Clear Requirements for Medical Device Development

How clear and well-defined requirements shape software development success

Ensuring Safety and Compliance in Medical Device Projects

MedAcuity was brought in to address performance issues and improve the controller for an implantable device. The scope of requirements caused disagreements among stakeholders, putting the initiative at risk. This project was tied to a critical funding event. To resolve this, MedAcuity adjusted staffing and guided decision-making to define clear MVP requirements. They also established a Change Control Board (CCB) to manage proposed changes. These steps helped define requirements faster, prevent unnecessary changes, and keep the project on track. As a result, the project successfully implemented high-priority requirements in the IDE release and secured the funding event.

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Clear requirements for medical device development process

project snapshot

SITUATION

  • MedAcuity was brought in to fix performance issues and enhance the controller for an implantable device.
  • The scope of requirements caused disagreements among stakeholders.
  • This jeopardized the success of the initiative, which was tied to a critical funding event.

Challenges

  • A clinical stakeholder pushed for additional features. This threatened schedule delays and budget overruns beyond acceptable limits.
  • Throughout development, stakeholders often proposed unplanned requirements. This disrupted the project’s momentum.



SOLUTION

  • Optimized team staffing to stay within budget: MedAcuity adjusted team resources to define clear requirements. This kept the project on track and within budget.
  • Steered decision-making to define MVP requirements: MedAcuity guided the team to establish clear MVP requirements, focusing on essential features.
  • Established a Change Control Board (CCB) to manage changes: MedAcuity created a CCB to evaluate proposed changes. This prevented scope creep and kept the project on course.

Results

  • Accelerated definition of clear requirements for medical device: MedAcuity clarified the medical device requirements. This reduced delays and sped up progress.
  • Filtered out low-value changes: The Change Control Board (CCB) ensured only high-priority features were implemented. This kept the project on track and within scope.
  • Successful IDE submission and funding: The clear requirements enabled a timely IDE submission. This led to successful feature implementation and secured company funding.

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