Seal Integrity Test Method Development
OBJECTIVE:
Develop a test method to assess the bond integrity of two-piece convex inserts in ostomy barriers
Background
In summer of 2026 I had the pleasure of working as the R&D CBI Intern at Hollister Incorporated, a global medical device manufacturer and healthcare company. One of the companies main product lines are ostomy products (pictured below), which are used by ostomates: people who, due to various health conditions, have undergone surgery rerouting waste to exit the body through an opening called a stoma.
My project involved only the barrier piece, not the pouch itself. My task was to improve the test method which assesses the seal of the flange to the barrier. During production on the manufacturing floor, two-piece convex inserts are assessed for bond integrity, and defective products are flagged for further assessment via a wick test. The presence of a strong bond is critical, as an improperly formed seal increases the risk of product failure, which can lead to leaks and spillage.
Background Research
I spoke with one of the engineers working at the plant in order to gain more context regarding the project and to determine how their existing test method functioned.
Existing Test
Their original test involved the operator running a finger around the seal and inspecting it visually for defects; however, depending on the amount of force applied, it was possible that the defects were created by the operator during the execution of the test itself.
From this conversation, I ascertained that the goal of this project was to create a more standardized, reliable way to measure the bond integrity, and deleveoped a full list of requirements:
- Find defects such as cold spots, glue strings, glue squeeze (in or out), or voids (pinholes) in the seal
- Assess the continuity of the heat seal
- Couple mechanical and visual inspection
- Be reproducible (two operators should achieve the same result)
- Not induce damage during inspection
- Work for all geometric variations (robust)
- Deliver results in real time
- Be measurable close to the production floor
- Be cost effective
- Be serviceable and operator-friendly
Prototyping
Multiple iterations of prototypes were modeled in SolidWorks and subsequently 3D printed from resin. It is comprised of three pieces: two cylindrical fixture pieces and one curved, angled piece to peel back the barrier from the seal. While I originally proposed a more complex, automated solution, the beauty of this analog design lies in it's simplicity. It maintains the original structure of the test as much as possible in order to facilitate easy implementation to the operators, while still providing sufficient contstraints to fully standardize the test. After affixing the barrier between the pieces (as shown below), the angled constraint piece is used to bend the barrier down. The piece is then rotated manually and the process is repeated.
Outcomes
After iterationg though the process based on feedback from the customer, my design was developed and perfected. I created 15 different sizes of pieces to account for all possible barrier sizes. The final design was then presented to the client and the Solidworks files were sent to the manufacturing plant in order to be printed, tested more throughly, and then implemented.
Other outcomes during the internship include:
- Proposed and developed a digital prototype for my team to assess ink colors. My solution was a fast and cost-effective alternative compared to the original plan of purchasing and testing physical inks.
- Led a team of three interns to develop a full system test for AnchorFast, another Hollister product
- Planned and organized the intern poster fair symposium to facilitate cross-department updates
- Wrote the first draft of a protocol for a formative usability study