This is the final post in a three part series exploring diagnostics innovation, digital pathology, and the future of infrastructure in digital health driven care:
- Blog 1: Rare diseases and the AI opportunity
- Blog 2: Rare cancers and the pharma challenge
- Now: Why even the best tools can’t scale without alignment.
Innovation is not failing. But it’s aging in place, unused, unintegrated, and underleveraged.
Digital pathology works, not only for diagnosis, but as the foundation for computational biomarkers.
AI is maturing. Biomarkers are known.
The science is ready.
But progress is slow, not because of scientific failure, but because of fragmentation and misalignment.
We are not short on potential. We are short on integration.
The Bottleneck Isn’t Science, It’s the Model
We should not be short on innovation, but we are.
Without integration, between diagnostics, clinical workflows, regulatory pathways, and trial design, tools remain underutilized. As a result, we are running while standing still.
Implementation and application stagnate because the existing model fails to support what already exists. Even more so, it creates a broken full circle:
Data doesn’t flow back from application to refinement. Insight doesn’t return to inform validation, development, or continued innovation.
What should be an evolving ecosystem is stuck. Fragmented and reactive.
“The science has moved forward. The model has not.”
Competition Is Costing Us All
In the absence of a common denominator, each company solves its own version of the problem –alone.
But defining that denominator isn’t theoretical. For some of us, it is already in motion: built from deep, cross-disciplinary work that spans diagnostics, clinical implementation, and regulatory alignment.
This isn’t about owning the solution. It’s about designing the infrastructure that finally lets the science deliver on its promise.
What we get today is duplication, inefficiency, and missed opportunities. Everyone builds – and no one wins.
“We’re not building a field. We’re burning it down, one proprietary use case at a time.”
We Must Solve the Denominator
The real opportunity isn’t to create more tools, it is to align the infrastructure that enables them.
Until we solve for that, innovation stalls. When we do, everyone moves faster – with more clarity, less risk, and better outcomes.
And importantly, regulators are ready to engage, but without collaborative integration, they’re left reviewing innovation in fragmented form. This slows down not just individual programs, but the entire field.
We Need an Architect – Not Another Platform
This isn’t about technology. It’s about design. We need neutral, trusted architects across diagnostics, pharma, and regulation. Partners who do not own the data or tools, but know how to orchestrate them, and build frameworks that reduce duplication, and align stakeholders.
“If we build with intent, we build something that lasts.”
This isn’t a call for a new owner. It’s a call for coherence across the field, so that what is already working in pieces can start working as a whole.
Pharma’s Role in Diagnostic Acceleration
Pharma is uniquely positioned to influence both innovation and access, but unlocking that potential requires more than product pipelines.
To move faster, with less risk, the focus must extend beyond the therapeutic asset to the diagnostic frameworks that support it.
Even when approvals and reimbursement are in place, clinical utility often defines success.
Can the diagnostic be used? Is it actionable? Will it be applied at the right time, by the right user?
Ultimately, the customer – the physician – the user – the pathologist and the lab – are part of the model too. And if the model doesn’t work for them, it doesn’t work for patients.
This is where aligned infrastructure creates real value: it ensures that what is built can also be applied, at scale, with impact.
Leadership here is not about being first. It is about being foundational.
What if pharma could bring innovation to market faster – with less risk, more clarity, and the right partners from the start?
Closing Thought
Innovation won’t fail because the science is weak.
It will fail because the existing model was never built to carry it.
But that is a choice.
We can keep operating in isolation.
Or we can align!!!
We owe it to patients to build models that diagnose better – and treat smarter.