Medical Device Software Development Handbook

Key Takeaways

• It is anticipated that more than a quarter of a billion copies of this practical technology will have been marketed by 2025.
• Software medical device is cloud-based or on-premise software designed for a range of healthcare facilities to store, process, and manage medical, financial, and administrative data.
• SaMD can help patients manage their health more successfully, increase diagnostic accuracy, and reduce human error by increasing patient awareness of their health state.
• By utilizing smart devices and apps to automate medical operations, hospitals may free up staff time for other, more critical responsibilities while also saving time and effort. Additionally, healthcare institutions require less physical space since SaMD can lower the number of hospitalizations.

A new health process that offers patients and medical staff significantly more chances has been made possible by new technologies. Thanks to the development of medical device software, smartphones and smartwatches are doubling up as diagnostic equipment.

While the hardware is undergoing transformative progress, the software that powers the medical devices needs to keep up as well.  The relatively new notion of “Software as a Medical Device” (SaMD) is opening up enormous possibilities for the development of enhanced applications for current or prototyped medical equipment.

We’ll talk about how to build custom medical device software and functionality in this post.

A Brief Overview of Software as a Medical Device

All goods and services that don’t require a particular piece of medical equipment fall under this category of software development for medical devices. For instance, SaMD systems can be used with a variety of non-medical platforms, such as laptops, desktop computers, mobile devices, etc.

This kind of software typically carries out one or more of the following tasks:

• visualization and display of medical data
• processing and interpreting medical data
• particular configuration and technical diagnostics of some medical devices, including health data management and storage

The following characteristics define software as a medical device:

• SaMD is not a component of medical technology, nor is it necessary for a medical device to carry out its features or tasks.
• Infrastructure and general-purpose computers are used to execute SaMD.
• To acquire data obtained by the device or to control its operation, it can interface with specific specialized medical devices, including the devices’ internal/embedded components and embedded software.

The SaMD concept demands specialized knowledge and skills that are not readily accessible in the American market when developing software for medical devices. To discuss the specifics of your project and find out more about our capabilities in medical device coding and other software solutions, please get in touch with our knowledgeable healthcare technology expert.

SaMD is used in various examples, such as:

• Patient imaging or scan analysis: Software that examines patient information to find patterns, indicators, or trends enables medical professionals to more accurately recognize subtle but significant alterations in patient conditions and/or to speed up diagnosis and treatment. For instance, in patients with acute stroke situations, this could involve help for decision-making for accurate classification between ischemic and hemorrhagic stroke. The result may significantly influence the therapy and/or medical intervention that is chosen.
• Prevention of sleep apnea by sound monitoring: An alarm that wakes the sleeper can be automatically set off by a smart device microphone when breathing is stopped while the user is sleeping. The same technology can be used to automatically identify atypical breathing patterns and notify emergency personnel when a situation warrants their attention (this can be done for elderly or single individuals).
• Adhesive or implantable sensors can be used for remote ECG monitoring to track the heartbeat patterns of cardiac patients and identify any unexpected or life-threatening ECG patterns or events (arrhythmia, bradycardia, etc.) that need to be reported right away.
• Applications for displaying medical data: These comprise all software that aids medical professionals in accessing, verifying, visualizing, sharing, documenting, and/or interpreting health information obtained from particular bioelectronic sensors or medical devices, including a variety of metrics like heart rate, blood pressure, skin temperature, and more.

Different Types of Medical Device Softwares

Medical device-specific software falls under a variety of categories. Since the scope and technologies, such as embedded coding and SaMD, can be rather variable, it is essential to formally outline the needs for your medical device software development before beginning a new project.

However, the bulk of initiatives and companies for actual medical equipment aim to use a variety of technologies. Let’s find out more about the key types of medical device software development.

1. SaMD (Software as a Medical Device)

SaMD is an independent medical software that utilizes information from medical devices, and it can treat diseases, plus perform medical procedures. It can be used on smartphones and other hardware devices that aren’t part of medical device software. In addition, it can be stored on a cloud as well. Examples of SaMD are ultrasound examinations and applications to control medication dosages.

2. SiMD (Software in a Medical Device)

SiMD is part of a medical device and accomplishes all medical purposes, however, it doesn’t operate independently from a device like SaMD. Further, SiMD controls and monitors the medical functions of a device and it is also known as embedded medical software.

