Medical Device Diagnostics at a Crossroads: Where Strategic Leadership Matters Most

In the wake of the COVID-19 pandemic, the diagnostics industry has undergone a profound evolution. What was once seen as a quiet corner of the healthcare ecosystem is now front and centre of clinical decision-making, public health strategy, and investment activity. For CEOs of medical device and diagnostic companies, this moment is more than an opportunity - it’s a strategic turning point.

We are entering an era where diagnostics no longer serve the system; but drive the system instead. The path forward is both exciting and complex; filled with rapid innovation, regulatory shifts, global market fragmentation, and a new generation of digital-native competitors. In this environment, the companies that lead will not be the ones with the best tests alone, but those with the most agile, visionary leadership.

There are four strategic imperatives every CEO in diagnostics should be thinking about now:

1. Diagnostics Are No Longer Just Tests - They’re Platforms

Historically, diagnostics have been viewed as adjunct tools. Valuable, yes, but limited to detection and confirmation. Today, the most successful diagnostic firms are shifting toward platform models: scalable, data-rich ecosystems that offer insights across patient journeys, therapeutic areas, and geographies.

Consider how leaders in genomics, at-home testing, or AI-driven imaging are positioning their platforms as essential infrastructure, not just one-time use kits. These companies are monetising longitudinal data, integrating with EMRs, and offering decision-support tools that influence not just diagnoses, but care pathways.

For CEOs, this means rethinking business models. It requires asking: ‘Are we building point solutions, or a connected ecosystem?’ ‘Are we thinking about value-based care and real-world outcomes, or just test performance?’ ‘Are we partnering with the right digital health players - or competing with them?’

 

2. Regulatory Strategy is Now a Commercial Strategy

The global regulatory landscape is becoming more complex, especially in diagnostics. The EU's IVDR, for example, has disrupted product pipelines and certification timelines for hundreds of companies. Meanwhile, the U.S. FDA is accelerating the digital health review process but tightening expectations on AI/ML transparency. Emerging markets each bring their own frameworks.

The implication? Regulatory process must be at the heart of go-to-market planning.

CEOs must ensure their leadership teams are aligned early and deeply with regulatory affairs. Organisations that invest in proactive regulatory strategy consistently outperform peers in time-to-market, risk management, and global scalability. This means investing in cross-border regulatory intelligence, hiring globally minded RA leaders, and engaging regulators as partners, not obstacles.

 

3. Talent is the Limiting Factor, and the Differentiator

Innovation in diagnostics is outpacing the industry’s ability to build teams that can sustain it. Today’s product leaders must understand not just assay development, but software, data security, and patient usability. QA professionals need to navigate MDR and IVDR as well as software-as-a-medical-device compliance. Commercial leaders must sell value, not volume.

Yet many companies are struggling to find (and retain) this hybrid talent.

For CEOs, this isn’t just an HR issue - it’s a board-level concern. Leadership teams must develop forward-looking workforce strategies: upskilling programs, talent mapping, partnerships with academic institutions, and flexible models that allow for global collaboration. The companies that win the next phase of the diagnostics race will be those with the adaptable, multi-disciplinary teams.

4. The Market Is Watching - and So Are the Buyers

Whether your company is venture-backed, publicly traded, or family-owned, diagnostics has never been under greater scrutiny. Investors, acquirers, and health systems are all looking for differentiated value: platforms with clinical depth, digital capabilities, global scalability, and regulatory readiness.

M&A activity is picking up across molecular diagnostics, digital pathology, and rapid testing - but acquirers are increasingly selective. Speed to market is no longer enough when buyers are looking for strategic fit, evidence generation, and clear reimbursement models.

CEOs must ensure their growth narratives are more than just pipelines and patents. Clear messaging on clinical utility, data strategy, payer engagement, and post-market evidence will increasingly separate attractive targets from the rest.

This Is Diagnostics’ Decisive Decade

The diagnostics sector is not operating in the background. It’s shaping how care is delivered, how populations are monitored, and how innovation is valued. For CEOs, this moment calls for bold, systems-level thinking.

It’s not enough to lead product development. This era demands leadership in ecosystem design, regulatory foresight, and talent transformation. The decisions made today - about partnerships, platforms, and positioning - will define the leaders of tomorrow.

Diagnostics are now driving healthcare. The question is: Are you driving diagnostics with equal ambition?