Put the power of digital into your medical device

Fact Sheet

CONNECT YOUR MEDICAL DEVICE DATA TO THE CLOUD

medical device services
medical devices technology consulting services
INCREASED INTEROPERABILITY AND CONNECTIVITY ENABLE DEEPER ANALYTICS FOR BETTER PATIENT ENGAGEMENT AND CARE

Major advances in digital are driving the MedTech and IoMT (Internet of Medical Things) industry.

A growing number of internet-connected medical devices create the ability to generate, collect, analyze, and transmit critical health data to improve care while gaining substantial operational efficiencies. The problem that companies face, however, is that to take advantage of this collected data, you need to have secure, high-performance device connectivity in the cloud that can provide actionable insights and, importantly, a patient-centric approach.

medical devices it services

Apexon is a digitally native company that helps MedTech and IoMT companies analyze, operationalize and connect the data in their devices to enable more efficient, innovative, and modern patient and provider experiences.

We work with leaders across the Life Sciences ecosystem, including device makers, biotech companies, providers and contract research organizations (CRO) throughout the product lifecycle to bring their innovations to market faster with greater functionality.

How we deliver
UNIQUE TECHNOLOGY ACCELERATORS FOR FASTER TIME TO MARKET
CLIENT-FIRST CULTURE
DEEP EXPERTISE IN EMERGING TECHNOLOGIES
DATA ENABLEMENT AND CLOUD EXPERTISE
DISTRIBUTED AGILE GLOBAL TEAMS
PROGRESSIVE DELIVERY
DATA DRIVEN
USER EXPERIENCE
Challenge & Trends

MEDTECH & IOMT

MedTech Trends
Telemedicine

Telemedicine

As remote health takes priority, IoMTs require health data to be transmitted continuously and dependably.

Patient-Centric Care

Patient-Centric Care

As patients take more responsibility for their care and utilize technology to track their wellness, providers want to take advantage of the latest advances in health apps, SaMD, and IoMT. In addition, the need to inform patients on treatment, medications and recuperation requires flexible access and utilization of patient data.

medtech for Digital Therapeutics (DTx)

Digital Therapeutics (DTx)

The increase in remote access to therapies, and the dominant role of AI and mobile technology have broadened the possibilities of DTx. Provider and device makers need to be able to take advantage of these advancements.

Remote Patient Monitoring

Remote Patient Monitoring

Effective and efficient treatment for chronic diseases requires remote patient monitoring. To achieve that, device makers and providers need the right combination of IT infrastructure, cloud computing, and edge analytics.

Technology Implementation Challenges
Device & Data Connectivity

Device & Data Connectivity

The real promise of the latest medical devices is the ability to get the data captured by the device into the cloud where it can be analyzed and accessed by providers and patients.

medical devices interoperability

Interoperability

There is a critical need for high levels of system interoperability and real-time data access. Standards like FHIR promise to provide modern and web-based suites of API technology.

Regulatory Requirements

Regulatory Requirements

Regulatory compliance and approval have a huge impact on time to market. This requires an experienced technology partner that understands these complex processes and laws. 

medical devices data security services

Data Security

As continuous patient monitoring increases, both invasive and non-invasive connected devices are at risk of data breaches, putting both providers and patients at risk.

APEXON

IOMT FRAMEWORK

Digital healthcare’s evolution has not happened overnight. The use of MedTech to provide care and wellness solutions has been growing steadily for a decade, but the effectiveness of providers and healthcare professionals increasingly relies on connected IoMT solutions to help diagnose, monitor or treat patients and their specific needs.

