Good ideas deserve a proper workup.
The Workup provides confidential pathology product development consulting for ideas in laboratory medicine, healthcare, AI, and beyond.
The right diagnostic development partner, when the project calls for one.
Some diagnostic ideas need more than a commercial plan. When appropriate, The Workup can help evaluate working with a contract diagnostic organization (CDO)—a specialist partner that can support diagnostic development, evidence generation, and the regulatory work a project requires.
For digital pathology and artificial intelligence / machine learning (AI/ML) programs, we look for partners with hands-on clinical trial experience—not just secondhand interpretation—and dedicated expertise in these technologies rather than a side practice. The aim is to connect clinical trial design with regulatory strategy from the beginning.
Early feasibility
Clarify the intended use, test the concept against real laboratory workflows, and identify the evidence and capabilities needed before committing to a larger development program.
Trial design and regulatory strategy
Bring clinical, technical, and regulatory specialists together to align study design, endpoints, and evidence plans with the intended diagnostic use and applicable requirements.
Study execution and evidence
Evaluate a CDO's direct trial experience and its ability to support study operations, digital pathology workflows, and AI/ML evaluation. Define responsibilities and deliverables before work begins.
Post-market compliance
Where applicable, plan beyond the initial study or launch for ongoing performance monitoring, change management, and post-market compliance with the appropriate specialists.
Not every Workup needs a CDO or a clinical trial. The appropriate path depends on the product, intended use, development stage, and regulatory context. Specialist services are scoped separately; engaging a partner does not guarantee regulatory authorization or commercial success.
Frequently asked questions
Could The Workup involve a contract diagnostic organization (CDO)?
Yes, when appropriate. The Workup can help assess whether a contract diagnostic organization (CDO) is the right specialist partner for a diagnostic development program, especially in digital pathology or AI/ML. This may connect early feasibility, clinical trial design, regulatory strategy, study execution, and post-market compliance. Not every idea requires a CDO, and specialist work is scoped to the project's needs.
What is The Workup?
The Workup is a confidential pathology product development consulting process for pressure-testing ideas, understanding the market, and deciding what should happen next.
Who is The Workup for?
The Workup is for pathologists, laboratory leaders, scientists, technologists, healthcare executives, founders, and technology teams with a pathology, laboratory, healthcare, or AI opportunity to explore.
Do I need a pitch deck or business plan?
No. An early idea, workflow challenge, product concept, or conversation is enough to begin. The Workup helps shape the questions, evidence, and relationships needed to understand the opportunity.
Can we talk before signing an NDA?
Yes. We can start with a high-level introductory conversation without sharing proprietary details. If it makes sense to go deeper, we put a mutual NDA in place before discussing confidential information.
Does every Workup lead to a new product or company?
No. A useful result may be to build, source, license, or partner on a solution—or to pause or stop because the opportunity is not strong enough. A clear decision is a valuable outcome.
How long does a Workup take?
The timing depends on the idea, the evidence available, and the people who need to be involved. The initial conversation is designed to determine the right scope rather than force every opportunity into a fixed package.