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Category: White Paper

January 14, 2025November 5, 2025White Paper

FDA Medical Device Regulatory Controls Explained

FDA regulatory controls

Part of the Medical Device Regulation Act involved establishing specific regulatory controls for each of the three classes of medical devices. The […]

January 14, 2025May 29, 2025White Paper

How the FDA Classifies Medical Devices

how the fda classifies medical devices

In 1971 a new IUD called the Dalken Shield entered the market and was implanted in almost 3 million women in the […]

January 14, 2025May 18, 2026White Paper

Pilot Production — Bridge Manufacturing and Production Readiness

pilot production

Pilot Production is the beginning of the end of product development. Pilot Production is part of our contract manufacturing services and is […]

January 14, 2025May 29, 2025White Paper

9 Prototype Testing Methods to Prove Your Invention Works

prototype testing methods

Prototype testing provides a cost-effective method for ensuring products meet user requirements and regulations. Simple proof of concept tests can predict future […]

January 14, 2025May 19, 2025White Paper

4 Brainstorming Techniques That Generate Successful Ideas

brainstorming techniques

Brainstorming can be a fun exercise to solve a particular problem or generate concepts. As an inventor, you probably already have an […]

June 1, 2021July 18, 2025White Paper

Webinar: Are You Ready For Manufacturing?

are you ready for production webinar

No matter what your product is, the end goal is to make it to production. Make sure your product is ready by […]

April 7, 2021May 13, 2025White Paper

Case Study: Creating a Custom Fixture for Medical Device Assembly

cardiac catheter fixture

The challenge Fixtures are used in product development and manufacturing for a variety of purposes. Most commonly they are used as a […]

February 4, 2021May 19, 2025White Paper

Case Study: How to Create Custom PCB Prototypes Using a Laser Cutter

custom pcb board

The challenge Printed Circuit Boards (PCB), are used to mechanically support and electrically connect electronic components in an organized way.  They contain […]

January 14, 2025February 9, 2026White Paper

How to Write a Product Design Specification (PDS)

how to write a pds

The product specification also referred to as a product design specification, product development specification, or PDS, depending on the product development company, […]

January 14, 2025July 18, 2025White Paper

The Basics of Structural Foam Molding

structural foam molding

Structural foam molding is a manufacturing process in the plastic injection molding family. The process creates a singular large and complex part […]

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5 Common Pitfalls in Military & Defense Product Development

A practical guide to reducing qualification, compliance, manufacturing, and integration risk before production.

Learn how defense programs reduce risk related to qualification, compliance, environmental testing, manufacturability, and production scale-up.

  • MIL-STD qualification failures
  • FAR / DFARS / NIST compliance gaps
  • Prototype-to-production breakdowns
  • Environmental and integration issues
  • Scaling and manufacturing delays

Defense Product Development Guide

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