Key in Medical Molding and Device Assembly.
It doesn’t get more mission-critical in manufacturing than in Medical Molding, tooling, and assembly. Advanced’s fully transparent three-part process: Plan, Innovate, Validate, ensures that, whether it’s a complete medical device assembly, or a simple component brought in under our Transfer Tooling Program, your part is completely documented with a robust and timely validation process that meets all specs, all the time. Advanced offers complete assembly and packaging, and we are a Medical Contract Manufacturer.
Medical components require an assessment of the design state and needs at every point of the production chain. What will make each point successful and how does it support subsequent stages? A total picture with a clear view of all dependencies is the first step.
- Project Engineers manage your project and they are your single point of contact, staying with your project from inception to delivery.
- Our Product Engineering Group evaluates for Manufacturability, Reliability and Quality Assurance at every point.
- IQ/OQ/PQ requirements are defined and protocols are established and built into regular technical reporting.
Once the whole picture has been documented in the planning phase — IQ/OQ/PQ are fully defined and protocols established and the full assembly process has been taken into account — solutions are proposed, tested and revised. This is the problem-solving phase where innovation is born. Unexpected connections are the foundation of creativity and our process and culture encourage that flow between all points in the production of your product:
- Manufacturing processes are thoroughly evaluated
- Lean initiatives are implemented
- Tool design is carefully reviewed for manufacturability, longevity and ease of maintenance
Executed in the care of nearly two centuries of plastics engineering experience, Advanced adds tremendous value in the design for manufacturability of your piece.
At this point the broader picture has been documented and we’ve engineered a creative solution. Now we validate with comprehensive and documented testing. Validating the solution means more than simply establishing that it will work. We need to know why it works, how it works, and at what point it will start to fail.
Getting that right is critical in Medical Molding, which is why we do things differently. Quality Control is testing a finished part to test whether it works, and that happens once production has occurred. At Advanced, we use Quality Assurance, which builds those controls in at every phase to validate quality before and during manufacturing. It’s baked into our process.
One of the biggest complaints in Medical Molding is that validation can take longer than tooling. That’s not the case at Advanced Molding Technologies. Because we have full inspection capabilities on all three shifts we can validate in record time; often moving your team through the process rather than the other way around.
Our goal, like yours, is 100% defect-free parts. To achieve that we need to know the precise location of points of failure — because before it got off course it was running off course. At Advanced, our Quality Program runs all the time and Validation is a key part of that.
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- FAIRs (First Article Inspection Reports)
- Capability Studies (Standard Deviation)
- Four Corner Window Studies
- Full DOEs (Design of Experiments)
- Complete Supply Chain Management
- Gage R&R (Reproducibility and Repeatability)
Advanced’s default CPK goal is 1.67 versus the industry standard of 1.33.
- Clean Room
- Medical Device Assembly
- ADCF Clean Room
- Two-shot Molding
- Header Manufacturing
- Precision Gears
- EMI Shielding
- Printing and Decorating
- Prototype Molding through QuickMolds™ prototype system
- Transfer Program for transfer tooling
FULLY AUTOMATED ASSEMBLY CELL
Advanced’s engineers research many automation processes and evaluate several automation specialists before creating their own concept design. Our engineers completed a detailed assembly process for 18 stages of automation and proceeded with building working “proof of concept” bench-top models of many automation stages.Once everything was validated, the final automation cell was produced and developed over a six month period.Although the automation costs were substantial at over $1MM, the projected payback in cost savings would be realized in just a couple of years of production (versus assembling with low cost labor in China). The automation cell was able to produce 4-6MM components per year, with “Six Sigma” quality, in under a 4 second cycle per assembly.
Advanced has leveraged extensive engineering knowledge of mold design, build, and qualification to develop our QuickMolds Prototyping System. You can expect lightening-fast turn around times – typically four weeks or less – while still meeting your production quality needs.
Get production quality parts at prototype prices – with lead times that beat your competition to market!
- The competition may change features to save time, but our molds are formed exactly to your 3-D models, including intricate details & shut-offs.
- Typically-used aluminum molds do not offer any machining advantages, and are often an excuse for poor quality. Our tool steel molds are very competitively priced, with added precision and quality, adding value to your total project.
- Complete engineering support means you benefit from a Project Engineer as the single point of contact, involving Quality, Production, and Packaging teams as needed.
- QuickMolds are built with integral heating and cooling channels, resulting in better parts, less molded in stress and a more aesthetically pleasing product.
- We offer any type of injection-moldable resin available.
- Because our molds can be dimensionally developed you get what you want, not just what you get.
- Fully validated IQ, OQ and PQ processes for Medical OEMs or full PPAP for Automotive market
If you already have tooling, but you are struggling with producing quality parts, we would welcome the opportunity to help you out. Our Transfer Program represents our engineers at their best, our process at its most robust, and your project back on track. We’re in the business of solving engineering problems and we love a challenge.
The backbone of our Transfer Tooling Program is what sets us apart from other manufacturers; our Plan, Innovate, Validate approach. With Transfer Tooling it’s more important than ever to understand the project in the broadest context possible and then to hone in very quickly on the solution that will bring the project back on task with as little disruption as possible. We have found over and over again that our project management is the key to resolving most issues, and tooling is rarely that big of an obstacle.
- Understand the broader plan
- Innovate the solution
- Validate the outcome
- Done quickly, efficiently and, in our case, with enthusiasm.
Advanced Molding Technologies, LLC (Advanced) is a privately held company located just north of the Twin Cities Metro. We pride ourselves on our engineering culture and enterprising approach to problem solving. We have over 48,000 square feet of space devoted to plastic injection molding, decoration, assembly, and packaging.
Whether it’s a nascent idea made real with QuickMolds, a complex high volume medical device, or a transfer program brought in mid-stream to get a customer back on track — are all approached with the same enthusiasm and desire to innovate inherent in our three part process: Plan, Innovate, Validate.
We’re eager to discuss your project with you, call us today!