microsurgical
Clip Applier
Kaleidoscope for Baxter International 2019-2023
Design Technical Lead
Warning: This project contains graphic surgical imagery. Viewer discretion advised.
improve the microclip experience for reconstructive surgeons?
How might we…
who use GEM microclips
our mission:
Explore the reconstructive microsurgery experience and identify opportunities for improvement to the microclip application process
Build upon existing GEM microclip technology
Create a novel solution that will grow Baxter International’s microsurgery business
Microvascular reconstruction is a surgical procedure that involves moving flaps of healthy tissue to a different part of the body for repair or reconstruction. When these pieces of tissue are moved, they require their own blood supply for survival in their new location. Reconstructive microsurgeons connect the vessels from the donor tissue to the recipient bed. These vessels are often only 1-3 mm in diameter, so microsurgeons must use magnification such a surgical microscopes or loupes.
Microvascular reconstruction
hemostatic clips and clip appliers
GEM Microclips are packaged in cartridges of 6, with the accompanying manual applier
To remove the donor tissue (called the flap), any smaller blood vessels must be ligated using small titanium clips, which remain in the patient’s body following the procedure. These clips come in a variety of sizes, though the “micro” size clips can only be applied with manual clip appliers.
Manual hemostatic clip appliers are only able to apply a single clip before needing to be reloaded by a scrub nurse. Automatic clip appliers, on the other hand, come pre-loaded with 10-15 clips each.
clip size compared to US quarter
Target Users
Primary users of microvascular clip appliers include cosmetic, reconstructive, oral and maxillofacial surgeons, as well as their surgical technicians, scrub, and circulating nurses.
exploratory research
clinical observation and interviews
Our cross-functional team consisting of mechanical engineers, designers, and human factors engineers joined 8 surgeons onsite, observing a variety of microvascular reconstructive cases. Through this activity, we gained a better understanding of the current bright spots and pain points of the microsurgical clip applier experience.
participant groups
reconstructive microsurgeons
scrub and circulating nurses
key insight
Currently, there is no automatic micro-sized clip applier.
Microsurgeons must hand the device back to the nurses after application to be manually reloaded. This adds time and frustration for both nurses and surgeons, who must reload 120+ clips per case.
Clip cartridges are small and difficult to load correctly
120+ clips may be used in a single case
user feedback
“Loading of clips is the worst part of using manual appliers.”
- Scrub Nurse Participant
“Automatic appliers remind me of a trigger on a gun – it’s all or nothing.”
- Surgeon Participant
current automatic appliers
• Too bulky for microsurgery
• Hard to control tip of applier with finesse
• Tip visibility is key to successful placement
• Must see number of clips remaining
design and ideation
cross-functional brainstorm
As the design lead for the project, I kicked the team off with a brainstorm activity, bringing in a variety of stakeholders and participants from across design, engineering, and human factors to create a cross-functional environment to ideate collaboratively.
Our goals for the brainstorm were to create a solution that affords users the ability to apply a number of microclips easily.
updated cartridge
augmented applier
fully automatic applier
concept downselection
The team met with key business stakeholders balance the user needs uncovered in research with the needs of the business.
Using the existing manual applier as the baseline, we ranked each concept against each other as well as existing appliers. Our business and design goals aligned in the fully automatic applier concept, which was chosen to proceed through the development process.
updated cartridge
augmented applier
fully automatic applier
ergonomic handle design
After downselection, I designed five testably different handle configurations that afford users both control and flexibility of hand position. I 3D printed rough models to informally test comfort and fit with the internal team prior to formal testing.
These handle concepts were informed by ergonomic principles and the user insights gained from our exploratory research. I worked closely with the engineering team to ensure that the closure force and feel aligned with the user’s need for control, precision, tip visiblity, weight and balance, & more.
user testing
evaluating handle usability
I developed and moderated a study alongside the Human Factors team, meeting with a select group of eight reconstructive microsurgeons across the country to evaluate handle preference, finger support preference, comfortability, safety and confidence, and overall acceptability of the five handle designs.
preferred handle design
Concept D was overwhelmingly preferred by participants when it came to the handle design. It was seen as intuitive, approachable, and comfortable by surgeons. The variety of surfaces offered flexibility in handling the device for a variety of users and grips.
competetive benchmarking
The team compared our early design for a micro-sized automatic applier to existing products on market to ensure that it will meet user expectations for fit, form, and function. Since there is no micro-sized automatic applier, we compared the device to automatic appliers with small-sized clips.
Benchtop testing of the competitive devices helped us better understand the user insights from the prior observational and usability studies. The smooth closure of the manual devices became our standard of excellence for designing the “feel” of the clip applier.
anatomy of the
ideal clip applier
the feel and control of the
manual applier
with the efficiency of the
automatic applier
design & development
design language
I combined attributes of the parent brand, Baxter, and the subsidiary brand, GEM Synovis, into a cohesive design language guiding the next phase of design development. This design language was distilled into three distinct themes, guiding the visual design of the clip applier to reinforce the values of the associated brands.
first design iteration
Applying the above design language to the architecture preferred by users, I designed the microclip applier to communicate its intuitive use, precision, and reliability. Through thoughtful consideration of ergonomics, clear visual cues, and refined aesthetics, I ensured that users would instantly recognize and trust the device's functionality, allowing for a seamless and reliable surgical experience.
instructions, packaging, and labeling
I also had the opportunity to create the product labeling, a critical part of any regulated medical device. I designed and tested the device tray, lid artwork, carton artwork, and the content and graphics of the Instructions for Use booklet. These elements were evaluated in usability testing alongside the device itself.
formative usability study
study goals
As a Formative study, the goal of this research was to inform the ongoing design and development of the multiclip applier, with a focus on usability.
I supported the Human Factors team in the design and development of this study, which included 7 reconstructive microsurgeons and 7 nurses.
prototypes used during study
study outcomes
Users found the device comfortable and easy to use, affording ambidextrous use. The loops provide additional control, and the device was found to be stable and easy to control.
The team noted improvements such as providing the appliers in a multipack.
key insight
The device is easy to use and would add value for both surgeons and nurses.
Participants also noted that smooth closure of the jaws was critical; they also recommended making the lockout mechanism more easily identifiable, and packaging the device in a multipack.
DESIGN IMPROVEMENTS
I worked with the engineering team to refine the closure mechanism to meet user expectations. Additionally, we explored CMF options for the clips and lockout system to improve visibility, landing on a gold anodized lockout clip and orange plastic lockout mechanism to address user feedback.
design outputs
maintaining design intent: design for manufacturing
The next phase of the project consisted of several months of careful stewardship of the design intent while working with engineering to design a functional and manufacturable device.
The team began working with production manufacturing partners, and as the lead designer I continued to refine the design of the device to better reflect the design language while also meeting the changing needs of the project throughout the manufacturing process.
holistic packaging & labeling design
Designing all facets of the device and its packaging allowed me to craft a cohesive experience for all of the various users along the device’s lifecycle - from the circulating nurse who identifies the package in storage and easily finds critical information, to the scrub nurse who is able to clearly confirm that information and safely dump or pass the device within the sterile field, to the surgeon who reads the IFU to learn how to use the device for the very first time.
fda submission
As the product development process moves into FDA submission and production, my role as the design lead lies in closing out the design process and making sure any further changes or developments are still aligned with the design intent of the device.
see more work
USABILITY TESTING on a Porcine model
To confirm the mechanical functionality and usability of the device, we ran a series of tests on porcine models. The device performed as expected, with a few improvements to the closure mechanism before design transfer.