How to Build Software for Medical Devices? Process, Costs, Types, and More

Dileep Gupta November 30, 2023

Healthcare technologies have advanced in the past decade, leading to a new era where software is integral to the development and function of medical devices. From diagnostic tools to treatment monitoring and beyond, software is a fundamental component that’s revolutionizing the healthcare industry.

Simply put, the medical device software (MDS) is an indispensable component that governs the functionality of medical devices, whether they’re integrated with the existing system or operate independently.

It is a well-known fact that technology and medical devices have combined to revolutionize the design and implementation of healthcare solutions. The software has seamlessly integrated into medical devices, surpassing traditional components. This integration has led to the generation of more dynamic and adaptable solutions, promoting innovative and patient-centric approaches in healthcare.

In line with these technological advancements, modern healthcare devices are now smaller, more portable, and accessible outside clinical settings, reaching into patients’ homes. Notably, even these compact medical devices demonstrate high efficiency and reliability, significantly impacting fundamental healthcare practices.

This blog will help you understand everything related to medical device software development. It will explore the crucial considerations, compliance requirements, the latest technological trends, and the overall process for building robust and compliant software for medical devices. So, without further ado, let’s delve right into the details.

What is Medical Device Software?

Medical device software (MDSW) is a standalone program designed to perform medical functions independently from hardware devices. It plays a crucial role in healthcare, covering a wide range of areas such as diagnostics, treatment, and patient monitoring.

MDSW is becoming increasingly important in modern healthcare. It is used in a wide range of medical devices, from pacemakers and insulin pumps to surgical robots and imaging systems. MDSW can help to improve the quality, safety, and effectiveness of medical care by:

  • Providing real-time feedback to healthcare professionals
  • Automating tasks and reducing the risk of human error
  • Allowing for more personalized and targeted treatments
  • Making medical care more accessible and affordable

A heart rate monitoring application is a notable example of medical device software. It operates on a wearable health device and is responsible for gathering and analyzing the user’s heart rate data. This software processes the information and presents it in a user-friendly interface.

In addition to this, it can notify medical professionals in case of any irregularities. In the field of healthcare, this software plays a vital role in diagnosis and continuous patient monitoring.

Now, medical device software development is the process of creating software specifically intended for medical use. This process includes designing, developing, testing, and deploying software that meets strict regulatory standards for safety and effectiveness.

Software development for medical devices requires the integration of medical expertise and technological innovation. It involves strict adherence to regulatory compliances and quality guidelines. The goal is to create reliable, accurate, and user-friendly software that supports healthcare providers in delivering improved care.

According to a recent study, approximately 83% of medical IoT devices in the US are reliant on outdated or unsupported software systems. These legacy systems are abandoned by their vendors and pose serious security risks, exposing nearly 98% of sensitive medical data traffic or encrypting it inadequately.

The abundance of outdated software systems across healthcare organizations highlights the urgent need for modernization in medical device software. Upgrading these systems is crucial for protecting sensitive medical data and ensuring reliable, accurate, and secure software. As technology evolves and software becomes more integrated into medical devices, adherence to regulatory standards and the development of innovative, safe, and compliant software solutions has become vital.

Advanced and reliable medical device software is essential for improved patient care, accurate diagnoses, and more efficient healthcare delivery. This will ultimately enhance the overall quality and effectiveness of medical services.

Types of Software for Medical Devices

There are two types of software for medical devices available across the globe, namely Embedded Medical Systems and Software as a Medical Device (SaMD). Both types play essential roles in modern healthcare. Let us look at them in detail below:

Embedded Medical Systems

The embedded medical system software (EMSSW) is the type of software that is embedded within a medical device and is responsible for controlling the device’s operation. EMSSW is typically designed to be highly reliable and to meet strict safety standards. It is used in a wide range of medical devices, from pacemakers and insulin pumps to surgical robots and imaging systems. They are ’embedded’ within the hardware and are often not standalone software. In addition to this, they are tightly coupled with the device and contribute to its primary functionality.

