Why Formlabs Separated Its Healthcare Unit Into Its Own Business Entity

Turns out, printing a body part requires a bit more prep work than printing prototypes.
Written by Kelly O'Halloran
May 13, 2021Updated: July 28, 2021

When Formlabs launched its medical-grade 3D printing product three years ago, they didn’t anticipate it requiring a company restructuring. 

As orthodontists saw reduced costs and wait times with fitting and printing custom aligners in-house, and surgeons could more easily and accurately locate and remove tumors using Formlabs surgical guides, rapid demand followed. 

 Soon, Formlabs’ newest healthcare vertical would become its fastest growing — and its most challenging, according to employees.

“We have to act as a member of our customer’s team, be it a dentist, hospital or a doctor, and ask if their product needs to be sterilized, if it needs to be made in a medical device facility and which body part it needs to touch,” said Director of Healthcare Gaurav Manchanda.

 That’s in addition to ensuring their materials meet all of the regulations, protocols and certifications as issued by the Federal Drug Administration and International Organization Standardization (ISO).

The steps and processes we follow in terms of verification and validation are far more intense.”

 
“The steps and processes we follow in terms of verification and validation are far more intense compared to our normal Formlabs materials in our other sectors,” said Materials Lead Sharon Soong.

 Recognizing how differently its healthcare function had to operate when compared to its other verticals — such as engineering, entertainment and jewelry — Formlabs elected to separate healthcare into its own business entity under the Formlabs name in 2019. 

“Customer demand is much higher, and what we do impacts patient treatment directly and immediately,” said Phil Carlino, head of dental sales. “We have to respond faster and have a higher level of service to our customers than the other industries we serve.” 

How’s it going since the split? We’ll let Carlino, Soong and Manchanda fill you in on their progress and what makes this line of work as fulfilling as it is challenging.
 

 

How is Formlabs’ healthcare unit structured?

Sharon Soong, Materials Lead: We spent the past three years building our medical and dental product line to be ISO compliant. Six people on our materials team are dedicated to this area and they work closely with four people on our manufacturing team in Ohio who are focused on compatible materials. We also have a regulatory team to make sure all of the products we develop meet customer specifications, are safe and perform adequately. About 15 people on our technical team are dedicated to biocompatible materials research. We also have started to grow our medical sales team.

Phil Carlino, Head of Dental Sales: We share a lot of resources between medical and dental, but our dental team is larger with about 30 people total. We have doctors, certified dental technicians, product managers, software engineers and a dental sales team. Our services team is one of the most important resources we have, and all of our teams work together daily to deliver feedback to the product team. 

 

Formlabs employee working with printers in Boston

 

What are you printing for medical teams, hospitals and orthodontists? 

Gaurav Manchanda,  Director of Healthcare: In the hospital segment, we typically see radiologists using CT or MRI scanners to capture patient data to convert it into a printable file that can be used for visualization models. These models help surgeons prepare for surgery and also size implants for patients. So, you could fit an implant onto the model of a mandible, which is printed at scale, sterilize it, and then it’s ready to implant in the operating room. 

Our surgical guides are also being used across medical and dental, which could be used to remove a tumor from bony anatomy, for example, or help insert screws in a spinal surgery. We also print prosthetic limbs and orthotics that can be custom-fit to patients. 

Carlino: In orthodontics, our highest use case is for aligner creation, where Invisalign is the biggest player. They print more custom parts than any other company in the world. We allow smaller or larger labs and practices to bring that technology in house. We also print splints and night guards, which are probably our most common dental implementations. Our fastest growing segment is for direct printed biocompatible materials like temporary crowns, permanent crowns, surgical guides and dentures. 

 

COVID-19 RESPONSE

Responding to dire COVID-19 needs, Formlabs has printed more than 50 million single-use testing swabs amid supply chain shortages. The company also partnered with frontline healthcare providers to split ventilators so that multiple patients could receive care from one unit as ventilator availability dried up. “Seeing the Formlabs team internally mobilize and get behind this unified effort last year was really fulfilling,” Manchanda said.


How does Formlabs navigate healthcare regulations when building printers to make patient-matched products?

Soong: Between 2018 and 2019, Formlabs invested more than $1 million in ISO-compliant cleanroom facilities in our Ohio production facility. We also have a dedicated crew that is trained to comply with ISO, since we need to make sure that each employee who is touching the process understands the standard operating procedures, such as inspections of incoming raw materials and rigorous quality control. Our crew has a couple of people with years of regulatory experience in the medical device industry, which helped us establish our system. 

Manchanda: There are some differences with how we approach regulations in dental and medical. On the medial side, we have general purpose medical resins because the range of applications is nearly infinite. As such, we’re a bit more dependent on market and customer research to identify needs. In dental, we have about a dozen specific indicators or applications. 

For example, during COVID-19 some hospital systems were looking at printing ventilation system components or personal protective equipment. We took one of our medical resins and tested that to the international standard for gas pathway applications in healthcare settings. So, we added that ISO standard to our datasheet after we received the testing. The more testing we do, the more ways customers push the limits of what can be done with them.

You can’t quantify the feeling that comes when seeing a child walk for the first time.”


Lastly, what’s the most fulfilling part of your job? 

Manchanda: I tend to get exposed to customers with really complex cases, where a surgeon isn’t even willing to attempt the surgery without a model in his or her hands to help visualize the procedure. We do have plenty of examples on our website of especially complex pediatric cases where the child’s life is saved, and the child is healthy and happy afterward. We’ve helped a child walk for the first time thanks to a 3D-printed ankle brace. You can’t quantify the feeling that comes when seeing a child walk for the first time. 

Soong: What makes 3D printing so powerful is that it’s up to the user to define what they want their materials to do. But for our users to know what they can do with it, it takes effort on our end during the development phase to think about how the customer might use a product in the long term. To see customers using their products two years later — and for different purposes than what we discussed during development —  is fulfilling because we use a more capable material than our competitors and spend more time investing in development. That’s very rewarding. If we feel the material can be used for three specific use cases, our customers always find more ways to use it. 

 

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