CASE STUDY Revised August 2016 Defining opportunity and co-creating concepts for diabetic foot ulcer infection diagnostics by UMIO The analysis carried out by UMIO ensured that there was a solid business case for the 7.9M programme funding and that the real unmet needs of healthcare practitioners were fully identified and addressed from the outset, before the programme technology research and development began. Programme Manager, ITI Scotland
Case in Brief ITI Scotland wished to ensure that a planned 8m ($12m) investment in a programme for the development of advanced wound care technology was backed by a solid commercial, clinical and market case. ITI Scotland, now subsumed into Scottish Enterprise, was a foresighting and technology seeding organisation set-up by the Scottish government in 2008. Its remit was to boost indigenous growth by providing research, skills, knowledge and capital to local start-ups and mid-sized companies. To narrow its scope of interest, ITI first identified several market and technology "hot spots" where Scotland-based universities and companies had particular R&D expertise and therefore the potential to innovate new technologies that would appeal to global markets. One such hot spots was chronic wound infection diagnostics. To determine the validity of the case for investment of substantial public funds in this sector, ITI chose UMIO to conduct a global market, clinical and commercial opportunity assessment as well as develop initial diagnostic wound care concepts. In just 8 weeks, we completed a multi-geography (UK, US, India, Germany) wound care practitioner capability gap analysis, a fourway segmentation, four individual market dynamic commercial and health economic models and defined 8 different infection diagnostic concepts, each targeting fully quantified, prioritised indicators of clinical and commercial value. Our Health Value Design innovation and strategy approach gave ITI Scotland the clarity and the confidence it needed to invest funds in its licensing programme. Our insights continue to be used to design new diagnostic technologies that have the potential to address a significant, ongoing healthcare ecosystem burden. CLIENT CHALLENGE There are currently over 382 million people worldwide with diabetes, a number expected to grow to close to 471 million by 2035. The lifetime risk of someone with diabetes developing a foot ulcer is as high as 25% and every 30 seconds someone in the world loses a lower toe or limb due to diabetes. (Source: International Diabetes Federation, 2013). Early diagnosis and appropriate treatment of infection in a diabetic foot ulcer (DFU) is known to have significant impact on amputation rates. However, diagnosis of foot ulcers currently relies on expert clinical judgment (about 50% of infections do not present clinically) and use of decades-old microbiological techniques that can take too long to deliver results. When there is a delay in knowing whether a DFU is infected and also by what species, practitioners tend to cover the risk by prescribing broad-spectrum antibiotics, a practice that if unchecked adds to the growth of antibiotic resistance. The case for a novel point-of-care DFU infection technology to expedite diagnosis, direct foot ulcer treatment decisions, and ultimately reduce amputations seemed clear. But ITI Scotland, a publicly-funded organization, required more than just epidemiological data to justify its investment. An integrated commercial, health economic as well as clinical use case - defined for multiple geographies - was needed before it could commit to investing public money in the order of 8m ($12m). ITI Scotland chose UMIO to conduct the work on the basis of the discipline and focus provided by our Health Value Design approach and our experience and understanding of diabetic wound care.
Figure One Diabetic Foot Care Management practice map (macro-version) Screening - Prevention and Early Detection Prevention of Wound Complications Detect Complications in a wound Treatment and wound monitoring Prevent Wound Occurrence Prevent Wound Re-occurrence Detect Wound Occurrence Prevent Infection in a Wound Prevent a Wound from becoming Chronic Detect Infection in a Wound Determine that a Wound is Non-Healing Treat a Wound Early Intervention Identify infective species Detect antibiotic resistance Early Intervention Infection Biofilm Formation Poor Vascularity Other co-morbidities Increased healthcare cost burden through failure to effectively care for a wound: Amputation Micro-vascular surgery Antibiotic resistance Hospital stays Pharmaceutical costs Diabetic population growth Community visits Diabetic Foot Ulcer Activities within the Care Pathway: Prevention and early detection and rapid, targeted intervention are critical to prevent escalating costs of care. HOW WE HELPED Diabetic foot ulcer care is becoming increasingly multidisciplinary, with a number of practitioner types involved at different stages of the wound management cycle. To enable a deep insight into the roles and requirements of all the stakeholders, UMIO drew on the results of over 60 qualitative interviews and practice observations with patients, wound care practitioners, microbiology lab technicians and purchase decision makers in the UK, US, Germany and India. Practitioners were selected from a number of generalist and specialist wound care disciplines and from within primary and secondary care settings. They included: diabetologists, clinical microbiologists, nurses, orthopaedic surgeons, vascular surgeons and general practitioners. UMIO analysed and dissected the current practice of managing a diabetic foot ulcer into 53 distinct activities organised sequentially along the infection prevention, diagnostic and treatment pathway (see figure one for these at the macro-level, showing seven higher-order activities and figure two at the micro-level, running along the bottom of the chart). For each activity, we also captured different measures of target outcome or performance that practitioners were seeking to achieve. These included: The time to detect an infection in a DFU, the time to obtain a result of speciation, the target per cent reduction in minor toe amputation, the reduction in in-patient stay length, and the reduction in repeat infection. A Capability Gap as the difference between current and desired capability to achieve a target outcome for an important health goal Next, for all the activities, we identified all the resources used as well as all the capability factors that were currently preventing practitioners from achieving their target outcomes (163 factors in total). The resource inputs included the current technologies used, unit and total costs and practitioner data such as the number, type and time spent with each patient. Each was modelled into 8 different typical patient scenarios. Next, almost 500 practitioners prioritized the capability factors on the basis of their importance and desire to address them - revealing what we term Capability Gaps (see definition on left). With this insight, not only were we able to determine the highest priority capability gaps but also we were able to map them to different activities in the DFU pathway, as well as determine which ones are consuming the most resources.
