Product lifecycle management

Our product lifecycle management team supports products from design transfer through commercial manufacturing, regulatory submission, sustaining engineering, and end-of-life. We work in regulated, audited environments and stay with the product through change control, field updates, and the full arc of its commercial life.

Our Approach

Product lifecycle management is the long arc of the product: from design transfer to manufacturing, through verification at scale, into regulatory submission, and on into sustaining engineering, change control, and field updates. We do this in regulated, audited environments because that’s where our products live and where most engineering organizations stop being able to help.

PLM is rarely glamorous and almost always decisive. The work is making sure the product the engineering team designed is the product the manufacturing team can build, the regulatory team can submit, the service team can support, and the customer can rely on for a decade.

Why Invetech

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products in active sustaining engineering
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design transfers to commercial manufacturing
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FDA and EU MDR submissions supported
Sustaining engineering, change control, regulatory updates, field issues, end-of-life planning. All in the same team that designed the product, in the same audited environment a regulated product requires. The institutional memory that usually walks out the door at handover stays in the room.
Design Transfer
Structured transfer from engineering to manufacturing: drawings, specifications, processes, and the institutional knowledge that usually walks out the door.
Quality Management & Documentation
Design history file, device master record, and the ongoing documentation a regulated product accrues across its life.
Regulatory Submissions Support
Engineering inputs to FDA, EU MDR, and equivalent submissions: verification, validation, hazard analysis, and the technical file that supports them.
Sustaining Engineering
Field-issue investigation, supplier changes, component obsolescence management, and design refreshes that don’t trigger a re-submission unless they have to.
Change Control & Field Updates
Engineering change control, software update strategy, and field-update logistics for deployed instruments.

Client Outcomes

Product Strategy

Explore strategic possibilities, define a purposeful vision and a path to realization

  • Worfklow Transformation
  • Co-creation Workshops
  • Product & Feature Roadmapping


We partnered with Hologic to reimagine cervical cancer diagnosis user experience with an Al assisted digital cytology workflow


Image courtesy of HOLOGIC, Inc. and affiliates
Research & Human Factors

Uncover unmet user needs and assess usability within healthcare environments

  • Discovery Research
  • Usability Evaluations
  • Human Factors Engineering

Global molecular diagnostics client

We helped a health-tech business to iteratively design and test usability of a Point of Care device for use in multiple US healthcare settings.

Concept Visualizations

Visualize ideas to inspire and align your stakeholders

  • Digital Design
  • Industrial Design
  • Virtual Reality Experiences


Design Challenge

We imagined the future vision of a 2030 sepsis diagnosis laboratory

Product Design & Implementation

Design and deliver physical and digital offerings to your customers

  • Interaction Design
  • UI/UX (User Experience)
  • Styling


We worked together with Leica Biosystems to desian, develop and realize the physical interactions and styling of the BOND-PRIME

Have a product moving through its lifecycle?

Tell us where it is in the arc: transfer, submission, sustaining, or end-of-life. We’ll bring the team that’s been there.