Sustenance by design in medical device engineering

Executive summary

Imaging systems, patient monitors, and surgical equipment that have served clinical environments for years generate substantial revenue for MedTech companies while commanding only a fraction of the engineering attention directed toward new product development. I have watched this disconnect between where revenue originates and where engineering resources flow persist across organizations throughout my career, and it remains one of our industry’s most persistent strategic blind spots. Products in the market for a decade or more often account for the majority of profitable revenue, yet sustenance engineering typically receives minimal investment until problems force reactive responses.

Critical components reach end-of-life without adequate planning because no one systematically monitored supply chain roadmaps during the product’s mature phase. Organizations that treat sustenance as something that starts after product launch respond to problems that better planning during initial development could have mitigated. When emergency redesigns divert engineering talent from innovation work that would strengthen competitive position, product roadmaps slip, and strategic opportunities disappear. Regulatory submissions that proceed under time pressure with incomplete documentation create quality system findings during subsequent audits. Customer relationships deteriorate when preventable service disruptions expose inadequate lifecycle planning that should have been addressed years earlier.

Lifecycle planning integrated into initial product development elevates maintainability and adaptability to core design requirements. Organizations that implemented this methodology reported reduced lifecycle costs while extending product longevity in ways that protected revenue streams as devices aged. The approach enhanced regulatory compliance efficiency and opened service revenue opportunities that transformed sustenance from a cost center to a profit contributor. Through two decades of MedTech work, Quest Global had been helping organizations move from reactive problem-solving to proactive lifecycle management.

When design decisions outlive design teams

High-risk medical devices like ventilators and defibrillators served clinical environments for an average of 13-16 years, according to research published by Samsung Medical Center and the American Hospital Association. During these extended periods, the environment in which these devices operated transformed substantially. Components that were readily available from multiple suppliers at product launch became obsolete as semiconductor manufacturers consolidated operations or exited certain product lines. Software architectures designed for devices operating independently required significant adaptation when connectivity and data exchange became standard expectations as healthcare IT infrastructure evolved. Regulatory frameworks shifted from models requiring periodic submissions to expectations for continuous post-market surveillance with real-time data capabilities.

Design teams at most companies operate under mandates that reflect new product development priorities because that is where revenue growth appears most visible to executive leadership. Success metrics focus on time to market and initial manufacturing costs because these factors determine project approval and career advancement. Component selection prioritized current availability and price without systematic evaluation of supply chain stability when I reviewed design decisions at multiple organizations. System architectures optimized for manufacturing efficiency rather than modularity, which would enable targeted upgrades. Documentation satisfied regulatory submissions without considering how it would need to evolve as products matured.

Sustenance teams inherited products years after launch without understanding the rationale behind design decisions that constrained their options when obsolescence or regulatory changes demanded action. Why did the original team select this particular component when alternatives with better long-term availability existed? What alternative architectures did they consider and reject? Original design teams had usually moved to other projects or left the organization when these questions arose during obsolescence crises, taking institutional knowledge with them. Lifecycle expertise is integrated into initial development documents, decision rationale, and ensures that future sustenance requirements shape architecture from the beginning.

What reactive sustenance actually costs

The cost of treating sustenance as an afterthought

The fundamental mismatch

The reactive sustenance cascade

Trigger: A critical component becomes unavailable without warning

1. Emergency response costs

2. Hidden fragmentation

3. Compounding pressure

4. Regulatory vulnerability

The proactive alternative

Sustenance by design

Designing products for their entire lifespan

Products designed primarily for launch excellence but expected to deliver lifecycle resilience across evolving operating environments created a fundamental mismatch that drove most reactive sustenance costs. Component selection decisions made during initial development determined options available years later when obsolescence forced changes. Teams that systematically evaluated component lifecycle status using databases tracking obsolescence announcements identified emerging risks before they became critical. Alternative sources were qualified proactively, enabling rapid response when disruptions occurred. Contingency plans documented during initial development transformed component obsolescence from an unpredictable crisis into a managed transition.

Modular designs balanced manufacturing efficiency against long-term adaptability by partitioning functionality to enable targeted upgrades at board or subsystem levels while maintaining system integrity. A diagnostic imaging system I worked on, which faced FPGA obsolescence, would have required emergency redesign across multiple subsystems under traditional architecture, but modular design enabled the team to redesign only the specific circuit board while other subsystems remained unchanged. Digital traceability is maintained automatically by development tools linking design inputs to verification activities, risk assessments to mitigation strategies, and regulatory requirements to design elements satisfying those requirements.

Portfolio rationalization identified high-value products deserving continued investment while flagging phase-out candidates whose market position made continued support economically questionable. Staged sunset strategies enabled gradual withdrawal that gave customers adequate transition time and maintained service commitments. Healthcare providers needed spare parts availability, software maintenance, and technical assistance to maintain service continuity until replacement solutions were deployed. Connected devices required security architectures supporting regular software updates to address newly discovered vulnerabilities, systematic patch management with complete documentation, and continuous monitoring to detect emerging threats.

