We recently asked our engineering and QA/RA leaders which new developments are likely to impact medical devices in the near- and long-term future.

Their responses cover a variety of technology, regulatory, and supply chain activities.

Technology

Kevin Meric, Industrial Designer: With recent advancement in software and cheaper headsets, Virtual Reality (VR) has become the most interesting new development in Industrial Design. It is set to change the future of medical device development. One major challenge in designing medical devices is understanding the context around the device being designed. By generating a VR use environment at scale 1, industrial designers and human factor engineers can brainstorm directly in the space of use of the product and therefore make better design decisions at a lesser cost.

A VR environment is fast and cheap to model in 3d compared to the logistics of accessing a surgical room in a hospital. By simply adding an early version of a 3d model of the device created for physical prototyping into the VR use environment, a lot of design decisions can be validated or corrected (placement, location and height of accessories like monitors and controls). This goes beyond the industrial design and human factor side of a device. Mechanical engineers can judge assembly and disassembly of parts, electrical engineers ameliorate cable management and system engineers can even improve their understanding of the risks analysis.

VR is part of a larger spectrum known as Extended Reality (XR) that includes Augmented Reality (AR) and the lesser-known Mixed Reality (MR). A recent blog post by Sunghyun Lee and Morna Gamblin expand on the subject and its positive impact in medical device development.

Brian King, Principal Optical Engineer: A really interesting change in the optics industry is the availability of “aspheric” or even “freeform” lenses. The surfaces of traditional lens are created by grinding glass with an abrasive, resulting in spherical surfaces. These spherical surfaces introduce distortions into images produced by the lens – a lot of traditional optical design involved the art of trading off distortions from different lenses in a multi-lens system to reduce overall distortions.

Aspheric and freeform lenses are essentially produced by methods akin to machining or even molding and can have non-spherical surface shapes. These shapes reduce the per-lens distortion and allow an optical designer to replace multiple lenses with a smaller number of optical elements. There is a price premium for utilizing these components, but the increase in system simplicity is often worth the premium – which is partially offset by the reduction in the overall number of optics.

Lorenzo Gutierrez, Microfluidics Manager: Working on several microfluidic projects for disease diagnostics and biomanufacturing is mind-blowing! Designing and building a microfluidic device for encapsulating biomaterials in a “business card” size footprint is inspiring. Potentially, this will become the building block for technologies in tissue engineering, disease diagnosis, and drug delivery systems.

Kashif Siddiqui, Systems Engineer: I just attended a conference on AI where a presenter discussed creating a bunch of new AI networks that are designed to process bio signals. A huge amount of effort is required to denoise the myriad bio signals that are captured by medical devices Their new method uses all the extracted noise as additional data and they found that AI tends to perform a lot better. There are creating new types of auto encoders that can have a profile fed in separately. That seems to be improving AI performance. So down the line, we might see a lot of people asking us to actually retain noise that we would otherwise be filtering out and getting rid of. It turns out maybe noise is a good source for AI learning.

Thor Tronrud, Software Engineer: The recent work that’s been done on getting Python as sort of a web assembly wrapper. Dynamically loading Python libraries into a browser and executing code locally on sort of JavaScript level seems interesting. This is especially true when using a web app to interface with external files or do something slightly more on the heavy lifting side and want to use a web browser interface. That opens up some possibilities. Web assembly in general is quite useful for that, albeit a little limited.

Regulatory Changes

Helen Simons, Senior Quality Assurance Manager: The FDA published a new draft guidance on cybersecurity expectations in April. A webinar Q&A session with the FDA was really interesting to hear why they’re bringing this out. The current guidance dates all the way back to 2014, which in the world of cybersecurity is a very long time. They tried to update it in 2018, but the content wasn’t accepted. There were too many comments. This new version is currently open for comment and significantly increases the expectation on cybersecurity documentation for medical devices. The guidance from 2014 was only nine pages long and the new one is 49 pages long, so a big jump from the FDA.

Sandy Reid, QA/RA Specialist: The other big FDA announcement is that they are planning to align with ISO 13485. For the longest while, FDA has had their QSR (Quality Systems Regulation). They are creating a new regulation of Quality System Management Regulation. The reason for this is the QMS has evolved. It is much more risk focused, which is what ISO 13485 focuses on. They want to align how the FDA looks at medical devices because they realize medical devices are global.

A number of regulatory bodies recognize ISO 13485 and they’re trying to streamline things for manufacturers. This doesn’t mean that the FDA won’t conduct inspections, but it does mean that their auditors are going to change how they audit and inspect. They only gave two months for comments on this new regulation, but they are allowing everyone free access to the ISO standard, right now. Manufacturers can start seeing what they need to align with if they haven’t done so already. There will be a one-year transition period for manufacturers to get things up to speed. They announced that in April, and the comment period ended. That’s the big news as far as the FDA and ISO goes.

Supply Chain Issues

Kenneth MacCallum, Principal Electronics Eng.: It’s not interesting in an awesome way, but it’s certainly impactful. This stupid global supply chain thing where now as we design new things, we have to be super focused on, “can we even get stuff to put in it?” Lead times are just ridiculous. Parts are a year out before you can get them. It makes you want to put everything on hold. Parts disappear in a day. So, if you pick a part and you think you might need it, you have to buy it right away or it’s gone tomorrow, and you can’t prototype anything. It’s really quite ridiculous and totally changing or affecting how we design new stuff, how we prototype stuff. It does tend to drive you towards going back to old fashioned parts as much as you can, because a lot of the older parts are often still available.

Another thing we found is, the crap parts are always available. And whenever you think, “Oh, maybe I could use that,” you dig deeper and you realize, “Oh, that’s why it’s available.” It’s just a really stupid part and nobody wants to use it. It’s a boring, sad new development rather than interesting, but it sure is impacting what we’re doing. I mean obviously we’ve had to stockpile to a degree too in some areas and that allows us to keep building. But it’s going to get harder and harder before it gets easier.

Iman Nikia, Analysis Team Manager:  For example, a Bluetooth module we’ve been seeking seems to be available, but at double or sometimes three times the normal price and the minimum order quantities are way higher, so you cannot actually get a sample. I’ve been trying to source this for a project and the minimum quantity is 500. This is not feasible for us nor for the client. So even when modules are available, they’re very expensive and they’re in the wrong hands.

Intrigued by our choices of new developments that will impact medical devices? Contact our team to see how we can apply them to your medical device project. We enjoyed sharing our choices and would love to hear your thoughts on other developments that will impact medical devices.