The COVID-19 pandemic exposed the necessity of virtual care and revealed its possibility as a more efficient means of administering treatment in an overwhelmed and understaffed infrastructure. Its fast-paced adoption highlighted the need for global standards and third-party certifications.
The upcoming revision to ISO 10993-17 proposes the use of release kinetics data to support toxicological risk assessments. Manufacturers should expect that this data will be needed to help mitigate the risks identified in exhaustive extraction studies.
Leslie Trigg, CEO of Outset Medical, is the new Chair of The Medical Device Manufacturers Association (MDMA) Board of Directors.
“Addressing unmet needs across pediatric populations is critical to advancing children’s health, and we are delighted to once again work with pioneering companies that seek to bridge this care gap.”
Both legacy players and startups have an important role to play when it comes to medical innovation—they need to work together to meet the increasing demand for minimally invasive treatments, value-based care and innovative, not incremental therapies. This is a mutually beneficial relationship that is key to medical technology development.
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.
Opportunities for intelligent computer systems span widely, including extensive use in medical science. Artificial intelligence enhances cognition analysis of complex health issues and improves the diagnoses. However, there are still some challenges in terms of data quality, regulations, market penetration and adaptation.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
