Before the design is minted, manufacturing comes into play. The product needs a Design for Manufacturability (DFM).
Our team is experienced in DFM, process development, and practical implementation resulting in higher yields and more reliable products including stable durability profiles for appropriate devices.
We can take your device from a DFM state to Design Outputs, such as raw material specifications, component specifications, drawings, process instructions, work instructions, Instructions for Use (IFU), marketing materials, cataloging, distribution controls, labeling, and packaging. Further work includes fixturing and equipment, process development, Process FMEA (PFMEA), and a Master Validation Plan (MVP) executed in a Process Validation (PV). After your processes are appropriately qualified and validated, process controls can be implemented. Early on, we can help your company find, assess, audit, contract, and qualify suppliers for device prototyping, production, or just components and subassemblies.
We have set up Controlled Environment Rooms (CER), white rooms, manufacturing lines, lean systems, and processes in-house and at Contract Manufacturing Organizations (CMO).
Our team members have run Operations departments and manufacturing plants. As well, the team has operated on the manufacturing floor as a process engineer, manufacturing engineer, and quality engineer.
We can provide the expertise to see things from an R&D and Manufacturing perspective providing a product that is Designed for Manufacturability (DFM) with lean concepts designed in the line.
We’ve worked with companies and projects from concept through design transfer and out to market. in addition, we have found and audited manufacturing partners for our clients in the US and outside the US.
Process FMEA, MVP, Process Development, and Process Validation are well understood at M.L. Reo Consulting delivering comprehensive solutions that provide robust and stable processes. We can support your project from inception to supplier contracts and beyond:
Need manufacturing and operations support?