If a concept for a device is new to the client’s portfolio of products, the first challenge can often be identifying whether the device would be classed as a medical device, and if so, which class would it fall in to. In basic terms, the answer to this question is based on the potential risk it poses to the user. The FDA provides a list of existing device categories and their classifications for guidance, but it can be worthwhile getting expert advice at this stage to ensure the right processes are followed throughout the device development.
Complying with the correct government and industry regulations helps ensure that the device won’t get rejected by the client or recalled after launch. At Haughton Design, our design processes are certified to ISO:9001 and ISO:13485.
When designing a medical device, it’s important to bring in the right expertise to help plan the project as some aspects of the process can take longer and more effort than expected. By planning some stages to run concurrently with others, the overall timeframe of the project could be reduced. For example, producing purely aesthetic prototypes can enable formative human factors studies to take place whilst the detail is still being worked on.
One of the defining characteristics of most medical devices is the ability to carry out its function accurately and repeatedly, whether it’s delivering a measured quantity of a drug or diagnosing a disease from a measured quantity of pathogens detected in a sample. The device needs to be manufactured in a controlled way, but also designed with any critical tolerances in mind from the beginning. Critical areas should avoid large tolerance stacks, where perhaps multiple components fit together.
Material choice is sometimes overlooked in the development process which can lead to low quality parts, feature failures, changes in dimensional stability, stress cracking through chemical contact, or other unanticipated results such as squeaking components. These failures could cause easily avoidable harm, just by selecting the wrong material.
Intellectual Property (IP) is highly protected in the medical device industry so ensuring that your design doesn’t fall foul of any existing patents from the offset could save a lot of time and money further down the line. Before we begin any new project here at Haughton Design, we typically carry out an Immersion stage where existing products and risk of IP infringement can be identified.
With the Covid-19 pandemic influencing supply chains of many industries, delays and price increases are increasingly common so it’s important to put contingency plans in place for any supply issues that could occur. If suitable, using generic materials and components can reduce the reliance on any one supplier and avoid needing to re-test or even re-design devices in the unfortunate event of delays or a dramatic increase in cost.
The team at Haughton Design uses a wealth of knowledge and experience to avoid these common problems and overcome challenges that clients face when developing a new product or medical device – get in touch to discuss how we can help you.
Design Director
Mark ensures that projects are delivered on time and are suitably resourced to guarantee quality of output. Mark is heavily involved in our design services, having a wealth of experience in healthcare devices, trainer devices, IVD’s, and inhalation.
Mark holds a Bachelor’s Degree in Product Design along with 20 years’ experience working on a wide range of design projects.
Get In Touch
Discover how Haughton Design's diverse team leverages their extensive experience to drive innovation in device development. Learn about our expertise and unique insights that ensure successful project...
Explore how commercial constraints influence innovation in businesses. Discover whether budget limits, regulations, and market pressures drive creativity or stifle progress in today's competitive land...
HD strive to foster effective collaboration on all projects to push boundaries in innovation. We discuss how collaboration with the NHS can provide unique insight....
Why do we trust the accuracy of digital devices more than their non-digital counterparts? HD discuss the 'why' and how this improves device development....
We discuss the whether the medical device industry can embrace paper as a viable alternative to plastic as we advance towards Net Zero....
What is the impact of emerging technologies on medical device and product development? Design Engineer, Dan Kirkham, discusses their applications....
We discuss transforming medical device development through the utilisation of interdisciplinary, and cross industry teams....
A pharmaceutical company approached HD to enhance the performance and improve the usability of a Dry Powder Inhaler within a short timeframe and, a tight budget. ...
Pharmapack 2024 was a captivating blend of innovation, collaboration, and foresight. Read our round up of the eco-focused event here....
2023's DDL event brought together industry experts in the field of respiratory health. Here we discuss the latest breakthroughs and innovations....
Should Human Factors as a standalone discipline be made redundant? Design Engineer, Elena, considers this for medical device development?...
Can we achieve the perfect balance of usability, sustainability & connectivity in medical device design? Design Engineer, Rob, considers how....
2023's PDA & PODD conferences provided valuable insight into the drug delivery industry. Here we discuss trends and hot topics from the conferences....
Ahead of the 20th PDA Universe of Pre-Filled Syringes and Injection Devices Conference, we cover where medical device innovations are expected to go....
As the world becomes increasingly connected and user needs constantly evolving, the design of safety critical IFU’s must keep up with this. Design Engineer, Rob, discusses the future of IFU’s, and...
With the speed at which the medical device world is changing, collaborative partnerships will be essential for success. HD discuss the benefits....
