PRODUCT MANUFACTURING

Securing an on-time medical device launch with a proactive BOM health check

Client
Leading medical device manufacturer
Completed
March 2025
Timeframe
3 months

Overview

Anticipating supply chain risk before it stops a certified production line

The global components crisis has taught the electronics industry a hard lesson: reacting to a shortage is far more expensive than anticipating it. This is especially true in medical devices, where a component can’t simply be swapped for an equivalent one: any change to the Bill of Materials can trigger a new regulatory re-verification, delaying certification and, with it, the launch.

One of our customers, a manufacturer of a certified medical device, was preparing to move into mass production and needed certainty that its supply chain could sustain the ramp-up without interruptions once manufacturing had started.

The requirements to be solved were the following:

  • Identify obsolescence, single-sourcing and counterfeit-risk components across the entire BOM before mass production started
  • Avoid line stoppages once production was underway, given how costly a mid-run redesign is for a regulated device
  • Build a documented, resilient sourcing strategy for every critical line item
  • Protect a fixed regulatory launch date

The challenge

How to detect supply chain risk in a regulated BOM before it becomes a production-stopping problem

Solution

A full BOM health check to map risk and pre-qualify alternates

Our Purchase Department and Product Engineering team carried out a line-by-line audit of the customer’s BOM: lifecycle status (active, NRND, EOL), sourcing depth (single vs. multi-source), traceability through authorized distributors to rule out counterfeit risk, and lead-time exposure per component. 

For every line flagged as high risk, our engineers pre-qualified alternate components that were compatible with the device’s existing regulatory file, so that if a shortage hit, the customer could react without opening a new certification process.

calendar supply chain

Our added value

  • Full visibility before it was too late. The health check flagged the highest-risk components months before they could have caused a stoppage, turning an unknown risk into a managed one.
  • Close cooperation between Purchase and Product Engineering. Alternates were pre-validated jointly so they wouldn't compromise the device's existing regulatory approval.
  • Uninterrupted, on-time start of mass production, protecting the customer's launch date in a highly regulated market.
Our Services
Global supply chain
Materials compliance
Obsolescence
Quality assurance

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