With COVID-19 shutting down non-essential businesses and postponing non-essential surgeries around the world, many medical device companies are experiencing a decreased demand for their products.
But COVID-19 couldn’t stop the innovators at Theken. They took a problem—a maddening shortage of personal protection equipment (PPE)—and came up with an innovative solution. In less than ten days, the team developed a reusable, autoclavable, titanium 3D-printed N95 respirator that only weighs 60 grams and could potentially replace hundreds of disposable masks. This device, along with Theken’s proprietary N99 filter material, is currently awaiting FDA approval.
A Call to Action
On April 1, 2020, Randy Theken, founder and CEO of Theken Group, a group of four medical device companies based in Akron, Ohio, received a call from Jeff Dulik, D.O., an orthopedic surgeon who asked if his companies could develop a solution for the personal protection equipment shortages in area hospitals. Perhaps there was a way to 3D-print reusable masks?
Theken, whose four medical device companies include NextStep Arthropedix (a developer of total joint replacement products). Slice Mfg, Studios (a design laboratory and contract manufacturing facility), LaunchPoint (Theken’s corporate innovation division) and Ə Ceramics (a developer and manufacturer of advanced ceramics for orthopedic implants) and his teams jumped into action. For more on the Theken Group, see OTW’s “Randy Theken’s New Company and Return to Orthopedics.”
In less than ten days, the team conceptualized and created a reusable, autoclavable, titanium 3D-printed N95 respirator along with a proprietary N99 filter material that has been submitted to the FDA for approval.
From an Idea to a Device in Under Ten Days
OTW spoke with some of Theken’s team to hear how they were able to accomplish this impressive undertaking in such a short period of time.
Theken Chief Technology Officer Cowan Moore described how the respirator went from an idea to a device. Moore explained, “First, the team worked with four different surgeons who gave some insight on how a fit test for an N95 respirator works, how they would use it in the OR, and how they would put it on and take it off. The team worked with Jeff Dulik, D.O., an orthopedic surgeon, Steven Ochs, M.D., a urological surgeon, Ian Dickey, M.D., an orthopedic surgeon, and Don Voltz, M.D., an anesthesiologist.”
The team used a 3D-scanner to take scans of a variety of faces and create a model of the respirator. They then used an FDM 3D-printer to print over 20 iterations of the respirator in plastic over a four-day period, making adjustments each time. Once the team was happy with the plastic prototype, they used a $1 million dollar GE Arcam EBM metal 3D-printer to create 50 titanium respirators in one build.
For a glimpse of how this magical process takes place, watch this video.
