![]() ![]() “Customers may not have the clean room space or bandwidth to perform these types of product builds. “This is a unique offering by Mikron,” says Jaworski. ![]() Mikron is able to produce documentation such as SOPs (standard operating procedures), Batch Records and Inspection Reports to support product builds in the clean room which are transferable to the customer when they are ready for commercial manufacturing. ISO 13485 certification and a qualified 2,000 sq ft Class 7 clean room facility in Denver allows Mikron customers to complete design verification builds and clinical trial builds required for regulatory approvals. Mikron’s Pre-production Services also offer extensive validation support including, but not limited to, Standard Operating Procedures development, DOEs (Design of Experiments), process development, installation qualification, operational qualification, performance qualification and process validation. Mikron subject matter experts can be engaged in the development and execution of these experiments as well as advising on control strategy. ![]() ![]() Now is also the time to complete process characterisation work to identify and quantify sources that could impact yield or product quality. A manufacturer might be advised to adjust part design to allow components to be more easily fed in bulk to the automation system or more precisely handled in the assembly environment. For instance, the early development stage is the perfect time to consider whether a different joining technique, like ultrasonic welding or laser welding, might be more appropriate than adhesive. When it comes to developing a medical device, there is a plethora of areas which can be optimised for manufacturing. Its really about helping them manage risk.” We really allow our customer to use our experience and expertise to gain insight into what will translate well into high-volume manufacturing and where the challenges may lie. “We look at the customer’s product and the assembly processes required and then our subject matter experts review areas where there could be challenges. “We typically start with a high-level risk assessment,” says Jaworski. “As their partner, we help them de-risk their programs, enabling them to move more quickly into commercialisation and high-scale manufacturing.” What is Mikron’s Pre-Production Services process? “Customers are, of course, adept at developing their medical devices and understanding what their product needs to do, but they might not be as conversant in what their assembly and manufacturing needs are,” says Bill Jaworski, Sales Director at Mikron Automation. Services can range from quick pieces of advice to a full engagement that could include design for manufacturing (DFM) analysis, PFMEAs (process failure modes effects analysis), process range studies, proof of principle feasibility studies, prototype component builds, process characterization and clean room assembly of design verification build or clinical trial builds. We are a full-service metal stamping and assembly manufacturer offering value-added tooling and prototype services so our customers can reduce their supply base and source their stamping programs all in one place, from start to finish.Mikron Automation, the leading partner for scalable and customisable assembly solutions, offers a full suite of Pre-Production Services, developed to help medical device manufacturers de-risk their programs and accelerate through the manufacturing design phase. Our Rapid Prototyping Department is an option for customers looking to take their concepts to high-volume production, but require some assistance in engineering and design of parts and proving out manufacturability of designs. We’ve invested in advanced tool making technologies that deliver extremely high precision and accuracy for all tooling projects, no matter how complex. Our in-house Tooling Department is where our experienced tool and die makers build and maintain progressive tools for progressive die stamping production at Wiegel. Tools can then run in virtual production first to ensure the most feasible and cost-effective manufacturing is met when parts are in live production. Our team of highly skilled design engineers can design and debug tooling using our industry’s top 3D modeling simulation and design software. All progressive die metal stamping requires progressive tool & dies to produce metal stampings. Before moving your project into high-volume stamping production, Wiegel offers pre-production services such as tool & die design and manufacturing and rapid prototyping. ![]()
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