SOFTWARE AS A MEDICAL DEVICE SaMD/DTx

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OPPORTUNITIES FOR GROWTH

Digital Health is a rapidly growing market driven by a need for more efficient and cost-effective healthcare, increasingly pushed towards remote monitoring and out of hospital care with the promise of better outcomes through personalized medicine.

Software as a Medical Device (SaMD) is the regulated sub-segment of Digital health solutions, including Digital Therapeutics (DTx).

Industry demands are accelerating convergence of digital health technologies, combining patient centric applications with telehealth and HCP dedicated apps as part of a holistic healthcare ecosystem, but also increasing complexity.

Accelerating technological change has created new ways for providers to engage with patients, creating a need to deliver SaMD solutions quickly to maintain market relevance thereby challenging the traditional business models.

OUR OFFERING

SaMD, holistic healthcare solutions.

We provide end-to-end capabilities to build secure, compliant and engaging omni-channel healthcare solutions capable of seamless integration with digital health ecosystems, by leveraging our strong domain expertise coupled with modern development approaches and deep regulatory knowledge.

  • STRATEGY

    STRATEGY

    Capture high potential opportunities for sustainable growth

    Understand the market and create value-driven solutions leveraging robust technology to meet business and end-user needs.

  • USER EXPERIENCE

    USER EXPERIENCE

    Create seamless and engaging user experience ensuring safety and ease-of-use

    Apply best practices in Interaction Design and Human Factors Engineering to engage and support users.

  • DESIGN & DEVELOPMENT

    DESIGN & DEVELOPMENT

    Accelerate time-to-market with SaMD solutions built to grow with evolving needs

    Framework and certified processes to rapidly design, iterate and maintain compliant, engaging solutions.

  • IoT & PLATFORM

    IoT & PLATFORM

    Build and scale your capacity to capture and manage medical data

    Design, customize, deploy platforms for reliability, security, growth and flexibility to meet future needs.

  • TRUSTED AI

    TRUSTED AI

    AI solutions trusted by HCPs and accepted by regulators

    Unlock value of data with AI solution design, implementation, verification and lifecycle support.

  • CYBERSECURITY

    CYBERSECURITY

    Ensure security by design

    End-to-end system security to manage threats and assure health data compliance.

LEGAL MANUFACTURER

Simplify compliance – from regulatory strategy to submissions and post-market support​

We can act as Legal Manufacturer to reduce your compliance efforts. We can also help you develop your capability to become Legal Manufacturer and support your immediate regulatory needs.​

WHY US?

  1. Global Domain Partner
    • 35+ years experience in the Lifesciences industry, Medtech and Pharma
    • Certified processes & proven expertise in product design and user experience
  2. Product Strategy and User-Centered Design Experience
    • Ensuring safe, commercially viable product meeting clinical needs with value-based outcomes
    • Market fit, enhanced stakeholder experiences and innovative solutions
  3. Advanced Engineering for Time-to-Market Acceleration
    • Operations efficiency through automation ensuring quality processes
    • Agile, DevSecOps, iterative product development, algorithms, leading-edge tools and processes, SaMD frameworks, platforms and accelerators
  4. Proven analytics & AI expertise in Life Sciences and Healthcare
    • Data intelligence to prove patient outcomes, cost reductions
    • AI/ML tools and frameworks for trusted, compliant applications
  5. Technology Agnostic Solutions with Just in Time Scalability
    • Seamless, cross-channel experience for Product extension (Web, Mobile Apps, Mixed Reality etc.)
    • Interoperability & Connectivity – Standards- based (HL7, FHIR, DICOM, others) and BLE, RFID, NFC, Cellular, WiFi.
  6. Deep Knowledge in Regulatory & Quality Compliance
    •Dedicated QA/RA expertise, certified and compliant processes, ISO 13485, ISO 27001 certified, FDA 21 CFR 820 and EU MDR & IVDR compliant
    • Capability to act as Legal Manufacturer of SaMD

SUCCESS STORIES

    • 1 4

    • K’WATCH

      CONTINUOUS GLUCOSE MONITORING

      We developed a connected solution across several of our domains: Mobile apps, innovative product development, connectivity (IoT), cloud backend development, data security, data analytics and reporting and regulatory compliance to deliver an end-to-end patient adherence solution.
      After launch, we provided functional support to Patients, Healthcare Professionals (HCPs) and Clinical Study Coordinators for issues related to connected system via dedicated 2nd and 3rd Line Support center.

    • 2 4

    • CHRONOTHERAPY TELE-MONITORING PLATFORM

      HEALTHCARE PROVIDER

      - Biological rhythms influence the pharmacology and tolerability and / or efficacy of drugs.
      - We developed a circadian tele-monitoring platform for chronotherapy clinical research and development (Cloud solution + secure IoT).
      - This solution improves drug efficacy, limits drug side effects and predicts patient status.

    • 3 4

    • MANAGE MY SYMPTOMS APP

      AI ALGORITHMS ENHANCE TREATMENT OF CHRONIC ILLNESS

      6 out of 10 adults in the US suffer from a chronic disease and 75% of healthcare costs are spent on treating these illnesses. Using AI algorithms trained on patient data, symptoms were predicated 24 hours in advance with 85% accuracy.
      Our prototype demonstrated the business case for investing in a 3-year clinical trial of AI technology.

    • 4 4

    • REMOTE PATIENT MONITORING SOLUTION

      GLOBAL CLASS 3 & 2 MEDICAL DEVICE MANUFACTURER

      Our team built an efficient, robust and compliant remote management solution including web and patient & clinician mobile applications with capability to schedule appointments, enabled collaboration between clinicians, and manage the entire patient journey from enrolment to release and billing.
      The solution enables collecting arrhythmia events’/episodes data via RF/BLE from the implanted pacemaker/ICD, and for any episode that gets generated it sends real time alerts to the clinician and a summary to the server for analysis.

LEARN MORE

Next-generation healthcare – Software as a Medical Device (SaMD) in the Intelligent Industry

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