Derek Fournier, Program Manager

 

Getting a design ready for manufacturing can be just as important as the design itself.  

Compliant time-to-market manufacturing is critical to the success of our medical device customers and is a key attribute to Cogmedix’s customer service.  Performing a thorough analysis of our customers’ Device Master Record (DMR) is a vital method to ensuring we can reduce time-to-market.

Ideally, we like to perform the analysis as soon as possible in the building of the partnership. This allows us to identify an immediate path toward success and assess a project’s eligibility for Cogmedix’s DFcx™ engineering services.

“Give me six hours to chop down a tree and I will spend the first four sharpening the axe.”

—Abraham Lincoln

Identifying gaps early on in the development of the partnership helps to create a collaborative foundation, avoid risk of downtime in the Scaled Product Launch (SPL™) process, and allows us to properly identify a supply chain that will best fit the requirements of the project.

As part of Cogmedix’s value-added services, we ensure our customers’ documentation is compliant; we also leverage our supply chain partners to provide the best service, cost and delivery possible.

An exhaustive review of the bill(s) of material, assembly drawings, part drawings, specification sheets, and work instructions allows us to create a detailed summary of areas that may need improvement to start our compliant, turnkey, finished medical device services.

Examples of some areas we analyze and validate:

  • Part Drawings—Revision, material, finish, approval, notes, quality requirements, critical dimensions/features, revision history
  • Assembly Drawings—Revision, notes, approval, revision history, quality requirements, special production requirements, accuracy to bill of material

 

  • PCBA Files—Gerber files, schematics, CAD ASCII or ODB++
  • Bill of Material—Correct structure, accuracy to drawings, supplier information, notes
  • Work Instructions (Assembly, Test, Inspection, Packaging)—Quality of instruction, special requirements, accuracy to BOM/assembly drawings

Findings that are discovered and corrected in an initial, detailed review can improve processes from the initial proposal all the way through to the packaging of the completed product.  Every item identified in the initial review helps streamline another process further downstream.  Preparation, compliance, and dedication are key ingredients to success in Cogmedix’s time-to-market services.