. We can reuse that information if there’s another project that has the same environment or user roles or types of clinicians working on it. If an experienced person is on the project, they can quite easily reuse information. Just working with others within our functional team allows everyone to use and to share that information as a resource.

We hold a regulatory meeting once a month where we review what’s going on in projects and any new or regulatory guidance changes. We also call ad-hoc meetings if anyone wants to bounce ideas around, gather other perspectives, or get an answer to a sticky problem that has come up in a project.

If I have a question, there’s usually someone on the software team or an EE who has dealt with it before or knows how to solve something. If I’m stuck, I like bouncing ideas off of coworkers. With a nice back and forth, you can rule out a lot. Often they’ll mention something and then you’ll think, “Oh, I can implement that”. I can get it working and the problem is hopefully solved.

I often have strategic discussions with clients about the strategy for their company, what their next goal should be, how to optimize their value for investors and how to balance unlike things like should you focus on regulatory risk or reimbursement risk or technical risk or manufacturability risk or margin risk, because they all need to get done. But how do you actually in reality choose between those things? There’s no substitute for experience.