Unfortunately, product and medical device development projects can suffer significantly from a wide range of factors throughout the process. Design development is often challenging and risky unless managed appropriately from the start.

At Haughton Design, we’re often asked to step in to save failing projects. Although each project will require a bespoke plan, the following insight into common issues should be helpful to those managing product development projects.


So, what can go wrong? Here’s a round-up of common issues and what can be done to avoid them:


Neglecting to think about how things are made:

Design for Manufacture (DFM) should not be reserved for the final detail design stage. We believe this consideration should be introduced early on during the concept stage, but not too soon that innovation and creativity suffers. Involve prospective manufacturers; they always appreciate being asked and can provide useful insight.

An overly sensitive design:

Mechanisms need to be explored to understand how all attributing factors effect the performance. By modelling dynamic movements using SolidWorks Motion, or similar, engineers can reduce the traditional iterative development processes in understanding performance sensitivity. Designs should be robust and not fail as soon as there’s a minor shift in a parameter, such as surface friction, manufacturing tolerances etc.

Poor risk management leading to an unforeseen failure:

Choose an appropriate level of risk management from the start and consider whether your traditional methods are actually ISO 14971 compliant. You may wish to accompany your FMEA with some targeted Fault Tree Analysis (a favourite of ours!).

Lack of stakeholder feedback:

The design may be pleasing to yourself and your immediate team. However, it can be surprising how other stakeholders will view things differently; keep them involved, and on side, regular status updates and formal stage sign-offs with all stakeholders involved will solve this.


Lack of user/ market insight:

A good designer, will start a project by spending time immersed in the challenge and observing the target market. This time is invaluable – always avoid fast-tracking to the ‘exciting’ concept stage and take time to capture user insights. How can reliable solutions be reached without fully grasping the problem? Invest in this stage as it will drive project performance later on!

Suffering from ‘mindset’ or ‘blinkered’:

This is a common issue we see, mainly if an individual or team has been fighting with a problem for too long… It’s always helpful to introduce fresh minds to the problem. An unburdened mind can flip conventional thinking, challenge constraints and breathe new life into projects.


Some simple activities to negate these issues which can be used throughout a project include:


Review the project frequently both by involving opinions from those outside of the design group and, by depersonalising the project to create a concise CDR document. In addition, gain feedback consistently from stakeholders, users, HCP’s, team members, potential manufacturers – as many people as you can!


Identify weaknesses and bring in new perspectives to introduce fresh thought process’ and ideas. Re-assess the brief and challenge any contradictions.


• When facing a design block or struggling to overcome problems with certain elements, undertake creative sessions such as brainstorming sessions or design sprints. There are also creative tools such as TRIZ for testing technical contradictions and flipping thought processes.


Build prototypes early in the process to test and review! Prototyping provides valuable feedback that is otherwise hard to measure such as proof of concept, technical feasibility, ergonomics, and human factors information.


Boost engineering resource! HD can manage projects for you, or work with your own project managers to suit your own development plan.


Please get in touch to find out more about working with the team at HD to solve your product and medical device development challenges.

David Mills - Medical Device Managing Director at Haughton Design David Mills 2 September 2021


Get in Touch with David Mills

Managing Director

David is able to draw on over 30 years’ experience in a wide range of design, development and project management. Originally apprentice trained with a HNC in Mechanical Engineering, he has extensive knowledge in designing for manufacture. A strategic thinker and co-founder of the Medical Devices Alliance, he keeps a close eye on business performance and developing the team around him. He enjoys spending time with his family, mountain biking and bodyboarding in his spare time.

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