Bridging the 'skills gap' for near-patient diagnostics
This article has been taken from The Gen newsletter - Summer 2008.
Click here to download the pdf.
In many clinical situations, there is a growing trend to decentralise testing. This trend moves testing from the central hospital laboratory into the emergency room or ward, from the hospital to the doctor's surgery, and even from the surgery to an over–the-counter solution. However, whether in the hospital or home, for a point of care (PoC) system to be successful it must also be intuitive and easy to use, and be able to deliver results that are fast, accurate and unambiguous, leaving no room for misinterpretation or error. Diagnostic companies of all sizes, from the smallest start-up to the largest multinational, are looking to exploit this evolving trend. The expertise required to design and develop these highly sophisticated products is often outside their core development skill and they need outside expertise to create a truly successful system.
Driving these developments even faster is the fact that patients and doctors want test results more rapidly. Speed has always been an issue in diagnostic testing. By moving the test from the laboratory into a local device, the inherent speed of the whole testing process increases significantly, and this presents further engineering and project management challenges.
To truly capitalise on this market opportunity, the right skill set is needed. From our own experience with clients with which we’ve partnered, we’ve identified that device developers need three distinct skill sets:
a solid understanding of disease pathology and diagnosis, often based on leading edge research
the ability to create a well engineered device which can produce the required performance, accuracy and repeatability
and a firm understanding of what is required to deliver a positive user experience and meet regulatory requirements.
Companies will possess the specific scientific expertise required to create the test, but could often lack the wider scientific, engineering, product design or even business skills necessary to turn their assay into a usable system.
Creating a tiger team
Partnering can offer a bridge for these skill gaps, providing access to individuals and processes necessary to create a collaborative team that builds on internal resources. It is essential for the team to have the expertise to break down what can be an exceptionally complex concept into medical, legislative, technical and user needs.
Generally, the skill set needed on these projects, with the exception of a few areas of specific expertise, is the same. However, we have found the availability of in-house skills to vary significantly from company to company. It is also our experience that the portfolio of team roles and skills will change throughout the process with different activities taking the lead. Flexibility to deal with the resource levelling is therefore imperative.
From the initial project conception, it is vital that the team has the ability to consider device design from the perspective of the potential user, whether nurse, doctor, paramedic, surgeon or consumer. Physical appearance, usability and clarity of results, perhaps considered cosmetic by many companies, can in fact be the real reason for success or failure no matter how impressive the efficacy of the test. The multi-disciplinary team must possess the necessary skills to carry out Voice of the Customer (VoC) research to really understand the needs of future users, and the context in which the device will be employed. By involving the members of the core team, the transfer of this knowledge into the product is seamless making the achievement of a CLIA (
Clinical Laboratory Improvement Amendments)
waiver easier to obtain – critical if individuals are to use the product without formal training.
In almost any sector, it’s true that the smaller the device the greater the engineering challenge. For PoC this is increased by the need to manipulate small volumes of fluids and avoid cross contamination. Many technical solutions can often fail when manipulating interdependent components within a very limited physical space. A combination of understanding the science behind the test, the science to measure and analyse the results and wide-ranging engineering skills, especially in miniaturisation, can aid development of a much more reliable and robust solution.
From start-ups to global companies
We’ve found that smaller organisations often require help to build on a test to create a product road map and development plan capable of sustaining their business in the longer term. Financial backers often look for this road map to ensure cash flow is maintained and a viable long term business is created. Strong business and market skills need to be applied to make sure this is in place and can be verified.
In contrast with start ups or smaller companies, larger global companies often have the majority of resources in-house and want to create products quickly and successfully. They may require access to the necessary and relevant engineering expertise to realise their product. If this is a non-core activity they don't necessarily want to build up an in-house team, for example. We also find that these larger companies appreciate the new perspectives an external partner can bring. Inertia and procedural roadblocks can build up within these companies, stifling new product development and compromising time to market – essential if market dominance is to be established and maintained. New perspectives help break down these barriers.
It’s clear that the availability and demand for fast and accurate point of care diagnostic devices has increased markedly in recent years. A more sophisticated understanding of specific diseases and conditions is being matched by the rapid development of testing technology and detection technologies are becoming more accurate and reliable. The miniaturisation required to turn a lab-based test into one that can operate satisfactorily as a hand-sized unit is now a more mature engineering discipline, for example, and the wider acceptance of handheld devices has encouraged faster adoption by the medical community. We’ve bridged the skills gap for many companies, helping them from core science and engineering through to market. It’s through this work that we have identified that creating a team with the right skills mix, that can bridge the skills gap to deliver against this challenging task, is imperative for ultimate success.
The challenge was to take an early-stage prototype that had been configured for the military market and redevelop it under ISO13485 for use in a clinical environment. This point-of-care application would enable the client’s technology to be commercially exploited in a new and growing market.
This project was undertaken as a team effort, with close involvement from the client throughout. Specifically our input focused on:
gathering of extensive VoC information
development of agreed product specifications
development of the core technologies within the system, using a combination of practical science skills and good design practice
concept generation of a number of system architectures
successful integration of industrial and technical requirements
Sagentia enabled the client’s predominantly life science based employees to realise their desired product development. The result was a universally accepted industrial design of an expandable PoC system with a clear brand identity, including competitive costs for the system’s high volume consumable.