Medical Product Design

Case Study: PulmonIR

PulmonIR is a medical technology start-up. The company was established in 2016 with the purpose of exploiting intellectual property that had been created as a result of research undertaken at Swansea University. The company secured an InnovateUK Investment Accelerator Award in order to create a functional diagnostic device.

The challenge involved creating a high level functional prototype that seamlessly integrated mechanical product design; electronic controls and a MEMS based infrared spectrometer to clearly demonstrate the product benefits. The device is intended for use within clinical and laboratory environments; a strong focus was placed on minimising product size so that the footprint was limited.

The functional medical device incorporates a MEMS based infrared (IR) spectrometer. This enables users to deposit a sputum sample in to a collection tray and insert it in to the unit. The IR technology can identify specific wave patterns associated with lung cancer and provide an indication of whether a patients needs to be referred for a CT scan to confirm the presence of the disease.

A Selective Laser Sintered (SLS) enclosure was produced and finished using durable gloss black and satin white paint. Custom metal work enabled the touch screen display, control PCB and IR technology to be firmly held in place. Furthermore, the device demonstrates first class design practices as the product can be fully dissembled and recycled after its life-in-service. To see more projects like this, please read our Case Studies.

Having developed a number of medical and healthcare products, we have identified a series of success factors that are common across the projects we have helped deliver:

• Understand the user: whether the intended user is a doctor, surgeon or patient, it is critical to understand how they would engage with your product. Functional prototypes are a sound way of obtaining user insight so that the product can be optimised for their needs. For example, when developing a respiratory product we identified that the target patient group also experienced dexterity problems as a result of their condition. This led us to focus on scaling-up some of the smaller components that were previously difficult to handle.
• Understand the environment of use: the environment of use can often impact on the preferred aesthetic. For example, a device that is intended for use within the home is likely to look very different to a device that is intended for clinical use. If a medical device was styled to appear more like a ‘consumer’ product, it would better fit in to the home environment but may also encourage the user to engage with it more readily. The appearance of a product used within surgery may need to be structurally robust and autoclavable; and therefore, its visual appearance is of less importance.
• Identify the testing requirements: the development and supply of new products within this sector is highly regulated and controlled by the Medical Devices Directive. Products are categorised by different ‘classes’ that determine the level of testing, risk analysis and regulatory approval, which is required before product launch. It is important to clearly define the classification of your product as this will affect the cost and time needed to realise your device. Correct classification is a specialist area of knowledge and a third party should be consulted.
• Establish the route to market: understanding how you will sell and distribute your medical product is critical to its success. Many believe that the NHS will simply purchase their product if it offers significant enough benefits, this may be the case; however, reaching those decision makers can be a lengthy and convoluted process. Your product may also displace an existing product or process – implementation of your offering may require change to occur and delay its adoption. A route to market should be clearly defined from the outset, with ‘thought leaders’ being involved in the product development process who could potentially influence buying decisions.