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Medical Device Development

Accelerate the journey from concept to product.

INO designs, develops, and delivers a first industrializable generation, and manufactures your products for clinical and pilot trials.

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Your Challenges

You have a paper concept or a promising lab prototype. You want to quickly reach the market with a robust product that meets regulatory requirements and is supported by the necessary documentation. INO can help.

Your Goals

  • Obtain an industrialized product supported by a complete Design History File (DHF).
  • Reduce time-to-market and secure the path toward regulatory approval.
  • Obtain prototypes for clinical validation while minimizing subsequent changes.
  • Prepare for production launch.

What INO Takes Care Of

  • INO acts as a development and industrialization partner for medical devices integrating optics and photonics.
  • Verification: test plans, test benches, traceable data, and reports.
  • Design: optics, mechanics, electronics, software, artificial intelligence (AI) integration.
  • Integration and testing: environmental testing (temperature, vibration, shock, humidity).
  • DfX: manufacturability, testability, cost, and assembly.
  • Documentation: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR).
  • TRL covered: up to TRL 7 (qualifiable design / first generation), then TRL 8–9 (manufacturing).

Our Tailored Offer

INO serves as a development and industrialization partner for medical device systems integrating optics/photonics.

Development of a Medical Device or Optical Subsystem

  • Design and prototyping.
  • Proven robustness: tolerances, alignment, aging.
  • Structured DHF/DMR/DHR, requirement traceability.
  • Industrialization and production transfer.
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Manufacturing (Post-Development)

  • NPI, qualification process, manufacturing file.
  • Traceability (lots, records), controlled scale-up.
  • Pre-series for clinical and pilot trials.
  • Production partner.
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Specialized Services

  • Environmental testing: temperature, shock, vibration, humidity.
  • Optical characterization and metrology.
  • Microfabrication: micro-optics, micro-structures.
  • Custom optical, optomechanical, and electronic design.
  • Custom optical fibre development.
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Why Choose INO?

ISO 13485 certified, INO excels in designing customized solutions, from ideation to prototyping to production of medical devices.
We collaborate with innovative companies to accelerate the commercialization of their optics-based products, meeting regulatory obligations while ensuring robustness, cost-performance balance, and deadlines.

Our service offer is built on:

Specialized Expertise

Microscopy, endoscopy, spectroscopy, systems engineering, advanced image processing, fibre optic probes, light–tissue interaction, imaging and detection, AI, and more.

Quality and Standards

ISO 13485 certification, ISO 9001 certification, and experience with medical sector standards (e.g., IEC 60601, IEC 61010)

Key Equipment

Clean rooms, optical metrology benches, climate chambers, microfabrication, high-precision alignment stations.

Benefit from the support of our experts across every aspect of technological product design.

Our Achievements

INO has manufactured medical devices for several clients. Here are examples of products industrialized by INO:120 systems manufactured
Production transferred

INO Case Study Intellijoint Surgical

Custom medical devices: product design of the innovative Intellijoint HIPMD

Over 600 cameras manufactured

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INO Case Study Cerus Corporation

A new generation of UVA LED illuminators for the INTERCEPT© Blood System

120 systems manufactured | Production transferred

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INO Case Study Eikon Therapeutics

From prototype to industrial product to create new drugs

38 systems manufactured | Production transferred

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Our customer testimonials

See what INO customers have to say about our services and solutions.

Our ongoing business relationship with INO is the ultimate proof of how satisfied we are with what they deliver!

Lloyd Ison, VP Device Engineering, Hardware and software Cerus Corporation

At Intellijoint, our design process is highly collaborative. INO was a great fit for us for this reason; we were able to maintain true collaboration while leveraging INO’s incredible technical competency and state-of-the-art infrastructure and facilities. I could tell our project’s success was important to INO; they have always been flexible, accommodating, and responsive. I look forward to working with the INO team developing our next disruptive technology.

Andre Hladio, Chief Technology Officer and Co-founder Intellijoint Surgical

Ready to accelerate the development of your medical devices?

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