Keep Your Device Current, Compliant, and Cost-Competitive After Launch.

Launched devices need sustained engineering — most companies are unprepared for it. We provide the ongoing engineering discipline that keeps your device viable, supply-secure, and compliant long after market clearance.

Sustaining Engineering & Product Lifecycle Management

The Problem We Solve

Medical devices do not stop needing engineering attention at market launch. Component obsolescence, post-market design improvements, cost reduction programs, and regulatory change notifications all require disciplined engineering management. Without a sustaining engineering capability, launched devices accumulate technical debt, face supply disruptions, and require emergency redesigns — all at the worst possible time.

What We Do

Four sustaining engineering disciplines — keeping launched devices viable, compliant, and cost-effective.

🔧 Engineering Change Management

Engineering Change Order (ECO) and Change Notice (ECN) management
Design change risk assessment and regulatory impact analysis
Change validation and verification planning
Notified Body or FDA change notification strategy
DHF and DMR updates reflecting approved changes

🔩 Component Obsolescence Management

BOM lifecycle monitoring for end-of-life and at-risk components
Last-time-buy planning and buffer stock strategy
Alternative component qualification and drop-in testing
Redesign scoping when alternatives are unavailable
Supply continuity planning and risk mitigation

💰 Cost Reduction & Value Engineering

BOM cost reduction analysis without specification change
Process efficiency improvements in manufacturing
Alternative material and supplier qualification
DFM refresh for mature products approaching price targets
Cost reduction validation aligned to regulatory requirements

📅 Product Portfolio & End-of-Life Planning

Device generation planning and feature roadmap support
Market withdrawal and end-of-life documentation
Product line rationalisation analysis
Next-generation device transition planning
IP and technology transfer support for portfolio transactions

Who This Is For

We work with companies managing the engineering reality of devices already on the market.

Companies with devices on the market for 2 or more years requiring active engineering management

Device makers facing component end-of-life issues without a qualified alternative

Organisations that have absorbed a product line through acquisition and need engineering continuity

Companies seeking to reduce COGS on mature high-volume products without regulatory disruption

Why 369 Innovations

We treat sustaining engineering with the same discipline as new product development — because a field failure on a launched device, or a supply disruption in a production program, has consequences just as serious as a development program failure. This is the capability most companies build too late.

Key Differentiator: Launched devices proactively managed — not reactively fixed when something goes wrong.