Industry

Medtech & Life Sciences

Success in the medtech and life sciences market requires juggling technological innovations, changing regulations, and getting new products on the market quickly while maintaining aging products and developing next-generation designs of successful products.

ALTEN Technology supports our partners’ success in the medtech and life sciences space by specializing in rapid product development while meeting strict requirements for quality, safety, and reliability. Our Denver, Colorado, delivery center focuses on FDA-regulated (and peripheral) products and has a quality management system certified to ISO 13485 to fully serve our medtech and life sciences clients.

Our experience working on complex class II electromechanical medical devices ranges from low-cost, disposable wearables to free-standing diagnostic instruments. From conceptualization through transfer to production planning for 510(k), we’re focused on helping you meet your specific goals while identifying and mitigating risk throughout the program and product life cycle.

 

  • Patient monitoring
  • Hand-held devices
  • Robotic surgical systems & accessories
  • Surgical navigation
  • Implantable devices
  • Maternal/infant care
  • Wearables
  • Diagnostics instrumentation
  • Disposables
  • Process automation
  • Sample handling
  • Imaging systems
  • Drug delivery
  • Cybersecurity

Medtech & Life Sciences Case Studies

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Hidden Costs of Product Development: Achieving Product Excellence Within Budget

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Predicting ROI for product development projects is challenging because three types of unexpected or unplanned costs often erode margins. Effectively preventing these hidden costs is key to ensuring your projects are successfully completed within budget.

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Real-Time Cardiac Analysis and Extended Existing Wearable ECG Data Recorder

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ALTEN Technology extended the battery life of a wearable ECG data recorder from 24 hours to seven days.

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Global Diagnostic and Therapeutic Cardiology Products

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ALTEN Technology’s sustaining engineering support cut lead time for high-priority projects in half and increased our client’s product and service revenue by $15 million.

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Improved Speed and Precision of a Flow Cytometer in 12 Months

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ALTEN Technology completed development through pilot production in 12 months and achieved 10 times faster sample throughput rates than competing cytometers.

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Support the Ongoing Design and Development of Novel Drug Delivery Systems with a DOD Use Case

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ALTEN Technology supported Design for Six Sigma and 99.999% reliability activities for a novel autoinjector.

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Cytometry System and Disposable Cartridge for Clinical Data Gathering

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ALTEN Technology transformed a feasibility prototype of a cytometry system into a complete repeatable product for verification and validation.

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Assessed and Harmonized Design History File of a Blood Separation Device

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ALTEN Technology organized a DHF, harmonized documentation, and closed all identified DHF remediation gaps for a blood separation device.

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