Software Ecosystem for Connected Medical Devices – Challenges and Solutions

Software Ecosystem for Connected Medical Devices - Challenges and Solutions

The medtech industry provides a wide range of items to monitor and treat patients. It is critical for health-care organizations to enhance patient outcomes, lower healthcare costs, increase efficiency, and expand patient engagement and education opportunities.

MedTech innovation is being driven by significant technical developments, which has resulted in the development of various connected software medical equipment capable of producing, managing, analyzing, and transferring data.
Alongside devices themselves, this data form a connected network of medical equipment, custom software applications, health systems, and services. With the advancement of medical device connectivity, new advancements in sensor and device connectivity emerged, allowing health care organizations to enhance patient care even in remote areas.

You can follow Hannah Schneider to find out more about custom software development for your firm. As an expert, she offers consultation services to firms.

The following are some of the challenges

The evolution of software-driven, connected medical devices

Software incorporated in medical equipment had limited usefulness until recently. Software, like so many other items, gradually took over the primary features and functions of medical devices.

Medical devices have become much more complex as a result of the mix of high-quality hardware and sophisticated software development, which means more development work for those who create them. When you add in the element of connectivity, which, while highly powerful and easy, may also pose a range of hazards, such as viruses and hackers, the panorama of medical device innovation has become substantially more complicated.

Teams developing modern medical devices must not only keep up with the market’s quick rate of innovation and needs, but also manage risk, which increases with the product’s complexity. Managing the advancements in medical devices through paperwork and spreadsheets isn’t a long-term strategy, and companies must innovate or risk falling behind.

Data safety and cybersecurity

Data breach is a key issue with connected medical devices, as the quantity and capabilities of these devices grow, raising the danger of data security. Medical device manufacturers frequently overlook the possibility of data breach because they are unaware of the risks, mitigation strategies, and consequences.

MedTech firms must utilize custom data anonymization, medical software encryption, role-based access control, data access audit, preprogrammed logout, and elaborate user authorization settings to combat the potential of data leak. After the ecosystem has been released, it must be assessed frequently and thoroughly tested.

To construct a full-fledged network of medical devices, however, a healthcare organization takes a large amount of time and effort from highly trained engineers who are well-versed in cloud expansion, big data, and data analytics technologies. To pay off the expense more quickly, a cost-cutting plan using the iterative development technique is proposed, which focuses on core functionality first to avoid too complicated features.

Gaining a thorough grasp of end users

Take-up speed and convergence of networked medical devices are rising as more suppliers implement value-based care (VBC) models. VBS’s Information and Evidence Center gives information about patients and operations.

The challenges include how well an organization’s IT infrastructure can manage and process links and data, as well as how confident patients and healthcare providers can be in the system’s protection and output. Medical device software development companies must gain a thorough grasp of end users and develop market models and situations that show how their current customers operate. The most recent tools not only enhance but also improve patient outcomes, as well as provide value to essential health-care stakeholders.

Medical Device Regulation is Becoming More Strict

For good purpose, the growing complexity of medical devices is driving authorities to revisit existing laws and guidelines. According to Stericycle’s Recall Index, the average size of a medical device recall in the first quarter of 2019 was 823,126, the highest quarter since 2006. Quality concerns were the primary cause of all recalls.

Compliance with industry and government requirements, whether ISO 14971 or ISO 13485, is a permanent weight for medical device producers, as regulatory authorities strive to keep up with the current pace of the market.

As a result, medical device compliance is becoming more expensive, and regulatory criteria are becoming more difficult to interpret. Navigating through the paperwork created by the development and design teams, including outputs from numerous software tools, is one of the most challenging and time-consuming components of establishing medical device compliance.

Solutions to a Successful Medical Device Ecosystem

Cloud connected medical devices

Medical equipment that are cloud-connected present both obstacles and opportunity. Those without the funding, internal expertise, or regulatory understanding may find that collaborating with seasoned partners who can help them develop, launch, and expand their service is the best option.

Traditional medical equipment custom software development companies are increasingly turning to companies to maximize resources as they grasp the value of cloud connectivity. Software customization is minimized. They help custom software development firms cut design costs and minimize delays in key product lifecycle milestones including clinical trials, FDA approval, and final market launch.

Security and Privacy Protocols, as well as Quality Systems

Collaboration begins with agile, quality-focused partners who are familiar with the hardware and software architecture of cloud connectivity.

Look for development companies that use quality systems and best-in-class security and privacy standards to protect against vulnerabilities that could affect data integrity and patient health. For organizations inexperienced with the process, regulatory regulations and industry standards for medical remote access can be burdensome, and classification guidelines can be perplexing.


The medical device ecosystem forces firms to reconsider their operations.

Their business potential extends beyond the patient-focused functioning of their equipment; it also includes the data generated by their devices. In a value-based system of care powered by analytics and software-based services and solutions, its value will only grow.

Engineers and academics can enhance diagnostic algorithms over time since data is collected centrally in the cloud. Machine learning algorithms can be used to sift through this data and uncover new patterns that could lead to new goods or services.
Portable diagnostics devices can be provided by connected medical equipment for in-home collection and diagnosis.”


Medical device manufacturers will benefit from an exciting new era in which their technology is now an ecosystem of hardware, sensor platforms, online mobile app development, and cloud connection.

Remote access, data analytics, and machine learning will all be attractive markets for new and current enterprises as a result of today’s linked medical devices. It will make it possible for gadgets to communicate with EHR systems in order to monitor patients’ healthy lifestyles.

A complex medical device software system can assist medical device software in streamlining their working processes, improving workflow efficiency, lowering the risk of human mistake, and improving patient happiness.

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