Sustenance Engineering in Medical Devices

Overview

A Strategic Approach to Improving Product Performance and Longevity

Enterprises today face tremendous cost pressures to extend the life of existing products and adapt to dynamic market needs. With our services for sustenance engineering for medical devices, you can optimize your spending and improve customer satisfaction through continuous product improvement, all while staying compliant across various geographies and maintaining the highest quality benchmarks.

Contact us

Our Expertise

Sustaining Success Beyond the Launch

The MedTech industry is a continuously evolving space. Going beyond the initial launch of products, medical devices demand continuous support, enhancements and compliance updates to thrive throughout their extended lifecycle. Partner with us to cater to the evolving market needs through continuous product improvement.

Domain and technology expertise

Talent pool of 2,500+ strong dedicated to medical devices sustenance
A team of 100+ domain experts
Partner to 10+ leading medical device OEMs

Dedicated Centers of Excellence (CoEs)

Established in-house domain-specific CoEs in regulatory, medical affairs and IVD
Generic CoEs in value engineering and reliability engineering

Solutions, accelerators and frameworks

Electronic Device Automation Testing (eDAT), Test Automation Framework (TAF) and CARE (Connected Assets in Regulatory Environment) — to accelerate the change implementation

Global standards and compliances

Supported in US FDA for Class I, II and III
EU Class I, Ir, Is, Im, Iia, IIb and III
60601-1, 60601-1-2, 60601-1-6 & 60601-1-8 [IEC / EN / UL / ANSI-AAMI / JIST / AS NZS / CSA]

Igniting a digital B2C sales engine for a leading hardware manufacturer

Expertise in capital equipment, implantables, surgical instruments, diagnostic devices, medical supplies and disposables and more

Services

Achieve Continuous Product Improvement for Maximizing ROI and Competitive Advantage

Extend product lifespan and achieve revenue protection with margin improvements. Accomplish a state of continuous product improvement, maximize ROI and mitigate potential risks, all while staying compliant and adhering to the highest quality benchmarks with HCLTech’s end-to-end sustenance engineering services.

Post market surveillance

Complaint data analysis (Post-market surveillance plan (PMS) plan and report
Post-market clinical follow-up (PMCF) plan and report
Risk management file and clinical evaluation report (CER) updates
Summary of safety and clinical performance (SSCP)

Component engineering

Raw material change
Obsolescence management
Electronic Computer-Aided Design (ECAD)/Mechanical Computer-aided Design (MCAD) support
Identification of alternate components/ vendors

Manufacturing

SKU rationalization
Redesign for operations/vendor requests
Manufacturing line/vendor transfers
Tool/mold obsolescence
New equipment design and IQ/OQ/PQ [installation qualification (IQ), operational qualification (OQ), performance qualification (PQ)]

Adverse event management

Field failure analysis and CAPA (corrective and preventive action)
Design analysis
Design support
Change management
Complaints handling

Product testing/V&V

Test method development and validation
Compliance testing
Environmental testing
Reliability
Product validation
Design verification testing

Product cost takeout

Teardown analysis
Benchmarking
Cost modeling and should costing
Functional analysis
Cost to function analysis
Feature enhancements

Insights

Explore Our Latest Insights

Unlocking the benefits of AI in healthcare

Innovations and groundbreaking treatments are being developed using AI, providing a beacon of hope for millions of patients across the world

Read the article

How AI is helping grow the Life Sciences and Healthcare (LSH) sector

HCLTech experimented with new options such as combining AI with various other technologies to deliver comprehensive solutions, services, platforms and products