The momentum of reshoring is gaining speed with the continuing rising costs in logistics and transportation, supply chain volatility, and port delays. Forum previously addressed key reasons to reshore, but how can we facilitate and address the pain points to quickly, accurately, and smoothly assist medical device manufacturers with the technical challenges associated with reshoring?
Medical device product solutions, as well as quality part and component production, demand superior testing methodologies. Forum offers a full range of metrology services, guaranteeing optimal operational performance and capability on every project.
Our Quality and Metrology Lab environment is fully air conditioned and monitored. The well apportioned and brightly lit 1,100 ft² lab is operated and fully staffed across three shifts of manufacturing operations. Our electronic records are backed up on multiple off-site servers for protection, and we maintain quality records and retain run samples to complete our history files. Our lab has an extensive array of electronic measurement equipment and a well-trained, experienced staff.
Forum can accelerate reshoring by offering:
- Complete Validation / Qualification / PPAP Protocols
- IQ / OQ / PQ
- Gage R & R
- ANOVA Studies
- DOE Design Analysis with Minitab
- First Article, In Process, and Final Inspection
The first part off of a mold is the true test to confirm that the process and mold meet the desired outcome, and the sooner a part is built to print, the faster reshoring projects can migrate to sustaining production.
2. CT Scanning Capabilities
If a product has been in production for any extended period of time, there is a distinct possibility that there have been EC changes, dimensional changes, or tool modifications during the product life cycle. But what happens if all those changes have not been captured in the 2D and 3D models? Does the part actually meet the print, or have deviations been approved by staff that are no longer part of an organization? Forum has invested in CT Scanning capabilities to address that very issue. Forum has the expertise to take the physical part and conduct a dimensional analysis to update the documentation and, if necessary, build new or replacement tooling.
Forum’s CT Scanner captures measurements with 10 μm accuracy and 4 μm resolution.
CT Scan Analysis:
- 3D Model-to-Part Comparison: Review color coded variation overlay images
- FAIs: Compare all the dimensions to the model and print
- Capability Studies: Evaluate the capability of critical dimensions
- Reverse Engineering: Scan parts & create 3D models
3. Validation (IQ/OQ/PQ)
A key element of any medical product or device is conformance to ISO 13485 or FDA standards and protocols. All of Forum’s validation activities follow ISO 13485:2016 requirements. Forum offers a complete Validation and Production Part Approval Process (PPAP) suite that can be tailored specifically to customer requirements. Forum provides services to help draft validation protocols and has hundreds of previously completed validations to assist customers in determining the necessary content for each protocol to align with specific quality requirements.
A successfully validated process is stable, dimensionally centered with the required tolerance, and capable. Early supplier involvement (ESI) is especially important as Design for Manufacturing (DFM) interaction can quickly identify and resolve issues like dimensional tolerance, proper part geometry for molding, molding techniques required, and the approval and acceptance criteria. Because Forum has a robust and advanced validation protocol process, our medical device partners can reshore with the confidence that their products will conform to all necessary standards and requirements.
4. Tooling Management
Forum is uniquely qualified to make this key pain point in a reshoring project carefree. We achieve this on multiple fronts by offering a detailed and robust tool transfer protocol that covers tool inspection, repair, maintenance, and validation. If new tooling is required, our tool designers can develop the optimal solution meeting all SPI Mold Standards.
At Forum, we are continually investing for the future. Our mold tool room is fitted with the latest equipment from computerized CNC machining centers and EDM machines to our precision grinding and polishing centers. All tools receive the highest level of care and service from tool design and manufacturing through their lifetime of production services. Leveraging our MRP system (iQMS), we track all of the necessary tooling data to schedule tool inspection and preventative maintenance, which is all done in-house in our tool shop.
To aid with minimizing the tooling investment impact to customer engineering and development budgets, Forum offers tooling financing options that allow for payment options up to five (5) years.
5. Engineering & Program Management Solutions
As an engineering-based company with a customer-first approach, we support customers through every step of their projects. Our engineers and program managers work directly with our clients to provide support through all project phases: from concept, planning, and design for manufacturing (DFM) to mold construction and final parts approval. The Forum Program Manager becomes the customer’s single point of contact committed to providing quick response times, helping ensure efficiency and simplify projects. Since program management is a vital activity for project success, we have some of the best in the business on our team to benefit our customers.
6. Supply Chain Management
Now more than ever, having a robust supply management system and process is critical in a successful reshoring effort. Our teams consistently review industry data to stay on top of emerging trends and supply chain volatility. Recently, a medical device customer faced the possibility of a production stop and line down unless Forum could find an alternate and approved source for their component. We worked with our material partners to find an engineering offset that not only maintained continuity of supply but also led to a material price reduction. Forum’s material team gathered the required information to support this alternative and safeguard the supply chain continuity.
Reshoring and changing injection molding partners doesn’t need to be a painful process. Forum continues to invest in people, equipment, systems, certifications, and value-added services to make us the right choice when a medical device company needs to bring their project back to a U.S.-based solutions provider.
Contact us today for your project questions or submit a RFQ here.