ToxStrategies is a multidisciplinary scientific consulting firm that strives to develop innovative solutions to address the scientific, technical, and regulatory challenges confronting our clients. We have a reputation for applying sound science in all that we do, for leading-edge thinking, and for tailoring our approach to meet the specific needs of our clients, whether a rapid response or a comprehensive analysis is needed.
In medical device and combination product development, it is necessary to characterize the biological safety of the device and its components. ToxStrategies’ scientists, including board-certified toxicologists, can assist with biological evaluations tailored for the type of device and based on the intended contact with patients.
Selected examples of our experience include:
- Medical device characterization support, including evaluating nature of body contact and duration of contact (per ISO 10993-1; i.e., IV bag, suture, implant, wearable, etc.), with definition of safety, efficacy, and regulatory requirements.
- Toxicology (biocompatibility) and analytical chemistry study design, technical evaluations of CROs, outsourcing, study monitoring, and regulatory document preparation for drug/device combinations.
- Comprehensive nonclinical strategic program definition and gap analysis for devices and/or combination products to ensure compliance with current applicable regulations and standards (e.g., FDA, international agencies, ISO, ICH, USP).
- Study design, outsourcing and results interpretation for non-GLP and GLP large animal studies for proof of concept, iterative device development, functionality and clinical usability.
- Specific material characterization and analytical chemistry study design, outsourcing, and execution per product type, including extractables and leachables, drug-material interactions and bioanalytical assessment of degradants and metabolites from in vivo model studies.
- Toxicological risk assessments for extractables and leachables (per ISO 10993-17) following chemical characterization and considering expected patient exposure to the device (per ISO 10993-18).
- Establishing allowable limits using points of departure (e.g., NOAEL, LOAEL, BMDL10) from available literature and authoritative bodies using uncertainty factors (per ISO 10993-17).
- Identifying and evaluating cohort of concern (per ISO/TS 21726, REACH, etc.) compounds.
- In silico evaluation for Cramer classification or alerting structures, and other material hazard classification and data systems (e.g., using predictive computational tools, QSAR, read across).
- Determining biological plausibility and writing study waiver justifications as appropriate.
- Data analysis and comprehensive study results interpretation for both drug and device elements of subject products.
- Market access support (non-regulatory expectations), post-market adverse event as-sessments, and potential litigation support.
- Support to integrated evidence generation programs (nonclinical and translational) for parenteral drug delivery and combination products.