3. Software as an Accessory to a Medical Device

Software as an accessory to a medical device doesn’t serve a medical purpose, and this is what separates it from the other two types. An example includes maintenance software for MRI machines.

Embedded Medical Systems and Embedded Medical Software Development

This field includes low-level programming for micro components with embedded memory and processors, such as microcontrollers and microchips. Most medical equipment has all of this inside the engine. Examples of medical devices with embedded systems that are controlled or configured by embedded code include:

• Heart rate monitors
• Electronic pacemakers intelligent (bio)sensors
• Programmable infusion pumps
• Glucometers
• Digital thermometers
• Digital blood pressure monitors
• Medical imaging equipment includes X-ray, MRI, ECG, CT, EEG, and a wide range of lab tools.

As it controls the use of various electronic components and aids in the integration of medical devices with non-specific or general-purpose software and hardware, such as PCs, EHRs, Wi-Fi, and many other systems, embedded programming is essential for healthcare equipment and biomedical applications.

While the embedded systems development of some medical devices simply requires basic programming knowledge, some projects call for highly skilled expertise in healthcare device engineering. Just consider how much time and effort it takes to calibrate and configure all the embedded circuits in a big, complex machine like a contemporary MRI tomography.

SaMD Regulatory Compliance Guidelines

To create more general, uniform regulations for software classed as Software as a Medical Device, the FDA has created several guidelines.

One such requirement is that clinical vocabulary be supported by the software as a medical device for use; this has to do with appropriate training and linguistic design in the user interface. Another rule calls for discussing clinical evaluation techniques and data that are pertinent to the usage of medical device software.

According to the FDA, developers of ‘Program as a Medical Device’ products should list any potential negative effects as well as other suggestions that should be attached to the software for analytical purposes.

The regulatory parties have a question about whether there will be an influence on presently regulated devices or any potential negative effects given the peculiarity of medical device software and the proposed framework.

Medical software must comply with HIPPA. Here are the factors that determine if the software for your medical device needs to be compliant with HIPAA.

• Why is the data being collected?
• Does this data contain any personally identifiable information (PHI) or is it identifiable?
• To what extent will PHI be accessible? Only the owner of the data (the patient), a doctor, a professional associate, or a manufacturer?
• Which of these organizations will be able to access PHI stored in the software?

Manufacturers of medical devices conduct verification and validation testing to make sure their products adhere to the specified design inputs and user requirements. Cybersecurity and HIPAA compliance are not entirely different, and both must be taken into account while designing software. Software must be subjected to verification and validation testing by manufacturers to guarantee that it complies with HIPAA regulations.

According to HIPAA standards, patient data is safeguarded and the organizations that store it have procedures in place to safeguard patient data in the event of any data breaches or threats. By validating and verifying their software against realistically predicted data dangers, manufacturers share responsibility for ensuring data protection.

The IEC 62304 Guideline in Medical Device Software Development Process

The International Electrotechnical Commission (IEC) 62304 standard mentions the requirements for the maintenance, development, and lifecycle management of the software used in medical devices. IEC 62304 compliance ensures that the medical device software is developed reliably, is safe to use, and is effective.

Additionally, this regulatory compliance outlines the software process improvement roadmap that must be followed to maintain the safety of medical devices.

Medical Device Software Development Process

Of course, developing custom software for medical equipment takes a lot of engineering work and expertise. Starting with the creation of a thorough medical device/software architecture, project goals and scope are defined.

Let’s talk about the key elements of developing software for medical devices.

Process for Developing Medical Device Apps Seen From a High-Level

Many different medical device software development approaches involve medical device software development and embedded system development. To combine the data, they need a variety of experts, broad engineering knowledge, and skilled health-tech engineers.

Generally speaking, a software development plan needs to take the following steps:

• Define the technology stack for your project to develop software for medical devices: Is the project entirely embedded or blended with Medical device software?
• Determine the FDA regulations for your particular sort of medical device and software and meet them (in compliance with HIPAA) Brand-new medical equipment, needs to be ISO certified and adhere to other requirements.
• Hire or assemble a team of developers who are skilled in embedded and/or traditional software development, which is necessary for medical device software development, depending on the scope of your project.
• Let a health tech engineer create the system requirements for your program or device.
• Make sure a capable project manager is chosen to organize the project’s many tasks and phases.
• Give these duties to the appropriate experts, such as UI/UX designers for health technology, back-end and front-end developers, QA specialists, and others.
• Make sure you have access to medical specialists for testing and consultation. Keep in mind that the end users of your medical product—physicians, nurses, and surgeons—as well as their patients should have their interests reflected.

