MedAccred is a Performance Review Institute medical device industry-managed supply chain oversight program dedicated to reducing patient safety risk. It focuses on critical manufacturing processes compliance and device quality and consistency.

Once with the manufacturer, the T2 samples are placed into the production line for process development and part qualification. The tooling undergoes a series of molding studies that help outline the optimal conditions and characteristics for creating parts using that tool. The manufacturer runs experiment trials to isolate process inputs and corresponding impacts on part characteristics. This initial testing helps the molder validate an ideal processing window that produces parts within specification.

As medical device design evolves to provide ever-improving healthcare outcomes, manufacturers are partnering with full-service, experienced custom injection molders to gain increased design freedom and process efficiencies.Partnering with Kaysun — one of the few injection molders in the country to hold MedAccred Plastics accreditation — is a consistent value-add from part and tooling design through material selection and process control. It empowers many medical OEMs to address issues before they impact production or the bottom line.

After initial process development, qualifications, and validations, the tool enters a regular production maintenance schedule. Here the tool is regularly monitored for wear and other potential issues affecting part quality or tooling lifetime.

“Kaysun exceeded our expectations in all areas. They made a complex, gigantic program easy from an engineering standpoint. Working with the Kaysun engineering team is like a hot knife through butter.”

Earning accreditation is a rigorous process, and only a small fraction of medical injection molding companies receive the distinction.

Medical device performance is largely dependent on the characteristics of the materials used and application needs such as strength, flexibility, transparency, biocompatibility, safety-enhancing microbe resistance, and temperature and chemical resistance. With thousands of engineered materials to choose from, it's important to work with experts in medical device injection molding.

After collaborating with the toolmakers on the design, the part is ready and approved for the T1 sampling stage. They will build the first tool with a 2-16-week lead time dependent on design considerations. T1 sampling demonstrates that the tooling functions correctly and produces ideal parts. After the T1 sampling is accepted, any necessary modifications and aesthetic mold texturing can begin. These additional modifications can take 1-2 weeks to complete. The modified molds, referred to as T2 samples, are sent for approval of texture and appearance. Once the T2 samples are approved, the toolmaker releases them to the contract manufacturer.

Tooling is the backbone of plastic injection molding. Without a proper tool design, your plastic part would never scale up properly. A quality tool design can save you enormous amounts of time and money during production. Before you contact a toolmaker, here are a few facts about tooling you should keep in mind.

Medical OEMs are tasked with providing consistent, high-performance solutions to the challenges posed by a variety of complex applications. Partnering with a custom injection molder that has the experience, knowledge, technical expertise, and certifications needed to adhere to the exacting standards of the medical industry is imperative.Not every molder is qualified, but those who are — like Kaysun — can move your business forward with confidence.

Leveraging the experience and knowledge of medical injection molders during the design phase of complex applications can help overcome the unique challenges of medical injection molding and improve outcomes.

Toolmakers provide necessary assistance with the tool design process because they are well-versed in fabricating techniques and tooling design. They can run mold flow analyses to optimize the tooling design and choose the best locations for parting lines, gate, and ejection locations. A quality prototype design engineer will work closely with toolmakers to ensure the fabrication of the optimal tool for your application.

Portable medical devices are a mainstay in hospitals, emergency vehicles, and outpatient environments. The devices must remain accurate and functional; however, drops, bumps, and excessive vibration are inevitable as equipment is transported from place to place.Overmolding is a proven solution for shock and vibration reduction, sound dampening, electrical insulation, improved chemical/UV resistance, effective oxygen and moisture barrier protection, and color infusion.

Tooling, also known as a mold, refers to the negative cavity space where molten plastic resin is injected to create a part. High quantity and quality parts require proper tooling. Since tool design and construction are complex, fabrication requires significant capital investment and enough lead time to create an effective tool.

Proper tooling design and choices need to accommodate for complexity, lifetime, application, and potential production volume of the tool. Choosing which tooling to invest in is the hardest part of the tooling process. If the part is going straight into high volume contract manufacturing, then it will be most cost-beneficial to invest directly into expensive production tooling for the long term. In other cases, such as low volume manufacturing, using a prototype tool may be more beneficial until production increases significantly.

The rapid advancement of the medical industry necessitates constant innovation and complexity in medical device design. Smaller sizes, more intricate geometries, progressive functionalities, and portability are among the greatest needs in today’s medical equipment — and among the biggest challenges for design and engineering teams.

Kaysun has carried the MedAccred Plastics accreditation since 2020, demonstrating our ongoing commitment to excellence and assuring medical OEMs of an unparalleled benchmark of production and quality standards.

The tooling design process starts out in the prototype development phase. Here 3D printing, cast urethane, and machining techniques create prototype tools. These low-volume prototypes troubleshoot, develop, and validate the tooling design during pilot production. While this step may seem unnecessary, cutting down on errors in the manufacturing and assembly process early can significantly decrease time and cost later.

About Synectic Product Development: Synectic Product Development is an ISO 13485 certified, full-scale product development company. Vertically integrated within the Mack Group, our capabilities allow us to take your design from concept to production. With over 40 years of experience in design, development, and manufacturing, we strive for ingenuity, cost-effectiveness, and aesthetics in our designs.  Learn more about our new product introduction services and see how we can help your next project.

The entire process from prototype to production can take months and significant investment to properly complete. Therefore it is vital to design your parts for manufacturing throughout product development. A product design prototyped using machining, or 3d printing, may not easily translate to a tooling design for high volume production. We recommend partnering with a product development company intimately familiar with the tooling design and the manufacturing process that will initially incorporate that knowledge into designing your product. If you are unsure how to get started or would like some expert advice on designing your tools, contact us and we would be happy to help.

Kaysun is experienced with medical product design, production, and assembly. We are ISO 13485:2016 certified and MedAccred Plastics accredited.