By Pushyarag Puthusserry, Kent Business School
Medical diagnostics are central to improving early disease detection, enabling more targeted treatment, and supporting the efficient use of clinical resources. Health systems such as the NHS increasingly rely on diagnostic innovation to deliver better outcomes while managing rising demand and constrained budgets. For diagnostic start-ups, the key challenge is not only to develop accurate and clinically meaningful tests, but to design business plans and business models that enable these innovations to scale and operate sustainably across different markets and health system contexts.
Clinical studies in advanced diagnostics show that ventures which plan early for commissioning, reimbursement, and integration into care pathways are far more likely to move from pilots to routine use. When clinical evidence is aligned with market insight, adoption strategy, and delivery channels, diagnostic innovations scale more smoothly across public, private, and patient-facing markets. This alignment helps innovations reach patients faster while delivering value that health systems can recognise and support.
Business planning underpins this alignment. A strong business plan links diagnostic technologies to specific clinical uses, target customers, and realistic growth pathways. It clarifies who the customer is, whether hospital laboratories, specialist clinics, insurers, or self-paying patients, and sets out the regulatory, reimbursement, and commercial steps required for adoption. Structured market research strengthens these choices by segmenting demand, sizing markets, and analysing competitive dynamics in the UK and internationally. This focus helps ventures direct time and capital towards the pathways most likely to support scale.
Health economics is integral to this planning. Early assessment of outcomes, resource use, and system-level impact enables diagnostic start-ups to engage credibly with commissioners and other funders. When expected effects on care pathways and budgets shape pricing, positioning, and go-to-market choices from the outset, innovations align more naturally with health system decision frameworks, which is especially important for international scaling where funding logic and purchasing processes vary widely.
Business model innovation builds on this foundation by shaping how value is created, delivered, and captured in ways that can be sustained at scale. Many diagnostic start-ups are moving beyond one-off test sales towards service-based offerings, platform models, and bundled solutions that combine diagnostics with decision-support tools. Hybrid approaches that link institutional contracting with patient-facing channels are increasingly common, and these choices influence adoption speed, scalability, and resilience across different health systems. By assessing alternative routes to market, partnership structures, and revenue models, ventures can clarify how diagnostic innovations sit within care pathways and the wider value chain. Decisions about collaboration with laboratories, clinicians, and distributors, and about the balance between standardisation and local adaptation, directly affect scalability, alignment with reimbursement mechanisms, and the potential for cross-market expansion.
My research and consultancy focus on start-ups and scaling ventures. The work centres on sustainable growth and international expansion through systematic business planning and business model innovation. In medical diagnostics, this involves supporting entrepreneurs to integrate market analysis, regulatory and commissioning pathways, and health economics into clear, actionable business plans. Business model tools are then used to test and refine alternative routes to scale across the UK and international markets. For the CADDA community, these insights show how strategic rigour in planning and business model design can strengthen commercialisation, reduce scaling risk, and increase the likelihood that diagnostic innovations deliver sustained value for patients and health systems.
To explore opportunities for partnership, please contact p.n.puthusserry@kent.ac.uk .