Apexon’s IoMT Framework addresses this as an ecosystem in the following ways:

MEDTECH & IOMT FRAMEWORK

Medical Device/IoMT Services

Medical Device Firmware
Medical Device Firmware

Design, development and testing

Medical Device Software & Mobile Medical Application
Medical Device Software & Mobile Medical Application

Companion application development, re-engineering

Verification & Validation
Verification & Validation

Human subject validation, design verification, system verification and tools validation

Test Automation

Automation framework development and automation scripting

Cloud Enablement
Cloud Enablement

Cloud engineering, re-engineering and migration

Connectivity & Interoperability
Connectivity & Interoperability

Ingestible and medical imaging, tracking and analytics, BLE connectivity, workflow management, Lab-as-a-Service, HL7

Product Life Cycle Management
Product Life Cycle Management

PLM strategy, roadmap, evaluation and implementation

Regulatory Compliance
Medical Device Firmware

Documentation, DHF creating and remediation, CAPA, FDA compliance and pre-compliance testing

Patient & Physician Apps & Portals
Patient & Physician Apps & Portals

Interfacing with sensors, personal care and wearable devices and apps

Digital Twin
Medical Device Firmware

Define parameters and duration to make making robust twin for better prediction, play key role in SDLC life Cycle, Support and Maintenance platform, Data Gathering too

CUSTOMER SEGMENTS
  • Medical Device Manufacturers
  • Healthcare Providers (HCP)
  • MedTech Startups
  • Life Sciences
  • Clinical Research Organizations (CRO)
Medical devices

Connected Device = Patient Care

Firmware
Firmware
Connectivity
Connectivity
Cloud
Cloud
Automation
Automation
DATA
DATA
Regulatory Compliance
Regulatory Compliance
Product Life Cycle Management
Product Life Cycle Management
Consumer health wearables
Consumer health wearables
clinical-grade medical devices
clinical-grade medical devices
INGESTIBLE SENSORS
Ingestible
sensors
IMPLANTABLE MEDICAL DEVICES
implantable medical devices
IN-CLINIC / IN-HOSPITAL DEVICES
In-clinic / in-hospital devices
certifications/ standards

FDA

SaMD categories I, II, III, IV
Medical Devices V&V:
– 21 CFR 820, 30
– 21 CFR Part 11
MDDS Class I, II, III

Interoperability

HL7 v2 / v3
– CDA
– FHIR
EDI v12

Care Delivery

HL7 v2 / v3
SNOMED CT
LIONIC
ICD
CPT

Devices to care components
Edge IOs

Edge IOs

Data logging and controlling

Processing & Communication Gateways

Processing & Communication Gateways

Data acquisition, controlling, wireless interfaces, wireless protocols

Patient & Provider Engagement & Integrations

Patient & Provider Engagement & Integrations

Business use cases, data visualization

Cloud Solution Layer

Cloud Solution
Layer

Presentation and cloud architecture

Data Engineering

Data
Engineering

Presentation, data engineering analytics

DELIVERING RESULTS FOR OUR MEDTECH AND IOMT CLIENTS

Improved Medical Device Platform

Improved Medical Device Platform

Enhanced mobile and web platform for type-1 diabetes patients and created scalable solution for BLE health data, encryption, and personalization driven by algorithms for CGM medical device.

Ingestible Digital Medicine

Ingestible Digital Medicine

Led ideation, development, and V&V of this FDA-approved MDDS class-II ingestible digital medicine including high-performance BLE connectivity and support for HIPAA and CFR compliance.

FDA-Compliant SaMD

FDA-Compliant SaMD

Led development and supported FDA compliance requirements from concept to launch for this companion mobile app for SaMD.

Willow Wearable Breast Pump

Willow Wearable Breast Pump

Developed companion mobile app and automated firm ware testing, while meeting FDA compliance requirements. Resulted in faster time to market and lower development costs.

Body Sensor and the IoT Ecosystem

Body Sensor and the IoT Ecosystem

Developed the front-end user experience on the patient portal for their main IoT product, and we are also building the Android-based app that communicates with and controls the IoT based products. In addition, we are involved in developing the companion app, web app, CI/CD over cloud, the secure AWS workspace and patient monitoring on the web app. This latter project includes patient engagement analytics, end-to-end quality assurance for deliverables and a potential headwind into the firmware side of the business.

PARTNER ECOSYSTEM

Advanced Consulting Partner AWS

As an Advanced Consulting Partner, Apexon leverages our in-house access to AWS Certified experts to help companies optimize their cloud strategies and accelerate the time to market.

Adobe ecosystem partner

Our partnership helps organizations move to the cloud at speed increasing application availability, technical flexibility and security improvements.