Search
Let's Connect

Diagnostics Design For Manufacturing

Life Science Outsourcing offers design for manufacturing (DFM) services tailored to diagnostic devices, optimizing product designs for efficient and cost-effective manufacturing.

Request more Information
A microfluidic diagnostic cartridge featuring multiple reagent blisters and intricate fluid pathways for automated testing.

Optimized Diagnostic Device Design
for Seamless Manufacturing

As part of our end-to-end solutions, LSO ensures your diagnostic devices are designed for efficient, scalable, and cost-effective production. Our DFM expertise streamlines material selection, process validation, and regulatory compliance—helping you accelerate market entry with confidence.

What is Diagnostics Design For Manufacturing?

DFM ensures that diagnostic devices are designed with manufacturability, scalability, and compliance in mind, reducing costs and improving production efficiency.

  • Design optimization: Enhancing diagnostic device manufacturability.
  • Material selection: Ensuring compatibility with regulatory and performance requirements.
  • Process validation: Implementing scalable, repeatable manufacturing solutions.
Custom blisters being manufactured
Microfluidic Diagnostics Blister Reagent Packaging

Who Needs Diagnostics Design For Manufacturing?

  • Medical device OEMs developing new diagnostic platforms.
  • Diagnostic startups optimizing early-stage prototypes.
  • Manufacturers refining existing diagnostic devices for mass production.

How Does Diagnostics Design For Manufacturing Work?

  1. Concept Analysis & Feasibility Study: Evaluating design feasibility for large-scale production, considering material properties, manufacturing costs, and performance expectations.
  2. Material Selection & Component Sourcing: Identifying biocompatible and cost-effective materials, ensuring availability and regulatory compliance.
  3. Process Optimization & Automation: Implementing lean manufacturing principles, reducing waste, and integrating automation to increase efficiency and reproducibility.
  4. Prototyping & Iterative Testing: Producing rapid prototypes for functional and regulatory testing, incorporating design feedback, and refining iterations for final manufacturing approval.
Technicians working in a sterile cleanroom assembling medical devices, representing LSO’s full-service manufacturing capabilities.

What standards apply?

  • ISO 13485 – Medical device quality management.
  • FDA 21 CFR Part 820 – Quality system regulation.
  • IEC 62366 – Usability standards for medical devices.

Why LSO?

  • Expert DFM engineering ensuring design efficiency and scalability.
  • Regulatory compliance expertise reducing time to market.
  • Integrated prototyping & production streamlining development.
Get Started with LSO

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

Sign up for email resources!

Receive the latest infographics, guides, and blog updates for medical device manufacturing, package testing, and sterilization.