Unleashing Precision through Miniaturization: Polydec's Expertise in Medical Device Components

June 30, 2023 By Sponsored Content

By David Kouidri, Polydec International Inc.

Introduction

Step into the captivating world of micro machining, where precision meets miniaturization and boundaries are shattered. In the rapidly evolving landscape of medical technology, devices are undergoing a remarkable transformation as they shrink in size and demand unprecedented levels of precision. At the forefront of this revolution stands Polydec, an innovative company based in Switzerland, that has mastered the art of miniaturization. Join us as we explore their groundbreaking journey, crafting ultra-small components that defy the limits of size while delivering impeccable precision. Discover how Polydec’s expertise is revolutionizing the medical field, pushing the boundaries of possibility, and shaping the future of precision manufacturing.

Micro parts down to 0.05mm OD (.002 inch)

Miniaturization and Precision

A pursuit for perfection in the quest for ever-tighter tolerances and micro-sized dimensions, Polydec has been operating in the realm of miniaturization for years, producing parts with outer diameters as small as 0.05 mm (.00196 inches) and tolerances as tight as +/- 2 microns (+/- .000078 inches). However, miniaturization goes beyond mere machining; it encompasses many pre and post-fabrication challenges, including handling, anodization, annealing, polishing, and surface finish requirements. Successfully overcoming these challenges requires a corporate culture built on precision, vast experience, specialized machinery, and meticulous pre-fabrication planning.

Building a Culture of Precision

The foundation of miniaturization, repeatability, and tolerance control lies in a proper company culture. At Polydec, cleanliness takes center stage, with the factory floor meticulously cleaned multiple times a day to remove machining oils and pollutants. This dedication to cleanliness fosters an environment that values precision and mission clarity. Furthermore, the layout of machines and equipment plays a pivotal role in cultivating a culture of precision, with careful placement to the millimeter, organized workspaces, and regular maintenance. All these elements combine to create an unwavering commitment to precision.

The Micron Production Culture includes cleanliness, factory organization, and exact placement of machines

Inputs Beyond Machining

Climate control and temperature control is critical when working with tight tolerances. For instance, the linear thermal expansion coefficient of 316 Steel, at 0.002 mm/°C, necessitates stringent climate control. At Polydec, a robust climate system maintains a temperature range of +/- 1.5 °C on the factory floor throughout all seasons, effectively ruling out temperature as a potential cause of deviation.

Additionally, pre-production planning is vital to ensuring tight tolerances and desired outcomes. Through Advanced Production Quality Planning (APQP) and Design for Manufacturability (DFM) discussions, Polydec leverages historical experience to anticipate and address challenges associated with raw materials, tooling, and post-fabrication processes such as polishing and heat treatment. This proactive approach guarantees optimal dimensions at the micro level.

Micro Manufacturing and the Importance of Industry Supplier Clusters

Production inputs are crucial to success. Polydec benefits from its location within an industry cluster in Switzerland that has flourished alongside the luxury watch industry. It offers a wealth of expertise that transcends multiple sectors, including miniature medical device component design and manufacture. Access to highly precise tooling, superior-quality materials, and specialized lubricants designed for micro manufacturing, all sourced from expert suppliers nearby, propels Polydec forward. Being part of a passionate cluster dedicated to solving new challenges in micro machining enables continuous progress and pushes the boundaries of what is possible.

Mastering Polishing in Miniaturization

Achieving the desired surface finish and dimensional accuracy during polishing requires meticulous planning and experience. Material removal calculations must be made in advance to compensate for surface finish requirements or deburring. Choosing appropriate polishing carriers presents its own challenges, especially for parts with outer diameters as small as 0.05 mm. Polydec’s expertise allows them to control material removal precisely, and they navigate the complexities of carrier selection, vent hole sizes, abrasives, and agitation levels. This mastery ensures an impeccable surface finish, with a roughness average (Ra) of less than 0.1 micron.

Surface finish of less than Ra 0.1

Selecting the correct abrasive or slurry for polishing is a science, with factors such as time, temperature, and part material influencing material removal. Polydec’s rigorous process control, guided by well-documented historical information and surface finish specifications, simplifies decision-making. Their wealth of experience enables them to choose the optimal polishing process for each unique scenario, achieving outstanding results consistently.

Quality Control

Enforcing precision, strict, and robust quality control protocols, including ISO 13485 & IATF 16949, is vital to maintaining repeatability and adhering to tolerance specifications. Polydec goes above and beyond customer requirements, internally imposing even tighter tolerance and CpK specifications. Statistical Process Control (SPC) is employed throughout fabrication to monitor and control quality, while a dedicated Quality Control (QC) department ensures rigorous inspections at every step. Polydec’s commitment to precision is exemplified by the fact that they have more QC staff compared to production staff.

Where Passion and Experience Converge

In summary, miniaturization is not merely a technical feat but a mindset driven by passion and experience. As challenges arise at this level, the problem-solving approach at Polydec involves meticulous troubleshooting and drawing on a highly skilled staff and immeasurable experience to swiftly overcome obstacles.

With their unwavering commitment to precision, Polydec continues to shape the landscape of medical device manufacturing, pushing the boundaries of what is achievable and pioneering the future of miniature technology.

For more information contact [email protected] or visit www.polydec-inc.com

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