Table 3 Checklist for evaluating new healthcare technologies in the B2C telemonitoring of chronic heart failure
Issues | Assessmenta | Explanation |
|---|---|---|
1. Understanding the Black Box | Small risk | Telemonitoring (i.e. measuring and transmitting physiological signals) consists of two parts – the algorithms aiding the nurses in reviewing the physiological data coming from the patients, and the telecommunication technologies – both with widely understood scientific mechanisms. |
2. Depth of research | Medium risk | There is a substantial amount of research on the clinical effectiveness of heart failure monitoring, with promising results, but not so much on cost-effectiveness. The available meta analyses show improved survival and better outcomes with telemonitoring, at same or higher costs. |
3. Downside risks | Small risk | Telemonitoring does not interfere with bodily functions. The care is provided by registered telemonitoring nurses while cure is administered by physicians and pharmacists. |
4. Financial considerations: • Market acceptability to medical personnel? | Medium risk | Telemonitoring technology is not excessively innovative or disruptive to the healthcare process. The business model (B2C) is an extension of the existing one (B2B), and the novelty revolves about logistics and operations. |
• Are technologies financially beneficial to adopters? | Small risk | A chronically ill person will spend approximately 1–2% of their average monthly income on a telemonitoring service. There is no risk in “over-spending” and no financial risk for the patient but the payment-borne-by-consumers model demands high attractiveness of the service to customers. |
• Creation of “turf warfare” among different physician specialties? | Medium risk | As B2C telemonitoring is directed toward the patients/consumers it is opening/creating a market and not encroaching on existing “turf”. However, telemonitoring centres can be seen by hospitals as competitors rather than complementary organizations. |
• Requirement for new types of medical personnel? | Medium risk | There is risk associated with the creation of a telemonitoring centre staffed by telemonitoring nurses in any jurisdiction. Creating the site, drafting and training personnel is risky. |
• Do technologies fit existing coverage, coding, and payment regulations? | Medium risk | With such a large population of heart-failure patients in the world today, the regulation is slowly turning to full coverage and payment for telemonitoring. |
• Do technologies create a product and/or customer pipeline? | Small risk | More advanced monitoring systems and packages tailored to individual patients (or other chronic patients) can be introduced later by adding new customer “pipelines”. |
• Market size and ease of penetration | Small risk | The market is not very large in Singapore and is therefore easier to penetrate. The US or EU markets are bigger but harder to penetrate. In terms of disease prevalence, the global market for telemonitoring CHF is similar to the general population, i.e. 1–2%. |
5. Regulatory issues: Seriousness of Problem | High risk | The FDA in the US has started to look over the medical app market and it is likely that clearance will be needed (likely other jurisdictions will require regulatory oversight). At the moment this risk can be averted by carefully making associations with existing healthcare organizations. |
6. Potential competition from other technologies | High risk | There’s not much protection in telemonitoring apart from the algorithmic core, resulting in fierce market competition if new players enter the field. However, a telemonitoring centre is a huge deterrent to any party wanting to go with a purely device/service-based business model. |
7. Likelihood of obtaining a patent | Small risk | Patents have been granted on the technologies involved in telemonitoring, on algorithms and software. The business processes and the business model cannot be patented. |
8. Production considerations | Small risk | The development of the software/app will have to follow regulatory guidelines. However, once in place and clear of production issues, the service can be easily upgraded and distributed. |