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Herb Schwartz, Ph.D., started his working career in aerospace as a design engineer for a jet engine company. After completing his graduate degrees in biochemical engineering, he took his engineering chops and his innate drive and shifted to orthopedics, where he initially focused on soft tissue repair and regeneration in an orthobiologics research department.
After a number of years in a research environment, he decided to venture out and start his own company, Schwartz Biomedical.
“During my journey with Schwartz Biomedical, I came across a unique material technology, now called BioPoly, that was in a lab at Colorado State University struggling to get the attention of the industry,” Dr. Schwartz said. “With the help of my engineering and scientist team (and a grant from the State of Indiana), we decided to bring BioPoly in-house to see what we could do with it.”
It took time, focus and persistence to reach regulatory clearance in the U.S., but Dr. Schwartz knew he had a revolutionary product. We talked with him to learn about his career, his insights and the path to 510(k).
You founded BioPoly more than a decade ago and have been on the market in Europe since 2012. Having recently gained FDA 510(k) clearance in the U.S., what has your journey been like?
Dr. Schwartz: With the help of investment capital from shareholders who truly believed in the BioPoly technology and team, we obtained EU regulatory approval or CE Mark for our BioPoly Partial Resurfacing Knee Implant and began implanting in 2012.
We also received regulatory approval for our BioPoly Patella, Shoulder and Trochlear Groove products in subsequent years in various areas (EU, Malaysia and Turkey, with South America coming soon). After gaining years of clinical experience in Europe and after multiple meetings and interactions with FDA, we received approval to perform an Investigational Device Exemption (IDE) clinical study for our partial resurfacing knee implant. With the IDE approval, FDA essentially agreed that our material was safe.
With that experience in hand, we approached FDA with a BioPoly implant that could receive 510(k) clearance. We had recognized that foot and ankle was a growing market and our marketing research indicated that the great toe or 1st MTP was in need of a better solution than what the market was offering. So, we developed the BioPoly Great Toe Implant to address this unmet market need. We are very excited to have our first 510(k)-cleared cartilage-articulating BioPoly implant, and there are many more BioPoly 510(k) products that are in development.
How would you describe BioPoly implants? Please explain the materials and technology you employ.
Dr. Schwartz: The BioPoly material is a new biomaterial that is truly a game-changer for our industry. BioPoly is a unique combination of polyethylene (UHMWPE) and hyaluronic acid, a naturally lubricating molecule found in cartilage tissue and synovial fluid. This combination of materials results in a hydrophilic polymer that takes on the properties of UHMWPE and hyaluronic acid, so BioPoly can carry anatomical loads while emulating the lubrication and articulation properties of cartilage. Because of these properties, we develop implants made from the BioPoly material to address focal cartilage defect repair, or partial resurfacing of joints.
What are some important lessons you’ve learned that you think may help other leaders?
Dr. Schwartz: For me, the biggest lesson learned is to keep your focus. No matter what, you will be pulled in numerous directions by good intentions from others, but as the CEO, it’s your vision that is being cast. Therefore, I have to emphasize again to keep your focus. Orthopedic ventures require significant time, significant resources and significant capital in order to achieve your goals; so, without focus, you have little chance of success.
Another important lesson is to keep your life balanced; God, family, then business. The business can be all-consuming and it is easy to be overwhelmed with everything that needs to be done. So, enlist help early, before it is too late.
As the business continues to grow, how have you optimized, expanded and motivated your team?
Dr. Schwartz: In our organization, we optimize by training our employees to work in multiple functions. Then we focus the team on very specific goals. Together everyone works to complete those goals as a team. I’m proud of my team and what they have done. With only a few people, tasks such as quality, R&D, manufacturing, regulatory and clinical affairs, obtaining CE marks, IDE approval, 510(k) clearance, etc. are accomplished within our timeline goals.
My wife, Sheila Schwartz, R.Ph., is our VP of Operations, and she has a propensity toward what makes people tick. She is goal-oriented and task driven, holding the team accountable for their work. The bar for our team is very high; however, they continue to meet the high standards and accomplish so much within short timelines. I think part of what motivates our team are the accomplishments that we achieve together, coupled with recognition and celebrations.
This looks like just the beginning for your organization here in the U.S. What’s on the horizon for BioPoly?
Dr. Schwartz: Yes, this is only the beginning for BioPoly in the U.S. First, we are planning to launch the BioPoly Great Toe into the U.S. market in the coming months. In fact, we already have the first patient identified. Second, as we prepare for a successful launch for the toe, we are already working on completing the product development tasks for the next 510(k) BioPoly implants.
The BioPoly material is a platform technology on which the orthopedics industry will change their thinking about implants. With the ability to favorably articulate with cartilage, BioPoly can be used in virtually any joint. In addition to being able to articulate with cartilage, BioPoly can also articulate with metal; therefore, there are some very interesting implants in our pipeline where BioPoly articulates with both metal and cartilage in the same implant. So ultimately, we plan to have an entire portfolio of products available in the U.S., most cleared through the 510(k) pathway.
Additionally, I mentioned that we have an approved IDE clinical study for the BioPoly knee product line. The BioPoly Knee addresses a huge unmet need in the market, and there are no predicate devices out there, so, a clinical study is required. Therefore, we plan to initiate that study soon and are looking for a partner or funding source to do so.
Herb Schwartz, Ph.D., started his working career in aerospace as a design engineer for a jet engine company. After completing his graduate degrees in biochemical engineering, he took his engineering chops and his innate drive and shifted to orthopedics, where he initially focused on soft tissue repair and regeneration in an orthobiologics...
