Starting a Software as a Medical Device Business: Key Aspects
ScienceSoft brings in the 18-year experience in healthcare software development to help businesses enter the software as a medical device (SaMD) market.
SaMD Market Overview
In 2021, the software as a medical device market was estimated at $4.4 billion. By 2027, it is expected to reach $8.2 billion, growing at a CAGR of 11%. Increase in 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.
- 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.
- 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
- Tinnitus sound therapy.
- Heart-rate monitoring app.
- Sleep apnea monitoring and prevention app.
- Regular clinical evaluation of SaMD.
- Intuitive UX for SaMD used by patients.
SaMD used to aid medical staff in diagnosis and disease management
- Treatment and care planning software.
- Drug prescription recommendation software.
- Drug dosage calculating software.
- DICOM viewer (e.g., for radiology images).
- SaMD integration with relevant software used by a healthcare organization (e.g., EHR, LIS) to ensure seamless information exchange.
ScienceSoft’s insight: Witnessing the surge in innovations in the recent years, FDA reviewed and authorized a variety of SaMD products leveraging AI and ML technologies. When deciding on the business idea, ScienceSoft's healthcare IT experts recommend considering AI/ML-based solutions for patient care and diagnostics, and are ready to help you develop and launch your product.
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
- Real-time health parameters monitoring 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).
- 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.
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
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.
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.
ScienceSoft is an international IT consulting and software development vendor with 34 years of expertise. ScienceSoft’s team has been implementing robust IT solutions for healthcare for 18 years and is ready to offer expert help in SaMD product planning and development. A quality management system for medical device software and SaMD development proven by ISO 13485 certification allows us to develop software according to the requirements of the FDA and the Council of the European Union. Reach out to us and get more details.