Starting a Software as a Medical Device Business: Key Aspects

Software as a Medical Device Business - ScienceSoft

ScienceSoft brings in the 16-year experience in healthcare software development to help businesses enter the software as a medical device (SaMD) market.

SaMD market overview

The software as a medical device market is expected to reach $86 billion in 2027 at a CAGR of 21.9%. Increasing SaMD popularity resides in the capability to facilitate disease diagnosis, management, and treatment using a SaMD on general-purpose devices (e.g., laptops, smartphones, tablets).

1. Analyze the market, competitors, and potential SaMD users to define a marketing strategy.

2. Ensure your software falls under the SaMD category, classify it and define the FDA registration strategy.

3. Define SaMD requirements and features and plan the development and testing process.

4. Decide on a tech stack, architecture, integration capabilities.

5. Create a PoC (proof of concept).

6. Develop a SaMD product.

7. Conduct clinical trials (for innovative products).

8. Submit a SaMD product for FDA registration.

9. Launch the FDA-registered SaMD product.

Note: SaMD documentation should be saved during all product development stages (design, coding, testing, implementation) for FDA registration.

SaMD business models

The development and further promotion of software as a medical device highly depend on the company market niche and intended software use. We provide a comprehensive classification and outline main technology and business planning focus areas.

By company type

Healthcare IT startup

A startup decides to enter the healthcare IT market with a SaMD product.

Focus on:

  • Detailed estimation of technology investments and operating costs, a fundraising plan (if necessary).
  • A highly qualified and experienced SaMD development team for timely software delivery and clinical trials launch and faster market entry.

Established healthcare IT product company

A product company owns a portfolio of healthcare applications (e.g., a practice management system, EHR, PACS, LIS) and decides to introduce a SaMD product to their customers.

Focus on:

  • Integration of a SaMD product with the existing application portfolio.
  • A SaMD product marketing strategy targeting current clients.

By SaMD purpose

SaMD used directly for disease management and treatment

Examples:

  • Tinnitus sound therapy.
  • Heart-rate monitoring app.
  • Sleep apnea monitoring and prevention app.

Focus on:

  • Regular clinical evaluation of SaMD.
  • Intuitive UX for SaMD used by patients.

SaMD used to aid medical staff in diagnosis and disease management

Examples:

  • Treatment and care planning software.
  • Drug prescription recommendation software.
  • Drug dosage calculating software.
  • DICOM viewer (e.g., for radiology images).

Focus on:

  • SaMD integration with relevant software used by a healthcare organization (e.g., EHR, LIS) to ensure seamless information exchange.

Key SaMD functionality

The features of SaMD products will highly depend on their medical purpose and target users. In the list below, we provide a look into the common SaMD functionality.

User functionality for patients

  • Health parameters measuring using general-purpose devices (e.g., smartphone).
  • Abnormalities identification (e.g., abrupt breathing).
  • Image analysis and comparison (e.g., photos of moles for melanoma risk assessment).
  • Therapeutic interventions (e.g., sound therapy – for tinnitus, video therapy – for anxiety).
  • Analysis of external data (e.g., air pollution) for symptoms prevention.

User functionality for medical staff

  • Patient health data analysis (e.g., ultrasound images) for disease detection and localization.
  • SaMD algorithms for complex calculations in treatment (e.g., anesthesia or drug dosage).
  • SaMD-generated suggestions for disease diagnosis, treatment, or management.
  • Medical image adjustment for view on general-purpose devices (e.g., smartphones, tablets).

Safe cloud data storage and exchange of PHI

  • Secure gathering, analysis, and transmission of clinical information from integrated healthcare IT systems by SaMD (using HL7 standards).
  • Storage and transmission of medical images (using DICOM standard).
  • PHI download via a patient’s account (e.g., for heart-rate statistics, drug dosage tracking).

Security and regulatory compliance

  • Role-based access control.
  • Two-factor user authentication for medical staff and patients.
  • PHI access logging.
  • Automated identification of unauthorized sessions.
  • Data encryption.
  • Compliance with HIPAA, HITECH, FDA, ONC regulations.

In-app SaMD guides for the medical staff and patients

  • Instructions to guide users through SaMD functionality (“how-to” videos, self-help guides, FAQ, etc.).
  • Inline suggestions for data input (e.g., showing data format, suggesting recent entries, automated data filling).

Marketing

  • Customer loyalty management.
  • User feedback surveys to analyze and improve a SaMD.

3D shape reconstruction

to create a model of an organ, bone, etc. based on ultrasound or radiology images.

Telehealth functionality

to enable remote communication between healthcare professionals and patients (for consultations regarding the SaMD usage, treatment progress, next steps in disease diagnosis and treatment).

ML-based analytical capabilities

to double-check doctors’ health-related decisions based on patients’ records and avoid medical mistakes (e.g., prescribing the medication to a patient allergic to one of its components).

As SaMD applications vary a lot, the development investments highly depend on the required technology and talents and start from ~ $ 150,000.

Planning SaMD app operating expenses, take into account:

  • Cloud costs (e.g., for hosting, cloud services usage).
  • SaMD application support: maintenance of the application and its infrastructure, help desk for healthcare professionals and patients.
  • Regular HIPAA compliance testing and internal infrastructure compliance and security audit.

Optimize investments and get payback faster

Cloud-native architecture

Opt for a cloud-native architecture to save on servers’ purchase and maintenance, ensure smooth SaMD app data backup and recovery in case of incidents, and easily scale SaMD storage up and down based on the number of app users.

Cross-platform development

Choose cross-platform mobile app development to save time and money, creating native-looking SaMD apps for Android and iOS.

Consulting and development services to succeed in the SaMD business

With a quality management system for medical devices proven by ISO 13485 certificate, ScienceSoft engages a team of sharp-minded healthcare IT experts in SaMD consulting and development.

SaMD consulting services

ScienceSoft healthcare consultants will:

  • Analyze and structure the SaMD concept.
  • Define SaMD features.
  • Choose an optimal architecture and tech stack.
  • Create a SaMD implementation roadmap.
  • Advise on advanced technologies (e.g., AI, machine learning, IoT, AR/VR).
  • Calculate SaMD investments and estimate ROI.
  • Help comply with HIPAA, HITECH, ONC, FDA regulations.

SaMD development services

Our team takes charge of:

  • SaMD idea productization and feature prioritization.
  • PoC development.
  • Integrations with healthcare software (e.g., imaging software, RIS, EHR), if needed.
  • User-oriented UX and sleek UI design.
  • Agile software development.
  • Comprehensive SaMD testing, including security and compliance testing (according to HIPAA, HITECH, ONC, FDA regulations).
  • SaMD support and evolution, if needed.

About ScienceSoft

ScienceSoft is an international IT consulting and software development vendor with 32 years of expertise. ScienceSoft’s team has been implementing robust IT solutions for healthcare for 16 years and is ready to offer expert help in SaMD product planning and development.