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Medical Device Manufacturing

Engineering Services

Engineering Services falls under the umbrella of services offered through MDM. With Engineering Support Services we provide further value to our clients through the following activities:

  1. Process Development and Validation
  2. Process Optimization & Efficiency
  3. Documentation Support
  4. Product/Package Design Assistance
  5. Clinical Trial Builds
  6. Packaging Design & Development

Our intention is to enhance value for customers by optimizing manufacturing processes and strengthening deficient areas. A comprehensive list of all our Engineering Services is provided below:

Process Development and Validation

MDM will work with your staff to identify the critical processes and test methodologies necessary to qualify the associated manufacturing steps. We can write the protocol, perform the required testing and provide you with a well-documented final report. Related services include:

  • Assembly process definition and design
  • Test procedure definition and design for process
  • Tooling and fixture design plus fabrication
  • Equipment and Process Validations (IQ, OQ and PQ)
  • Design of Experiment (DOE)
  • Validation protocol development, testing and reports (IQ, OQ and PQ)
  • Sterile package seal strength characterization

Process Optimization & Efficiency

The focus here is to create and maintain high levels of Process Repeatability and Process Capability (CpK). Optimizing the process such that output values fall well within the prescribed specification range ensures that both product and process are robust. This in-turn leads to reduced costs in terms of waste (scrap and labor), resulting in higher yield of qualified products and reduced cycle times.

  • Cost Savings
  • Material and Labor Savings (waste elimination)
  • Yield Improvement
  • Cycle Time reduction

Documentation Support

Documentation is a vital part of all our services. For Engineering Services creates critical documents such as BOMs, Routers and Work & Process Instructions. The activities performed under this category would include:

  • Process Documentation
  • Validate Protocol & Test Reporting
  • Tool and Fixture Drawings

Front End Design Assistance

MDM's Product/Package Design and Engineering support services are frequently utilized to provide guidance on product and package design, specifications and development. This includes consultation services such as the following

  • Design for manufacturability analysis
  • Consult on parts design
  • Consult on Material selection
  • Sterile package design
  • Shelf and shipping box design and configuration

Shelf and shipping box design and configuration

Due to our extensive work with start-ups we have regularly manufactured products for the customer's clinical trials. For clinical trial production, MDM provides label designing, tooling and fixture designing, risk analysis, FMEA (failure mode effect analysis), product inspections and process validations. Through our sister divisions MDM coordinates support services such as sterilization validations and package testing and validations. In addition our engineers can assist you in defining and developing assembly processes, writing product and packaging specifications and validation protocols and reports.