Figure Two Four segment positioning on diabetic foot care pathway with capability gap ranking UMIO uncovered priority practitioner capability gaps and turned these into a number of distinctive POC infection diagnostic concepts. This ensured we focused the development of DFU technologies on actual, priority and desired practitioner capabilities. Programme Manager, ITI Scotland. Given the range of practitioner types involved as well as variations in foot ulcer management regimes between and within the four countries studied, we recommended that a capability-based segmentation would enable ITI to gain even deeper insight and focus for defining the clinical and commercial value of future DFU diagnostic technologies Using our advanced capability-based segmentation modeling techniques, four distinct segments of diabetic foot ulcer practitioner were uncovered, each defined by a) the target outcomes they wished to achieve, b) the capability gaps they most wished to address, c) the settings in which they practiced, d) the activities they performed along the pathway and e), the current technologies and solutions they use. Our practitioner segmentation revealed a completely new picture of diabetic foot ulcer practice AND how the capability gaps vary across the care pathway (see figure two). With this deep insight, next we were able to co-create ideas for highlyrelevant, resource-defined and problem-focused new concepts to address the capability gaps. With 8 concepts created, we then formulated a multi-platform diabetic foot infection diagnostic strategy and technology road map, focusing the creation of concepts on different capability gaps for individual segments at different points along the care pathway at different intervals of market introduction. The strategy and road map were both informed by a technology feasibility study and competitor review, conducted in an efficient and focused manner enabled by the knowledge of prioritized capability gaps for the health goals and target outcomes within scope. Finally, we built a dynamic, integrated commercial and health economic model using all the inputs gained from our systematic analysis. This computed the total cost of DFU care in four markets and also the potential savings from resource reduction derived by the introduction of each of our 8 novel DFU concepts. Performance, adoption, bill of material, margin and pricing assumptions were incorporated to inform a fully-costed business modeling and scenario planning tool.
THE OUTCOME We enabled ITI Scotland to establish a complete picture of how diabetic foot care practitioners wish to improve their capabilities to achieve target patient and health outcomes, given current resources, pathways, stakeholders and modes of practice. Our deep analysis and modeling of diabetic foot ulcer goals, activities, resources, contexts and capabilities - shaped into concepts, strategy, roadmap and value case provided ITI with both the deep understanding, direction AND confidence to address this complex market. As a result, ITI - and later Scottish Enterprise - were able to push ahead with their R&D licensing programme, bringing focus, system and evidence to the innovation activity of both start-up and established wound care technology enterprises in Scotland. ABOUT UMIO Transforming health value... Rethinking health innovation We help health companies, institutions, policymakers and change agents to define, design and shape differentiated, transformational and sustainable health value-propositions, business models, growth strategy and system interventions. We do this by redesigning health innovation itself - the sequence, content and activities for specifying problems, finding opportunities, designing value, framing strategy and co-creating solutions. Our work also helps organisations to become more open and explorative, enabling them to continuously seek out and discover new innovation and growth opportunities. What we can do for you Our thinking, perspectives and methods will help you to: Design transformative health value propositions Shape existing value propositions Find opportunity in adjacent-to-health ecosystems Focus the innovation effort Reduce decision risk - Add evidence Determine an early-stage value case Grow revenues, find an assured growth path and keep learning and evolving ahead of the rest Experience Over the past ten years, we have identified opportunities, validated concepts and designed market strategies and value-propositions in multiple markets, settings, diagnostic and therapeutic areas for global, mid-size and small pharmaceutical and medtech clients, and public sector organisations.
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