Clinical Knowledge Key to Advancing Orthobiologics Technologies
Excerpt from ODT | April 2018
Michael Barbella: Please discuss the current trends in orthobiologics. What forces are driving these trends? Have they changed in recent years?
David Yonce: The overall orthobiologics market continues to be fueled by the need for products that deliver enhanced, consistent, and predictable healing across various clinical indications. Increased focus on demonstrated effectiveness and the recent clarification and guidance from the FDA regarding Human Cellular Tissue and Products, combined with the general declining use of allografts and autografts, is driving increased attention towards alternative synthetic technologies.
David Yonce, Vice President, Innovation and R&D
Barbella: What opportunities does this sector present to companies that operate in this space?
Yonce: Lifestyle changes such as obesity and an increasingly active aging population contribute to higher demand for orthopedic biomaterial solutions such as meniscal repair and replacement, cartilage repair and viscosupplementation. It’s also likely we will see advances in orthobiomaterials with properties that offer the potential to replace traditional load-bearing or structural materials, such as PEEK.
Barbella: What challenges/concerns are facing the orthobiologics industry? How can the industry and companies in this sector overcome these challenges?
Yonce: Downward hospital pricing pressures drive the need for greater comparative and post-market data that demonstrate value. Conventional technologies often lack clinical evidence with cost differentiation, thereby gaiting approvals, reimbursement and coverage. DSM Biomedical recognizes the importance of improving clinical value by optimizing patient outcomes with innovative solutions that reduce healthcare costs.
Barbella: Why is it so difficult/challenging to mimic the body’s natural biological healing process for bone?
Yonce: The next generation orthobiologic technologies in development are based upon scientific and clinical knowledge gained through experience. These insights provide better understanding of the tissue’s response from cell-signaling, material-biology interactions, and the implants’ surrounding environment. Accounting for these multi-factorial elements will contribute towards an improved physiologic balance and better healing conditions.
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- Biomedical fibers for:
- Arthroscopic procedures
- Cerclage cables
- Ligament fixation
- Meniscus tears
- Rotator cuff damage
- Soft tissue applications
- Spinal stability
- Bone void fillers
- Extracellular Matrix (ECM) technology for soft tissue repair
- Graft containment devices
- Resorbable fixation plates and screws
- Motion preservation devices for the spine
- Polymeric plate systems
- Spinal cages
- Spinal plates
- Total disc replacement devices
- Drug delivery systems for delivery of pain, anti-inflammatory and antimicrobial drugs
Bioceramics materials and technology - More>
- Calcium phosphates (α-TCP, ß-TCP, MCPM)
- Resorbable/ceramic composites (PLA, PGA, PCL)
- Multiple configurations (powders, granules, porous shapes, settable pastes, settable putties, anorganic bone)
Collagen materials and technology - More>
- Purified collagen
- Solution and slurry processing
- Collagen blending and compounding
- Multiple configurations (sheets, putties, injectables, gels, three dimensional shapes, coatings, fibers, and powders)
Polymers and metals processing technology - More>
- Resorbable materials [Polylactide (PLA), Polylactide-co-glycolide (PLGA), Polycaprolactone (PCL), Polycarbonate (e.g. TMC)]
- Non resorbable materials (PEEK, TPU)
- Implant-grade metals ( titanium, stainless steel)