Developing a new medical device can be a multi-million-pound venture. There is no simple answer to the question; “How much does it cost to manufacture a medical device?”. Design Development Engineer, Phil, discusses just some of the ways you can reduce new product and medical device manufacturing costs.

Developing a device through to the manufacturing phase and eventually on to its release into the market can be a long and costly process. Medical device manufacturing costs are influenced by several factors. In this article, I will briefly cover; component design, design for manufacture, material selection and packaging.

The physical form and design of a product or medical device has a significant impact on manufacturing costs. Therefore, it’s important to optimise the size and not overcomplicate the design of the components in your medical device by including unnecessary features. The more complex a part design, the more sophisticated and complex the injection mould tool. Overly complex tools are the worst way to sap the cost of your medical device development budget, increasing tool manufacturing and trial times. Streamline your device by removing any features which do not directly contribute to the function of the device or add to its ultimate market appeal.

Additionally, employing DFM (Design for Manufacture) principles to optimise line of draw, component depth, wall thicknesses, draft, feed points, material flow and cooling will ensure the moulding process is quick, and cost effective in high volumes. Careful consideration of these requirements in component design ensures accuracy, minimizes defects, and reduces scrap rates – all significant contributors to the cost of components and the final product or device.

Material selection is also a key driver in the success of the device, from both a functional and cost perspective. There is an abundance of engineering grade materials out there, all claiming to perform the best in the areas that count for the component being designed. Some materials may also be a fantastic environmentally friendly alternatives to the big brand names and more commonly known materials. When considering the required material characteristics and performance of engineering polymers, some grades are fantastic. My mind is blown after each meeting with new polymer manufacturers or suppliers with how these engineered materials keep pushing the boundaries of what is possible. Especially the newer eco, bio-based alternatives which perform just as well as traditional polymer grades.

The breakthroughs in the potential sustainability of the polymer supply chain for the future look very promising. However, there is always a balance of things and compromises to consider, so you should specify the correct polymer for the job. Often there are times when expensive, high performing engineering grades are selected for components which are only going to be used in a single use or very low life cycle device. Sometimes these materials are selected for components with clips that clip just once before being disposed of, even though the polymer can perform thousands of clipping cycles before failure. In areas like this, where possible, considering lower performance and cheaper base materials for your device is a way to help reduce costs without impacting functionality or quality of the component and final device or product.

Often, we are asked to not only design a device, but also the device(s) packaging. There are plenty of costs which can be stripped out of device packaging, and it has a bigger impact on cost than you may initially think. Excess packaging is not only wasteful and often damaging to the environment, but it adds to the overall size and weight of each unit, which therefore increases shipping costs. If there are millions of devices being shipped worldwide, the extra costs soon add up!

Regular design reviews are always a great opportunity to double check if there has been any neglect or oversight of human factors during the development phase. Attempting to incorporate a user centred approach to the device design late on in the project can be disastrous on a development budget. Thoroughly appreciating human factors should be one of the top priorities of the concept stage, and not be an afterthought just before the device is ready to be released for human factors trials.

Having regular input and design meetings with your intended manufacturer during component development is a highly effective way of quickly identifying potential areas for cost saving. It will identify opportunities for tooling simplification and areas where a reduction in part thickness could be adopted. By questioning and considering the necessity of all features can be a great way of reducing complexity and removing any unnecessary material. Utilising a final CDR (Critical Design Review) to evaluate the design and functionality of the device before pressing the button on cutting a tool is essential.

Keeping unnecessary complexities out of the design, choosing appropriate materials, and employing DFM techniques without reducing quality, usability or functionality is a real balancing act between innovation and cost optimization. However, at HD we have a great depth of experience in our medical device development team. Having walked the device development path many times helps us to pinpoint the areas that can be optimised on new medical device projects. As a medical device developer in the UK, HD understands what it takes for a device to survive in a price and quality sensitive market. Making innovative, customer-centric devices at optimised costs offers a critical competitive advantage and can boost overall revenue for our clients.

Here at HD, our med tech and pharmaceutical clients are continuously impressed by our DFM expertise and the subsequent costs this saves them throughout their projects. If you would like to learn more or discuss a project, please get in touch.

Phil Sampey 8 June 2022

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Get in Touch with Phil Sampey

Senior Design Development Engineer

Phil graduated from Staffordshire University with a degree in Automotive Technology. Since joining HD, Phil has primarily been working on a number of medical device projects, supported by his wide range of experience from prototype manufacturing, plastic injection moulding and CNC machined parts, to designing bespoke gearbox systems for various industries. Phil also assists with the management of our ISO 13485 & ISO 9001 QMS and network of approved manufacturing suppliers.

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