Karen Taylor, Director, Deloitte Health Solutions Center, sheds light on 4P medicine and its role in healthcare diagnosis.
Diagnostics play a pivotal role across the entire healthcare chain from examination, detection and prognosis to patient stratification and condition monitoring. Diagnostic tests influence most health care decisions, and support clinicians to make more accurate diagnoses and prescribe the correct treatments. Early access to diagnostic tests can help avoid adverse health outcomes and the high cost of late or unnecessary treatments.
Diagnostics can also enable a shift from symptomatic, interactive therapy to predictive, preventive, personalized, and participatory medicine and care from 4P.
This article provides an overview of our research findings, and explores what the future of diagnostics in Europe might look like. It is drawn from a comprehensive literature review, semi-structured interviews with 40 key stakeholders, questionnaire responses from 250 diagnostic firms, survey responses from 751 frontline clinical staff (physicians) and insights from Deloitte colleagues.
Why diagnostic services in Europe need to change
The diagnostics industry includes a wide range of diagnostic devices and tests, from relatively low-use high-value imaging tests to low-cost, high-use in vitro diagnostic (IVD) tests. However, IVDs, which affect more than 70% of medical decisions, account for only 0.8% of healthcare spending.
Prior to the COVID-19 pandemic, the demand for diagnostic services (imaging, pathology, endoscopy and genomics) was increasing at a faster rate than capacity. Furthermore, the overall costs of providing health care have been on the rise.
The pandemic has spurred innovation in diagnostics across the health ecosystem, accelerating adoption and shifting the testing site from central hospitals and laboratories to one closer to the patient (57% of physicians surveyed recognized this shift and 77% of companies said their products were part of this move). ).
Turning challenges in product development and adoption into enablers
We identified six cross-cutting challenges to the development and adoption of new products which, if addressed effectively, could become enablers for the future of diagnostics (Fig.
Digital Infrastructure: 51% of diagnostic companies identified healthcare digital infrastructure, especially interoperability and connectivity, as the biggest challenge in bringing new diagnostics to market. They also identified data sharing as critical to improving diagnostic services.
Regulations: Companies face many challenges due to medical devices in the EU in May 2021 and IVD regulations in May 2022; Including more stringent evidence requirements and lack of capacity causing concerns about the time taken to perform conformity assessments. Interviewees suggested that regulators should create target product profiles and clear indications of requirements to enhance transparency and guide compliance with product development.
Product innovation: Innovation pathways must align with clinical needs and be co-developed with end users. Keeping diagnostic data secure is also vital, thus Security by Design should be included from the start. However, concerns about the new regulations were making Europe a less attractive market for product launches.
Financing and Investment: New regulations appear to undermine access to innovation financing and increase the costs of meeting stricter evidence requirements. A third of diagnostic companies said they were “not feeling well” or “not at all ready” for sufficient funding for product development and launch. Furthermore, each European country has its own reimbursement policies for clinical evidence. A Europe-wide innovation ecosystem is needed to support manufacturers in product development and launch.
Supply chain: Supply chain issues affecting European manufacturers include the post-pandemic recovery, Brexit, and geopolitical turmoil. The interviewees developed multiple strategies to protect their supply chains, including higher levels of inventory and access to multiple sources of materials and components. However, new regulatory requirements for product traceability and global ambitions to achieve net zero are expected to have significant effects on the supply chain.
Workforce: Healthcare systems across Europe are facing significant staff shortages. Adopting new diagnostic technologies can help improve efficiency and enable clinicians to make more accurate and timely decisions. Physicians felt that the lack of workforce training and skills in new technologies was a major barrier to technology adoption. While healthcare systems must provide such training, companies have a responsibility to ensure that appropriate educational materials, on-demand support, and on-site training are provided.
A new diagnostic model enables quadruple medicine
Disruptive technologies and advances in science and analytics combine to change the way we prevent, diagnose and treat disease, as industry is now entering the Fourth Industrial Revolution. Digitization, robotics, and automation have led to the emergence of smart laboratories and smart imaging systems to handle demand more quickly, accurately, and at lower cost.
Our doctors have identified telehealth, robotics, biosensors, and artificial intelligence as the technologies that are already beginning to advance diagnosis, but are less confident about others. Our research identified several disruptive technologies that are being adopted in the pockets, but that, if adopted on a large scale, will enable the future of 4P medicine.
Conclusions for the health care system
Healthcare systems are in transition, moving from ineffective, highly reactive, and episodic models of care to 4P models of care. Diagnostic companies can take advantage of opportunities to become insightful partners in clinical pathways, helping diagnose patients earlier and faster, identifying more appropriate treatments and delivering more patient-focused, value-based care.
Changing the tweaks to increase the priority given to improving access to diagnoses has the potential to improve equity and improve health outcomes for all. This requires an industry-wide effort to help all stakeholders appreciate the role of innovative diagnostics in healthcare, and a concerted effort to translate innovation into improved outcomes.