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Why Now Is the Time for Organ-on-Chip Companies to Step Up and Lead the Human-Based Research Revolution

Updated: Aug 18

Henning Mann, PhD, HM.BioConsulting

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šŸšØĀ The Policy Shift We've Been Waiting For

In 2025, the FDA, in collaboration with the National Institutes of Health (NIH), announced a transformative pivot: they will prioritize human-relevant research technologiesā€”such as New Methodology Approaches (NAMs)/ Organ-on-chip (OoC) platformsā€”over traditional animal models for biomedical innovation (https://www.youtube.com/live/vz1uF42wnKQ). Backed by a key agency like the Government Accountability Office (GAO), this isn't a theoretical trend. It's now policy, funding priority, and scientific expectation.


For OoC companies, this is the momentĀ to step forward, redefine translational relevance, and take command of an accelerating market opportunity.

šŸ§  NIH, FDA, GAO, BIO, and KOLs: Major Forces Aligning in Favor of Organ-on-Chip Technologies:

Recent peer-reviewed studies (e.g., PMID: 40316753Ā and PMID: 40086787) confirm that OoC models not only rival animal models in predictive accuracy but also outperform them in complex tissue modeling, thereby encouraging the use of NAMs for more human-relevant safety assessments.

With the Biotechnology Innovation Organization (@BIO) supporting broader adoption, another key group, reaching into most industry hubs across all US states, is pushing for the adoption of these innovative technologies. However, they also highlight concerns about regulatory harmonization and clinical translatability, requesting guidance and collaboration between industry and regulatory agencies to increase adoption.

Altogether, this is not just a pivot in philosophy ā€” it's a redefinition of how the U.S. will fund, validate, and translate biomedical research.


šŸ§¬ Whoā€™s Leading the Charge?

Forward-looking OoC companies are already gaining traction with regulators, investors, and the pharma/biotech ecosystem. A selection of leading innovators includes:

  • Emulate, MIMETAS, CN Bio, TissUse, AIM Biotech, InSphero, Altis Biosystems, HesperosĀ 

  • And more, all of which can be reviewed on the 3R Collaborative Tech Hub

This cohort isnā€™t just innovating; theyā€™re working on redefining preclinical research itself.


āš ļøĀ The Challenge: Adoption in the Market.

While the Technology may seem ready, Validation is still ongoing.


Over the past decade, OoC systems have evolved from conceptual innovations to platforms,Ā which have been validated for simulating key human functions. Yet despite this scientific maturity, many platforms still lack fully validated data sets, including clear predictability scores, which hampers their market penetration.


The challenges now lie with:

1) Finding the Context-of-Use (#COU) niche where those innovative technologies may bring a significant gain in predicting clinical trial outcomes.

2) Defining where in the drug development process their tool most efficientlyĀ complements existing in vitro and in vivo assays. Pricing and scalability positions vendors in different spots on the drug developmentĀ time line, depending on cost, complexity and scalability.

3)Ā Executionā€”positioning, partnerships, and scale. Lastly, industry-wide standardization in hardware and readout compatibility is becoming increasingly important.


Where the real opportunity lies is in closing the gap between scientific promise and market impact: many companies risk being strategically unpreparedĀ with misaligned positioning, suboptimal commercialization strategies, and weak messaging on the value of human-relevant data to pharma and industry users, regulators, and investors.

Being technically strong is no longer enough. Market readinessā€”from regulatory alignment to investor and client/user narrativesā€”is the new frontier.


šŸš€Ā What OoC Companies Should Be Doing Right NowĀ / How HM.BioConsulting Can Help You Win the Moment

As a business development consultancy built with decades-long combined experience in the preclinical industry - including OoC ā€“ HM.BioConsulting is an accelerant for OoC innovators. The team at HM.BioConsulting has deep scientific and commercial rootsĀ in the very technologies now at the forefront of regulatory and investor focus, combining experience in OoC sciences with strategic business development expertise. We help companies:

  • Align your roadmapĀ with NIH/ FDA/ EMEA validation expectations

  • Secure strategic partnerships with CROs, pharma, and agencies.

  • Navigate complex and long regulatory landscapesĀ for toxicity / safety/ efficacy applications

  • Pursue pharmacological validation of their models to show clear gains compared to the current state-of-the-art assays.

  • Develop scalable go-to-market plans and licensing paths, and craft compelling arguments that resonate with investors and pharma.

  • Develop your sales narrative, pipeline, and revenue

  • Position clearly in a crowded and fast-moving field

  • Translate your tech into a fundable, scalable business

  • Craft compelling narrativesĀ for non-dilutive funding, co-development, and M&A

  • Communicate human-relevance and translational value to funders and end-users

Without the right business development approach, even the best platforms risk being overshadowed in this rapidly advancing field.


šŸ•’Ā Why Now? Because Timing is Everything

We're at a historic inflection point. NIH is setting new standards. The FDA is laying out pathways. Venture and pharma funding will be directed toward human-relevant platforms. The OoC space is fertile ground for the future of translational science.

The question isnā€™t ifĀ organ-on-chip will replace animal testingā€”itā€™s whoĀ will own that future.

šŸ”— Learn how HM BioConsulting can help you seize the momentum: www.hmbioconsulting.com


šŸ“š Sources and Further Reading

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