Client Success Stories: Enhancing Digital Health Solutions for Obstructive Sleep Apnea

At Rx Device Consulting, we specialize in providing expert guidance to medical device companies navigating complex regulatory and technical challenges. One of our recent collaborations involved an international company developing an innovative digital health device designed to offer at-home therapy for mild obstructive sleep apnea (OSA) and snoring. As the company sought to update their software platform, they turned to us to ensure compliance with critical software design controls and cybersecurity requirements. Here’s how we supported their journey.

Evaluating Software Changes and Requirements

The company’s development team was implementing key updates to their software platform, necessitating a thorough review and update of their software design controls. We led the effort to evaluate these changes, focusing on updates to software requirements and hazard assessments documentation. This process was essential to ensure that the software maintained its effectiveness and safety, particularly in light of the new features being introduced.

Rx Device Consulting conducted a meticulous review of the software changes, ensuring that all new requirements were properly documented and integrated into the existing design controls framework. This foundational step was crucial for maintaining the integrity of the software’s development lifecycle and ensuring that all updates were aligned with regulatory expectations.

Comprehensive Cybersecurity Assessment

Given the increasing importance of cybersecurity in digital health solutions, we performed a detailed cybersecurity assessment of the updated software. This assessment was conducted in accordance with FDA guidance documents related to cybersecurity, ensuring that the company’s device would meet the stringent requirements necessary for market approval and patient safety.

Our cybersecurity assessment included a thorough threat model analysis, identifying all systems exposed to potential threat vectors. We provided the company with a comprehensive set of mitigation recommendations designed to enhance the robustness of the software platform. These recommendations were aimed at addressing identified vulnerabilities and strengthening the overall security posture of the device.

Updating Software V&V Test Protocols

In conjunction with the cybersecurity assessment, we also updated the software verification and validation (V&V) test protocols. These protocols were designed to rigorously test the new software mitigations, ensuring that they were both robust and effective. Our approach to V&V testing emphasized the need to validate not only the functional aspects of the software but also its security features, providing a comprehensive evaluation of the updated platform.

Regulatory Assessment and Compliance

Understanding the regulatory implications of software changes is critical for maintaining market access. As part of our engagement, we performed a detailed assessment of all software modifications relative to FDA guidance. This assessment was aimed at determining whether the changes were significant enough to require a new marketing application with the FDA.

Our expertise in regulatory strategy allowed us to provide the company with clear guidance on the necessary steps to maintain compliance. By thoroughly assessing the impact of the software updates, we helped the company navigate the complex regulatory landscape and ensure that their product remained in good standing with regulatory authorities.

Partner with Rx Device Consulting for Regulatory Success

Our collaboration with this international company underscores the value of expert guidance in navigating the complexities of medical device development, particularly in areas such as cybersecurity and software design controls. Rx Device Consulting is committed to helping companies bring innovative digital health solutions to market while ensuring compliance with regulatory standards. If your organization is developing a medical device and needs expert support, visit our website or contact us today at info@rxdeviceconsulting.com. Partner with us to bring your product to market with regulatory compliance.