For instance, the software in an MRI machine plays a crucial role in its operation. It oversees imaging procedures, handles data collection, and coordinates scanning sequences to generate patient body images.

Software as a Medical Device (SaMD)

SaMD, or Software as a Medical Device, is distinct from embedded systems as it operates independently on any hardware medical device. It functions as standalone software with a specific medical purpose. SaMD can be a mobile app, cloud-based software, or even a desktop application designed for medical use.

A mobile application used for monitoring blood glucose levels in diabetic patients is an example of SaMD. This application enables users to input their glucose readings, track patterns, and gain insights to manage their condition effectively. It operates autonomously and is not integrated into any particular device.

Also Read: 15 types of healthcare software you can use to take your medical business to the next level

Benefits of Medical Device Software Development for Healthcare Businesses

Medical device software not only ensures heightened operational efficiency but also offers enhanced precision and safety in the delivery of healthcare services. Let us look at the multiple benefits of medical device software development in detail below:

Streamlined Workflows

The integration of software solutions in healthcare optimizes operational workflows, enhances efficiency, minimizes paperwork, and automates routine tasks. This transformation allows medical professionals to divert their focus from administrative duties to a more patient-centric approach.

Regulatory Compliance

By strictly adhering to industry regulations, Medical Device Software (MDS) development guarantees compliance, minimizing the risk of penalties and prioritizing patient safety within the healthcare ecosystem. Here are some of the region-wise healthcare regulatory compliances that you should consider during the medical software development process:

United States (US): HIPAA, FDA, HITECH

Japan: PMDA

China: NMPA

Australia: Data Protection Act, MHRA

European Union (EU): MDR, GDPR, EMA

India: CDSCO

Canada: CMDR, PIPEDA

Brazil: ANVISA

International Compliances: ISO and IMDRF

Improved Accessibility and Affordability

MDS development expands healthcare services beyond conventional clinical environments, enhancing accessibility and affordability for patients seeking medical assistance.

Enhanced Patient Care

The development of Medical Device Software (MDS) supports enhanced patient care by enabling precise diagnostics, advanced monitoring, and tailored treatment plans. Its implementation significantly contributes to delivering care that is more effective and efficient.

Technological Integration

Implementing state-of-the-art technology such as AI, IoT, and cloud computing elevates the performance and functionalities of medical devices, resulting in advanced healthcare solutions that offer superior patient care. This integration optimizes diagnostic accuracy and treatment precision, thereby revolutionizing medical services.

Data Accuracy and Analysis

Software as a Medical Device development guarantees precise data collection and intricate analysis, empowering healthcare practitioners to derive insightful conclusions, thus enabling well-informed decision-making.

Competitive Edge

Businesses that invest in MDS development secure a competitive edge in the dynamic healthcare industry. By deploying innovative medical software, these enterprises offer advanced services and solutions that not only set them apart from competitors but also bolster their brand presence in the market.

Factors to Consider for Medical Device Software Development

There are several critical factors that demand meticulous consideration and strategic planning when it comes to software development for medical devices. By carefully considering all of these factors, businesses can create software that is safe, effective, and compliant with regulatory requirements.

Adherence to Regulatory Compliance

Adherence to stringent regulatory standards, such as those established by the FDA, is crucial. Compliance with these guidelines guarantees the safety, effectiveness, and quality of medical device software. Also, regulatory adherence is essential for meeting the necessary market approval standards and ensuring patient safety by navigating complex legal and quality requirements.

Security and Data Privacy

Implementing robust data security measures, including encryption and access controls, is crucial. Protecting sensitive patient information from breaches or unauthorized access is essential to maintain patient trust and comply with data protection laws like HIPAA.

Usability and User Experience

Creating a user-centric medical device software design is important for ensuring that the software is intuitive and offers ease of navigation for both healthcare professionals and patients. A thoughtfully designed interface not only boosts efficiency and minimizes errors but also fosters seamless interaction between users and the software. Ultimately, this results in improved patient care and heightened user satisfaction.

