Medical Devices

Bio Medical Research Ltd.

Overview

Bio-Medical Research (BMR) are a team of passionate creators and engineers who together, invent and design some of the most cutting-edge wearable technology in the world.  We have been creating ground-breaking EMS (Electrical Muscle Stimulation) technology for over 50 years.

Challenges

Develop a standardise risk assessment of the in-house products & processes.  The FMEA technique allows the teams to proactively understand the potential risks & drive actions around the high risks to reduce or eliminate them.

Our Solutions

Train different teams on how to use the FMEA (Failure Mode Effective Analysis) tool to conduct a risk assessment.  This tool can be used for both process & product risk assessment.  The FMEA creates a risk register which when evaluated allow for an action plan to be defined & then drive a before & after assessment of the risk where actions have been implemented.  This is robust technique & used widely amongst different industries to support their risk assessments.

Outcomes

  • Standardised approach to risk assessment
  • More in-depth understanding & detailed assessment of risk
  • Stronger assessment to risk using the Severity, Occurrence, Detection rating scale resulting in the Risk Priority Number (RPN)
  •  Appreciation for the time required to complete a successful FMEA

Feedback

  • " There is a lot more involved than originally thought"
  • " It would be important to have the right people available for this development"