The Role of 3D Micro Printing in Device Development

By MedTech Intelligence Staff
May 5, 2023


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, RC - Device Design & Manufacturing, Supply Chain

As 3D printing gains a more prominent place in the manufacture and protoyping of medical devices, advances in technology and materials are expanding indications. We spoke with John Kawola, CEO of Boston Micro Fabrication (BMF), about the move toward micro 3D printing and how this technology supporting the drive for miniaturization and minimally invasive medical treatments.

What is micro 3D printing vs. traditional 3D printing?

Kawola: The easy answer is, it’s smaller. The focus of our company, which was founded about five years ago, was to take some of the existing 3D printing technology that has been developed over the past 25 to 30 years and use a combination of high precision optics and high precision movement and software and materials to achieve a much higher level of resolution and precision.

We often refer to our platform as pulse or projection micro stereolithography (SLA). It’s a variant to some of the previous technologies that can achieve features, resolution and precision that you couldn’t achieve in the past. The need in certain segments of the market to get that high level of precision follows another macro trend that we ride alongside, which is miniaturization. Things are getting smaller in almost every industry, and as things get smaller, they get harder and harder to make the conventional way with molding, machining or stamping. We use the term “micro” because we’re typically talking about parts that are centimeter in size and the tolerance required is in the tens of microns typically. There is a range of parts that are much, much smaller than this—on the scale of 1 mm in size that the micro 3D printing technology also addresses.

Do the device developers print on demand with your technology or is it printed through your company?

Kawola: Our primary business model is that we are selling our platform, our machines and materials and software to the OEMs. Most of the manufacturers are bringing in the technology for prototyping and development, because they couldn’t prototype at this scale before. The No. 1 way they would prototype is make the device bigger. This gives them the ability to do a one-to-one basis prototype. But, about a third of our customers today are industrial customers and they are starting to implement plans to use these printers to print parts for production.

The conditions where you’re making choices about 3D printing in production (i.e., should I 3D print or should I mold?) depend on volume. In most cases, you should mold or machine. But when volumes are not that high—tens of thousands vs. millions—or the parts are very complex or very customized, such as in the dental industry, the math starts to make sense where you might consider 3D printing versus molding.

Another reality is that molding something like a computer mouse may cost tens of thousands of dollars for the mold. But if you were to mold something very, very complex and small, the mold might be $250,000. So, it’s different math.

How is micro 3D printing currently being used in the MedTech market?

Kawola: IMcoMET is using the technology for a skin cancer biopsy device. There’s a lot of work happening in neurovascular for surgical tools to treat an aneurysm or prevent a stroke. In neurovascular, the most common device used is a coil, where you can go in and choke off in aneurysm or a tumor, and there are a lot of small components in that tool. There’s a lot of work being done in drug delivery devices as well with micro needle technology and patches. Coming through Covid, people have learned that the needle and vial model is very difficult to scale, so we have seen acceleration in development of microneedle technology using our platform. And then looking at implantables, whether it’s an implantable drug delivery device or an implantable stent, there’s a drive and a need to make these devices smaller. This trend follows the current drive in medicine for less invasive treatments, which requires smaller devices.

What is needed to expand the use of 3D printing in manufacturing?

Kawola: One of the big limitations in terms of why 3D printing hasn’t been used for production of parts is that the materials were not good enough. The materials were just a proximate of end-use medical device materials, but that gap is starting to close. There are more and more materials being certified for use, and that opens up the use of 3D printing for the end use device. And when you get into volumes that are in the tens of thousands, that starts to be the sweet spot for considering 3D printing versus molding.

While the bar for materials to be good enough is high, what we’re finding in medical devices is that the technical hurdle is not that high because a lot of medical devices are consumable and one-time use. They don’t have to last for 10 years and they don’t have to be flame retardant, things that they need to be in the electronic space. There’s certainly a regulatory hurdle, but in terms of the technical hurdle a lot of materials that have been developed are good enough today for some of those one-time use applications.