Product Risk Mitigation

Labeling and Packaging Design and Safety Review

Identify and resolve labeling and packaging issues at any stage of development through our expert consulting. Our services help ensure product safety, reduce the risk of errors, and minimize costly revisions for medical devices, medication-related devices, and pharmaceuticals ensuring compliance and improving overall product usability.

Product Safety Advisory Boards, Focus Groups and Clinician Surveys

Access feedback on perceived or potential error risks from end-user clinicians such as nurses, pharmacists, and physicians using products across treatment settings. Our experts will help you define advisory board goals, select appropriate participants, manage contracting, conduct sessions, analyze insights, and provide actionable recommendations based on clinician input and board objectives. MSB assembles focus groups and deploys clinician surveys for additional feedback.

Drug and Device Risk Assessments

Pinpoint potential errors and develop strategies for mitigating risks with MSB experts. Our evaluations focus on specific product aspects, such as design changes or special use requirements. We perform assessments during product development stages, prior to regulatory submission, ensuring safety and compliance before marketing approval or clearance.

Product Trademark Name and Safety Testing

Evaluate proposed pharmaceutical brand names for look-alike and sound-alike similarities to prevent medication errors. Utilizing data from name simulation studies with healthcare practitioners, insights from ISMP-reported name issues, Phonetic and Orthographic Computer Analysis (POCA) system scores, and comparisons of product characteristics, MSB performs comprehensive brand name safety testing, ensuring safe, and distinguishable product names.

Safety Implementation Support

Execute recommendations quickly with comprehensive oversight and guidance to manufacturers, their third-party agencies, and internal teams. Our experts will assist you in identifying and implementing the critical changes needed to improve product safety, ensuring that all processes align with industry standards, regulations, and best practices to reduce risks and enhance overall safety performance.

Reported Error Briefings and Notifications

Stay informed about potential safety pitfalls with project-specific error research, as well as ongoing, quarterly, biannual or yearly reviews of specific products, product classes, competitor products, or enterprise lists of products. With exclusive access to ISMP and ECRI error reporting databases, we can help you continuously enhance safety.