We take Medtech's digital health vision from concept, through development, to reality.

An end-to-end, specialist digital health partner for the design and development of connected medical devices and regulated digital health solutions that expand device value, optimize disease management, and integrate with ecosystems of care.


No matter where your company is on its digital health journey, our multidisciplinary team can help. From defining your digital health strategy, the development of medical device software, connectivity, digital health infrastructure, and SaMD applications, to integration, managed service operation and life cycle management.

Solution Areas
connected-medical-devices-and-digital-health-solutions-medtech1
for implantable, wearable, or personal medical devices
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Hospital-at-home
for connected medical equipment
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What makes S3 Connected Health the specialist digital health partner for medtech
20-Years-Experience

20+ years experience in medical devices and digital health
Deep domain expertise includes s/w engineers, regulatory experts, UX specialists, medical professionals, and business analysts

Complete-digital-health

Complete digital health solution stack
With a wide spectrum of capabilities from electronics design to cloud services operation

End-to-End-Digital

End-to-end digital health solution design
One partner, from defining digital health strategy, connected device development, solution development, roll-out and operation

Affinial-Digital-Health

Affinial digital health platform
Providing best practice implementation of digital health infrastructure and services

Our end-to-end approach to delivery
Solution-driven creation of connected medical devices and digital health solutions, our end-to-end process supports you at any point of your journey, ensures efficiency in program delivery, and covers the full digital health stack.

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Full Digital Health Stack
End-to-End Digital Health Solution Creation
 

Concept Design
& Definition

Discover
Identify
Ideate

Development
& Validation

Specify
Implement
Validate
Certify

Operation
& Life Cycle Management

Roll-out
Manage
Evolve
Project Governance

Multidimensional reporting of project progress, risks, and mitigations

End-to-end program management
Data strategy and evidence generation
Cybersecurity end-to-end design and operation
Regulatory strategy
Digital Solution

Support every stage from concept and development, through to launch, operation, and evolution

Business opportunity and
strategy development
Solution ideation, target
product profile development
User needs
analysis
User experience design / usability engineering
Solution ideation, target
product profile development
Solution validation
Regulatory approval
Design inputs and project planning
Legal manufacturer
System requirements and management
Service readiness
test
Operating model design
Solution
roll-out
Data service
Clinical systems integration
Managed service (operations, support)
Solution performance optimization
Go-to-market support
Solution upgrades
SaMD Applications & Connected Medical Device

Accelerate development with expertise in digital health, connectivity, and end-to-end cybersecurity

Platform strategy
Prototype development
Technology assessment
and selection
Connectivity strategy
Platform/solution mapping
Application design inputs
Device
design
inputs
Regulated
AAMI TIR 45,
scrum-based development
with
continuos integration
and
delivery
Automated
end-to-end system verification
and
integration
DHF/TF and regulatory submission
Application and
device upgrades
Services and capabilities
Digital health
consulting
Solution
design
Technology
consulting
Medical device
software and
connectivity
Digital health
platform
Digital health
infrastructure and
service
Healthcare software
and SaMD application
development
Device and solution
integration and
evolution
Solution management
and data services
Life cycle
management
Digital health <br />consulting

Digital health
consulting

  • Primary and secondary research
  • Business case and strategy
  • Reimbursement strategy
  • Value proposition validation
  • Evidence strategy and planning
Solution <br />design

Solution
design

  • Target product profile dev
  • User needs, behavioral insights, journey mapping
  • UX Design
  • HFS and usability engineering
  • Regulatory planning and risk management
Technology <br />consulting

Technology
consulting

  • Technical review/gap analysis
  • Technology assessment, prototyping, and selection
  • Connectivity and data architecture
  • Platform strategy
  • Cybersecurity modelling and planning
Medical device <br />software and <br />connectivity

Medical device
software and
connectivity

  • System design options and architecture
  • Proof-of-concept/prototyping
  • Embedded software development
  • Device Connectivity
Digital health <br />platform

