Our work is focused in all industries using polymers, elastomers, composites, adhesives, sealants, metals, and more. We partner with global organizations, providing engineered solutions in a variety of capacities.
Recent FDA feedback in biocompatibility testing has highlighted ISO 10993-1:2018 Clause 4.7 with the recommendation to consider testing biocompatibility across the life-cycle of the medical device. This is a relatively new landscape for biocompatibility testing. Application of engineering and scientific principles can lead to successful test design and execution. This presentation focuses on the foundational science behind appropriate accelerated ageing and testing.
Characterizing the hazards of medical devices has always been a challenge. The COVID-19 pandemic altered the landscape further. Materials are at the core challenge as supply chain disruptions have led to the need to “quickly” change materials to continue to make critical devices. The science industry has shifted with analytical characterization equipment being capable of detecting into the nano and picogram scale – which is great – but provides its own challenges. The understanding of toxicology and the effect of chemistry on the human body is evolving in real-time. When you combine all these factors into an industry that is classically slow to alter charted course – it leads to a perfect storm.
October 2022 Issue: Women in Medtech
Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population. The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing.