Onno: I am from a small rural town in the north of the Netherlands. I studied music, then languages, and I have a university degree in Chinese studies. I spent my twenties playing in bands, doing photography, and living abroad, because I have always been curious about how things work, with a special interest in technology and business. In my late 20’s I came back from living in China and joined CAM Bioceramics, a calcium phosphate manufacturer in the Netherlands, as a logistics employee. Over the years I worked my way up to responsibility for marketing and sales, and I discovered what I really enjoy: standing in the middle between what the market needs and the people inside who can deliver it.
Guillaume: And the road from there to CaP?
Onno: In 2014 I joined an orthopedic startup in Scotland working on coating technologies, then came home when two kids were on the way. Before CaP came calling in 2020 I managed global distribution for a hospital facing medical device company, focused on CSSD materials. A former customer from my CAM Bioceramics days had bought a share in CaP, and they wanted someone they trusted who knew the calcium phosphate contract manufacturing market. Together with Keith, Larry and the existing production team, we started what I think of as CaP 2.0: we built out the team, doubled the facility, and upgraded our quality system from ISO 9001 to ISO 13485.
Guillaume: Keith, your story starts much closer to East Troy.
Keith: I was born in the Milwaukee area in 1985. Wisconsin roots: nature, fishing, hunting, cabins up north. I attended the University of Wisconsin Whitewater and graduated with a degree in integrated science/business. I came to CaP as an intern in 2007 as a production technician, and went full time in 2008 after graduating. I moved from production tech through production management, operations management, and now sales. Along the way I became a co-inventor on some of our patents, including our carbonate apatite product and bioactive glass coatings on calcium phosphates.
Guillaume: The company was founded in 2006 by two scientists, Dr. Larry Shimp and Dr. Bill Hubbard. What did they see that others did not?
Keith:The start of CaP can be traced back to a single conversation. A medical device company needed a US source of synthetic hydroxyapatite and could not find a reliable US supplier. Bill and Larry had worked together, Bill was from southeast Wisconsin, and they started the business here to fill that void. This industry is a tight network with the same key players continuously circulating. Bill and Larry had connections to those key players, they understood the need through them, and they acted on it. To this day, if you ask people in this industry about CaP Biomaterials, a lot of them think first of Larry Shimp.
Onno:Larry is an MIT PhD chemist and a calcium phosphate and bone void filler expert who had already professionalized manufacturing setups in his previous roles. When he started CaP, he took everything he had learned and did it better. That is why CaP punched above its weight from day one. There is a lot about this company that is very smart and not obvious from the outside.
Guillaume: A device team is developing an orthopedic or dental product and needs a calcium phosphate material. What usually goes wrong when they pick a supplier?
Keith: Batch consistency at scale is a big one. Materials can meet specifications on paper, then fail when they go through volume production, and in my mind that traces back to both a weak quality system and a lack of process knowledge. A second problem is a lack of technical support. People generalize calcium phosphates, but altering physical and chemical properties change the material functionality including the biological properties and how the material handles for the surgeon. Customers often come to us because a general supplier was providing material that met specifications but did not behave consistently in their process. And then there are unannounced material changes. Some suppliers make them. We do not. If we plan any changes, discussions have already been reviewed by the customer, and the proper notifications and approvals are made before we implement.
Guillaume: Walk me through the first 90 days with a new OEM.
Keith:We start by looking to deeply understand our customers’ product needs. The intended use, the properties they want to see, and the biological response they expect at the end. Our team has extensive experience with these materials, from the raw materials through to the finished device, so we are there for our customers during their R&D phase. Our customers are the specification holder, our knowledge and process capabilities just get them to that exact product they need faster.
Guillaume: You both push back on the idea that calcium phosphate is a commodity. Why?
Onno:There are companies out there that will give you lists of special things they can supposedly do. Impressive specs on paper. Then you ask them to manufacture five kilos a month of a granule with the required consistency, and they struggle. Our R&D happens at full manufacturing scale. This might require the bigger upfront effort, but being able to manufacture at scale beats being good in a petri dish.
Keith: Larry’s knowledge has really been passed down to each of us here at CaP, and with the team expansion, we have entered a whole new level of organizational maturity. Manufacturing these materials partially remains an art, as much as it is pure science. We understand the chemical formulations, but ultimately the years of hands-on experience have developed the art of the process.
Guillaume: Your booth says portfolio of patented materials. What sits behind that?
Onno: We continue to invest in our patent portfolio, and we have recently been awarded new patents, both US and European. Every patent we own represents real-world material and process knowledge that is unique, and allows us to offer our customers solutions they won’t find elsewhere.
Guillaume: Where does CaP sit on the regulatory side?
Onno: We are very black and white about it. As our customers design the final device and hold regulatory responsibility, product design and development are not in our ISO scope. We are a contract manufacturer working to customer specifications, and the customer stays in the driver’s seat. For our patented materials however, we have built a convincing data set using Dr. Bill Walsh and his accurate and demanding models. We have an expansive testing suite, including solubility and dissolution testing that very few labs in the world offer. It’s great to see that over the years many of the larger coating and device companies have found out about this and work with us for their regulatory submissions, where our data supports their technical documentation for their FDA 510(k) and CE submissions.
Guillaume: Who is the right fit for CaP? Is there such a thing as calling too early?
Keith: There is no such thing as too early in this case: If you have an idea, come talk to us. The team here knows the realistic lifecycle of these products. Maybe we do not work together for a year after initial discussions, but coming early means we can give you guidance, put samples in your hands, and prepare ourselves for any specific production requirements your product may have.
Onno: Ideally we want a customer willing to let both companies work to their strengths. A no ego approach to developing the best product is the most fun, and it leads to the best result. We now work with some of the largest device companies in the world, and they often arrive with a finished spec sheet. The added value, and honestly the fun, is sometimes strongest with small and medium sized companies, where we iterate together toward the perfect product. That being said, another thing we’ve done and can be a fun challenge is to take on board fully developed manufacturing set-ups from customers, where they want to focus on their end of the business and outsource the headache of manufacturing to a company with a solid, specialized QMS and grasp of these materials.
Guillaume: Several of the largest strategics have added you to their approved vendor lists. What does that tell the rest of the market?
Onno: Getting added to the approved vendor lists of several multibillion dollar companies has been great validation of the direction we’ve chosen, because they thoroughly test your quality system and processes. One of them told us they had been keeping an eye on us for several years and felt we were now at the maturity level where they could work with us. They came to us with a lot of trust, and corresponding business.
Guillaume: Where is CaP going, give me the five year vision, in human words.
Onno: Continue building a company where we are proud of what we do. We want to be a good employer. We provide income and healthcare to a lot of families, so de-risking the business and growing it in a controlled manner matters to our shareholders and management team. When I tell people this is the company I work for, I want that to mean something. Practically speaking, we have built clean rooms and have added a lot of expertise in the contract formulation, packaging and sterilization space, and are involved in advanced conversations on what next steps will be like for those services.
Keith: The pride comes from the trust we are earning in this industry. We do not want to be another generic vendor on a list. We want to be the strategic partner that accelerates our customer’s product development, and to be a robust manufacturing source. We strive to maintain that reputation through real life actions.