Digital health
platform

  • Leverage a cloud-based digital health platform to enable device-based solutions in new care settings
  • Use an extensive range of digital health services for patient-centered solutions
  • In-field device support and operations management
Digital health <br />infrastructure and<br /> service

Digital health
infrastructure and
service

  • Development of digital health infrastructure and services
  • Scalable and extendable back-end architecture
  • Assessment of digital health platform need
  • Integration with clinical and business services
  • 3rd party logic and algorithm plug-ins
  • Integration with common cloud services
Healthcare software <br />and SaMD application <br />development

Healthcare software
and SaMD application
development

  • Mobile and Web SaMD
  • Enterprise SaMD Applications
  • User experience design and Human Factor Engineering
  • SaMD-Hardware compatibility & testing
  • Software compatibility and updates
Device and solution <br />integration and<br /> evolution

Device and solution
integration and
evolution

  • Solution usage and business analytics
  • Support for consent management
  • Pseudonymized data export
  • Integration with 3rd party systems
  • Algorithm generation and data science
  • Insights generation and reporting
  • Compliant data visualization
  • Mining public healthcare databases
Solution management <br />and data services

Solution management
and data services

  • Connectivity design at the point-of-care
  • Device integration
  • EHR/HIS integration strategy
  • Billing information generation and integration with payer systems
  • Integration engine technology selection
  • SMART on FHIR application development
  • Integration via Affinial Platform

Life cycle <br />management

Life cycle
management

  • Hosting, configuration, localization, and deployment
  • Operations and monitoring
  • Solutions support - L2 & L3
  • Maintenance
  • Governance, reporting, reviews & Management
  • Training
  • Global deployments
We have delivered…
20+ Regulated Medical Devices
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Regulated Medical Devices

ISO 13485 Medical Devices – Quality Management

ISO 27001 Information Security Management System for the provision of S3 Connected Health’s Digital Health products and managed services to clients worldwide

ISO 14971 Medical Device Risk Management 

IEC 62304 Medical Device Software 

IEC 62366-1 Medical Device Usability

UL 2900 Software Cybersecurity

Health Insurance Portability and Accountability Act (HIPAA)

General Data Protection Regulation (EU) 2016/679 (GDPR)

50+ In over 50 countries
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In over 50 countries

Europe
Austria
Belgium
Croatia
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Poland
Portugal
Slovakia
Spain
Sweden
Switzerland
Turkey
United Kingdom

Americas
Argentina
Canada
Chile
Colombia
Ecuador
Mexico
Peru
United States
Venezuela

APAC
Australia
Hong Kong
Korea
Macau
Malaysia
Taiwan
Thailand
Africa

Morocco
Tunisia
South Africa

Middle East
Egypt
Israel
Kuwait
Lebanon
Qatar
Saudi Arabia
United Arab Emirates

20+ Across 20+ Therapy Areas
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Across 20+ Therapy Areas

Endocrinology
Type 2 diabetes
Type 1 diabetes
Gestational diabetes

Immunology
Rheumatoid Arthritis
Crohn’s disease
Psoriasis
Psoriatic Arthritis
Ulcerative Colitis
Systemic Lupus Erythematosus

Oncology
Breast Cancer
Lung Cancer
Prostate Cancer
Non-Hodgkin’s Lymphoma

Respiratory
COPD
Asthma
Sleep Apnoea
Hypoxic Respiratory Failure

Cardiology
Congestive Heart Failure
Stroke
Atrial Fibrillation

Central Nervous System
Multiple Sclerosis

Neurology
Spinal Muscular Atrophy
Epilepsy

Musculoskeletal
Rare Disease – Osteochondrodysplasic

Certifications and regulatory compliance
BSI-Assurance-Mark-ISO-13485-KEYB
IEC 62304 Certification
BSI-Assurance-Mark-ISO-27001

Our medtech customers