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UniSafe Whitepaper

UniSafe is a passive, springless safety device for pre-fillable syringes. It’s designed with a patient-centered approach to boost confidence in medical device design.

JUNE 2020
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Introduction

The market for pre-filled safety devices is expected to triple by 2020, growing from US$250 billion (£205 billion) to $797 billion. Just between 2017 and 2018, sales are projected to see the biggest increase yet, with a 34% annual growth rate1.

Both pharmaceutical companies and healthcare providers are seeing a shift in market demand. Patient safety and confidence now matter more than ever when delivering effective treatment.

Regulations in recent years have required this focus, making safety injection devices a key area for device innovation. These devices not only enhance the patient experience and boost adoption (thanks to being safer and more effective), they also deliver long-term economic benefits by enabling self-treatment.

Growing government regulations and increased end-user demand are now major drivers shaping device development across medical device teams. In response, we’ve seen major advances in innovation and technology for designing and using these safety devices.

Background

Today’s market is largely made up of retractable and non-retractable safety syringes that use spring components for activation. This can cause issues like accidental activation—where a device activates during shipping—or under-dosing, where users find it hard to see if they got the full dose (for example, if a spring at the front of the syringe barrel blocks the view).

These scenarios can impact treatment outcomes—the patient may get an incorrect dosage, the device may not perform as intended, and it could be uncomfortable to use, plus there’s a risk of injury. All of these can be obstacles to continuing treatment.

By deeply understanding long-term treatment and injections, combined with top-level research, design, and engineering, Owen Mumford Pharmaceutical Services has responded to market needs by developing a safer, more effective syringe device.

UniSafe is designed to boost patient confidence during injections, removing the risks and challenges of typical spring-based syringes.

Evaluation objective

The design for UniSafe aims to provide a patient-focused, safety-first experience while reducing potential barriers to treatment (like painful use, bulky design, or discomfort).

The objective is to see if the design of UniSafe gives patients or users a comfortable, safe, and effective treatment experience. METHODOLOGY A study was done with nurses (50) and patients (57), all of whom administered or received injections for various conditions in Rheumatology, Oncology, Respiratory, Cardiology, and Gastroenterology. Everyone took part in interacting with the device design. The study was managed by an independent research house2.

Methodology

A study included 50 nurses and 57 patients giving or receiving injections for various needs in Rheumatology, Oncology, Respiratory, Cardiology, and Gastroenterology. Everyone engaged with the device design. An independent research house2 managed the study.

Results and discussion

The study’s feedback showed that UniSafe was found easy to use, creating high confidence in drug delivery.

Key aspects of the device design that stood out include:

  • UniSafe features a clear pre-filled syringe so users can see the medication and labeling without turning the syringe barrel, which helps reduce the risk of under-dosing. In the study, 94 percent of nurses said it was easy to check medication in UniSafe before giving a dose, and 89 percent of patients said UniSafe made it easy to know when the full dose was delivered.
  • Also, the device is built with a strong, secure grip so the end-user or healthcare provider can safely administer treatments. For 88 percent of nurses and over 75 percent of patients, the grip was crucial—especially for feeling confident the device would not slip during use.
  • UniSafe is engineered with a larger, ergonomic plunger head and a smoother, well-integrated finger flange for a more comfortable feel and cohesive look. This makes it easy and intuitive to use, no matter hand size, dexterity, or condition. The device suits all patient types—in the study, 82 percent of nurses felt their patients would find UniSafe easy to use, and 83 percent of patients said they felt more confident with it.

Conclusion

The study shows how the design of UniSafe puts patient needs first, delivering a safe and comfortable experience. Following a ‘patient-centered approach,’ the device is intuitive, easy to use, and adds extra safety for users.

Patient-centered design keeps evolving, and Owen Mumford Pharmaceutical Services is working with pharmaceutical partners to meet rising demands for injectable treatments.

The safety syringe market is set to grow at a 9.7 percent Compound Annual Growth Rate (CAGR) as health and safety awareness increases between 2013 and 20193. Companies adopting patient-centered design are keeping up with this, adapting to market changes and customer needs. The drive for new injectable devices is an ongoing feedback loop between users and manufacturers, and continued development is key to encourage treatment adherence and help patients manage their conditions on their own.

With up to 16 billion injections happening every year, manufacturers are being called on to supply devices that are intuitive, safe, and easy to use for both patients and healthcare workers.

References

  • 1. Roots Analysis, “Needle stick safety injection devices market 2014 -2024”

  • 2. UniSafe Safety Device End-User Study – November 16

  • 3. Transparency Market Research “Safety Syringe Market to Expand at 9.7% CAGR Due to Growing Health Safety Awareness and Technological Advancements” (Available at: http://www.transparencymarketresearch.com/ pressrelease/safety-syringes-market.htm) CONTACT DETAILS pharmaservices@owenmumford.com www.ompharmaservices.com

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