Design, Testing & Support Services
Supporting your medical device manufacturing project with DFM / DFA, verification and validation services.
- Medical Device Design for Manufacturability and assembly (DFM and DFA)
- In-house updating of 3D models for approval
- Strategic partnerships with manufacturing prototype experts
- Process Failure Mode and effect analysis (FMEA and FMECA)
Medical Device Manufacturing Process Development and Analysis
As each new project passes through the various stages of our project introduction manufacturing process, JunoPacific's NPI team reviews the designs, making sure we’re utilizing the most robust and cost effective approach to manufacturing your medical device. Can we reduce assembly by using two, three, and even 4 shot molding or Spin-stack® injection molding? Does it make sense, based on projected yearly volumes, to invest in higher cavitation custom plastic molds? Are device design changes still in the works? Is there a less expensive manufacturing material that meets all your requirements? Can we take advantage of volume buys to reduce the resin price? These are just some of the questions our NPI team reviews in our Design for Manufacturability (DFM) and DFA process.
Manufacturing Process Validation
|Short and long term capability studies, Cp/CpK studies||IQ/OQ/PQ/PPQ|
|Verified outsourced ETO and Gamma Ray sterilization||Scientific Molding|
|Quantitative mold flow, cool, shrink, and warp analysis||Manufacturing Validation/Verification Plan (MVP)|
|Gage R&R studies||High/low challenge DOE’s|
A key element of a successful manufacturing project is assuring that the plastic components will be moldable and functional, meeting all your requirements. A plastic Part Design Review is held to determine the most appropriate design for your manufacturing process needs. Often clients bring us device designs that work on paper, but not in the manufacturing process. So they look to JunoPacific's engineers to develop a device design they can produce in the most functional and efficient manner possible. When engineering expertise in unavailable to you within your own company, JunoPacific is available to translate your ideas into working plastic molds and plastic molded parts and components.
Following the Part Design Review and customer award of the project, JunoPacific conducts an internal meeting where the engineering department reviews the entire manufacturing project with our managers to address internal concerns, quality sampling plans, and plastic part tolerance requirements.
From these discussions, JunoPacific develops a Manufacturing Validation and Verification Plan and carries out all necessary tests and experiments with supporting documentation to ensure we’re cGMP compliant for your finished medical device. These tests can range from simple IQ/OQ/PQ to full process FMEA’s, 8 point window studies, gage R&R validation & verification, tensile and torsional testing, leak and flow testing, and sterilization validation, all while maintaining an unwavering focus on process for continuous improvement and lean manufacturing.
At JunoPacific, we let nothing escape us, ensuring total success. We maintain meticulously kept reports and conduct comprehensive meetings to ensure precise and efficient operations, keeping our projects on track and moving forward. With more than 225 employees working three shifts in California and Minneapolis, see how you can utilize our expert custom plastic injection molding manufacturing knowledge for your medical device manufacturing project today.