Endurance surgeries can last 10+ hours, making equipment comfort a critical factor. This enables surgeons to focus on the task at hand, rather than having to continually adjust and reposition their equipment. The aim of this medical soft goods development effort is to make the equipment both functional and comfortable.
Integra Life Sciences partnered with Priority Designs to develop soft goods for their next generation premium surgical headlamp. The key target of this initiative was to design an integrated padding system to provide a more comfortable wear experience over time, and increase value over their competition. Throughout the project, Priority Designs’ medical, soft goods wearables and prototyping specialists developed a lighter, more ergonomic, and more comfortable head lamp system for surgeons as well as creating a simple and easy to use Instructions for Use (IFU) which clearly articulated the premium value of the new headlamp.
The Integra DUO LED Surgical headlight is a premium headlamp system worn by surgeons, often for endurance surgeries (10+ hours). During surgery they can experience fatigue, irritation or pain caused by current headlamps.
The goal of the new headlamp system design focused on addressing these main features:
- Improve comfort by reducing and re-distributing weight.
- Distribute weight by considering padding coverage, materials, and placement of pads.
- Integrate air-flow to reduce heat and sweat build-up.
- Utilize user feedback to create a comfortable headlamp experience.
- Create a “premium” fit and feel while operating for long durations.
Integrate Instructions for Use (“IFU”) and creating a redesigned carrying case.
For the creation of this wearable medical device, Integra partnered with Priority Designs on 2D design, material and assembly exploration, soft goods prototyping, production material sourcing and transfer to manufacturing. In addition to the headlight, our team created the full instructions for use (IFU) and a premium carry case to house the entire headlight system.
Priority Designs explored solutions outside of padding, in reference to weight distribution which ultimately helped dial in on the final solution. Alternative solutions were considered to provide user comfort, including:
- Reducing surface area by creating “touch-points” across the padding.
- Foam, gel, and fabric layering to define comfort “zones.”
- Evaluation of “hammock-like” assemblies that distribute the weight across the top of the head, and not just the brow and occipital basket.
- Integration of air-flow via form, material, or die-cuts.
- A materials investigation to address all defined functional attributes.
To define comfort goals of the soft goods wearable, proof-of-concept samples were created for end user evaluation to verify improved comfort in re-designed padding systems. Samples followed one pad construction/attachment method, but explored multiple materials layering options for comfort and re-distributing weight.
When sourcing materials, our team considered: materials organization and procurement, assembly evaluation and testing, and creation of Functional User-Testing samples for evaluation and definition of “comfort.”
As comfort criteria was established, there was a challenge to find a production facility who makes silicone gel components without backing. Production was not readily available, so Priority Designs molded gels in-house in our prototyping shop. With samples created, another materials investigation of design and functional exploration was launched to ensure the same quality feel with a new material. The final material used was determined to provide “more comfort than existing products,” giving Integra a claim over and above competitive products.
Priority Designs launched a production investigation for materials meeting cleanability and established comfort standards. The key considerations were:
- Evaluation of silicone foam (as a replacement for molded gel)
- Evaluation of material layering and perforations to achieve a “like” comfort and feel as well as to facilitate air-flow.
- Creation of refined assemblies for client and factory evaluation.
With these considerations, the established cleanability standards were:
- Headlamp was to be cleaned daily with a mild detergent or soap.
- All materials must maintain breathability and wicking application applied and must not show any wear or fading for 1-year.
From there, Priority Designs worked with the manufacturer to make sure that the established comfort requirements were maintained in production. On-site assembly review was conducted at the factory to evaluate sample construction and compliance. Each pad assembly needed to maintain the size, height, and durometer (softness) of the submitted sample. Using a Shore Durometer gauge hardness of material for the Testing Pad was measured and criteria for production compliance was defined.
To provide a premium experience surrounding the use of the headlamp, our team re-designed the Instructions For Use (IFU) to make them simpler and easier to use. The new IFU would include clear instructions for donning and doffing, cleaning, use, troubleshooting, how to store, legal information, safety warnings, etc.
With the help of Priority Designs’ in-house design team, the re-design of the Instructions for Use (IFU) included creating design concepts, layout of pages for booklet, review and coordinating with Integra team, and preparing files for print production.
The final headlamp solution was lighter weight, had integrated airflow, reduced fatigue while wearing the device, and improved user comfort.
Integra was able to introduce an innovative system lighter than any headlamp system on the market. This claim was validated through user testing, by comparing previous headlamps and padding systems against Priority Designs new solution.
The engineered comfort solution established the comfort level Integra can claim in their marketing. In addition to improving overall user comfort, user experience was improved through the development of the re-designed, easy to use IFU that accompanies the headlamp, as well as the carry case.