CASE STUDY

Product verification required for clinical trials accelerated by 3 months for multinational healthcare provider

Prototype achieved

3 months before deadline

When this healthcare company partnered with us their product verification of a blood cell counting device,  required for clinical trials, accelerated by 3 months.

OUTCOME

Consolidated documentation: Produced validation documentation and an inclusive technical file for the client to progress straight towards regulatory submission.

Software issues resolved: Data analytics meant informed design decisions were made quickly resolving software issues.

Reduced development timelines: Accelerated the design and development process achieving DVT efficiently, 3 months before the deadline.

CHALLENGE

  • Developing a testing strategy
  • Specific in-house expertise
  • Operating within budget
  • Project time constraints

About this healthcare company

This multinational health solutions company partnered with us to test their blood cell counting device for patients with chemotherapy, in preparation for regulatory submission and clinical trials.

Location: Multinational

Company size: Large enterprise 1000+ employees

Industry: Medical

Just wanted to say a very big thanks for pulling all the stops out and the good progress made. Seems we are very close to a resolution and this is promising for our product

Head of Quality & Regulatory, Multinational Healthcare Provider

Approach

Strategy planning

Acted as independent partners to consult and execute DVT strategy ensuring smooth delivery of all design milestones

Executed regulatory plan

Carried out regulatory plan and undertook validation activities in preparation for achieving Class II CE mark.

Conducted reviews and audits

Conducted software design reviews and audits with stakeholders to ensure software quality aligned with IEC 62304.

Testing

Precision and equivalency testing was conducted across new prototypes and pre-production devices to assess reliability of blood test results.

Managed agile processes

Managed agile processes to support with development, issue tracking, and communicating progress between all stakeholders.

Remote blood cell counting device to transform chemotherapy patient support

Many patients undergoing chemotherapy treatment, roughly 10.5%, experience complications that lead to emergency admissions. Monitoring patients at home could mean early identification of risks leading to potentially life-saving interventions. Patients could also avoid being called into hospital unnecessarily therefore improving hospital efficacy.

This health company is transforming the way chemotherapy patients are supported, whilst empowering them to be actively involved in the monitoring of their well-being at home. Providing a home remote blood cell count device, as part of a wider end-to-end patient monitoring service, means oncologists have regular access to patients’ well-being. Using this self-test information obtained at the patient’s home avoids missing key symptoms and allows for early intervention.

Many thanks to AND for all of the hard work and quick turn around here. It is very much appreciated.

Director of Operations, Multinational Healthcare Provider

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