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

The healthcare industry has always been tech-savvy, so adding medical device software development isn’t surprising.

Healthcare technologies vary from treatment monitoring systems to diagnostic tools. However, the most significant transformation is software as a medical device (SaMD).

SaMD is at the forefront of producing advanced, life-enhancing medical devices. With such technological improvements in the healthcare sector, software development for medical devices is on the rise.

The healthcare sector is among the businesses of the future that are listed with innovative ideas; hence, medical device apps and software development have great potential.

This blog will explore the types, processes, costs, and various other factors involved in medical device software development in the same context.

Let’s read further!

What is Medical Device Software Development?

In medical device software development, developers create a program that can perform several health and medical functions. The device is designed to work independently and without external factors.

Medical device app development software covers functions such as patient monitoring, determining a diagnosis, and offering treatment.

The workflow of such a device depends on its functions and the type of medical equipment it requires to operate.

What the software design for medical devices can improve for healthcare and medical organizations:

» Get the patient’s health status in real-time.

» Reducing human errors and automating repetitive tasks.

» Customized treatment planning

» Enhanced accessibility of medical and health care.

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The Type of Software Design for Medical Devices

There are two medical device software development types, namely:

SaMD

SaMD is an acronym for Software as a Medical Device. It can cover all software development programs without integrating specific medical equipment.

The software as a medical device follows the same regulatory standards as other medical devices or instruments.

You can further integrate such software during the development process with other embedded systems.

Embedded Medical Software

Embedded software, however, is designed to work from within software devices, as its name suggests.

Just like the innovation of hospital management software in India, embedded medical software has recently been adopted on a larger scale in the economy.

In its development process, you must directly incorporate the software solution into the hardware. The integration enables the medical equipment to connect without the involvement of external servers or other systems.

What is the Medical Device Software Development Process?

Medical device Software engineering requires considerable effort, knowledge, and expertise from developers. Depending on the project's requirements, you may need to start by hiring an app developer or a software engineer.

The process will start by determining the project's goals and scope, which will involve creating an advanced medical device or software.

As great business ideas, including healthcare, rise globally, let’s explore the development process for medical software and healthcare apps in India:

Stage 1: Know the Regulations

Before anything else, understand the regulatory rules for medical devices. Critical regulatory bodies include:

» FDA for the U.S.

» EMA for the EU

» TGA for Australia

Some essential guidelines include:

» FDA’s guidance on Software as a Medical Device (SaMD)

» EMA’s Medical Device Regulation (MDR)

» ISO standards for risk management and quality systems

Following these rules ensures your software meets the legal standards.

Stage 2: Research the Market

Once your product meets regulatory requirements, it's time to research the market and figure out what your users need. Focus on:

» Analyzing existing products and their strengths/weaknesses

» Tracking current trends in medical technology

» Talking to your team to pinpoint issues your device can solve

» Defining use cases to clarify your software’s role

This step helps you align your product with real-world needs.

Stage 3: Choose the Right Software Partner

Now, it’s time to find a software development partner. Here’s how:

» Define your selection criteria

» Research companies and review their portfolios

» Discuss their development strategies and see if they meet healthcare standards

Your chosen partner will be crucial to your project’s success, so pick wisely.

Stage 4: Plan and Design Your Software

Work with your development partner to plan the architecture and design of your software. During this phase:

» Conduct a detailed analysis of user needs, software features, and third-party integrations

» A solutions architect will design the software structure

» Your UI/UX team will design the user interface to ensure it’s simple and intuitive

Good planning sets the stage for smooth development.

Stage 5: Develop and Integrate

Now, start building your software. Depending on your needs, you can either:

» Develop a Minimum Viable Product (MVP) that focuses on core features. This technology is great for startups with limited budgets.

» Build a proof of concept to test the integration of your software with existing healthcare systems.

After deciding on the best approach, your team will pick the right tools, integrate APIs, and conduct thorough testing.

