The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.
The EU’s General Data Protection Regulation (GDPR) will go into full effect on May 25, 2018 — as will penalties for non-compliance. While most of the GDPR affects the back end of medical device data handling, the Cloud, Databases, and transportation of data, some of the GDPR affects software on medical devices themselves:
FDA’s most recent guidance on human factors, Applying Human Factors and Usability Engineering to Medical Devices, highlights the importance of enhancing patient safety by adopting human factors engineering processes in the design and manufacturing of medical devices.
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
Advancements in eye-tracking technologies have made them convenient and affordable to incorporate into user research. Peering into an observer’s perspective can be a valuable source of data for optimizing diverse user interfaces. Few barriers remain to using eye trackers; the only question is how to do so effectively.
Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.
The data gathered at investigative sites during clinical trials is the backbone of the pharmaceutical and medical device development process. Without it, assessing the efficacy and safety of therapies would simply be impossible. Whether they are linked to a medical practice, part of an academic medical center (AMC), or operate independently, investigative sites are an important resource.
According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.