As the Global Medical Device Industry Manager at MathWorks, Arvind Ananthan has immense experience working with medical device engineers, academic researchers, and regulatory authorities. Having a background in signal processing and electrical engineering, Arvind joined MathWorks 15 years ago as a technical sales engineer working with embedded systems before moving into his current role, where he identifies and addresses challenges faced by the medical device industry. We recently had the opportunity to interview Arvind to learn more about how MathWorks software and toolboxes help with the development and testing of medical devices.
Rukmani Sridharan, Medgadget: When did MathWorks realize the need to cater to the healthcare space and how do you help medical technology companies with their products?
Arvind Ananthan, MathWorks: MathWorks is the leading developer of mathematical computing software. Engineers and scientists worldwide rely on its products to accelerate the pace of discovery, innovation, and development. MathWorks have always had customers in the healthcare space, but we started creating dedicated teams towards the medical device industry from 2010, when they started to catch up with the technology available for complex workflows.
The two main tools we have available for clients is MATLAB and Simulink.
MATLAB is a technical computing platform used for algorithm development, data analysis workflows, software development and for visualization; it can be used to quickly prototype something without writing a full set of code. Simulink, on the other hand, is for system-level design, simulation, dynamic system modeling and rapid prototyping of software for real-time PCs and embedded systems. Medical device manufacturers use both these tools and the wide array of functions available within these tools to develop, implement, test, and validate their software.
Medgadget: What are some of the examples of medical devices developed using MathWorks software?
Arvind Ananthan: There are several success stories of devices that are currently in use in the healthcare industry developed with MathWorks products.
Respiri, the world’s first digital wheeze detection company, uses MATLAB and the Computer Vision toolbox to identify wheeze sounds from audio recordings of patients trachea.
The algorithm classifies data based on energy patterns and other common characteristics of a wheeze such as amplitude and frequency to help doctors remotely diagnose the severity of wheezing.
The technology, named Airsonea, is awaiting FDA clearance in the United States and has already been CE marked for European markets.
Batelle NeuroLife neural bypass technology is another example of the successful implementation of MATLAB software. The technology helps patients with permanent paralysis use their limbs again by bypassing damaged neural pathways and converting the intent of action into muscle movement. An array using 96 individual electrodes implanted into a patient’s brain records neural activity at 30,000 samples per second, generating large datasets. Algorithms written using MATLAB decode the resultant brain signals, identify the intended movement and generate signals that stimulate the patient’s arm to perform the movement. Even a seconds-long delay between thought and movement would make the movement appear unnatural; as a result, all data processing, classification, and decoding are done in real-time.
Medgadget: Can you take us through how MathWorks implements Model-Based Design to reduce the time required for complex workflows?
Arvind Ananthan: If you take a few examples such as developing a motor controller for an infusion pump, or processing of ECG signals obtained by a pacemaker, these workflows typically heavily rely on software in order for their device to function. The traditional method of designing the software was to come up with a set of requirements for the software, write the code and implement it with the hope that it works. If this fails, the process is often repeated using a trial and error approach until the software works as required. Model-Based Design helps combat some of the issues encountered while writing code for complex workflows. Using a virtual representation of a real-world system, companies are now able to iterate their software and requirements to closely represent the end-goal software before final implementation into hardware systems. This allows users to identify and correct errors continuously by integrating testing with design and links design directly with requirements.
Medgadget: Do you work with regulatory authorities to ensure that the medical devices developed using your software are compliant?
Arvind Ananthan: MathWorks is well known in the software development arena for generating reports at every step of the process. Medical devices have to conform to a process standard called IEC 62304, which is an international standard that describes the software development and maintenance processes required for medical device software. The required processes, tasks, and activities are classified based on the hazard (risk to patient, caregiver, or environment) level of the device software. The IEC Certification Kit provides customizable templates for providing documentation to certification authorities.
Regulatory authorities like the FDA do not certify or validate the software (such as MATLAB) used in medical devices – this responsibility lies with the medical device manufacturers. We provide tools with sample validation and tailored guidance through our consultants for addressing individual needs of tool validation.
Medgadget: Why do people pay to use MathWorks software as opposed to the several open-source software packages available with similar functionality?
Arvind Ananthan: One of the main strengths of MathWorks as a company that has existed for over 35 years is that we provide a large breadth of functionality combined with excellent support and extensive documentation. One of the often-cited reasons for using open-source software is the ease of access with which it is available for download and use, while commercial software such as ours has to be purchased. However, there is no such thing as free software – you most likely end up paying for it in terms of the engineering hours that are required to maintain the code. Code written in MathWorks software relies on the power of functions maintained by large teams of quality engineers. This ensures that customers can rely on the software for the lifecycle of their product development, which can last up to a decade in some cases.
Medgadget: What are some of the challenges you face that are unique to the medical device industry?
Arvind Ananthan: One of the interesting things we have noticed is that the medical device industry is falling behind on the technological curve when it comes to adoption compared to other industries such as aviation or automotive. However, they are catching up very quickly so this is an exciting space to watch in the coming years.