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Randy Theken’s Views on Contract Manufacturing, Additive Manufacturing and Much, Much More

Hard work, innovative ideas and humility are the attributes for success that Randy Theken says have applied to his 25+ year career in orthopedics. Mr. Theken founded a mechanical testing lab, five orthopedic companies and now a contract manufacturing company, with other endeavors in the works. One could argue that his formula works.

Randy Theken cropped

Mr. Theken is an engineer by education. His nature is to tinker, improve and lead change. 

After years of mechanically testing orthopedic and spine implants with Theken Orthopedics, he saw holes in the device market and formed Theken Spine. His spine market knowledge led to Theken Disc and the orthobiologics company Therics. He then sold the spine portfolio to Integra LifeSciences in 2008. Identifying needs in joint replacement and trauma, he founded NextStep Arthropedix for hip and knee joints in 2013, followed by NextStep Extremities for hand, ankle and foot implants in 2016. NextStep Arthropedix’s struggle to find a contract manufacturer to additively manufacture its hip cup led Mr. Theken to found Slice Mfg. Studios. 

Our conversation with Mr. Theken began with his expansion into the supplier side. We asked about the lessons learned from previous companies that he’s applying to his new ventures, his take on new technology and his advice for a successful career.

On Starting a Contract Manufacturer
Mr. Theken is used to outsourcing. Theken Spine outsourced about 90% of its manufacturing. NextStep Arthropedix outsources about 60% of its manufacturing, with Slice producing the other 40%. When NextStep Arthropedix couldn’t find an additive manufacturing partner and brought the skill in house, Mr. Theken realized that other device companies were probably struggling with the same issue and decided to contract out its services. He then wondered about other skill sets and capabilities that the company could leverage. Slice competes on its uniqueness, offering design, prototyping, testing and FDA regulatory services, as well as conventional manufacturing, laser and EBM additive manufacturing, finishing, laser marking, sterile cleaning and sterile packaging.

“Think of us as a boutique. We’re not a 1 million-square-foot facility; we’re only 40,000-square-foot,” he says. “But you can come to us and you can walk away with your widget designed, developed, tested, manufactured and sterile packed. We’re not bigger. We’re not the best. We just collectively have all of the tools in the tool bag.”

On Communication
One reason for founding Slice was obtaining goods in a timely manner. “This is not a knock on other contract manufacturers, because many of them do it well. One of the things that I’ve taken away from being on the other side of the fence as a medical device company and going to contract manufacturers is communication,” he says. “One of the big factors with our customers is that we’re constantly communicating and updating the data with them on where things stand. It’s offering realistic lead times vs. telling a customer we can do this in eight weeks, and eight weeks turns into 16. That was one of the most frustrating things and still is today.”

On Serving Customers Well
Mr. Theken believes that nickel-and-diming customers creates aggravation and unnecessary work for his company and his customers. “A customer will want us to prototype something via 3D printing, and we’ll do it for free. They’ll send a print and a widget, and in a two- to three-day turnaround time we deliver. I did this back when I did testing,” he says. “You have to realize that it goes a long way when someone calls you on the phone, you step up to the plate, and in the next two or three days they have a part sitting on their desk for free. Psychologically, that goes a long way.”

On Offering Additive Manufacturing Options
NextStep Arthropedix uses EBM to manufacture its hip cups. Mr. Theken believes EBM to be the superior form of additive manufacturing, in most cases. However, knowing that laser-based is preferred by many manufacturers, Slice bought both types of additive technology. “We started with EBM—the Arcam, now GE, machines. We specifically chose those, because we believed that is the right equipment for trying to manufacture orthopedic devices that require trabecular, bony-in-growth structure. To this day, that belief remains true,” he says. “The other side is laser-based 3D printing, which is more suited for devices or widgets that require a much finer resolution. At the end of the day, the EBM machine is much more efficient and more cost effective than laser based and produces the same result. You might say, ‘Well, Randy, why the heck do you also have laser?’ If you have a part that needs very fine definition, then you would use a laser.”

On Ceramics
Theken Companies plans to launch a ceramics company this year. “We will soon have a ceramics company that will be the first company to be able to compete against CeramTec,” Mr. Theken says. NextStep Arthropedix is seeking FDA 510(k) clearance for a ceramic hip ball, and then the new ceramics company will begin to court other device companies.

On Antimicrobial Coatings
Another area of interest for Theken Companies is antimicrobial coatings to address surgical site infection. “We’re creating a solution using anodizing techniques that will place a coating over top of the implant that makes it antimicrobial, so that infection cannot occur specifically within the implant,” Mr. Theken says. “You can apply this in everything—spine, joint, trauma—anything being implanted into the body.” The coating company will launch after the ceramics company.

On Microelectronics in Implants
A third endeavor in the works involves use of microelectronics intraoperatively to place the device, and embedding microelectronics in implants to monitor patient recovery. Theken Spine developed but never commercialized the eDisc in the early 2000s. Mr. Theken is again working with eDisc’s electronics developer. “One thing that excites me the most about orthopedics is the potential for integrating microelectronics into implantable medical devices,” he says. “We’re working on it now, and we’re going to try to choose a device that is easier to start off with, [perhaps] more external devices like instruments that have microelectronics built into them.”

On Young Engineer Skillsets
Most of Mr. Theken’s career has been dedicated to small and medium sized companies. As a serial entrepreneur and leader, he’s held many roles. “The young engineer entering orthopedics would find themselves more valuable by being involved in getting a device designed, developed, tested, approved and out to market. Although the larger companies give you a lot of structure, you get boxed into doing one thing and one thing only vs. getting into a mid-size or smaller company [where] you quickly get your feet wet and understand what it takes to get a product to market. I think that helps accelerate a young engineer’s career to go to the next level and provide real value to a larger company.”

Mr. Theken respects that success comes in different forms and is measured differently by everyone. His definition of success has evolved from what he thought it meant 20 years ago. “Some people ask, what is your biggest challenge. I think, geez, that’s trying to get my two boys out of school and to college,” he says. In business, he’s found waking up and focusing on the challenge—the problem—has led to his success.

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