The medical device industry is experiencing swift transformation driven by the integration of software, hardware, and healthcare. Connected devices and software as a medical device (SaMD) lead this evolution, offering opportunities to enhance patient care, health results, and operational effectiveness.

Despite the enormous advantages that Software as a Medical Device (SaMD) can offer, innovators face many challenges as they move from product concept to market commercialization.

These hurdles include dealing with complex regulatory frameworks, prioritizing patient safety in an increasingly software-driven landscape, and addressing technological challenges. This article identifies the five main issues founders face in the SaMD and related device sectors to help them navigate these complexities and achieve success.

The top five issues facing founders

1. Handling regulatory compliance

Regulatory framework compliance is critical to the growth of SaMD and linked devices. To protect patient safety and effectiveness, organizations like the FDA, EMA, and their foreign equivalents enforce strict guidelines.

Active regulatory engagement – To reduce delays, connect development objectives with regulatory expectations, and obtain clarity on changing requirements, it is crucial to foster early and continuous communication with regulatory authorities.
Strong risk management and quality systems – Demonstrating the safety and efficacy of devices requires the establishment of strong quality management systems based on ISO 13485 and the implementation of risk management frameworks like ISO 14971.
Data privacy and cybersecurity – Due to the delicate nature of medical data, founders must give data privacy and cybersecurity first priority. To do this, they must follow laws like GDPR and put strong security measures in place.

2. Making patient safety a top priority in a society driven by software

In the context of software-centric medical devices, ensuring patient safety necessitates a comprehensive strategy that goes beyond conventional hardware considerations.

Human-centered design – Creating devices that are easy to use and intuitive requires taking patient preferences and needs into account during the design phase.
Cybersecurity resilience – It is critical to defend medical devices against online threats. Protecting patient data and device integrity requires putting strong cybersecurity safeguards in place, such as threat modeling and vulnerability assessments.
Post-market surveillance and real-world evidence: It is essential to set up strong post-market monitoring systems and use empirical data to track gadget performance over time and spot possible safety concerns.

3. Ensuring the best possible patient experience and usability

An intuitive and user-centric experience is essential for the effective adoption of SaMD and linked devices. Healthcare workers need technologies that easily fit into their workflows because they work in fast-paced situations.

User-centered design philosophy – As highlighted by Don Norman’s seminal work, The Design of Everyday Things, which examines the intricate relationship between human cognition and the technology it produces, incorporating end users in the design process is essential to producing goods that meet their needs and expectations.
Human factors engineering – Patient safety can be improved by optimizing interface design, lowering cognitive load, and minimizing the possibility of errors through the application of human factors engineering concepts as described in the ISO 9241 standard.
Training and support – Support materials and efficient training programs are necessary to enable users to take full advantage of the device’s capabilities. The Health Renaissance study on the effect of training on the usage of electronic health records cites research showing that improvements in decision assistance provided by health information technology can enhance the quality and efficiency of care delivery. This demonstrates how crucial this element is to user satisfaction and device uptake.

4. Securing interaction with current systems

The successful adoption of SaMD and linked devices depends on their ability to interface seamlessly with the current healthcare infrastructure. Adoption may be hampered by interoperability issues, but effective integration can enhance data interchange and streamline processes.

Interoperability standards – In order to facilitate data transmission and guarantee compatibility with a variety of healthcare systems, adherence to industry standards like HL7, FHIR, and DICOM is crucial. These standards are now more crucial than ever for the effective deployment of health IT systems, as stated in the Office of the National Coordinator for Health Information Technology’s (ONC) Interoperability Roadmap.
Application Programming Interfaces (APIs) – Creating safe, well-documented APIs facilitates easy connection with HIS, EHRs, and other medical devices, enhancing system efficiency and data flow. Epic and Cerner’s usage of FHIR-based APIs to facilitate data sharing between their EHR systems and third-party apps are two instances of successful API integrations in the healthcare industry.
Interoperability testing – To make sure the device works as intended inside the intricate healthcare environment, thorough testing is essential to identifying and resolving integration issues. Guidelines and frameworks for carrying out efficient interoperability assessments are offered by the Interoperability Standards Advisory Committee (ISAC).

5. SaMD innovators should keep up with the latest developments in technology

For developers of SaMDs and linked devices, the quick development of artificial intelligence, machine learning, and software engineering offers both tremendous opportunities and difficulties.

Founders must skillfully strike a balance between innovation, product stability, and regulatory compliance in order to stay ahead of the competition.

Learning and adaptation – Keeping up with new developments in technology and changes in regulations is essential to fostering an innovative culture. Establishing strong knowledge management systems and promoting staff training can assist companies in adjusting to the changing environment.
Adoption of new technologies – Careful assessment of emerging technologies is necessary to ascertain how well they match product objectives and legal requirements. Adoption that is phased in and supported by thorough testing and validation can reduce risks and optimize gains.
Modernization of legacy systems – Research and development may be impeded by the legacy systems used by many medical device firms. For long-term success, a strategy plan for updating these systems while maintaining continuous operation must be developed.

The development of SaMD and connected devices is a difficult undertaking that calls for a multifaceted approach. SaMD entrepreneurs navigating this environment must prioritize regulatory compliance, patient safety, usability, system integration, and technical innovation. By establishing a strong foundation of dependable practices, fostering a creative culture, and forming strategic connections, businesses may overcome challenges and offer revolutionary medical solutions.