Interoperability with Medical Systems

Developing software that seamlessly communicates and integrates with other devices in the healthcare ecosystem is fundamental. This interoperability facilitates smooth data exchange across diverse platforms, contributing to enhanced patient outcomes and more efficient healthcare delivery.

Risk Management

Thorough risk analysis procedures are essential to identify potential hazards and mitigate risks associated with the software. This encompasses comprehensive risk assessment, management, and mitigation strategies, ensuring patient safety and minimizing potential harm.

Collaboration with Stakeholders

Involving stakeholders, such as healthcare professionals, patients, and regulatory bodies, is crucial to ensure that the software meets precise requirements. This helps in enhancing its functionality and relevance in real-world healthcare settings. This collaboration further guarantees the software aligns with user needs and regulatory standards.

Testing and Validation

Comprehensive testing and validation processes are critical to ensure that the software is error-free, functions reliably, and meets established quality standards. These procedures identify and address potential issues or bugs before the software is deployed for practical use, ensuring its efficacy and performance.

Continuous Improvement and Maintenance

Implementing strategies for continuous improvement is essential to keep the software updated and aligned with evolving healthcare demands. Furthermore, regular updates are crucial for addressing emerging challenges and maintaining high performance and safety standards.

How to Build Custom Medical Device Software?

Navigating the development process for custom medical device software involves critical steps to ensure compliance, precision, and operational excellence. Let us look at them in detail below:

Understand Your Regulatory Requirements

In order to begin the medical device software development process, it is essential to have a comprehensive understanding of the intricate regulatory standards, including those established by the FDA, HIPAA, and other local regulatory bodies. These standards play a critical role in guaranteeing the safety, quality, and effectiveness of medical device software.

Compliance with these regulations is indispensable to obtain market approval and ensure patient safety. Familiarity with these standards will shape the entire medical device software development life cycle, dictating the software’s scope, features, and safety protocols.

Market Research and User Requirement Clarification

For effective and user-friendly medical device app development, it is essential to conduct comprehensive market research. This research allows us to gain a deep understanding of the healthcare landscape, industry trends, and user needs. By engaging with healthcare professionals, patients, and stakeholders, we can identify specific user requirements and preferences.

These insights are crucial to define the software’s features, design, and functionality. By tailoring the final product to meet the specific needs of the users, we can ensure that it is more effective and user-friendly.

Find an Experienced MDSW Development Firm

It is vital to partner with a custom medical device software development firm with a strong reputation and extensive experience in developing medical device software. It is further crucial that they have a proven track record of adhering to regulatory requirements.

A reliable medical software development company like Appinventiv will not only assist in software development but also provide valuable insights and guidance. Their expertise will be critical in ensuring compliance, building robust, high-quality software, and offering innovative solutions.

Planning Stage with Your Hired Development Company

Now, it is time to collaborate with your chosen medical device software development company and do project planning. It involves defining the project scope, establishing milestones, and strategizing the approach.

This phase of software development for medical devices is critical for setting the groundwork, clarifying expectations, and aligning the development process with specific goals and timelines. Effective planning ensures that the project progresses in the right direction, minimizes delays, and meets the defined objectives.

Development and Integration

The medical device software development process begins after the necessary preparations have been made. Emphasizing quality, accuracy, and regulatory compliance is of utmost importance during this phase. Furthermore, the software must seamlessly integrate with the healthcare environment to facilitate the exchange of data between different systems.

Implementation and Monitoring

After completion, the software will be implemented into the healthcare setting. This phase of software development for medical devices necessitates careful monitoring and assessment of the software’s performance. Continuous monitoring during the medical device app development process is crucial for identifying any issues or areas that need improvement, guaranteeing efficient and effective operation of the software.

