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Medical Device Software Development: A Comprehensive Guide to Regulations and Processes

By Caroline

The MedTech industry is rapidly advancing. Medical device software plays a crucial role, driving innovations in medical practices and offering new solutions to the market.

To understand more, let’s explore the complexities of software development in the medical sector, examining the processes to follow, the challenges to overcome, and the opportunities to seize for success in this field.

Is Your Software a Medical Device?

The first step is to determine whether your software qualifies as a medical device. To do this, you must clearly define its intended use and indications for use. Once these parameters are established, you can evaluate if your software meets the definition of a medical device.

What is a Medical Device?

According to the FDA, a medical device is a device “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals”.

Additionally, searching for existing product classifications relevant to your software can be helpful. Finding a classification that aligns with your software’s intended use is a strong indication that it could be a medical device.

Types of Medical Device Software

Medical device software can be classified into two categories based on where they run: Software as a Medical Device (SaMD) or Software in Medical Device (SiMD).

Software as a Medical Device (SaMD)

A Software as a Medical Device (SaMD) is a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”, according to the International Medical Device Regulators Forum (IMDRF). They are stand alone software solutions and operate on general-purpose computing platforms like smartphones, tablets, or personal computers.

This category includes software solutions that enables a healthcare professional to view images from an MRI scanner on a smartphone for diagnosis, software that collects and analyzes data, then uses an algorithm to develop a treatment plan for a specific condition or disease.

Software in a Medical Device (SiMD)

Software in a Medical Device (SiMD) are software solutions that are an integral or external component of a physical medical device, contributing to its functionality and performance. SiMD can’t function independently, and rather are reliant on their associated medical hardware.

They support core functions of a medical device, such as controlling radiation delivery in radiotherapy machines, managing pacemaker operations or controlling an infusion pump motor.

Standards and Regulations for Medical Device Software

Due to their significant impact on clinical outcomes, software medical devices must undergo rigorous development processes guided by standards and regulations.

These regulations and standards ensure safety, effectiveness, and security. They provide a framework that includes best practices for organizational structure, project management, risk management, as well as design, implementation, verification, and validation processes.

IEC 62304 Standard for Medical Device Software Development

IEC 62304 is a reference for the medical device software development lifecycle, focusing on the safety of these systems.

It specifies required activities for each process of the software lifecycle based on the risk level the software presents to patients and users. It establishes a software safety classification system that divides medical software into three safety classes. As the risk level increases, so too does the number of required activities.

The three medical software safety classes according to IEC 62304:

Class A: No possibility of injury or damage to the patient.

Class B: Potential for injury, but not severe.

Class C: Potential for severe harm or death.

Other standards also apply to product development, including ISO 60601-1, titled “Medical electrical equipment – General requirements for basic safety and essential performance”, for SiMD and ISO 82304-1, titled “Health software – General requirements for product safety” for SaMD.

Medical device software developed in accordance with these standards is more likely to comply with current international regulations and achieve market approval.

Quality Management System (QMS): A Mandatory Requirement

In the context of medical device development, establishing and applying a QMS is a mandatory requirement. The ISO 13485 standard, titled “Medical devices – Quality management systems”, outlines the requirements for quality management systems in medical devices development, but is not specific to any discipline. IEC 62304 complements ISO 13485 by providing requirements for software development.

Additionally, risk management must be implemented in accordance with ISO 14971, titled “Medical devices – Application of risk management to medical devices”, which specifies a process that also applies to software as a medical device.

Cybersecurity Risk Control

Medical device software is connected to the Internet, hospital networks, and other medical devices, increasing potential cybersecurity risks. While IEC 62304 doesn’t address cybersecurity activities, FDA guidance provides recommendations for considering cybersecurity in premarket submissions.

During the software development process, it’s crucial to identify, analyze, evaluate, and control cybersecurity risks associated with the intended use.

Identified risks may prevent use of the device, such as a cyber attack disrupting software operation, or relate to sensitive healthcare information in the event of data breach.

