Original thinking from the Santegic team on regulatory change, cybersecurity in healthcare, and the commercial realities of digital health innovation.
If you're building Software as a Medical Device and you've started looking seriously at ISO 13485 certification, you've probably already discovered something uncomfortable: the standard wasn't written with software in mind. ISO 13485 is a rigorous, well-established framework for quality management in medical device manufacturing. But when you apply it to a SaMD product; a clinical decision support tool, a diagnostic application, an AI powered patient monitoring system; you're not implementing only one standard. You're navigating the intersection of several simultaneously, while also trying to provide a product and, in many cases, secure your next round of funding.
Read MoreMost health tech ideas do not fail because the idea was bad. They fail because the gap between idea and execution was never properly bridged. The concept existed. The clinical problem was real. The market opportunity was...
Read MoreIn healthcare product development, the gap between a compelling idea and a validated product is where most programmes encounter their most significant and costly difficulties. Concepts that exist only in documents...
Read MoreDeploying technology in a healthcare environment carries a weight that most other sectors do not experience. The systems being built, integrated, and scaled touch patient data, clinical workflows, and operational processes where the consequences of failure extend beyond financial loss...
Read MoreIn healthcare product development, speed is rarely the problem. The problem is making the right decisions early enough that speed becomes an asset rather than a liability. Teams that move quickly without validating core assumptions do not save time. They accelerate ...
Read MoreThe withdrawal of OpenEvidence, one of the most well-funded AI clinical decision support platforms in the US, from EU and UK markets is a significant signal for every health AI company with European ambitions. The reason given was direct: the complexity of...
Read MoreAccording to PwC's 2025 Global Compliance Survey, 85% of CEOs say regulatory complexity has increased in recent years. In healthcare, that figure will surprise no one. The regulatory landscape facing NHS organisations, digital health suppliers, MedTech companies...
Read MoreTwelve deals above $100 million. Average deal sizes climbing to $36.7 million. AI capturing nearly half of all healthcare venture investment. In the first ninety days of 2026, the US digital health market absorbed more than $4 billion in capital, and the conditions driving that investment are structural, not cyclical. For European and Irish healthtech...
Read MoreNIS2 readiness. Regulatory complexity. Market expansion into a heavily scrutinised sector. These are not generic business challenges that a generalist consulting firm can address with a standard methodology and a repackaged framework. Each one demands healthcare consulting expertise that is grounded in sector knowledge, regulatory context, and...
Read MoreDigital Transformation in Healthcare: Strategy Guide for Health Systems Digital transformation in healthcare is no longer a future ambition it is an operational necessity. Health systems across the UK, Ireland, and globally are under increasing pressure to improve patient outcomes…
Read MorePatient Experience: Fixing Ireland’s Healthcare Bottlenecks Ireland’s Healthcare System is at a Crossroads Ireland’s healthcare system stands at a crossroads in relation to patient experience and access. Despite world-class professionals and significant public investment, patients and providers continue to struggle …
Read MoreA pilot programme in Utah has quietly crossed a threshold that most healthcare systems have treated, until now, as firmly human territory. The state has launched a one-year programme allowing an AI system from....
Read MoreAmerica's largest insurers are not experimenting with AI in healthcare administration. They are rebuilding around it. Claims processing, prior authorisation, and reimbursement workflows are being restructured at scale, with billions of dollars....
Read MoreThe 2026 Physician Fee Schedule Signals Medicare’s Continued Shift Toward Value CMS is reinforcing a structural transition toward performance-based reimbursement and clinician level accountability. Why This Matters Now The CMS 2026 Physician Fee Schedule Final Rule offers another signal that…
Read MoreDigitising Patient Access in Ireland: How CERTIFY Health is Solving Today’s Healthcare Challenges Ireland’s healthcare system is under pressure like never before. With 911,000 patients on waiting lists, a shortage of 15,000 healthcare workers projected by 2035, and only 11% …
Read MoreThe cyber security expectations placed on MedTech companies and healthcare suppliers have changed materially over the past two years. What was once a background consideration in NHS and health system procuremen....
Read MoreThere is a widening gap in healthcare procurement between organisations that can describe their cyber security posture and organisations that can demonstrate it. For healthcare executives, CIOs, and governance leads operating in...
Read MoreNIS2 does not apply directly to most Irish MedTech companies. That is the detail many vendors have noted and moved on from. It is also the detail that is obscuring a more important commercial reality. When the HSE and...
Read MoreThe EU's decision to delay parts of the AI Act will give healthcare organisations additional time to prepare for full compliance obligations. For digital health leaders and governance teams managing complex implementation programmes, that breathing...
Read MoreIn June 2026, the National Data Guardian (NDG) for Health and Social Care wrote to NHS England to seek clarification on how external Palantir staff had gained access to identifiable patient data within the NHS Federated Data Platform (FDP). The watchdog described the situation as...
Read MoreWhen a ransomware attack hits a healthcare organisation, the immediate instinct is to frame it as a technology problem. Systems are down, data is encrypted, the IT team is under pressure. But in a clinical environment, the consequences extend far beyond the server...
Read MoreTop Cyber Security Risks in Healthcare and How to Mitigate Them Cyber security risks in healthcare are escalating at an unprecedented rate, driven by increased digitisation, interconnected systems, and the growing value of healthcare data. For healthcare executives and digital…
Read MoreCyber Security in Healthcare: Strategy, Risks, and Compliance for Health Systems Cyber security in healthcare has become a board-level priority as health systems digitise operations, expand data ecosystems, and face increasingly…
Read MoreFive years on from the Conti ransomware attack that brought the Health Service Executive to a standstill, the most important observation about the current landscape of healthcare cyber security threats is not that the HSE has recovered. It has, significantly. ...
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