The healthcare and medical devices sector is changing swiftly due to a convergence of several factors. Factors such as the growing connectivity of medical devices, rising healthcare costs, increasing numbers of older adults, demand for personalized medicine, scientific advances, and rapid globalization are leading this transformation. These developments present a unique opportunity for medical device companies that can successfully navigate the changing healthcare landscape.

At Cyient, we work in partnership with our customers to solve problems, helping them stay ahead of the curve. We design customized devices, offer end-to-end product development, maintenance, and manufacturing support, streamline the supply chain, and more. Our ISO 13485-certified processes and quality management system ensure high-quality product development, enabling our customers to meet their compliance objectives.

Medical Devices: Product Engineering Expertise and Capabilities

With 20+ years of OEM and electronic box-build experience in medical devices, Cyient is a preferred partner for comprehensive design and manufacturing services for medical device and life sciences companies worldwide. We leverage our medical domain expertise to deliver high-quality, cost-competitive solutions in the healthcare markets highlighted below -

Orthopedics

Orthopedics

Ear Nose & Throat

Ear, Nose & Throat

Diagnostics

Diagnostic Imaging

Respiratory Care

Respiratory Care

Consumer_Healthcare

Consumer Healthcare

Endoscopy

Endoscopy

Digital_health

Digital health

Opthalmology

Ophthalmology

Invitro_Diagnostics

In-Vitro Diagnostics

Pharmaceuticals

Pharmaceuticals

Urology

Urology

Cardiology

Cardiology & Patient Monitoring

Our Digital Solutions

Product_development

Product Development

  • New product (NPD)
  • Technology refresh
  • Sustaining engineering
  • Reverse engineering
  • Value engineering
  • Design for circulatory
Regulatory_Compliance

Quality Assurance and Regulatory Compliance

  • Reliability engineering
  • V&V—test automation
  • MDR/IVDR compliance
  • Technical publications
  • Product regulatory compliance (RoHS)
S2 Manufacturing.jpg

Manufacturing

  • PCBAs
  • Box build
  • Precision machining
  • 3D printing
  • Cable harness assembly
Firmware

Embedded Software and Firmware

  • Platform development
  • Device driver development
  • Connectivity driver development
  • Unit, integration, sub-system and system test
Software  Development

Software Development

  • Software app. development
  • Cloud (AWS, Azure, GCP)
  • UX/UI, APIs, microservices
  • Automated testing, Cl/CD
  • WPF, WCF, docker container services
  • Kubernete
Digital

Digital

  • IoT
  • Cloud computing
  • Analytics, machine learning, and artificial intelligence
  • AR/VR
  • Digital twins
  • RPA and BOTS

Impact Delivered

Developed a next generation clinical analyzer capable of processing eight samples for 40 parameters

Value Delivered

  • Manufacturing localization
  • 25% overall cost reduction
  • NRE cost reduction
  • Compliance testing/certification
Clinical_Analyzer

Launched the Hemodialysis System in 75+ countries (EMEA, NAM, APAC) that meets EU MDR, US FDA, NMPA, ASEAN MDD regulatory requirements

Complete ownership of:

  • Product specification
  • Feasibility assessment
  • Product development
  • Product launch in these markets
Hemodialysis

Designed and developed a home health device for monitoring six vital signs—ECG, pulse rate, heart rate, temperature, NiBP (non-invasive blood pressure) and blood glucose

Value Delivered

  • Low-cost home health device for Asian market
  • Compact, portable, human-factor-engineered device
  • GUI development
Home_Device

Electronic hardware redesign and verification of ultra-low temperature(ULT) freezer comprising smart features that enable hospitals/labs to safeguard patient specimen samples and reduce warranty claim costs

Value Delivered

  • Compatible with legacy products
  • Edge/modular design for backward compatibility
  • Predictive algorithm development
Freezer-casestudy

Cybersecurity testing for networked patient monitoring system as per FDA guidelines

