How We Use 3D Printing to Develop a Better Product


3D printing has been a key technology for product prototyping for well over a decade. In the last few years, however, the quality of 3D printed parts has improved so much, that it is even playing a role in manufacturing. At the same time, cost and print time has come down so much, that you can think of a part in the morning and have a functional prototype before sunset. The ability to iterate quickly results in faster time to market and higher quality products. That’s why at Bold Type, we try to design and 3D print prototypes within the first 2-3 weeks of a project.

Here at Bold Type, we specialize in product development for connected wireless medical devices and we’re firm believers in testing as early as possible.  We use 3D printing all the time so we can get a product prototype in front of the users. That prototype is going to let us see exactly how the user is going to interact with the product, what usability challenges may exist, whether the design is appropriate for the intended use, or if there is the potential for mechanical risks.  This helps limit the number of costly mistakes that crop up later in the process or – worst case scenario – prevents the launch of a product that users just don’t feel comfortable using.

3D printing helps not only with improving the user experience, but with streamlining time to market as well. Anyone who’s taken products to volume production knows that tooling can be an expensive and time-consuming part of the process, so it’s extremely important to ensure that when you’re ready for the tooling phase, you get everything right in the first try. You need to make sure that all the parts fit together correctly, that all the different components fit together properly, that you’re not going to have some weird misalignment problem between the board and the mechanical housings or between two components in the mechanical housings.

Of course, 3D printed parts are not the only option when rapid prototyping is required. For functional prototypes that look and feel more like injection molded mass production parts, we often use cast urethane prototypes. Even then, however, 3D printed parts often function as the “master pattern”. The combination of these two technologies, allow us to prototype parts that look nearly identical to the final product in just 1-2 weeks instead of 2-4 months.

3D printing can also play a role in the regulatory strategy for medical devices. Manufacturers need to demonstrate that they are following FDA design controls requirements and following a process to mitigate risk. Usability testing is also part of developing medical devices, and the best products are a result of formative usability studies that guide the design process, and summative usability studies that validate a product meets its intended use. Performing user research early and often demonstrates to FDA that you’re serious about ensuring great usability and mitigating risks, and 3D printing helps you do that.

A more recent and exciting trend in 3D printing is actual manufacturing. For a long time, 3D printed parts have been intended for prototyping, but not production. This is primarily due to the relatively high cost at higher volumes when comparted to injection molding. A secondary limitation has been that the quality and strength of the parts is not as good as molded parts. Where 3D printing shines, however, is in its customizability. If you need to make 1,000,000 identical devices, injection molding is probably the way to go. But if your product needs to be customized for each patient, injection molding is simply not practical. In these cases, 3D printing opens the door to entirely new product concepts that are optimized for each user. The challenge in these cases will come in performing process validation on the manufacturing side, but fortunately there is now plenty of precedent, and we have partners who specialize in precisely this field.

At Bold Type, we specialize in the hardware and software components of wireless connected medical device development – housings, electronics, embedded software, mobile apps, web applications, cloud connectivity, and cybersecurity. A big part of our success is our ability to get to the user testing phase early, gathering that feedback to make sure that we design the product to fit the client need. Incorporating a key technology such as 3D printing allows us to build the right product for the client, with minimal risk and in full regulatory compliance.




Electrical Impedance Myography in Duchenne Muscular Dystrophy

I was involved in some very cool projects during my post-MIT years in Boston, working with some very smart people like Lucy Lu Wang, Seward Rutkove and Eugene Williams.

For this Technolog Thursday post – a multicenter study evaluating the effectiveness of EIM in measuring muscle pathology in Duchenne muscular dystrophy, a degenerative neuromuscular disease that occurs primarily in young males.


Edwin Armstrong’s Impact on Connected Medical Devices

My doctoral work was on the design of ultra-low power circuits and systems for medical devices.

If you’re suffering from insomnia and want to geek out on some math, here’s your chance:

During that time, I came across the work of Edwin Armstrong, who is an engineering hero of mine.

You’re probably wondering exactly who Edwin is but the funny thing is, he’s had a dramatically bigger impact in your life than you know.

Edwin Armstrong was a true genius of the 20th century. He invented wireless communications techniques and architectures that are used to this day – think frequency modulation (FM) and the superheterodyne receiver. He also invented a type of receiver called a “super-regenerative amplifier” (SRA), which is a lot less common these days.

I decided to design an SRA and went down the theoretical rabbit hole to develop a mathematical model that would explain its frequency response.

This was tricky because most systems are linear, time invariant and employ negative feedback. The SRA is nonlinear, time variant, and employs positive feedback, taking advantage of the huge amplification that happens when a system becomes unstable.

It’s fricking genius and one of the reasons I admire Armstrong so much.


An Attic Full of Medical Device Innovation – and a PhD Thesis

A few weeks ago I turned the big 4-0, so I figured I’d go big and share my PhD thesis with you all:

Before grad school, I’d had the good fortune to work on medical devices at GE Healthcare and on wireless chips at Bitwave Semiconductor.

My awesome advisors at MIT allowed me to bring those two worlds together resulting in my doctoral thesis: “Digitally-Assisted, Ultra-Low Power Circuits and Systems for Medical Applications.”

The three and a half years it took me to finish my PhD were the most eventful of my life. I got engaged, married, had my first daughter, and my wife was 9-months pregnant with our second daughter when I defended my thesis.

After getting married, my wife and I rented a house in Winchester, MA with a finished attic.

I spent most of my last year at MIT in that attic writing this thesis and making progress on a startup I co-founded with two other grad students and a Harvard Med School professor.

Needless to say, I was working long hours, so getting to work from home was a great blessing. I could take short breaks throughout the day to spend with my wife and daughter.

More than a decade later, I’m still focused on medical innovation, and I’m back to working from home and spending my breaks with the kiddos.

I guess the more things change…