Uniquely suited to assist global pharmaceutical, biotechnology, medical device and other healthcare technology companies in evaluating the safety of their products
Med Safety Board is dedicated to serving the healthcare industry around the world to ensure the safe use of pharmaceuticals & medical devices. We provide services that span a product’s lifecycle, from pre-marketing assessments through in-market evaluations and line extensions.
Drawing upon the clinical and medication safety knowledge of its experts, along with real-time analysis of reported errors, Med Safety Board is uniquely positioned to help companies determine the potential safety risks with their products and how to address any vulnerabilities for user error.
Labeling & Packaging: Design & Safety Review
We can design product labels, or we can evaluate the labeling and packaging your team creates for potential safety issues. This can range from a single label, to a group of labels, or an entire portfolio of products. Med Safety Board can also review the Instructions for Use (IFU) and other educational/training materials associated with a drug product.
Drug, Biologic, & Device Assessments
Assessments can be conducted in the development or pre-market stage before submission to regulatory agencies for marketing approval or clearance. Using aspects of failure mode and effects analysis (FMEA), Med Safety Board can help companies identify where in the medication-use process an error could occur and how to mitigate those risks.
We provide consulting and guidance to help with regulatory submissions and responding to regulatory agency requests related to labeling & packaging changes, medical device testing requirements, and/or conducting risk assessments, whether pre- or post-submission.
Product Name Safety Testing
We offer safety testing to evaluate proposed brand names for potential look- and/or sound-alike similarity with other drug products. We utilize data from name simulation studies involving practicing healthcare practitioners, knowledge gained from product name issues reported to ISMP, name pair scores generated by the Phonetic and Orthographic Computer Analysis (POCA) system, and comparisons of product characteristics for overlapping or dissimilar attributes.
Education and Training on Safe Practices
Med Safety Board can design and present educational programming on pharmaceutical product and medication-related device safety and error prevention to any audience – industry colleagues, your customers, or to healthcare consumers.
Understanding how a product will fit within the healthcare environment in which it is intended is crucial to identifying and mitigating potential risks. Med Safety Board can use our network of healthcare professionals and pharmacists working in the field to evaluate sample packaging and labeling, taking into consideration its setting of use and storage, to identify potential risks.
Insights and Qualitative Research
By bringing together key product users and/or medication safety thought leaders, Med Safety Board can convene focus groups to identify potential safety concerns, gain insights, validate best practice opinions, and brainstorm safety enhancement ideas for new or established pharmaceutical products and medication-related devices.
In order to provide the widest breadth of safety services, we can also collaborate with other companies, including market research and human factors engineering agencies, to help you facilitate that process, if needed.