Stage 6: Deploy and Monitor

Once development and testing are complete, it’s time to release your software. At this stage:

» Train your staff on how to use it

» Create user manuals and documentation

» Deploy the solution and monitor its performance regularly to ensure it meets security and compliance standards

Stage 7: Provide Ongoing Support

After launch, continuous support is crucial. Focus on:

» Quickly responding to user feedback and concerns

» Fixing bugs and releasing updates

» Ensuring your product runs smoothly long-term

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Tech Stack to Use in Medical Device Software Development

There are always many technical solutions and tools for medical software app development.

The tech stack, including frameworks and programming languages, is necessary for any development process.

For instance, developers are going for mobile app development using Python as the lead programming language.

Similarly, here’s an idea of the tech stack required to develop a software app in the healthcare and medical sector:

» Development Tools: IDEs, compilers, debuggers, emulators, and testing tools

» Cloud Platforms: Azure, AWS, Digital Ocean, Google

» Front-end Technologies: Angular, React, Vue, Node.js, JavaScript

» Advanced Features: Integration with wearables, IoT devices, AI, ML, AR/VR, 3D imaging/printing, and medical SaaS

Benefits of Medical Device Software Development

Here are some of the benefits of software development for medical devices:

1. Easier Workflow

Automates functions and reduces the burdens of administration, thus making it easy for doctors to be in front of patients for quality interaction.

2. Better Accessibility and Cost-friendly

It ensures that its service extends outside hospitals and medical facilities to other places where people can be appropriately and cost-effectively taken care of.

3. Compliance with Regulations

MDS development ensures strict adherence to industry regulations, thereby reducing the risk of penalties and injury to patients and placing safety as a priority for patients within a healthcare ecosystem.

4. Improved Patient Care

Precision diagnostics, tailored treatments, and complex monitoring can advance patient care visibly, helping healthcare providers achieve better-quality care.

5. Simple Tech Integration

Implement technology solutions such as AI/ML development services and IoT integration.

Furthermore, there are several benefits of cloud computing for small businesses, including healthcare and medical businesses.

Integrating technologies will enable better performance and improved functionalities of the software design for medical devices.

6. Accurate Data Analysis

Medical software assists businesses in effectively analyzing data, making informed decisions, and gaining a competitive advantage.

7. Competitive Advantage

Through investment in the development of MDS, organizations gain a competitive advantage within this dynamic healthcare sector.

They can offer advanced, unique, and second-to-none services and solutions, distinguishing them from other companies in the industry and ensuring a strong brand in the market.

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Factors to Consider for the Process of Software Development For Medical Devices

Many critical factors need careful consideration and strategic planning in software development for medical devices.

By considering all such aspects, a firm can develop software that is secure, effective, and compliant with regulatory compliance requirements.

1. Comply To Regulations

Compliance with strict regulatory standards, including those of the FDA, has to be maintained.

Compliance with such regulations ensures that the medical device software is safe, effective, and high-quality.

Additionally, for compliance, it is necessary to meet market approval requirements and ensure the patients' safety by negotiating legal and quality complexities.

2. Data Security and Privacy Measures

Robust data security measures should be implemented, including encryption and access control systems.

Such moves ensure that patient information is protected in case of breaches or unauthorized access, which builds much-needed patient trust and abides by data protection laws, such as HIPAA.

3. Improve User Experience

User-centric medical device software design would be crucial because doctors need to be able to work intuitively and provide easy navigation for patients.

4. Adaptability with the Systems

Ability to design software that is easy to communicate with and interact with other parts of the healthcare ecosystem.

This interoperability enables information to flow from one platform to another, thereby improving patient outcomes and facilitating delivery.

5. Risk Management

Risk analysis procedures are essential to highlight several potential hazards and ensure that software risks have been mitigated.

The process includes comprehensive risk assessment, management, and mitigating strategies to maintain the patient's safety and minimize the cause of harm as much as possible.

