Device Manufacturers Face Challenges to Balance Opportunity and Risk

Author: Dan Sterling | Date: April 30, 2020

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an increased risk to patient safety and product efficacy. Software architects face difficult decisions regarding product development and patient safety.

Medical Devices: Five Principles to Keep Up with the Connected World.

Every software architect faces a series of decisions that impact the market success, market-entry, and efficacy of the product. Software architects understand that there is no perfect choice in technologies and that decisions must be defensible. They must take many factors, including software longevity, patient safety, and usability into account. Ultimately, the final decision must take into account the benefit of universal technology and code safety.

The safety of patients is a crucial step for regulatory approval. The international standard IEC 62304 uses a class system of Class A/B/C to classify software and its potential to create a hazard. This classification system makes it easier for architects to place different safety levels depending on the class of each software system. Documentation of each software system, its class, and its purpose makes it easier to assess risk-management and have a strong understanding of the potential risks and how to address them. Sterling’s technical awareness of its products will ensure patient safety and allow for regulatory approval and quick delivery to the market.

Architects must also take software sustainability into account. Medical device software is typically used for 10-20 years and needs to be sustainable and adaptable to future developments. Developing a sustainable software is essential, and software architects take into account various factors such as the popularity and lifetime in the market. One challenge that software architects face is their dependency on third-party vendors for proprietary software. Maintaining strong relationships with these third-party vendors is a must. However, dependence on third-party vendors can hinder future development.

Software architects ensure that their product is easily usable by the user and try to limit misuse and potential hazards that could occur. This is the practice of looking after the usability factor. Besides the architectural design of the product, software architects take into account who their potential users will be, the different requirements that it must pass, and the platform system on which the software will be used. All of these factors make an impact on the usability of the device and the user’s experience.

Cybersecurity is a threat to software developers and can have drastic consequences. In recent years, the Food and Drug Association has enforced cybersecurity requirements for medical devices to limit and reduce the threat of potential risks. Manufacturers follow ISO 14971 to manage risk, perform security upgrades, and prevent any new dangers that may arise. Sterling’s services can provide for the overlooking and decision making to assess the risk of technological advancements of the products.

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