By Colette Hamilton
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31 Oct, 2022
The chances are, if a physician decides to adopt your new technology into their daily practice, they will first need to secure approval from a clinical governance oversight body and the relevant budget holders. To do this, they will need to submit their case for investment and evidence backed assurance that the technology in use is both safe and cost effective, compared to currently available treatment options. Collating supportive evidence and building the case is time consuming. Doctors may have neither the time and/nor expertise to do this themselves, and limited access to the right in-house support. For these reasons, MedTech industry marketeers sometimes create an off the shelf business case for doctors, to save them time and avoid multiple doctors having to reinvent the business case "wheel" across the healthcare system. However, because hospitals are cash limited, when budget pressures are high, many business cases are rejected or deprioritised and parked until the next round of funding round. There are many reasons for this, falling outside the scope of this post, but here we focus - on the quality of the business case itself and list the top 10 reasons why business cases fail: Business cases that have a low chance of success are characterised by a failure to: INSTIL TRUST - marketing departments treat the case as though it were a piece of marketing material and cover it in branding. This raises concerns about commercial bias for decision makers. ADDRESS THE RIGHT AUDIENCE - the case is made from the perspective of the supplier and the physician i.e., the technology user, instead of the stakeholder who will be making the decision. The case therefore fails to address what's in it for them if they invest. In building the case, the developer has failed to consider what keeps the decision makers awake at night, along with the behavioural incentives and disincentives which will impact on their decisions. PROVIDE ADEQUATE CONTEXT - context matters. For example, if the new technology addresses an area of high unmet need and there are no effective alternatives, or if the existing standard of care has very little evidence to substantiate it, other than "it has always been done this way", then the evidence supporting the case may be scrutinised through a different lense. INCLUDE ALL OPTIONS - economic decisions are all about balancing benefits and risks, based on understanding the that "if you do this" then "you can't do that". Decision makers expect a full appraisal of options for solving a particular healthcare challenge, including alternative drugs, devices, digital health products, combinations and the "do nothing" option. ADDRESS ORGANISATIONAL PRIORITIES - hospital providers operate within their own organisational ecosystem, with their own goals, objectives, pressures and cadence of decision cycles. They must also operate within externally imposed boundaries, such as laws, policies and contractual commitments. For example, if the hospital needs to free up theatre capacity to clear an elective waiting list backlog, then a case that focuses on surgical hand strain isn't going to hit the right chord compared with another that does. If the clinical director of the surgery unit is an upper GI surgeon and needs an electroporator, then it's likely to be prioritised over a business case for disposable instrument packs for gynaecology. ADDRESS HORIZONTAL IMPACT - decision makers need to understand the impact on costs, capacity and workflows across budget and organisational silos, including for support services, such as porters and patient transport and path lab services etc. ADDRESS LONGITUDUNAL IMPACT - decision makers need to understand the impact along and even beyond the patient's episode of care. Will the new technology have in impact on length of stay, readmissions within 30 days and emergency visits? ADDRESS COST IMPACT - when economic studies, or clinical studies with economic end points, are published, they invariably address the question of cost effectiveness or cost utility. However, whilst useful when comparing the relative merits of competing priorities, these don't address the financial impact for the hospital i.e., the impact on operating costs; income and financial flows across budget silos. These must usually be calculated or estimated for the purpose of the case, using a budget impact model. CONSIDER IMPLEMENTATION - in order to understand now benefits, risks and costs will change over time, a detailed implementation plan should be included with non-recurrent implementation costs, phased activity costs, timelines and discounting of benefits. COMMIT TO MONITORING & EVALUATION - essentially a business case is a commitment to deliver Y benefit for X investment. Without a plan to monitor if cost estimates were accurate, and benefits were delivered, the business case is incomplete. Of course, business cases that strongly address the above points have a high degree of success, subject to other conditions being met. See "Conditions to Meet to Unlock Investment by HCPs in New Technologies". It should also be noted that many hospitals have a proforma based system for submitting business cases so the case should be structured to allow easy cutting and pasting of content into the proforma. The business case and financial modelling methodology deployed by Imperetus has a 95% success rate across the EU.