It is estimated that diabetes affects 387 million people worldwide, with 52 million living in Europe1. By 2025 it is estimated that over four million people will have diabetes in the UK alone, according to the Diabetes UK 2010 report2. With this number only set to increase, self-management in the treatment of diabetes is vital to providing a great quality of life for the patient.
Over the past decade, the development and advances in injection pen devices have simplified the administration of insulin, making insulin delivery easier whilst increasing accuracy. Research into the advantages of insulin pen delivery include; improved patient compliance and greater acceptability3 as well as improved health-related quality of life4.
Owen Mumford, a global industry leader in medical device design and manufacturing, understands the importance of self-management in the treatment of diabetes. Owen Mumford’s Unifine Pentips Plus pen needle (designed to encourage frequent needle change and provide a more comfortable injection experience) recently received the Red Dot Award in Product Design, out of a total of 4,928 entries from 56 countries.
Before looking to design and manufacture the device we first looked to understand the market context, including the needs of the end-user and healthcare professionals. We knew there was a need in the market for a device that helped people adhere to a healthy injection routine, therefore making the process as easy and comfortable for the patient as possible was important.
Experts agree that the most accurate routine when using injection pens consists of the immediate removal of the pen needle after injection and replacement with a new needle just prior to injection4,5.
We understand the importance of pen needle change in a good injection routine, therefore, producing a device that encourages pen needle change was vital. As mentioned, the first step toward device creation is understanding the market and the need, and so to achieve this we spoke to industry experts, healthcare professionals and patients.
The market need was then delivered to the design team, to begin concept generation. We take a pen to paper approach as the very first step towards designing a device. The design team take the market need and use this to begin with feasibility and concept generation. With Unifine Pentips Plus, this initial idea stage was crucial to the design of the device.
After the initial idea stage we moved onto user preference studies, these are tests to identify and select which concept is stronger than another. From this, we were then able to begin finalizing design ideas and develop the device.
With the design of Unifine Pentips Plus, we took a familiar and proven design and added extra functionality for the end user in order to meet the market need. To accomplish this, we focused on using simple, effective design features to combine standard pen needle packaging with a convenient removal chamber. The two main challenges we faced when designing the device were sterility and how the device would retain the used pen needle. All the materials needed to be suitable for irradiation sterilization and the shelf life of the product needed to be robust without the sterility being compromised at all.
With Unifine Pentips Plus, one element, in particular, that we needed to focus on was testing the seal integrity on the device. As the chamber needs to remain sterile and sealed until the moment of use, we tested this through physical, laboratory and engineering testing. Unifine Pentips Plus was put through testing in our state of the art facilities, including a full environment chamber to test ISO standards and a category 4, world-class edge-to-edge clean room production facilities.
The convenience of UPP lies with the built-in removal system that can be used as a space to store the used needle until it can be disposed of in a suitable sharps container. This means when the user doesn’t have a sharps container with them they have a more immediate interim solution before they can dispose of the needle safely. Another beneficial design feature is its unique size, making it easy to handle when attaching and removing the needle. All these design features aim to make a big difference to the end-user, making the injection routine as easy and convenient as possible.
Initial research into the impact of Unifine Pentips Plus on pen needle change behavior amongst people with diabetes, provided very positive feedback. The study found the rate of pen needle change increased by 61% compared to the user’s conventional needle7. This product is a true example of Owen Mumford’s focus on making life simpler for the end user when using pen needles and trying to maintain a good injection routine.
As we look ahead, our focus will remain on designing and manufacturing high quality products that fulfill regulatory requirements, end-user and healthcare providers’ needs. With good diabetes self-management being so important to the lifestyle and benefits of those living with and treating diabetes, our motivation is to make those lives easier. As the market changes, we’ll continue to innovate by bringing together world-class research, design and engineering expertise to create products that improve lives and help to increase adherence to treatment regimens.
1International Diabetes Federation, (2014). Key findings 2014. [online] Available at: https://www.idf.org/diabetesatlas/update-2014 [Accessed 6 Nov. 2015].
2Diabetes in the UK: key statistics on diabetes. (2010). 1st ed. [PDF] Diabetes UK. Available at: https://www.diabetes.org.uk/documents/reports/diabetes_in_the_uk_2010.pdf [Accessed 27 Oct. 2015].
3Lee, W., Balu, S., Cobden, D., Joshi, A. and Pashos, C. (2006). Medication adherence and the associated health-economic impact among patients with type 2 diabetes mellitus converting to insulin pen therapy: An analysis of third-party managed care claims data. Clinical Therapeutics, 28(10), pp.1712-1725.
4Lee, I., Liu, H., Liau, Y., Lee, W., Huang, C. and Sheu, W. (2009). Improvement in health-related quality of life, independent of fasting glucose concentration, via insulin pen device in diabetic patients. Journal of Evaluation in Clinical Practice, 15(4), pp.699-703.
5Hicks, D. (2010). The first UK injection technique recommendations. [Coventry]: Forum for Injection Technique.
6Ginsberg, B., Parkes, J. and Sparacino, C. (1994). The Kinetics of Insulin Administration by Insulin Pens. Hormone and Metabolic Research, 26(12), pp.584-587.
7HRW, (2014). Impact of Unifine Pentips Plus on pen needle changing behaviour amongst people with diabetes medicating with injectable formats