COMPONENTS & ASSEMBLY
OPENING THE D ORS OF PERCEPTION ALTHOUGH THERE IS NO CRYSTAL BALL TO HELP PREDICT THE COHESIVENESS OF A MEDICAL DEVICE’S DESIGN, MATERIALS AND PRODUCTION PROCESS, THERE ARE TWO DOORS DEVELOPMENT TEAMS CAN UNLOCK TO OPEN UP THEIR PROBABILITY FOR A SUCCESSFUL SCALE-UP. DEL R. LAWSON, PHD, R&D MANAGER IN 3M’S MEDICAL SOLUTIONS DIVISION, PROVIDES THE KEYS TO THOSE DOORS.
T
he medical device design process is bound to have challenges as it progresses into the production stage. Catching all of them can be tricky, but the good news is that many are preventable. Although development teams cannot employ a crystal ball to help predict the cohesiveness of a medical device’s design, materials and production process, there are two doors they can unlock to open up their probability for a successful scale-up. Both rely on proper planning and, when done correctly, can test for potential setbacks before challenges evolve into more significant issues during full-scale production.
friction on certain materials and designs often follow suit. It can be difficult to predict where friction might manifest production issues; one area particularly subject to such stress, however, is the adhesive liner. The adhesive release liner supports a major aspect of a medical device’s designed functionality, and ensuring it is applied properly protects the product’s usability. Adhesive liners must be applied with balanced tension to reduce the impacts of manufacturing. Too tight, and the liner can wrinkle or inhibit the run speed. Yet when liner release values are too loose (low adhesive holding force between the liner and adhesive layer), they could fall off prematurely on the converting equipment. If a team plans to remove and reuse liners, look for any scratches or damage that could affect the final product.
Engineers looking to advance or refresh their design mindset with a more holistic approach should question two factors in the early stages of the development process: the production and material effects on device performance. KEY #1: MANAGING PROCESS EFFECTS FOR SUCCESS Development teams who challenge their assumptions and processes may uncover obstacles they may not have otherwise caught presented by the speed, friction and pressure during scale-up. To improve medical device developers’ overall design, walking through the below questions can be an excellent place to start this effort. How have you factored in friction? As production rates and machinery increase to meet the advancing needs of a project, the impacts of
12
WWW.MEDICALPLASTICSNEWS.COM