6. Involvement of Stakeholders

Stakeholders, such as doctors, users, and regulatory agencies, must be involved to ensure that the software developed meets specific requirements.

The involvement allows functionality to be improved, and it is essential to real-life healthcare applications.

Such collaboration ensures that the developed software meets the needs of its users and is within the regulations' context.

7. Testing

Tight testing and validation procedures ensure that no faulty or buggy software that fails to meet the required quality is produced.

These procedures identify problems or bugs that may arise in the software before it is deployed for use in practice.

Such testing ensures that the software is workable and performs adequately.

8. Maintenance and Updates

These strategies ensure the software is constantly updated to address changing healthcare needs. Constant updates are essential for facing new issues and maintaining high performance and safety.

The Popular Medical Device Software Development Examples

Medical software can transform healthcare businesses, enhancing efficiency and patient care.

Here are some significant examples of medical device software making a difference:

1. Medical Imaging Diagnosis

The software improves the diagnostic functionalities of scanning devices like CT scans, MRIs, and X-rays. It allows doctors to improve diagnostic imaging of conditions and earlier detection of conditions.

2. Managing Electronic Health Record (EHR)

EHR software is applied in EHRs to assist in organizing patient electronic record keeping, making communication between patients and health professionals easier and more effective.

3. Monitoring Patients Remotely

Medical software assists health professionals in tracking patients' health status in real-time, especially chronic patients whose histories must be traced constantly.

4. Surgical Navigation

Surgeons get real-time assistance in operations by planning them using 3D anatomy models of the patient, which results in better outcomes.

5. Wearable Devices

Healthcare businesses may hire a wearable app development company to create devices that patients can use as wearables.

These medical devices provide significant stats and metrics on the patient’s health status, such as oxygen levels, sugar levels, heartbeat, and more.

6. Medical Research

The software makes data collection and analysis much more accessible for researchers, speeding up and improving clinical trials.

7. Pharmacy Management

Pharmacies use software to manage their inventory, monitor medication flows, and track patient adherence to certain medications.

8. Telemedicine Advantage

Medical software is used for virtual consultation and remote monitoring. Such facilities increase healthcare access for patients in remote areas.

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What is the Cost of Software Development for Medical Devices?

As medical device software development is on the rise, here is an estimate of the software development services to develop these advanced technology medical devices:

Conclusion

In conclusion, as innovative ideas for healthcare businesses surge, medical device software development demand also increases.

However, there are still some complications with the regulation compliance and guidance for SaMD that need to be improvised. Also, cybersecurity-related issues need to be addressed.

However, medical device software development is still a territory with more significant potential for the future that will revolutionize the healthcare sector.

If you need a professional team to partner in your software development or app development project, contact Arramton Infotech.

Frequently Asked Questions

Q. How much does it cost to develop medical software?

Ans: If you wish to get customized medical software, the development cost may typically vary between $30,000 and $300,000. However, the cost mainly depends upon the project's complexity, the technology stack's budget, features, and more. Remember, this is just a rough estimate; it may cost much more depending on the process.

Q. How do you classify software as a medical device?

Ans: The most common categorizations for the medical software devices are as follows:

» Class I: These are low-risk devices. For instance, they may include handling surgical instruments, bandages, etc.

» Class II: These devices are considered intermediate-risk devices.

» Class III: These devices are high-risk devices. They are significant for sustaining lives.

Q. What is the software standard for medical devices?

Ans: IEC 62304 is the international standard for medical device software. It determines the framework for processes occurring throughout a medical device's product life cycle, which may include a specific set of processes, activities, and tasks.

Q. What are some examples of software as a medical device?

Ans: A few examples of software design for medical devices are:

» Remote-based patient monitoring systems.

» Imaging diagnosis.

» Surgical Navigation.

» Wearable applications devices.

» Managing Electronic Health Record.