Medical Product Design

We design innovative medical and healthcare products around the needs of the user, which offer clinical and lifestyle benefits. Our experience within this sector is varied and extends from lower arm prosthesis; diagnostic devices and sharps disposal systems. Our team will help define your product concept and assist you through the entire development process, allowing you to realise a full working prototype that is fit for final production and assembly. Given the highly regulated nature of this sector, we develop all medical products using a systematic approach that enables risks to be assessed and minimised at key points. Our internal design management processes ensure all decision making and engineering rational is fully documented.

Our team has experience of developing products in the following areas:

Diagnostic Devices
Intravenous
Prosthetics
Respiratory
Sharps Disposal

Our Approach

  • Foresight

    We will clearly define the scope of your project. Understand the target user group and identify any potential technical, commercial or intellectual property barriers that may prevent your product from getting to market.

  • Concept

    We will generate an array of design ideas that address your project brief and present them in digital sketch format. A strong focus will be placed on adding value to the product by understanding the user’s needs.

  • Development

    A preferred concept will be developed in order to create a refined design solution. Even at this early stage, we will consider the intended manufacturing process; material; finish; assembly process; and disposal method.

  • Detail

    Once a final design has been selected, we will create a detailed 3D CAD model of your product. If your device requires custom electronics, this will be developed concurrently to the mechanical element of the design.

  • Prototype

    Using the latest technologies, we can build a full working prototype of your product. Such a high fidelity demonstrator can be used to communicate the product benefits to investors and obtain quality user feedback.

  • Optimise

    This phase is dedicated to preparing your product for manufacture; ensuring that all 3D CAD models are fully optimised and that critical to quality (CTQ) features are properly specified using an engineering drawing.

  • Certify

    It is likely that your product will require accreditation, which can be obtained from a number of certified bodies following rigorous testing. We can advise on relevant third parties capable of supporting product approvals.

  • Manufacture

    We have established a network of manufacturing partners in the UK and Far East. Via this network, we are able to produce your product and supply it fully assembled and tested to a given standard of quality.

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.

Success Factors

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.

Gethin is an expert designer who provided some excellent design consultancy work for Olberon Medical Innovation. He is conscientious, personable and a professional individual. ITERATE respect your time-line and provide work of a very high standard. I wholeheartedly recommend their product development services.

Dr Arash BakhtyariCEO (Radiologist)Olberon Medical Innovation

How Can We Help?

We love working with ambitious clients, solving technical challenges and creating great medical products that achieve commercial success. If you would like to discuss your project, please email gethin@iterate-uk.com or call 01291 442181.