Medical Device Manufacturing and Operations Services

We help you with the manufacturing, operations, and logistics of your medical device.

Our Medical Device Manufacturing and Operations Services

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).

Design For Manufacturability

Design for Manufacturability (DFM) starts early in the design of the device. Get this right and you save time and money downstream when the pressure is on to deliver products for preclinical studies, first in human (FIH), further clinical trials, and eventually market release. We have extensive experience in DFM and can help you through the design process.

Design Output

Device Master Record (DMR):

Your product's Design Inputs are ultimately embodied in Design Outputs and evident in the traceability matrix. We can help you draft and release useful Design Outputs and create a Device Master Record (DMR) to index all Design Outputs in preparation for Design Verification and Validation (DV&V) testing or fixing gaps in your system.

Fixturing and Equipment

All levels of Prototyping:

In-house CNC Machining Capability, Rapid Prototyping, Assembly, Fabrication - implants, catheters, surgical instruments, PCBA, programming, electromechanical systems, and chassis ...We use these same skills to build fixtures and equipment for DV&V or produciton.

Process Development

Develop a process from windowing studies, screening, characterization, and optimization studies using appropriate statistical techniques such as Design of Experiments (DOE). We use JMP as our statistics application. Here are some of the processes we have developed: laser welding, laser cutting, laser ablation, ultrasonic welding, bonding, melting, gluing, cutting, heat setting, heat treating, pickling, electropolishing, plating, anodization, tumbling, harperizing, magnetization

PFMEA

Process Failure Modes and Effects Analysis (PFMEA) is a ground-up risk analysis of each process from a manufacturer's perspective. The typical resolution of the analysis includes process setup, execution, and inspection from line clearance thorough packaging, labeling and sterilization, and distribution as appropriate for the device.

Master Validation Plan (MVP)

Master Validation Plan (MVP) lists all the processes in a snapshot to plan what processes require full validation or qualification - Installation Qualifications (IQ), Operation Qualification (OQ), and Process Qualification (PQ). Test Method Validation (TMV) underlies all this work to achieve valid test results.

Process Validation & TMV

Installation Qualification (IQ), Test Method Validation (TMV), Operational Qualification (OQ), Process Qualification (PQ)

Process Control

After Process Validation, necessary process controls should be implemented to monitor processes at the appropriate points.

Suppliers

We can help you find Contract Manufacturing Organizations (CMO) or component suppliers including assessments, audits, contracts, and qualifications, and then the implementation of your process onsite with the supplier.

Manufacturing and Operations Experts

Manufacturing Floor & Operations Executive Experience

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.

Manufacturing Hands-on Expertise

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:

Process FMEA (PFMEA)
Master Validation Plan (MVP)
Process Development with appropriate statistical techniques
Process Validation
Installation Qualification (IQ)
Operational Qualification (OQ)
Process Qualification (PQ)
Process Controls
Contract Manufacturing Contracts
Contract Manufacturer Audits and Assessments
Manufacturing line setup
Controlled Environment Room (CER) setup

Need manufacturing and operations support?

Product Realization, Delivered.