Herb Schwartz, Ph.D., started his working career in aerospace as a design engineer for a jet engine company. After completing his graduate degrees in biochemical engineering, he took his engineering chops and his innate drive and shifted to orthopedics, where he initially focused on soft tissue repair and regeneration in an orthobiologics research department.
After a number of years in a research environment, he decided to venture out and start his own company, Schwartz Biomedical.
“During my journey with Schwartz Biomedical, I came across a unique material technology, now called BioPoly, that was in a lab at Colorado State University struggling to get the attention of the industry,” Dr. Schwartz said. “With the help of my engineering and scientist team (and a grant from the State of Indiana), we decided to bring BioPoly in-house to see what we could do with it.”
It took time, focus and persistence to reach regulatory clearance in the U.S., but Dr. Schwartz knew he had a revolutionary product. We talked with him to learn about his career, his insights and the path to 510(k).
You founded BioPoly more than a decade ago and have been on the market in Europe since 2012. Having recently gained FDA 510(k) clearance in the U.S., what has your journey been like?
Dr. Schwartz: With the help of investment capital from shareholders who truly believed in the BioPoly technology and team, we obtained EU regulatory approval or CE Mark for our BioPoly Partial Resurfacing Knee Implant and began implanting in 2012.
We also received regulatory approval for our BioPoly Patella, Shoulder and Trochlear Groove products in subsequent years in various areas (EU, Malaysia and Turkey, with South America coming soon). After gaining years of clinical experience in Europe and after multiple meetings and interactions with FDA, we received approval to perform an Investigational Device Exemption (IDE) clinical study for our partial resurfacing knee implant. With the IDE approval, FDA essentially agreed that our material was safe.
With that experience in hand, we approached FDA with a BioPoly implant that could receive 510(k) clearance. We had recognized that foot and ankle was a growing market and our marketing research indicated that the great toe or 1st MTP was in need of a better solution than what the market was offering. So, we developed the BioPoly Great Toe Implant to address this unmet market need. We are very excited to have our first 510(k)-cleared cartilage-articulating BioPoly implant, and there are many more BioPoly 510(k) products that are in development.
How would you describe BioPoly implants? Please explain the materials and technology you employ.
Dr. Schwartz: The BioPoly material is a new biomaterial that is truly a game-changer for our industry. BioPoly is a unique combination of polyethylene (UHMWPE) and hyaluronic acid, a naturally lubricating molecule found in cartilage tissue and synovial fluid. This combination of materials results in a hydrophilic polymer that takes on the properties of UHMWPE and hyaluronic acid, so BioPoly can carry anatomical loads while emulating the lubrication and articulation properties of cartilage. Because of these properties, we develop implants made from the BioPoly material to address focal cartilage defect repair, or partial resurfacing of joints.
What are some important lessons you’ve learned that you think may help other leaders?
Dr. Schwartz: For me, the biggest lesson learned is to keep your focus. No matter what, you will be pulled in numerous directions by good intentions from others, but as the CEO, it’s your vision that is being cast. Therefore, I have to emphasize again to keep your focus. Orthopedic ventures require significant time, significant resources and significant capital in order to achieve your goals; so, without focus, you have little chance of success.
Another important lesson is to keep your life balanced; God, family, then business. The business can be all-consuming and it is easy to be overwhelmed with everything that needs to be done. So, enlist help early, before it is too late.
As the business continues to grow, how have you optimized, expanded and motivated your team?
Dr. Schwartz: In our organization, we optimize by training our employees to work in multiple functions. Then we focus the team on very specific goals. Together everyone works to complete those goals as a team. I’m proud of my team and what they have done. With only a few people, tasks such as quality, R&D, manufacturing, regulatory and clinical affairs, obtaining CE marks, IDE approval, 510(k) clearance, etc. are accomplished within our timeline goals.
My wife, Sheila Schwartz, R.Ph., is our VP of Operations, and she has a propensity toward what makes people tick. She is goal-oriented and task driven, holding the team accountable for their work. The bar for our team is very high; however, they continue to meet the high standards and accomplish so much within short timelines. I think part of what motivates our team are the accomplishments that we achieve together, coupled with recognition and celebrations.
This looks like just the beginning for your organization here in the U.S. What’s on the horizon for BioPoly?
Dr. Schwartz: Yes, this is only the beginning for BioPoly in the U.S. First, we are planning to launch the BioPoly Great Toe into the U.S. market in the coming months. In fact, we already have the first patient identified. Second, as we prepare for a successful launch for the toe, we are already working on completing the product development tasks for the next 510(k) BioPoly implants.
The BioPoly material is a platform technology on which the orthopedics industry will change their thinking about implants. With the ability to favorably articulate with cartilage, BioPoly can be used in virtually any joint. In addition to being able to articulate with cartilage, BioPoly can also articulate with metal; therefore, there are some very interesting implants in our pipeline where BioPoly articulates with both metal and cartilage in the same implant. So ultimately, we plan to have an entire portfolio of products available in the U.S., most cleared through the 510(k) pathway.
Additionally, I mentioned that we have an approved IDE clinical study for the BioPoly knee product line. The BioPoly Knee addresses a huge unmet need in the market, and there are no predicate devices out there, so, a clinical study is required. Therefore, we plan to initiate that study soon and are looking for a partner or funding source to do so.
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Heather Tunstall is an ORTHOWORLD Contributor and owner of Tunstall Content.
