Making the Unknown
Known with Revolutionary

  • Whole Implant Testing
  • Scientific Writing
  • Immune Response Testing
  • Sterility/Bioburden Testing

Making the unknown known

We are a commercial non-university-based provider of bioactive surface testing, microbiology testing and immune response testing inviting small to mid-sized medical device manufacturers to make the unknown known. Too often, researchers and manufacturers are inhibited by boilerplate testing, murky data, ambling timelines and demanding written assets. These challenges can foster uncertainty in the development process, putting products at risk for delayed launches and reduced efficacy.

We eradicate this uncertainty by illuminating the unknown and helping manufacturers and researchers step into the light

Why Choose Us?

We Start with the Right Testing to Accelerate the Whole Process

We do the right testing from the start to then generate the right data and provide an experience-based perspective on how to effectively use that data. Few organizations have been more innovative and integrative than ours in the realm of bioactive, microbiology and immune response surface testing.

Our Difference

  • Whole implant testing is historically difficult to evaluate. Get clarity from in-depth research performed by our biologists, chemists and physicists.
  • Some solutions uncover only surface-level outcomes, but we look far beyond.
  • We address clients’ most complex and challenging project requirements with new methodologies and assays.
  • Our evidence – and data-based recommendations make testing easier to evaluate.

The bottom line: the right testing accelerates the process of bringing unique, life-changing medical devices to market.

Our Services

More About Our Labs

We are a commercial non-university-based provider of bioactive surface testing, microbiology testing and immune response testing inviting small to mid-sized medical device manufacturers to make the unknown known. Too often, researchers and manufacturers are inhibited by boilerplate testing, murky data, ambling timelines and demanding written assets. These challenges can foster uncertainty in the development process, putting products at risk for delayed launches and reduced efficacy.

CT Chamber

The CT Chamber is a technology used for testing medical devices. It can test any shape or size implant or biomaterial for biocompatibility. It bridges the gap between lab testing and testing in the body by using a 3D model that mimics a wound niche. This model can induce a cellular response to an implanted material and measure cellular metrics in real-time. The CT Chamber combines human cell bioreactor and cell seeding chamber technology with analysis and imaging tools to accurately test how a medical device would perform in the body. It can determine the reaction of the immune system and how well the device integrates into the body.

Testing the evaluable risks on the benchtop to the extent feasible using the device in its final finished form (a device in its final finished form includes all manufacturing processes for the “to be marketed” device including packaging and sterilization, if applicable). Before considering an animal study to support a premarket submission, FDA recommends completion of nonclinical benchtop performance testing with the device in its final finished form to evaluate potential harm(s) identified during the risk analysis.[1]

[1] General Considerations for Animal Studies Intended to Evaluate Medical Devices Guidance for Industry and Food and Drug Administration Staff
Document issued on March 28, 2023.

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