Expert Risk Tracker Shwetha Mahadevappa Redefines Medical Device Safety

Trust is one of the greatest investments anyone could make in healthcare. Patients who put their lives in the hands of healthcare institutions and personnel do so with an unmitigated amount of trust, as all they want to be is well again. Expert Risk Tracker Shwetha Mahadevappa ensures this by guaranteeing that every medical device used in patient care is top-notch and will do what it is supposed to do for the best of the patient.

The Safety Imperative in a High-Stakes Industry

The medical device landscape is undergoing remarkable change. No longer confined to traditional hardware, today's medical technologies encompass everything from AI-powered diagnostics to implantable sensors and wearable monitors. This evolution brings many opportunities for patient care but also introduces complex safety challenges.

As a senior engineer in risk management in the medical device industry, Shwetha Mahadevappa is crucial in ensuring patient safety, quality, and regulatory compliance. She conducts thorough risk assessments, develops and implements risk mitigation strategies, and ensures adherence to international standards like ISO 14971. By proactively identifying and addressing potential hazards, she helps prevent adverse events and ensures that medical devices are safe and effective for patient use.

Shwetha's commitment to ethical practices and patient safety fosters trust among patients, healthcare providers, and regulatory authorities. By prioritizing safety from the outset, she contributes to better healthcare outcomes.

In her role, she prioritizes evidence-based patient care while developing expertise in risk assessment, quality management, and accelerating innovation. Her passion for improving efficiency without compromising patient outcomes drives her to simplify portfolios, enhance processes, and identify continuous improvement opportunities in risk management throughout the product life cycle. Shwetha's ability to foster cross-functional collaboration highlights the dedication to aligning business objectives with impactful solutions.

Contributing to Innovative Developments in Medical Device Safety

In her previous role as an R&D engineer, Shwetha contributed by developing new product ideas and focusing on the sustenance engineering of proven products. As part of the Sustenance Engineering Portfolio at BD, she protected the core business through effective life cycle management. As an R&D lead, she was responsible for the Design Control Process, better risk mitigation, and various product life cycle phases. Her efforts in sustenance engineering helped increase product life and revenue, with higher customer retention.

Shwetha has also actively contributed through several patents filed, including those for advancements in hazardous drug delivery solutions used for treating cancer patients. Her patents US20240094679A1, US20230166025A1, and US20240085857A1 display the efforts to improve safety and efficiency in IV therapy.

Her work addresses the challenges associated with single-use medical devices, which are designed for limited use and can pose unintended risks if not disposed of properly. Tracking the duration that medical devices have been in service is crucial in healthcare environments. Many devices, such as syringes, needle-free connectors (NFCs), and catheters, have a limited shelf life. Failure to monitor these devices can lead to device failure and patient harm, with studies showing that approximately 10 to 15 percent of medical devices in hospitals are past their expiration date. The FDA receives over two million medical device reports each year of suspected device-associated deaths, serious injuries, and malfunctions.

Recognizing Advancement in Medical Device Safety and Tracking

Shwetha's innovative solution provides a reliable method for tracking the elapsed time of medical devices, ensuring healthcare professionals can make timely decisions and preparations. This enhances safety and efficiency, reducing the risk of using expired or compromised devices.

She has also provided solutions for non-disconnectable injector Luer connections to prevent accidental loosening or disconnection of lines with hazardous drugs. In oncology practices, hazardous drugs pose significant risks to healthcare providers (HCPs). Closed System Transfer Devices (CSTDs) with Luer connections are used to mitigate these risks, but accidental disconnection can lead to exposure.

Shwetha's innovation establishes a non-detachable Luer connection, ensuring secure connections and reducing exposure risks. It also facilitates bi-directional rotation for clear visibility of syringe markings and prevents reuse, ensuring single-use integrity. These prevent accidental disconnections, reducing the risk of exposure to hazardous drugs.

For her contributions, she has received numerous accolades within the company and was most recently honored with the Society of Women Engineers' FY24 Patent Recognition Award.

The Drive to Ensure Safety in Medical Devices

Shwetha Mahadevappa currently serves as the senior risk management engineer in the Medication Management Solutions business of Becton, Dickinson and Company (BD). Her primary responsibility is to ensure the safety and efficacy of medical devices throughout their lifecycle, which is crucial in safeguarding patient health and maintaining the integrity of the healthcare system.

No stranger to the work, she collaborates with engineering, design, medical affairs, regulatory, commercial, and product teams to identify all product hazards, estimate and evaluate associated risks, and ensure these risks are controlled, mitigated, and documented. She also leads training, mentors team members, processes risk-related requests, and analyzes data for reporting. Additionally, she investigates and resolves non-conformances, supports company initiatives, and complies with regulatory requirements.

Shwetha leads risk management across product development, manufacturing, and post-market surveillance, maintaining a closed-loop process that integrates post-market data into new product development, process improvements, and clinical evaluations. She represents risk management during audits, keeps current with regulatory trends, and develops Quality Management Systems to ensure compliance and address FDA Warning Letters.

An Ardent Advocate for Women in STEM

Apart from her technical work, Shwetha Mahadevappa is a passionate advocate for women's empowerment in the workplace. She actively participates in the Women's Initiative Network (WIN) activities and has been a dedicated member of the Society of Women Engineers for the past few years.

Shwetha leads activities within the WIN initiative on the company's internal forum, creating posts on various topics that help women in the BD community explore new ideas, learn from diverse perspectives, and build leadership competencies. She has also volunteered to organize events, including quizzes and "Chat with a Purpose" sessions with global women leaders.

As a SWE member, she actively engages in SWE seminars, community volunteer events, networking, mentoring, and professional development activities. She has judged student scholarship and SWE award programs, enriching her understanding of professional development and the importance of leadership in fostering growth and learning. These experiences have strengthened her ability to inspire and motivate colleagues, contributing to a more inclusive and diverse workplace.

Ensuring a Future of Safe Medical Devices

Shwetha Mahadevappa's work is more than just improving hospital procedures; it pushes for a new system for medical device safety in a changing healthcare landscape. By focusing on early intervention, holistic risk assessment, and cultural transformation, she and professionals like her are providing better safety standards crucial to modern medicine.

Her diverse experience and her passion for empowering women in the workplace and encouraging more girls to pursue STEM careers make her a true pioneer in medical device safety.