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Case Study: Meeting FDA Requirements and Satisfying Customer Demands

The Challenge

A leading medical device company was faced with the need to rapidly redesign and improve a sports-therapy device. There were several major hurdles to clear. First, the product required the submission of a 510(k), like any new medical device. This document verifies that the device is safe and performs as specified.

Second, the product needed to meet customer demand in a short period of time. In 2014, the market for wearable medical devices was $3.5 billion. That's expected to rise to $7.8 billion by 2020. A short time-to-market is imperative to capitalize on these gains.

The Distron Solution

Here are the specific steps that Distron took to ensure that the medical device company was able deliver a high-quality, FDA-compliant device in a short amount of time.

  • Selected a third-party designer: Distron recommended and helped manage a third-party PCBA designer to improve the device's functionality.
  • Conducted a DFM review with engineering staff: Research shows that conducting a DFM review early in the design process can help lower manufacturing costs while ensuring that the device has an easily repeatable manufacturing operation. This reduces product defects and improves test yields.
  • Design and automate an electronic Device History Record (DHR): To ensure that quality standards are met, the FDA's Quality System Regulation (21 CFR Part 820) requires every medical device to have a detailed attached record which refers to its manufacturing process.
  • Create product-specific manufacturing cell: Cell-based manufacturing takes its cues from the lean and just-in-time philosophies. With it, Distron's goal was to produce this medical device as efficiently as possible, on-time and at a reduced cost.
  • Supported production requirement: Distron held finished goods inventory and delivered specified quantities as required on demand.


As a result of Distron's collaboration with the medical device customer, the product passed the exacting quality standards set down by the FDA. This was helped by Distron's ISO 13485 certification, this ensures that products manufactured at the Distron plant meet or exceed regulatory requirements.

In addition, Distron's cellular manufacturing processes, supported by the Kanban supply chain philosophy, allowed the medical device company not only to meet customer demand, but to meet it quickly. The importance of reduced time-to-market, especially in a rapidly changing industry, cannot be understated.

As a final bonus, Distron was also able to design and manufacture environmentally friendly packaging for the product. This shows a commitment to manufacturing service. Every aspect of the process has been considered, from the product's conception until the moment it is received by the end customer.

For more information about Distron, or to engage them for contract manufacturing services, contact one of their experienced sales representatives today.

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