Capabilities

From ideation to commercialization - our comprehensive approach to medical device development.

Operating Philosophy

Operating Philosophy - Speed to Market = Precision Planning + Ruthless Execution

Core Skills

Ideation to Commercialization

Integrated capabilities spanning devices, program management, quality/regulatory, design transfer, and portfolio strategy.

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Skill

Medical Device Development

Mechanical, electromechanical, and smart devices with disposable system design and IP-first thinking.

  • Mechanical, electromechanical, and smart devices
  • Disposable system design
  • IP development and filing
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Project Management

Regulated program leadership with clear gates, timelines, and accountable owners.

  • Design control: 21 CFR 820.30, ISO 13485
  • Phase-gate management
  • Speed-to-market focus
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Quality & Regulatory

Global approvals strategy, DHF strength, and submission readiness for FDA/EU and beyond.

  • ISO and CE mark approvals
  • 510(k) submissions and worldwide approvals
  • Robust DHF and documentation
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Design Transfer to Manufacturing

Supplier selection, V&V rigor, and scalable production with KPIs in place.

  • Contract manufacturer selection
  • Supply chain setup
  • Comprehensive V&V and KPIs
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Portfolio Strategy & Roadmaps

Prioritized funneling of opportunities with leadership alignment and clear go/no-go.

  • Strategic portfolio reviews
  • Program ranking with leadership
  • Funnel to selection and prioritization
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Our Expertise

Depth of Support Across All Areas

From medical devices to connected systems, we provide comprehensive support across the entire product development lifecycle with deep domain expertise.

Medical Devices

Medical Devices

Comprehensive support for medical device development from concept to commercialization.

  • Mechanical devices
  • Electromechanical systems
  • Smart connected devices
  • Disposable systems
  • Surgical instruments
System Design

System Design

End-to-end system architecture and design solutions for complex medical technologies.

  • Hardware architecture
  • Software platforms
  • Firmware development
  • System integration
  • Design for manufacturability
Operations/Supply Chain

Operations/Supply Chain

Strategic operational excellence and supply chain optimization for medical device manufacturing.

  • Manufacturing strategy
  • Supplier selection & management
  • Quality systems (ISO 13485)
  • Cost optimization (COGS)
  • Production scaling
Connected Devices

Connected Devices

Next-generation IoT and cloud-connected medical device solutions with robust security.

  • IoT architecture
  • Cloud platforms
  • Mobile applications
  • Data analytics
  • Cybersecurity & HIPAA compliance
Comprehensive Overview

Services Overview

Platform services, core services, metrics, and partners across strategy, development, execution, manufacturing, and digital surgery/AI-ML.

 
1Strategy & Ideation
2Portfolio and Programs: Design and Development
3Crisp Execution
4Manufacturing and Commercialization
5Digital Surgery, AI with ML
Platform Services
  • Human centered design
  • Clinician and Patient integration
  • Cadaver lab studies
  • Electromechanical systems
  • Single use, disposable systems
  • H/W design
  • S/W and Firmware
  • Portfolio planning
  • Project Management
  • Design control
  • Validation and verification (V&V)
  • Contract manufacturer selection
  • Manufacturing, COGS and capacity planning
  • DFM analysis
  • Integrated and connected device architecture
  • Cloud based platforms
  • Full stack development
  • Mobile App
Core Services
  • IP
  • Rapid prototyping
  • Board of advisors
  • CAD
  • Firmware: C++, Python
  • PCBA layout
  • Molding
  • Imaging platform
  • Biocompatibility and Sterilization
  • Strategy and portfolio consulting
  • Project Management: PMI/PMBOK, Agile, GIRA
  • Risk assessment
  • COGS analysis and cost reduction plans
  • Launch plans roll out
  • Supply chain consolidation
  • 510(K) and other approvals
  • Big data analytics
  • AI/ML
  • Cybersecurity
  • Robotics
Metrics
  • Initial design
  • Proof of concept
  • Prioritization
  • Design assurance
  • Time to market
  • Biocompatibility and sterilization validation plans
  • Comprehensive plans
  • QMS support
  • Risk Assessment
  • COGS
  • On time delivery
  • Supply chain definition
  • 510(K)
  • An integrated solution development
  • Customer focused system design
  • Implementation
Partners
  • IP teams
  • 3D and Additive printing
  • Internal and External teams
  • Biocomp and Sterilization partners
  • Board of advisors
  • RA/QA
  • Quality experts
  • Testing labs for electronics
  • Offshore and onshore partners
  • Cybersecurity, HIPPA compliance and testing

Domain Specializations

Leveraging our deep expertise across multiple medical domains to deliver innovative solutions that transform patient care and advance medical technology.

Pain Management

Advanced solutions for pain management and relief systems

PnB drug deliveryCatheter systemsUltraShield and Imaging

Medication Delivery

Innovative drug delivery and infusion systems

Infusion Pumps: ElastomericInfusion Pumps: ElectromechanicalSoftware based drug library

Plastic Surgery

Precision instruments and devices for aesthetic procedures

Liposuction ToolsSkin abradersImplants: Mammary, others

Endoscopy and Robotics

Advanced minimally invasive surgical systems

Arthroscopes, Shavers, Irrigation and CannulaLaparoscopesFluorescence Imaging and Hyperspectral Imaging

Ophthalmology

Specialized devices for eye care and vision correction

Intra Ocular LensesPhacoemulsificationIOL delivery systems

Drug and Device Combination

Integrated solutions combining pharmaceuticals and devices

Drug stabilityPowered injectors

Orthopedics

Solutions for musculoskeletal care and rehabilitation

Powered Surgical InstrumentsAI based algorithmImplants and Wound Management

Ready to Transform Your Medical Innovation?

Partner with us to bring cutting-edge medical solutions to life

Start Your Project

Contact Healthcare Evolution, Inc.

Email

info@healthcareevolution.com

Schedule a Call

Book a strategic planning session to discuss your medical device development needs.

Confidentiality

We respect the sensitive nature of healthcare innovation and are prepared to sign NDAs before detailed technical discussions.