Medical Device Software Development Tech Stack

There are many technical options and tools available that can be used for the creation of medical equipment software. Your project’s scope and specific settings are dependent on it (which should be discussed and specified with your vendor). Please get in touch with us if you wish to discuss specific technological alternatives and the procedure for developing medical device software with a professional company.

The typical technology stack used in medical device software engineering can mix any of the following:

• Compilers and Integrated Development Environments (IDE)
• Debug devices and software for embedded programming languages such as C, C++, MicroPython, Python, and Java (Debugger) Emulators
• Software and device testing
• Azure, AWS, Digital Ocean, and Google Cloud development
• Wearable, mobile, and Internet of Things devices used in integrated health tech solutions
• Development of the front end using Angular,  Node.js, React, Vue, and Core JavaScript
• C#, JavaScript, Node.js, TypeScript, PHP, Dart, and SQL Middleware are examples of supporting software. Additional modules from different vendors include those for 3D printing, ML, AI, AR/VR, medical SaaS, and more.

Costs of Developing Medical Device Software

Due to the wide range of medical device software, the development costs, which begin at around $150,000, heavily rely on the skills and technology needed.

When budgeting for medical device software operating costs, consider:

• Cloud prices (e.g., for hosting, cloud services usage).
• Support for the medical device software application includes infrastructure upkeep, a help desk for patients and medical professionals, and application maintenance.
• Internal infrastructure compliance and security audits, as well as routine HIPAA compliance testing.

Key Functionality of Medical Device Software

Medical device software features will be heavily influenced by their intended medical usage and target market. We give a brief overview of the typical medical device software functionality in the list that follows.

1. Patient User Functionality

• Monitoring health metrics in real-time with general-purpose equipment (e.g., smartphone).
• Identification of abnormalities (e.g., abrupt breathing).
• comparison and analysis of images (e.g., photos of moles for melanoma risk assessment).
• therapeutic approaches (e.g., video therapy – for anxiety, sound therapy – for tinnitus, ).
• analysis of extraneous data, like air pollution, to prevent symptoms

2. User Features for Medical Staff

• Analysis of patient health information (such as ultrasound images) to locate and diagnose disease
• medical device software algorithms for intricate computations in medicine (e.g., anesthesia or drug dosage).
• proposals produced by medical device software for the diagnosis, management, or treatment of diseases.
• Adjusting medical images for general-purpose devices (e.g., smartphones, tablets).

3. Safe PHI Data Interchange and Storage in the Cloud

• medical device software is a safe collection, examination, and transmission of clinical data from integrated healthcare IT systems (using HL7 standards).
• medical picture transmission and storage (using the DICOM standard).
• using a patient’s account to get PHI (e.g., drug dosage tracking, for heart-rate statistics,).

4. Security and Adherence to Regulations

• access control based on roles.
• Patient and medical staff user authentication with two factors.
• Access PHI logging.
• identification of illegitimate sessions automatically.
• Encryption of data.
• Observance of HIPAA, HITECH, FDA, and ONC rules.

5. Medical Device Software Patient and Medical Staff Guides In-App

• User-friendly instructions (such as FAQs, how-to videos, and self-help manuals) to walk users through medical device software capabilities.
• tips for data entry inline (e.g., suggesting recent entries, showing data format, automated data filling).

6. Marketing

• managing customer loyalty.
• Surveys of user opinions to evaluate and enhance a medical device software.

Conclusion

Medical device software offers distinctive characteristics that go beyond those of the conventional medical device or hardware, even though it could be a little complex in contrast to other software. In contrast to previous devices, medical device software may use technology and connectivity to other devices and people to continuously assess performance, efficacy, and safety.

Despite the distinctive features of standalone health applications, creators ought to give clinical evaluation and risk-based standards first emphasis. In the end, your business has a choice between engaging with the IoT and avoiding interruptions or ignoring it.

To get a custom healthcare software developed for your organization, get in touch with Arkenea, one of the leading software development companies that is exclusively focused on the healthcare sector.