Support and Maintenance

Post-implementation, ongoing support, and maintenance are crucial to ensure the software’s reliability, security, and optimal performance in the healthcare environment. This phase of the medical device software development life cycle includes addressing issues, implementing updates or patches, and ensuring the software remains up-to-date and compliant. Ongoing support and maintenance guarantees the continued efficiency of Medical Device Software.

How to Choose the Right Medical Device Software Company for Your Project?

There are several factors that you need to consider while choosing a custom medical device software development firm for your project. Let us look at them in brief below:

Overall Experience and Expertise

Evaluate the company’s experience in developing medical software and its understanding of healthcare regulations. This ensures their capability to create compliant and effective solutions.

Portfolio and References

Review their past projects to ensure that they have successfully delivered similar solutions. Consider references from other notable experts and check out their case studies to understand their competency.

Expert Skills

Evaluate the team’s competencies and expertise. Ensure that their experts have specialized knowledge in medical software, including AI, IoT, and compliance standards. This will help you understand if they have a comprehensive understanding of healthcare technology requirements vital for your project.

Regulatory Compliance

Ensure the company is well-versed in healthcare regulations, compliances, and medical device software development standards such as HIPAA, FDA, and GDPR to guarantee the software’s adherence to legal requirements.

Post-Deployment Support

Verify their post-deployment support, regular updates, and maintenance offerings. This guarantees a lasting partnership, providing efficient and adaptable solutions in the constantly changing healthcare environment.

Why is Appinventiv Your Right Medical Device Software Development Partner?

With almost a decade of experience in the field, we are an ideal partner for your custom medical device software development needs. With our extensive expertise in the industry, we have a proven track record in delivering cutting-edge healthcare software development services. Our team is well-versed in the complexities of development, boasting advanced knowledge in areas like AI, IoT, and regulatory compliance for medical device software.

Adherence to stringent regulatory standards is at the core of our operations. We prioritize compliance with industry regulations like HIPAA, FDA guidelines, and other healthcare compliance standards. This helps us ensure that our solutions are not just innovative but also align perfectly with the stringent legal requirements in the healthcare domain.

Furthermore, our commitment to providing ongoing maintenance, updates, and support services ensures that our solutions stay at the forefront of the ever-evolving healthcare landscape.

For instance, we developed Health-e People, a dedicated health assessment app that allows users to store and monitor their healthcare data and find medical caregivers.

Our team of medical software developers also developed Soniphi, the first resonant frequency-based personal wellness system, functioning as a patient engagement platform providing remote monitoring care plans for all patients.

Get in touch with our experts for all your medical device software development needs, and we will help you build innovative, compliant, and future-proof medical device software!

FAQs

Q. What are the 5 phases of medical device development?

A. The five phases of medical device development include:

  • Concept and Feasibility
  • Design and Development
  • Clinical Evaluation
  • Regulatory Approval
  • Production and Post-Market Surveillance

Q. What is the tech stack used in medical device software development?

A. The tech stack for software development for medical device typically comprises various tools and programming languages such as:

IDEs and Compilers: Common integrated development environments for coding.

Embedded Coding Languages: Including C, C++, Python, MicroPython, and Java for low-level programming.

Testing Tools: Software and devices for quality assurance and validation.

Cloud Development Platforms: Azure, AWS, Digital Ocean, Google Cloud for data storage and management.

Integrated Health Tech Solutions: Linking wearables, mobile apps, and IoT devices for comprehensive health data integration.

Front-end Development Frameworks: Angular, React, Vue, Node.js, and Core JavaScript for user interface development.

Q. What is the cost of building a medical device software for your business?

A. The cost of creating a medical device software usually ranges between $45,000 to $300,000. There are several factors that impact the overall budget for development such as:

  • The overall software complexity
  • The software delivery timeframe
  • Location of the hired medical device software development company
  • Integration of advanced technologies
  • The post-deployment maintenance and support, etc.

Get in touch with our healthcare professionals to get exact cost estimates based on your custom business requirements.

THE AUTHOR
Dileep Gupta
DIRECTOR & CO-FOUNDER
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