The business case and pathways to implementation

Planned component obsolescence management avoided emergency premiums and compressed schedules that characterized reactive responses, while efficient regulatory update processes reduced consultant fees and internal resource consumption. Predictive maintenance strategies lowered field service expenses by enabling scheduled interventions during planned downtime. Product lifecycle extensions protected revenue streams that would otherwise erode as products aged and competitors introduced newer alternatives. Healthcare providers particularly valued long-term support commitments for capital equipment where procurement cycles spanned multiple years, and the total cost of ownership heavily influenced purchasing decisions.

Proactive regulatory compliance reduced the probability of warning letters, consent decrees, and product recalls. Supply chain resilience through standardized components and pre-qualified alternatives prevented production interruptions. Subscription-based firmware updates provided recurring revenue while delivering continuous value through performance improvements. Cybersecurity patch services addressed regulatory requirements while generating service revenue. Mid-sized OEMs without resources to build internal sustenance capabilities could access sustenance-as-a-service, providing lifecycle support through predictable costs.

In-house development provided complete control over processes and intellectual property, which mattered most for companies whose competitive advantage depended on proprietary sustenance methodologies. Strategic partnerships offered immediate access to specialized expertise and proven methodologies refined across multiple clients, accelerating implementation while reducing risk. Quest Global’s engagement approach included transparent governance, maintaining client control over strategic decisions, systematic knowledge transfer, building internal capabilities progressively, and collaborative working models respecting client ownership of sensitive information. Hybrid approaches balanced control with efficiency by retaining responsibility for strategic planning and sensitive activities while accessing specialized support for complex tasks.

Proven results and enabling technologies

An infusion pump manufacturer facing high service costs redesigned products to incorporate embedded connectivity and performance monitoring sensors, enabling continuous data collection from deployed devices. Predictive analytics algorithms processed this operational data to identify degradation patterns preceding component failures and enable proactive scheduling during planned downtime. Service dispatch costs reduced substantially while device availability improved, strengthening customer relationships that translated into contract renewals. A surgical imaging manufacturer struggling with escalating costs from custom mechanical components redesigned using standardized materials, cutting production costs by 20% while simplifying future sourcing. A cardiac device manufacturer that had implemented digital traceability maintained uninterrupted market access when the EU MDR introduced stricter documentation requirements, while competitors struggled with compliance gaps.

AI algorithms now analyze device performance data collected from thousands of deployed units to identify subtle degradation patterns preceding failures, enabling maintenance interventions before problems impact clinical operations. Machine learning models process component manufacturer roadmaps, supply chain intelligence, and technology evolution trends to forecast obsolescence risks years before components become unavailable. Digital twin technology creates virtual replicas, enabling engineers to simulate design changes, test software updates, and optimize maintenance strategies without disrupting devices serving patients.

Compliance strategy and capability building

Regulatory requirements mapped to specific design specifications during initial product design ensured that compliance was built into product architecture rather than verified after design decisions had constrained options. Documentation systems maintained automatic traceability between requirements and implementation evidence so that when requirements changed years after initial development, impact assessment could proceed quickly. AI-driven regulatory intelligence platforms continuously monitored developments across global markets, predicted emerging changes, and recommended proactive updates, maintaining compliance ahead of enforcement deadlines.

Authorities increasingly expected manufacturers to systematically collect real-world device performance data, analyze this data to identify potential safety trends, implement timely corrective actions, and report findings transparently. Organizations with connected device capabilities satisfied these expectations efficiently through automated data collection and analysis workflows. Dedicated centers of excellence provided strategic oversight across product portfolios, developed best practices, and coordinated activities spanning multiple product lines.

Capability development needed to extend beyond technical skills to encompass regulatory interpretation that went beyond literal compliance to understand regulatory intent. Data analytics skills enabled evidence-based decision-making, while strategic planning capabilities aligned sustenance activities with business objectives. Financial analysis capabilities quantified business impact in ways that justified investment to executive leadership. Sustenance engineering has traditionally been perceived as lower-status work compared to new product development, yet it requires sophisticated judgment about complex trade-offs and creates tangible business value.

Partnership capabilities and strategic decisions

Building holistic organizational capabilities for sustenance engineering internally required significant time investment, typically spanning 18-24 months, and substantial financial commitment for systems, tools, and personnel. Quest Global brought two decades of MedTech experience spanning component continuity management, regulatory adaptation across major markets, cybersecurity architecture for connected devices, and end-of-life management.

Evidence from implementations across device categories demonstrated that sustenance by design delivered tangible returns justifying investment. The strategic question had shifted from whether to integrate lifecycle planning into product development to how quickly organizations could build or access necessary capabilities. Some companies chose to develop internal expertise, while others engaged external partners to accelerate capability development and access specialized expertise that would take years to build internally. Most organizations found that hybrid models combining internal strategic control with specialized external support provided optimal results.

Regulatory requirements will continue intensifying in response to device complexity and connectivity. Product lifecycles will extend as healthcare providers seek to maximize capital equipment investments. Sustenance engineering increasingly separates market leaders from companies struggling to maintain relevance. Organizations that embed lifecycle resilience into their development processes will protect revenue streams, strengthen customer relationships, and create sustainable market advantages that competitors find difficult to replicate.