We have extensive experience in helping our clients scout, identify, acquire and productize new biomaterial technologies while managing the regulatory burden of novel biomaterials to the FDA and other agencies. We frequently conduct early bench studies and manage preclinical evaluations to examine the feasibility of biostable and bioresorbable biomaterials (synthetic and biologic) for a given clinical application. Our work in this area includes optimizing device tissue mechanobiologic interactions using surface modification strategies, new novel porous biomaterials, and working with technology partners to achieve improved biointegration mechanisms, bioactivity (growth factor, drug, and cell delivery), biostability or controlled degradation, hemostasis and wound repair at the device interface with minimal chronic response. We have designed unique studies to evaluate comprehensively the host response to implanted biomaterials, devices, and tissue repair meshes and scaffolds. Combined with our soft tissue biomechanics expertise with our specialized focus on the biologic response of acellular as well as bioactive and functionalized implant biomaterials following implantation we have been successful in helping numerous companies achieve rapid FDA approvals or successfully negotiate FDA responses, especially for 510k strategies to avoid NSE letter issuance.
Research & Verification Protocol Development
New research protocols to develop actionable and quantified design inputs for device tissue interface issues, & design optimization are developed by DII for its clients. Similarly we develop novel verification test methods that take into account consensus standards as much as possible to reduce regulatory burden and need for justification rationale in 510k and PMA submissions.
Histopathologic response of implanted biomaterials & devices (H&E)