Hs Design, located in Gladstone, NJ is a product design firm that specializes in creating medical devices.
Tor Alden explains, “We felt that we needed to be more than a design firm. We could have been a design firm where other product development firms will come to us and source out the design, but we would lose control of the human factors, we would lose control of the engineering. Part of the magic that we are able to do now with this collaboration of specialties is to work very tightly together to try and prove out some of the more challenging system architectures.”
HSD works in the medical life science, surgical and consumer healthcare, and creating both patient-centric and disposable-centric solutions. They do this with a collaborative resource approach that includes design research, human factors, industrial design, user interface design, engineering and rapid prototyping. The goal is to fulfill the need to commercialize products through partnerships with global contract manufacturing teams aimed at rapid transfer to production.
From that perspective, product development was a good fit for HSD to explore. The fact that they are not an OEM or an actual manufacturer puts them on an even playing field where there are no prejudices towards different design processes or manufacturing processes. This keeps the team open-minded and focused. However, it also allows them to continue to explore new avenues for manufacturing.
To expresses one of the biggest issues folks have or most common preconceived notions going into a project are centered on regulations and regulatory processes. “A lot of people, when they hear the word FDA, get scared or they get mad or they just say, ‘This is a problem.’ HSD, we actually get along pretty well with the FDA and we agree with a lot of their processes that they’re asking for, because they make a lot of common sense. If you design in a common sense methodology, you’re well on your way of meeting all the FDA requirements. With that said, that’s the same, it holds true to a QMS procedure or a process.”
As far as technical advancements or tools that HSD uses, that has really changed. Tor laughs when asked about technological advancements in medical product design tools, “… we hear in public news that people are saying, “Oh, there’s 3D printing now.” 3D printing has been around for over 20 years. We’ve had our first Fused Deposition Modeling machine probably about 20 years ago. In essence, it’s not new. What’s new is the cost in time and the quality of the parts that we’re getting. It’s allowing us to use the process in almost every stage of development. We’re using 3D prototypes that are going out for user tests for these formative evaluations.”
Currently, HSD is developing a program for a drug delivery device company where they are 3D printing the actual products that are being filled for user testing with a placebo. It is possible today to do things that may have taken months now in a week’s worth of time. That time to market and the appreciation of getting a physical product in your hand is a really definitive result for using 3D printing.
There are other industries and companies, orthopedic companies for example, that are printing titanium or metal objects that are actually used in patients. Pilot prototyping has emerged as a great way to test feasibility. It is much easier to print 100 units, alpha prototypes, to use to test ergonomics, use cases, and durability. That said, 3D printing is still in the prototyping world.
The other real technical advancement that is now available and completely different is the augmented reality and virtual reality tools that are now being made available for the design process. HSD just completed a project, the Canfield WB 360 which actually won an IDSA gold last year, that was a “room-based system” that would have been incredibly expensive to build a prototype for. There was a formative evaluation, where using augmented reality, the team was able to create models and capture user insights without that physical prototype.
This specific project alone doesn’t prove that AI or VR are the reason the solution won an award, however it helped validate the way it is possible to adjust and modify a project seeing it in 3D.
Another tool is a HoloLens. Engineers and designers can touch, design, and capture valuable data without seeing it on a CAD model. With 3D printing now we can do it in multiple textures, multiple finishes, multiple durometers. Everything just becomes much easier and affordable.
It also means that quality has a chance to improve because a team can iterate many times over without the same cost as you had before. In certain cases, the costs go down and it is possible to do more with internal prototyping. This saves time, saves money, and brings home a better design because we’re able to go through more iterations.
Design is no longer a standalone business. Specifically, medical device design. Design needs to work in a highly collaborative manner. It’s working with a lot of experts and system thinkers that are really changing the environment of the healthcare space. As designers, we have to learn to speak in a lot of different languages; medical, engineering, marketing, and we need to be able to communicate the value of design in the overall impact and value to the user. Just by saying you have a good user experience isn’t good enough. We have to prove it and we have to make sure that it’s understood through all the stakeholders.