Keeping Current with the Medical Machining Market

As a machine shop, participating in the machining of parts for the medical market is good business. It requires relatively high skill sets because the parts can be complex, and some of the material requirements can be more stringent than the metals found in general machining. Measurement and traceability are also demanding. However, most shops that successfully participate in this market find it to be well worth the effort.

In fact, so many shops have added medical machining to their list of industries served that there is a backlash occurring within the medical machining industry. The OEMs that many precision machined parts shops serve are in the process of re-evaluating the number of suppliers they have contracts with in an effort to consolidate and simplify their supply chain.

That’s not unusual in metalworking manufacturing in general. Many industries, including aerospace and automotive, have been working toward a similar goal. This trend is causing machine shops to increase their in-house capabilities. In other words, many shops are moving out of their comfort zones and into processes that augment their comfort zone while providing the services that medical customers are looking for.  

Understanding the OEM trend toward supplier consolidation made us interested in finding out how a successful medical machine shop is reacting to it. After contacting several sources, we were directed to Troy Innovative Instruments in Middlefield, Ohio. Troy’s history is anchored in the manufacture of highly engineered implants and instruments to industry leading OEMs.

A Manufacturing Pedigree

The genesis of Troy Innovative traces back to 1952 when Ed Cseplo founded his company, Troy Manufacturing. It still exists today and is run by his son, Paul. Also involved in the early days was Paul’s brother, Tom.

One of the key accounts for Troy Manufacturing was the Polaroid Camera Co. The shop honed its precision machining skills as the exclusive vendor producing rollers for the cameras, a high precision and critical part of the camera’s operation. Size tolerances are tight and mirror surface finish specifications are high for these rollers.

We know what happened to Polaroid. As the digital revolution progressed, suppliers to the film camera industry regressed. It was adapt or die time for shops dependent on that business.

Troy Manufacturing made the transition by expanding its machining capabilities into other areas of metalworking and continues to succeed in Swiss and conventional turning, precision grinding, electropolishing, gun drilling and heat treating. It shrugged off the loss of Polaroid and moved forward into other areas of manufacturing, expanding its base of customers. Today, it is a general-purpose machine shop.

The Doctor Calls 

Through the ups and downs of business for Troy Manufacturing, Tom Cseplo was looking for a new machining niche to pursue. He found it in medical machining of orthopedic implants and medical instruments. This market became the foundation of Troy Innovative Instruments, which Tom founded in the mid-1990s. Meanwhile, his father and brother continued running Troy Manufacturing.

When Troy Innovative began, medical machining was only beginning to get a foothold in the metalworking world. Doctors had ideas of implantable “parts,” but lacked the contacts and resources to get them made. Shops that had technical and machining skills as well as quality and traceability infrastructure needed for medical were primarily involved in supplying the aerospace industry. If approached for a medical implant job, many shops chose to no-quote on the prototype business in favor of their aerospace customers.

The timing for Troy Innovative was good, as the aerospace industry in the mid-1990s was suffering from a business downturn. Many shops began looking for other markets to serve and in doing so, use the skills and equipment available for aerospace in a different market. It was a supply and demand issue because aerospace shops had capacity and capabilities available and doctors were looking to have implants and instruments made.

It turns out that machining medical implants and instruments demands almost the identical skills, materials and technologies as aerospace, including a strict regulation environment. So many aerospace machine shops hung out their “medical machining done here” shingle, and in some cases, never looked back. 

Moving Into Medical Machining

The greater Cleveland, Ohio, area, where Troy Innovative is located, is home to a significant and sophisticated medical community. Tom Cseplo knew this when he spun off Troy Innovative. He also had a customer waiting.

Walt Disney said, “It all started with a mouse.” In the case of Troy Innovative, it started with Dr. Arthur D. Steffee. The company was built initially to cater to the needs of Dr. Steffee, a surgeon, who was the founder of AcroMed Corp. in Cleveland. AcroMed grew into DePuy Synthes Spine and took Troy Innovative along for the ride as the shop became a keystone in the Orthopedic Contract Manufacturing Community.

According to Mr. Cseplo, “Dr. Steffee was a surgeon who had a knack for knowing what he wanted from the instruments available to him in the operating room. He knew what he wanted, but didn’t know how or by whom it could be manufactured.”

