Additive Manufacturing

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 vast experience of working with the following processes:

Fuse Deposition Modelling (FDM)
Rapid Machining
Selective Laser Sintering (SLS)
Vacuum Casting
Stereolithography (SLA)

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: Integrated Manufacture of Polymer and Conductive Tracks (IMPACT)

IMPACT is an InnovateUK funded project focused on the development of a new 5-axis 3D printing capability that is able to deposit polymer (using the Fuse Deposition Modelling process) and conductive ink within the same build volume. The 18 month programme, which was completed in March 2019, brought together a number of leading industry and academic partners that included: C Enterprise Ltd (CEL); Printed Electronics Ltd (PEL); Warwick Manufacturing Group (WMG); and ITERATE Design + Innovation. The output of this collaboration was an industrial grade platform capable of producing fully functional electro-mechanical parts 500 x 500 x 500 cm in size.

ITERATE worked alongside Ambionics to create a lower arm prosthetic that leveraged the capability of this new technology. Prosthetics are often difficult to manually assemble due to their complexity and are also weight critical. Prosthetics that are uncomfortable to wear, over sized or too heavy are rejected by the user. This prosthetic incorporated silver ink tracks, which removed the need for copper wires. Using a myro sensor connected to a linear actuator, the thumb opens and closes to create a firm grip when the user tenses a functional part of their arm, which is located inside the socket.

Through the undertaking of this project, ITERATE accumulated a vast amount of knowledge on how to design 3D printed polymer parts that integrate conductive tracks. This new technology has the capability to create fully functional electro-mechanical products straight off the machine bed. The 5-axis capability ensures that the parts created has a much higher structural integrity than those created on a traditional 3-axis machine. Whilst this project concentrated on producing a lower arm prosthetic, the potential for this technology to be applied across the aerospace, automotive, medical, consumer and industrial sectors is huge! To see the result of this project, please click here.

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 products that achieve commercial success. If you would like to discuss your project, please email gethin@iterate-uk.com or call 01291 442181.