In a recent article, “Digital diagnostics: A path forward for IVD players”, published by McKinsey & Company, digital diagnostics are discussed as a new opportunity, not just for growing the business of in vitro diagnostics (IVD) players but also for bridging gaps in the system and providing additional value to patients, healthcare providers, and payers. While McKinsey’s research mainly covers IVD manufacturers, diagnostic laboratories are also recognized as part of this opportunity.

Growth is slowing in the diagnostics industry as historically unmet demand is being met. Thus, for IVD players, simply having a test is no longer sufficient. On the other hand, the discrepancy between clinical importance and funding remains significant. IVDs inform 70% of all clinical decisions made—yet only 1% of NHS expenditure will be invested in diagnostic testing in the UK. Similar results are found in the US, where, with just 2% of total healthcare spending, IVDs influence more than 66% of clinical decision-making.

A great place to look is digital diagnostics, which combines data and analytics with traditional IVD testing to generate new clinical insights and more efficient workflows. McKinsey research shows that select digital markets adjacent to diagnostics, including clinical decision support, remote patient monitoring, and population health management, are projected to outgrow the core diagnostics market over the next several years.

Where to play in digital diagnostics?

According to the same research IVD manufactures can provide differentiated clinical value across the patient journey regarding prevention, diagnosis, treatment, and long-term health.

Any new diagnostic test or solution, digital or not, must meet three criteria to be successful:

• Deliver real, quantifiable clinical value on patient and population level.
• Integrate effortlessly into clinical workflows.
• Be cost-effective for health systems.

It’s obvious that the same approach should refer not just to the IVD manufacturers but also to diagnostic laboratories and other stakeholders involved in the patient journey. IVD manufacturers should be fully engaged in the digital health ecosystem working together with other stakeholders like digital health companies, healthcare providers, pharma industry, health authorities, non-governmental organizations.

How to play within digital health ecosystem?

The key word according to McKinsey is data:

• Data collection. Collect and tokenize data from connected devices.
• Data products. Use data to create new products (e.g., new tests).
• Data services. Combine data with services (e.g., consulting) to create new offerings and business.
• Data integration. Integrate and pack multiple data sets together (e.g., devices and LIS).

Real-world data and evidence are becoming more important in the field of medical devices (including IVD). Both the European Commission and FDA actively work in this direction. Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. To better conduct HTA on medical devices is recommended considering (1) multi-source evidence such as real-world evidence; (2) standardizing HTA processes, methodologies, and criteria; and (3) integrating HTA into decision-making.

How to get started on digital diagnostics?

Digital diagnostics can be challenging because it requires IVD players to build new capabilities (such as connectivity and data analytics), navigate a complex data regulatory environment, and clearly articulate a value proposition that resonates with customers, who are often sceptical.

Data analytics platforms could be a key part of the solution. Sqilline’s experience with Danny Platform, a big data healthcare analytics platform, shows the benefits of integrating massive amounts of Real-World Data (RWD) from various hospital and outpatient sources (EHRs, laboratories, registries, etc.). Embedded with propriety Machine-Learning and Natural Language Processing algorithms, Danny Platform extracts both structured and unstructured (free text) data to preprocess, normalize and ensure high data quality.

Two experts in digital health and diagnostics give their opinion on how to get started and what could be the opportunities along the way.

“Access to medical devices and IVD is crucial, and it should be in line with the vision for value-based healthcare.” Dr. Aleksandar Michev, Vice Chairman of MedTech Bulgaria, highlights that value-based healthcare aims to enhance patient outcomes relative to healthcare expenditure, emphasizing longitudinal, patient-centric results over short-term transactions. Dr. Michev advocates for healthcare systems to embrace value-based procurement, an innovative approach fostering patient-centric, high-quality, and affordable healthcare. In both value-based healthcare and value-based procurement, data analytics plays a pivotal role in achieving success.

“Today, we find ourselves surrounded by data, yet lacking in knowledge – a significant paradox in both personal and professional spheres,” emphasized Dr. Vasil Deliganev, Managing Director, and Owner of Medi Vision. “Sqilline’s Danny Platform represents a breakthrough in this modern puzzle. It is a proven, productive solution that offers tangible benefits, serving as a unifying platform for integrating data across clinics, medical devices, and IVD diagnostics. This facilitates a comprehensive review of diseases, patient outcomes, and decision-making enhancements. Furthermore, it opens avenues for creating new analytical and consulting solutions, potentially transforming government and business decision-making through real-world data (RWD) and evidence. This, in turn, holds the promise of bringing informed decision making in the healthcare sector, not only in Bulgaria but beyond.”