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Roundtable Recap: Developing Next Generation Safety Critical Medical Devices

Today’s blog post was guest written by Michael Hayes from MathWorks’ Startup Marketing Team.

Safety is a vital aspect of product development across many industries, perhaps none more so than Medical Devices. There are intense certification requirements specific to the medical field. Furthermore, one of the primary barriers to entry for new medical devices is establishing trust with patients and healthcare providers. For startup companies entering this space, safety must be designed into their product at the outset. To address this trend, MathWorks recently hosted a virtual roundtable: Developing Next Generation Safety Critical Medical Devices

The roundtable was facilitated by MathWorks Medical Device Industry Manager, Kirthi Devleker, and featured expert panelists from three diverse Medical Device companies. They shared their approaches, lessons learned, and best practices pertaining to safety and compliance. Topics included risk management, simulation, automation, data privacy, and the role of model-based design in developing demonstrably safe devices.

Lane Desborough, CEO of Nudge BG

Insulin requirements are subject to a wide array of variables and even minor errors in dosage can have dire consequences. Automated supervision that integrates hardware, algorithms, and human factors can alleviate the burden of managing Type 1 diabetes. Lane shares how his companies have utilized model-based design (MBD) to identify and mitigate risk earlier in the development cycle. MBD simplifies and expedites the development process by illustrating “what not to build”. It is also an alternative to human trials which are often unsafe, always costly, and time-consuming. Lane points to real data illustrating the high degree of accuracy predicted outcome of simulation versus actual results of clinical trials. In short, simulation enables safer products to be developed faster by avoiding wasted effort and unexpected outcomes.

Emily Luvison, Principal Lead Cybersecurity Compliance, Digital Health Technologies – Genentech

Emily Luvison leads the strategic development and execution of a cybersecurity compliance framework for digital health. There is a trend of medical devices collecting, transmitting, and storing the personal health data of patients. Regulation framework and new customer attitudes have emerged hand in hand with this trend across a global market. Emily shares how startup companies can gain customer confidence by demonstrating compliance to certification standards. Incorporating security and privacy by design from a product’s inception can reduce rework needed down the line.

Nicolas Chbat, CEO of Quadrus Medical Technologies and adjunct Professor of Biomedical & Mechanical Engineering at Columbia University

Nicolas Chbat explores the concept of “Dynamic Stability”. In the context of medical devices, if a product is not stable, it is not safe. Biologic variables and feedback often necessitate a dynamic solution. Nicolas shares how modeling can develop a mathematic understanding of variables. He advocates designing for both implicit and exogenous feedback. Simulation in conjunction with domain expertise may be applied. Understanding the underlying physiology and biological processes enables the creation of an accurate, useful model. Nicolas then describes the roles of sensors and data analysis in validating the model and developing a prototype with hardware in the loop.

Check out the full recording below!

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