“Robust risk control measures, such as data encryption, multi-factor authentication, and strict access controls, must be implemented during the software development process, as well as security audits and penetration testing during and after the development. They are vital to safeguard software against the growing prevalence and complexity of cyber attacks.”

Patient Data Protection

In the sensitive context of healthcare, ensuring patient data protection is essential from the earliest stages of medical device software development. Mechanisms must be incorporated to guarantee the confidentiality and integrity of patient information.

For example, developers might opt for data anonymization or the use of secure storage solutions. These practices establish a solid foundation for considering data security throughout the software lifecycle. Moreover, they ensure compliance with regulations such as HIPAA (Health Insurance Portability Accountability Act) in the U.S. and GDPR (General Data Protection Regulation) in Europe. Both protect patient data usage and outline the rules to secure it.

The Software Development Process for Medical Devices

Medical device software undergoes the same development phases as any other type of software; however, it requires particular emphasis on compliance with specific standards and guidelines, which vary according to the software’s classification.

Here are the five steps involved in developing software for medical devices:

1. Planning and Defining Requirements

The first step is to precisely define the software’s requirements in collaboration with stakeholders such as healthcare professionals and potential patients. This phase involves identifying necessary functionalities, determining regulatory constraints, and planning the product’s complete lifecycle.

The goal is to ensure that the software fully meets the medical sector’s performance and compliance requirements.

2. Architecture and Detailed Design

During this stage, the technical team establishes the overall architecture of the software, selecting appropriate technologies and defining interactions between various modules. The design must be robust and flexible to facilitate future upgrades and integration of new functionalities.

Detailed designs may also be created to guide developers throughout the software development process.

3. Development and Coding

Medical device software developers implement the software code based on the specifications defined in the earlier phases. This stage requires particular attention to code quality and the application of programming best practices, focusing on minimizing errors and maximizing efficiency.

4. Testing and Verification

Medical software must undergo a series of rigorous tests to ensure it meets all safety, functionality, and performance requirements. This includes unit testing, integration testing, performance testing, and system testing.

Verification ensures that the product or system meets the specified requirements and is built correctly.

5. Release

Once tested, the software is ready for release. This stage involves ensuring that all verification activities have been completed and evaluated, documenting the released version and making it available for utilization (aka installation or deployment).

Emerging Technologies in Medical Device Software for Healthcare

The integration of medical device software into healthcare has significantly shifted the landscape, enhancing both patient care and operational efficiency. New technologies have emerged to drive these advancements such as connected medical devices and software as a service (SaaS).

Connected Medical Devices (IoMT)

Connected medical devices, part of the Internet of Medical Things (IoMT), enable real-time health monitoring and data-driven decision-making. This cloud-based technology not only improves patient outcomes by facilitating more personalized and timely care. In this category, we include devices such as smart inhalers, wireless heart monitors, Bluetooth-enabled glucose monitors, and remote patient monitoring tools.

While the Internet of Medical Things (IoMT) holds great promise for transforming healthcare, it also presents several concerns and challenges: security and privacy, data integrity and accuracy, interoperability, reliability and continuity of care, and regulatory compliance.

Software as a Service (SaaS)

Software as a Service (SaaS) is a software distribution model where applications are hosted by a third-party provider and made available to customers over the Internet. Instead of downloading and installing software on individual devices or servers, users can access the software through a web browser or an API (Application Programming Interface).

This allows users (patients, medical clinics, hospitals, ect.) to focus on using the software without having to worry about the underlying technical details for managing and maintaining the infrastructure, including servers, databases, and security updates.

While the SaaS offer cost-effective and more accessible solutions that reduce buyers’ IT burden, they also present several concerns and challenges: data security and privacy, data ownership and control, reliability and availability, and integration with existing systems.

Medical device software development is a field where innovation and regulation are inextricably linked. By adopting rigorous development processes and embracing technological advances, medical device software development teams can significantly improve the quality of healthcare products brought to market.