What does it take to build solid medical device software? Two things are a must—a deep understanding of medical standards and regulations and a team of software engineers with high-end skills and expertise in healthcare software development. Creating medical device software means implementing the most advanced digital technologies that can match the latest trends in the healthcare domain.
It can be treatment monitoring systems or various diagnostic tools, you will need a professional healthcare software development company that can efficiently build software for portable medical devices. The blog will take you through the comprehensive process of developing medical device software. We shall cover the process from the start to the launch of the software product.
What is Medical Device Software Development?
The process of developing and building applications that can integrate with medical devices is called medical device software development. These devices deliver functions related to health. Various types of medical devices, such as wearables or complex robotic surgical equipment, can be integrated with medical apps to manage health and treat patients.
The need for medical device software is rising with the increasing number of outdated or unsupported software systems. In the US alone, 83% of medical IoT devices rely on outdated software systems. The abundant outdated software systems across the healthcare sector either need to be disposed of ensuring the safety of sensitive medical data traffic, or these systems must be upgraded for data protection. So, the need of the hour is an advanced and trustworthy medical device software for improved patient care.
The medical software industry is estimated to reach $167.59 bn by 2032, up from $19 in 2022. Hence, there is a huge opportunity for entrepreneurs who wish to establish a successful business in the healthcare industry. With the widening scope of providing digital health solutions to patients worldwide, starting over with medical device software solutions makes sense. Since everyone nowadays wants high-tech digital solutions, including the healthcare sector, enabling professionals to work with speed and efficiency.
The latest trend in the development of medical device software systems is the adoption of AI in healthcare. AI-based solutions can create systems that can analyze large amounts of data and provide insights about a particular type of treatment. Recent research found that 73% of healthcare organizations have implemented AI technologies, and medical device software development is the key area of application.
Medical device software is required by several groups of people dealing with the healthcare industry directly or indirectly. Some of the leading sectors are:
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Medical Device Manufacturers
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Biotec Firms
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Clinical Research Organizations
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Diagnostic Equipment Manufacturers
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Hospitals and Healthcare Facilities
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Healthcare Startups
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Pharmaceutical Corporations
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Research and Development Laboratories
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Telehealth Service Providers
Types of Medical Device Software
The classification of medical device software can be done in two major types:
Software as a Medical Device (SaMD)
This device classification covers various software programs that do not require any special medical equipment. These types of devices have similar standard regulations to those of other medical devices or instruments. They are integrated with various other embedded systems during the ongoing development of medical devices’ software. They can work on smartphones, desktops, and tablets. They are used in telemedicine platforms, healthcare data analytics tools, and electronic health record systems.
Embedded Medical Software
This software is designed and developed to make it function inside a medical device. They are incorporated directly into the hardware and can function without connecting with external systems or servers. They can work on all types of special medical equipment. They are embedded medical software systems that are excluded from regulations. They are primarily used in smart wearable health devices, medical imaging, and glucose monitoring systems.
The Process of Medical Device Software Development
To develop smart medical device software, you can hire dedicated developers who are well-prepared to build the system with a systematic and well-defined process. As a leading healthcare software development company in the USA and India, we recommend the below process:
Find out a solid medical device software idea
You must come up with a solid idea of a viable medical device concept that requires thorough research into various requirements of medical device software in different sectors of the healthcare industry. Consider various factors such as risk analysis, medical regulatory compliances, and medical usability tests. All these must pass through your concept and idea before you start with medical device software development.
Do an in-depth product research.
To develop medical device software, a comprehensive understanding of the basic requirements is needed. So, the second stage is to conduct an in-depth product discovery and find out the current problem in the market. Accordingly, decide how your medical device software can help provide a viable solution. It includes evaluating customer needs, consolidating insights and data, identifying medical device digital goals, and defining the key medical device functions.
List down the basic software features.
You must define the basic features of the software. So list down the features before starting the development process, as it will lay down the blueprint of your project. The features will help you to map out a detailed process of medical device software development. Partnering even with an established medicine delivery app development company will help you map the suitable features needed in your medical device software.
Develop medical device software architecture.
The next phase identifies the best practices to implement an extensive and robust medical device system. As it is a must that your software should handle safety measures, and ensure to meet the user experience objectives and compliance concerns. So, you must hire dedicated developers who can design medical device software that has modular programming, is scalable, and is flexible for future growth. For projects like EHR software development and similar systems, you need the following technologies:
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Healthcare-specific knowledge or hospital information system
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Health information exchange
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EMR systems experience
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Hospital data integration
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InterSystems IRIS
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Data lake
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Datafabric
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HealthConnect
Create UI/UX design
The next stage is creating a robust UI/UX design for medical device software. This is a key part of the process and requires a systematic integration of user experiences with medical functionality. UI designs involve incorporating the right set of visual elements and interactive media management tools, helping media teams understand and navigate through different medical solutions.
Conduct product usability testing.
For a lengthy and comprehensive healthcare software development, you must closely monitor and test its usability periodically. This involves recruiting volunteers who fit the target user base to test the medical device. Product usability testing will meet standards as mentioned by medical regulatory authorities.
Execute the medical device software development.
The next important step is to write code for all the product components. It has two steps: one is front-end development and the second is back-end development. Various phases in this stage involves:
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Choosing the right tech stack and documentation
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Conducting software architecture plan
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Creating features for a structured sequence
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Infrastructure setup for testing and CI/CD for testing servers
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Client and server development
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Quality Assurance
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Regression testing
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Product infrastructure setup and prod servers.
Integrate various mandatory HIPAA and similar systems.
To ensure safety and privacy of sensitive medical and patient data, you must ensure your medical device software is well integrated with HIPAA/GDPR systems. These systems make sure the patient data is highly safe and secured all the times. With this, you also ensure to build trust with the users and ensure a successful and sustainable medical device product.
Test your medical device software.
Your medical device software must be rigorously tested to ensure accuracy and efficacy prior to approval. The testing process includes verifying medical device functionality and usability. It also provides the software is created in conformance with federal medical devices regulatory requirements and standards. The testing phase includes integrated simulations that are performed within virtual test environments that lead to field trials of medical software.
Launch your software
The final stage involves launching your medical device software successfully for the users and target audience.
Benefits of Medical Device Software Development
Some of the top benefits of a medical device software development are:
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It creates market growth and expansion, letting companies explore new markets and widen their product range.
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It gives a competitive edge with unique designs and features
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Generates substantial revenue through licensing, subscription, and added services
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Gives better patient outcomes with efficient treatments and diagnostics with advanced algorithms and a decision support system
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Automation streamlines workflows with integrated software solutions
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Enhances accessibility like telemedicine and affordability
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Provides robust data insights and analytics
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Provides personalized services
Conclusion
Developing medical software needs specific expertise and a deep command of technology. Whitelotus Corporation is a decade of experience in building immersive and efficient healthcare solutions. We are a reputed medicine delivery app development company with deep expertise in providing user-centric and innovative healthcare software solutions. If you have a unique medical device software idea, share it with us, and let us collaborate to create an outstanding healthcare solution for your target audience.