Mr. Cseplo and Troy were in a position to deliver products based on the design ideas that Dr. Steffee had been hoping to bring to the operating room. Many of these early designs were for spine systems used to stabilize the patient’s back. These systems evolved, along with the orthopedic industry, as more complex implants could be manufactured, and the surgical techniques developed to successfully implant them.

As the relationship with AcroMed and later DePuy developed, Troy was able to branch out into other orthopedic disciplines including trauma, sports medicine, small bone and extremity implants. Branching out into other disciplines means branching out into other operations.

Mr. Cseplo started his medical manufacturing business with a single automatic Swiss-type machine. Today, he runs 14 Citizen CNC Swiss-types along with five-axis machining, grinding, wire EDM, gun drilling, optical and CMM touch probe inspection along with laser marking for UDI (unique device identification) codes for traceability.

“As the customers need us to do more,” Mr. Cseplo says, “we will continue to develop our in-house capabilities. Like many shops, we are looking at additive and other emerging technologies with an eye on where they might be used in our operation. We see the supplier consolidation that is going on in the medical machining industry, and we plan to be one of the players left standing.”

Expanding Into New End Markets  

Mr. Cseplo added operational capabilities to the company’s stable of processes to serve the medical machining community and found out that there were other industries outside the medical tech world that were interested in those same capabilities. To that end, Mr. Cseplo brought Brett Crawford on board as vice president of sales and marketing to help get the word out.

Mr. Crawford found a customer nearby in the firearms industry that was looking for a reliable supplier to machine components for its line of light, medium and heavy machine guns to fulfill a Department of Defense contract. These were bolt and slide mechanisms that are relatively complex pieces.

Troy had in place the necessary machining, quality control and traceability processes because of its work in the medical machining industry. They were also able to do some assembly work of the machined components. 

“We got the work,” Mr. Crawford says, “primarily because we had added five-axis machining to our shop’s capability. Having learned how to program and run these machining centers and optimize them allowed us to be competitive in bidding for the firearms work. Moreover, with the CMM and optical gaging equipment we could measure and document the part’s quality.”

Currently, Mr. Crawford is in the process of signing up reps around the country to help spread the word on Troy Innovative’s capabilities. According to Gus DeAngelo, Troy’s CFO, “our shop currently has a business mix of about 75 percent medical and 25 percent defense and military. My hope is to bring those numbers closer to 50-50 by tapping into other industries. That’s what Brett’s charge is. He and his network will become the eyes and ears for the shop, helping it stay abreast of what may or may not be coming next.”

In an ironic twist, Troy Innovative is looking at going after aerospace business. “Its requirements match up almost perfectly with our capabilities. It would be a natural market,” Mr. DeAngelo says. The manufacturing technology and skill sets for these two industries are coming full circle for Troy Innovative.

Integrating New Operations in the Shop

Most shops have a comfort zone that is based on the kind of work it does. People learn their jobs and become proficient at them. Today, however, that model is being tested not only in a medical shop, such as Troy Innovative, but in machine shops across the country in almost all industries.

“The key to moving along Troy’s business capabilities lies in its 40 employees,” Mr. DeAngelo says. “My goal for the company is 14 percent growth per year. We hit 13 percent last year. Planning for slow but steady growth allows our people to acclimate to new jobs and apply the appropriate technologies to produce them profitably.”

The company applies a team approach to implementing new processes and quoting new jobs. The machinists, programmers, QC people, tooling and fixturing work together to create a process that will deliver the desired results. Collectively the talent is in the shop as well as the desire to do good work. Management’s job is to create an environment where those collective skill sets can come together with a purpose.

Moving Forward

The future looks good for shops in the medical machining industry. Business is virtually guaranteed to continue being good as the Baby Boomers age and need more and more “spare parts.” Orthopedic advances are pushing the boundaries of conventional machining capabilities and requiring shops to consider other ways of making things.

It’s an interesting time in manufacturing, for sure. Seemingly contradictory techniques of subtractive and additive machining are coming together to allow the manufacture of parts that could only be imagined.

It’s the shops that can recognize change and have the infrastructure in place to adapt to those changes that will do very well. Manufacturing is never a steady state. It is a dynamic that requires the willingness to change. 

For more information about Troy Innovative Instruments, call 440-834-9576 or visit troyinnovative.com.