Value Delivered

  • V&V for four products, with complete documentation for 510(k) approval
  • Ensured legacy product line compliance with FDA's cybersecurity guidelines
Cybersecurity

Value Proposition

Medical_Domain_Expertise

Medical Domain Expertise

Leverage medical domain expertise to deliver high-quality, cost-competitive solutions and optimized processes to enable developmental consistency, reduced time, and flexibility

  • End-to-end product development and life cycle management
  • Embedded service line
  • Modular design for platformization
  • ASICs for miniaturization and IP protection
Technology_Accelerators

Technology Accelerators

Solutions, accelerators, and frameworks across the life cycle of medical device development to help customers achieve faster time-to-market and cost efficiencies

  • CyMedge for accelerated development of smart connected healthcare products
  • SDx for accelerating software-driven architecture and embedded AI, fusion
  • PlatfromX for platform and application engineering
  • CyFAST for end-to-end test automation
  • CyARC for accelerating regulatory compliance
Regulatory_Compliance

Regulatory Compliance

Certified quality management system to meet compliance requirements by regulatory authorities such as FDA

  • Compliant with ISO 13485, IEC 60601-x
  • EUMDR/IVDR expertise with multiple country regulations and compliance requirements
Facilities_and_Governance

Facilities and Governance

State-of-the-art manufacturing facilities and infrastructure
available globally

  • Fully equipped in-house testing labs
  • Verification and Validation (V&V) factory

 

Standard KPIs and 3-level Governance models to meet business objectives and customer satisfaction

Voice of Customers

Gerard Majoor
Global Platform, Program and Project Management
Office Leader, Patient Monitoring, Philips

Thanks for the great work in 2021 colleagues. Half a year ago we still thought that we could not solve this. And now we are on track and did achieve our targets. Thanks to your passion, energy, teamwork, and good planning and daily management.

I am very happy with, and grateful for that. I look forward to our collaboration in 2021.

1 / 5

Mr. Bjorn Hille
Head of Procurement, Mohlenhoff

Cyient is more than just a partner to Mohlenhoff. Our long-standing collaboration is all about mutual respect and appreciation because quality and trust are our top priorities.

1 / 5

Roque Carmona
Senior Vice-President, Group Chief Procurement
Officer, Thales, on Cyient receiving the Thales Supplier Performance Award 2020

Cyient has been one of our trusted partners for several key initiatives including design engineering, manufacturing, and our "Go-to-India' programme. A successful partnership must adhere to the highest delivery standards and ensure performance excellence. We congratulate the Cyient team on achieving this distinction especially during the challenging times. Together we shall continue to contribute to the prestigious 'Make in India' initiative of the Indian government.

1 / 5

Chuck Pickering
VP Energy - Global Content Ops, IHS Markit

Cyient continues as our most valued outsourcing partner. Our most recent project has once again proved Cyient is capable of delivering satisfactory results for a job once deemed impossible to outsource.

1 / 5

Seth Reid
Vegetation Management Quality Control Advisor —
LiDAR SME, SCE

A key benefit to using Cylent's LIDAR and Vegetation Management services Is reliability for all of my data needs. As a LiDAR specialist at Southern California Edison, I wanted to acquire aerial imagery and LIDAR for addressing vegetation risk management across our Transmission network. By collaborating with other SCE departments, we developed additional use cases for the LIDAR data and reduced SCE's overall spend to maximize business value. Cyient managed the data acquisition process. delivered PLS-CADD models and Planimetry for our Transmission Line Engineering group, vegetation models for me, and developed wetlands delineation for our Environmental group. Working with a knowledgeable partner like Cyient who understand the vegetation process made the entire project easier to coordinate with less Iterations. I think Cyient's depth and breadth of GIS capabilities and proven delivery model can add value to any Utility dealing with vegetation, asset, or environmental management.

1 / 5

Insights

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Decoding De Novo Submission Process For Medical Devices in the US

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