by Elizabeth Hofheinz, M.P.H., M.Ed., September 17, 2019
A small medical device company does its best to leap over the myriad of obstacles it encounters. But juggling machining issues, supplier issues, legal and regulatory hurdles, etc., can make any executive tire of this corporate “whac-a-mole.” Then someone walks in and offers them a zip file worth of solutions…that individual is from Diener Implants, a contract manufacturer located in Tuttlingen, Germany, that offers much more beyond the device itself.
Company co-founder Guntmar Eisen states, “When we founded Paradigm Spine and I started the international operations years ago, I set out to locate a company that would handle our instrument production. I was fortunate to find the best, Christian Diener, an instrument manufacturing company founded in 1900. It is a 5th generation family-owned company that began in general instrumentation and over time specialized in orthopedic instrumentation with a focus on spine.”
Paradigm Spine, Eisen’s second startup experience, benefitted mightily from working with Christian Diener and turned to them for his next venture. “For those whose background is not in manufacturing it is bothersome to have to work with multiple suppliers (instrument supplier, tray supplier, etc.) and people who do labeling, packaging and sterilizing. In 2009 I introduced the owners of Christian Diener, Michael and Carolin Baur, to the spine business and suggested that we start another company that would complement their business.”
Back to that zip file…
Guntmar Eisen and his new partners signed the papers and got down to work. Diener Implants was brought to life in 2009 and became the implant supplier for various spine companies. “Our goal was to be the only place that companies would have to go for all of their production needs. Then, when I founded EIT in 2014 I immediately wanted to build out our second source manufacturing. ‘Why don’t we invest in 3D printing?’ I said to Michael and Carolin. They agreed, because these are proven materials that create cellular structures and do everything cheaper and better compared to machined implants. So we invested in 3D printing machines and became one of EIT’s suppliers.”
A rare gem, Diener Implants can unload work and worry from a company’s shoulders. Guntmar Eisen: “All 3D printing suppliers that deliver these parts have a background in the printing side and they have to learn about the medical world. They must improve their QA systems to meet medical-specific requirements, get certified and FDA listed and ISO certified, among other things. As most of these suppliers are native to rapid prototyping or to the automotive industry, they typically have to spend time and money upgrading their quality systems as they are not accustomed to the necessary precision and quality requirements of the medical device industry. It’s a big learning curve because they have to ‘grow into’ the medical world.”
With Diener Implants, it was the opposite. “Though founded in 2009, the company has more than 100 years of history in the medical device arena. Also, my many years of experience in supplying spine and orthopedic implants to the industry means that we are already ISO 13485-certified, FDA listed, and we know the ins and outs of traditional machining.”
3D learning curve…
What was new for Diener Implants were the intricacies of 3D printing. Eisen: “We embarked on this effort in partnership with 3D Systems, one of largest 3D printing companies in the world. They not only do contract manufacturing, but they supply the machines as well. The challenge was to validate these direct metal laser printers to qualify for spinal implant production. 3D Systems supported us with this and treated us as a partner, although we are now competing on the contract manufacturing. Over time, Diener Implants added three additional 3D printing machines from 3D Systems, making it now four validated machines for series production of implants.”
New company…mature knowledge…
Guntmar Eisen has more than 25 years’ worth of experience with the spine business in the orthopedic and spine market, and a deep well of experience with the logistics and supply chain mechanisms in the industry. “Typical machining companies are manufacturing experts but are not necessarily experts on the products they manufacture. The vision of Diener Implants is that we understand the nuances of spine and orthopedics and have designed and launched numerous products in our careers. We know what industry wants.”
“For smaller businesses in particular we are a strong partner and can even aid with design. For example, we built a partnership with steripac GmbH, a German medical device packaging company that has worked with Paradigm Spine, EIT, and others. Now, along with EIT, they have developed an elegant sterile packaging technology named 3dpac involving modified blister packs that reduces manufacturing costs. We can now provide a one-stop-shop for sterile packaging and the related instruments through one vendor, Diener Implants.”
“The client can rest assured that they are ordering sterile packaged implants, complete with labels and package inserts from people with a substantial amount of expertise. In a typical situation, a company begins to design prototypes in various shapes and forms and at some point, does early testing on a combination of instruments and implants. Then there is typically a wetlab cadaver testing followed by scalable manufacturing. We are well poised to provide leadership and to partner with a company throughout the entire process. Often, you do a prototype with one company and then you need a bigger company with the capacity to scale up. However, with Diener Implants, we have all of the necessary machines and decades of experience needed in order to help a company scale up to where they want to be.”
René Pröll, Managing Director of Diener Implants, spent nearly 15 years at Paradigm Spine where he purchased medical device implants from contract manufacturers. “Many of my responsibilities were in the commercial arena and involved quality control and timeline management, things that Diener Implants does very well. A startup looking for a new manufacturing partner or for guidance on sterile packaging can turn to Diener Implants. So can a company that needs help determining the best way to manufacture finished goods or an existing medical device company that wants to mitigate its risk. If a production site has delivery or quality issues, then we can provide leadership in that arena as well. We have validated processes in place, so we are able to accelerate things so as to be a second source manufacturer.”
They can also accelerate access to markets. Eisen notes, “Because we are qualified to the latest ISO standards helping customers with the new EU Medical Device Regulations (MDR) and are registered with the FDA, and ANVISA – the Brazilian Health Regulatory Agency, customers have the benefit of being able to sell their products all over the world.”
René Pröll: “With four dedicated 3D printing systems, and our ability to do internal post-processing of the parts, we are set-up for scale. Since the orthopedic industry—and especially spine—is moving rapidly into 3D printing we know the market is only going to expand. While many companies have traditional titanium machined implants or PEEK, the structure you can create with 3D printing…the lattice…is a ‘must have’ for any company’s portfolio. We are actually one of the few companies that already has validated serial production for 3D printing.”
While it’s never a dull moment in the orthopedics industry, according to Guntmar Eisen, this is a particularly interesting time. “All of the bigger industry players are heading in the direction of 3D printing, and those in the cage business have to consider to move from away from PEEK or traditional machined titanium to the 3D printed versions that are also more cost-effective. Those companies would benefit from having one partner to take their manufacturing from A to Z.”
Diener Implants…a new company with an old manufacturing soul.
Meet Diener Implants at the upcoming congresses:
- NASS, Chicago, IL, Sept 25-27, Booth #2430
- EuroSpine, Helsinki, Finnland, Oct 16-18, Booth #2B
Company contact:
René Pröll, Managing Director, cell +49-151-16749367, rene.proell@diener-implants.de
