Last week, in association with SEHTA, we hosted the first in a series of three webinars dedicated to the design and development of Medical Devices.
eg technology’s Director and Co-Founder, Danny Godfrey kicked us off on Wednesday by looking at the key aspects of the early stages of a successful product development programme, focusing on the most important, yet often overlooked factor – the user.
New product design for medical devices is complex. There isn’t an easy, shortcut route to market and the process is comprised of multiple necessary steps and stages. However, as each device design is varied, so is the focus and approach throughout the project… no two projects are the same. For example, there will be different areas of emphasis within a design programme when designing a single piece implantable, in comparison to some complex lab automation. Despite this, there are common stumbling blocks within the design process which tend to cause confusion and as a result are sometimes omitted completely. These often involve consulting the user at the start of the programme, defining specifications and undertaking software design within a medical framework. These last two will be tackled in future webinars.
So how can we improve our understanding of the user and create a user-centric design process? Here are five key takeaways from Danny’s webinar.
1. The full process must be considered
Having that initial brainwave which sparks the product design process can lead many engineers to get ahead of themselves. However, product design, specifically within the Medical sector, is a stringent process which typically has a cycle of between two and five years, especially when ground-breaking tech is involved. Even simple product iterations will be subject to the same overall process. So, what are the key areas which need to be considered? Among others, you will need to consider: available technology, finance, the target market, the team required, regulatory requirements and finally, the User. It is easy to neglect any one of these factors, but each is dependent on the other and if one is neglected or omitted then the programme will usually run in to difficulties.
2. Why is the user important?
Engaging with the user can be done at several stages in the development process. Initially, you will be able to assess whether there is actually a need and a market for what you are planning. Thereafter, you can gain insight into the practical application of a product, and this can be fed into the User Requirements Specification. Whilst your team may be filled with very capable engineers and designers, they will not be immersed in the day-to-day experience of clinical use. Their technical skills therefore need to be guided by the knowledge of users, without which the likelihood of the product being successful is minimal.
Even within set verticals, there are multiple user groups, all of which may have different requirements. Identifying the complete network of product users, from consultant to nurse to patient enables designers to develop a product which addresses the full spectrum of user issues. An understanding of the infrastructure of the user organisation is also vital. Larger organisations have stringent procurement processes with multiple departments and budget holders involved in a single purchase. Developing a product with this in mind will mitigate the likelihood of facing barriers later in the procurement process.
3. What is usability?
Usability seems an obvious inclusion in product design, but even the word “usability” can mean different things to different users. However, in the context of medical device design, it has a very specific meaning associated with designing a device to be inherently safe. Although different user groups will have requirements regarding aesthetics, ease of use, portability, comfort and reliability to name a few, the common usability requirements across users are the safety, intuitiveness and reliability of a device. Medical devices must have minimal margin of error, be easy for the operator to use and safe for all involved.
4. Get to know your user
So, how do you start to find out all of this information? Talk to the users. This may seem daunting, but there are numerous approaches you can take. Firstly, look at your personal network; do you have colleagues or friends who can provide you with an introduction? A personal referral will generally open doors, not cost you much more than a cup of coffee and may lead to further opportunities. Secondly, you could make a direct approach to hospitals, patient groups, key opinion leaders and charities. This may require more time and determination, but many hospitals have a service to support new product development (although this can be hard to access), whilst patient groups are generally open to ideas which may help improve the quality of life of their members. Finally, there are a number of specialist agencies who arrange introductions for a fee. There is obviously a financial implication to this, but is certainly a quicker route to the right people.
You should typically look at talking to a minimum of six to eight users, ideally individually, to gain a good insight and identify areas of consensus. However, this group should demonstrate diversity in job role, location and background to ensure that you receive a wide picture of the product requirements.
5. Be prepared
Once you have secured your user interview and chosen a suitable, private venue to meet, it is important that you understand the persona of the person you are speaking to. They will often be time poor, over stretched and keen for solutions, so understanding who they are, their motivations and whether or not they are a typical user will help guide your approach. Are they representative of the user group or do they have a strong personal opinion? Make sure you talk their language. You should understand the clinical area and understand the terminology and care pathway as well as possible. Stumbling on this will be a quick way to alienate the user.
You should outline your objectives prior to the interview. Are you looking for commercial insight, the first stages of a User Requirement Specifications or a more hands-on formative study? By asking the right questions, you should be able to identify whether your idea is suitable, whether there might be a better approach which could solve additional user issues and also gain feedback which could guide early prototypes for formative studies.
With this is mind, it is extremely important that you legally cover yourself. Prior to having sensitive conversations which may leave your IP unprotected, ensure you have an NDA in place.
Finally, make sure your questions are consistent, open-ended and offer the user the ability to provide additional information wherever possible. Keep asking who, how, what, where, when and then follow up with why. You want to get their opinion and full thought process to ensure you have as much information as possible, as the output from your interviews will form the specification for designers.
This insight-led design will create a more user-centric and efficient design process. So, make sure you keep the user at the heart of your design programme.
Join our next webinar on Tuesday 16th June at 10am as we look at writing User Requirement Specifications and Product Requirement Specifications, their importance within the product development process, how they differ and more importantly, how to define them.
For more information or to chat to one of our team about your medical device product design and development process please do not hesitate to get in touch:
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by giving us a call on +44 01223 813184
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