Opportunity Analysis

MediPath^TM Innovation Roadmap Stage 2 – Opportunity Analysis

Developing medical technologies is a high-risk business, with an estimated 80-90 per cent of new product launches either failing or not meeting their sales and marketing objectives.

Opportunity analysis is where we consider all the factors that feed into an innovation – how it fits into the market, what needs it is meeting, how it is differentiated from competitor products and the generation and selection of top concepts that are commercially viable. In addition, opportunity analysis usually includes an early assessment of intellectual property. These steps all contribute to build knowledge around the product to avoid potential market failure and to maximise profitability.

Questions to consider when reviewing a new product opportunity:

1. Is it something the customer actually wants?
2. Are there enough customers who want it?
3. Can it be made and sold at a price that allows the seller to make a sustainable profit?
4. Can it be sufficiently differentiated from competitor offerings?

How things can go wrong

An interesting case study of the impact of failing to understand the market comes from the experience of Interleukin Genetics who developed a genetic test to diagnose periodontal disease. This contradicted existing clinical guidelines of the American Dental Association who stated that ‘clinical measurements remain the single best method for assessing disease’. In essence, the company was unable to articulate the benefits of the technology sufficiently enough to challenge the status quo, resulting in market failure. Ultimately, the company’s repeated failure to understand the market led to lay-offs for the majority of its staff and the search for buyers for its intellectual property.

Unmet Need Identification

Defining an unmet need, which is essentially a problem without a solution, is the most important and perhaps the most challenging aspect of new product development. There are many different methodologies which can be employed to identify and validate unmet needs. These range from traditional market research, such as questionnaires, interviews and surveys which can be very useful at driving incremental innovations. However, such techniques have limitations and when looking to drive radical innovations it is important to use more sophisticated techniques such as lead user and ethnography methodologies, which can help innovators identify problems that their end users cannot articulate.

Converting Needs to Design Inputs/Outputs

The process of evaluating and analysing user needs requires a process that involves prioritising and segmenting the needs into secondary and tertiary needs, which are to a sufficient level that they are measurable. These segmented needs can be translated into design inputs and design outputs, which govern the performance and safety of the device. This process is also the basis in which validation and verification is based, which is important for the regulatory documentation and shows that you have made the right device (validation) and you have made it right (verification).

Concept Selection and Validation

The prioritised needs are the ideal starting point to generate concepts and solutions, which are based on the validated problem. Although there are many creative tools that can also be used to generate new concepts, the most important phase is to select the best concept, which meets both market and business needs. There are many innovation tools that are powerful, not only in selecting the optimal concept, but can also be used to identify deficiencies that can be improved by iterative design modifications. One key element of concept selection is to ensure that the process involves benchmarking against the market leader, other key competitors and indeed some of your own alternative concepts. Once the leading concept(s) have been identified, an additional key step is validation with the intended users. The above process is a powerful means to reduce commercial risk.

Preliminary Intellectual Property

The competitor analysis discussed above combined with the development of new concepts, can be used to determine: i) is the new concept patentable; ii) is there freedom to operate. The patentability is based on whether it is novel, non-obvious and reduced to practice, and some thought and creativity should be used when articulating a concept to highlight that it meets these criteria. Freedom to operate is not necessarily a terminal barrier but may require a strategy that involves licensing appropriate IP or designing modifications to the concept which will circumvent existing problematic IP.

Intellectual property does not need to be limited to filing patents to protect the technology, but may involve design patents, creating trademarks, copyright and other legal means to protect important features of your product and the means by which it might be branded and/or marketed.

Tailor your roadmap to your device – free consultation

The Innovation, Commercialisation and Regulatory Team are offering a new service in which we walk through the MediPath™ tool, starting from an introductory half-day session to more detailed evaluations and support depending on your needs. 

If you would like to discuss any of these stages or to understand how the roadmap can de-risk your innovation and accelerate the speed to market, we are offering a free 30-minute consultation. Contact us on [email protected]

Patrick Trotter PhD MBA (TechMgmt), Stefanie Lowry BSc, MSc