Your Practical Guide Developing Advanced Signal Processing Software for Medical Devices

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By Kenneth L. Londoner, Co-Founder and CEO, BioSig Technologies, Inc.

The software is quickly becoming a critical product differentiator in the medical device industry. While launching an innovative product is no small feat, keeping your new device relevant and competitive can be the biggest challenge in the market. New or improved software is essential to this business, but the process of developing, upgrading, and expanding software capabilities is not without its own set of complications and hurdles to overcome.

Software development for a medical device must consider what determines the value of the product by analyzing the market (i.e. the end user) while considering the complexities of feasibility, regulation and safety associated with its use. Unlike many consumer software companies, which can beta test new applications with a large and diverse base of end users (and adapt based on consumer feedback), there is no equivalent. in beta testing for technologies that address the lives and health of patients. To put it simply, a medical product should 1) perform and function as intended, and 2) anticipate and address any safety issues or potential risks associated with the use of the device in advance.

Although the software development lifecycle described here is broadly applicable to a wide range of medical devices, for the purposes of this analysis, my comments will focus on software development for cardiac devices – and more specifically, the implementation of software. advanced signal processing software in a cardiac device. . But before diving into these specificities, let’s take a look at the beginning of the life cycle.

Identification of user needs

During the first phase of the software development life cycle, formally known as the idea or concept phase, clinical experts analyze the customer (doctor) and the market. Then, in consultation with clinical partners, cardiology experts will develop proposals for potential new product ideas or redesign designs that could benefit physician clients and, ultimately, patients receiving treatment. From there, software engineers provide feedback on proposals, considering feasibility, time, cost, and other associated requirements that may present development challenges.

Design & Development

The design and development phase is where most of the design work is done and documented, and where most of the expenses associated with developing a new product are incurred. Once the product development terms have been agreed, the next step is to establish the User Requirements Specification (URS) and the Software Requirements Specification (SRS). Possibly explicit, the URS defines the needs of the user (the doctor) while the SRS describes the exact functions and expected performance of the software.1

Then, while development engineers write the code to create software features, software test engineers develop verification test design cases (VTDs) to demonstrate that the product works according to the intended requirements. VTD is one of the most critical aspects of the design and development process and is consistently cited as the number one issue during FDA inspections.2 Developed incrementally throughout the software development process, VTDs are non-subjective progress reports that assess whether the software meets the intended end use and end user needs.3

The importance of risk management

If software deficiencies or failures are detected, engineering teams should work together to establish mitigation mechanisms.4 Risk management activities begin during the design and development phase and continue throughout the life cycle of the device. For example, if a software component is malfunctioning, a potential mitigation mechanism could be to ensure that the deficiency will have no effect on patient safety. But the mitigation mechanisms are not always so simple. Depending on its risk management level, the issue may require the FMEA process and review by the Change Control Board (CCB). The Change Control Board is made up of representatives from the development team responsible for overseeing the development process. They will meet regularly to discuss any proposed software changes, challenges, defects, etc.

Organizations typically overlook the role of the Change Control Board, and many projects fail due to a lack of CCB intervention.5 But early communications about changes and ensuring that all relevant stakeholders are aware of project requirements and goals are critical to the development process.

Integration of advanced signal processing

Advanced signal processing capabilities can meet the widespread demand in healthcare for more accurate and efficient tools for data analysis. Digital signal processing involves extracting and analyzing physiological information and data from the body to better inform clinical diagnosis or treatments.6 In the field of cardiology, signal processing software can offer physicians advanced insights into cardiac signals that can improve physician workflow and decision-making and improve procedure outcomes.

In cardiology and beyond, advanced signal processing capability is the definitive, innovative and underlying competitive advantage of the product itself.

Potential features of advanced digital signal processing software include:

  • advanced filtering that removes noise or artifacts that could compromise data integrity/validity;
  • the ability to provide real-time, high-fidelity diagnostic signal data; and
  • Customizable and personalized features that support software integration into existing clinical practices and workflows.

Leveraging this kind of innovative technology requires a well-executed software development process, requirements, and a team of engineers with the expertise to synthesize complex and abstract mathematics and algorithms. Integrating advanced software into a cardiac device relies on an expert in information technology, known as a digital signal processing (DSP) engineer.

Competitive algorithms are based on the ability of the DSP engineer to analyze volumes of frequencies and signal amplitudes to develop the optimal algorithms that take into account the needs of the end user, the objectives of the hospital or the company. health care organization and feasibility requirements established by software engineers, clinical trial results and regulations.

User interface: intuitive usability

Once the signal processing engineer has designed the optimal software algorithms, the engineer must validate their algorithm clinically and then work with the software engineers to integrate the algorithms into the user interface. Throughout the development lifecycle, the essential objective is to ensure that advanced software remains intuitive for the end user. Software usability is one of the biggest challenges in the medical device industry, so user requirements established early on are critical throughout the development lifecycle.

In my experience, the only reason to integrate advanced signal processing software is to give the end user more efficient, accurate and intelligent clinical data. As a clinical decision-making tool, the advantage of this type of software lies in both the superiority of the data it provides and the seamless delivery of that data to users who need it.

Marketing and post-market surveillance

Once the development lifecycle is complete and the product is ready for manufacturing and distribution, the role of the software engineer remains an essential piece of the puzzle. After the product launch, your business can track the end-user experience to collect meaningful data and ensure product satisfaction. Feedback from clinical users can also provide the building blocks for future software releases, upgrades, or adaptations when, you guessed it, the software development cycle begins again.

References

  1. Specifications required by the userCambridge Med Solutions, January 15, 2014: http://cms.com/user-requirement-specifications/
  2. How to design medical devices with sustainability in mind., Online medical device, March 30, 2022:
  3. https://www.meddeviceonline.com/hub/bucket/industry-perspectives-manufacturing
  4. Design validation and regulatory requirementMedical Design Records, January 1, 2017: https://www.medicaldesignbriefs.com/component/content/article/mdb/features/articles/26238
  5. Risk management software for medical devices MD+DI, : https://www.mddionline.com/news/software-risk-management-medical-devices-0
  6. Definitive Guide to Change Management for Medical DevicesGreen Light Guru, January 22, 2021: https://www.greenlight.guru/blog/change-management-medical-devices
  7. Bio-signals in medical applications and challenges using the artificial IntelligenceSwapna et al. Journal of Sensor and Actuator Networks. February 25, 2022.

About the Author:

Kenneth L. Londoner is the co-founder and CEO of BioSig Technologies, Inc. He is an expert in capital markets and capital architecture and a senior life sciences executive. Beginning his career as a research analyst for J. & W. Seligman & Co., Inc., an institutional money management firm, he found himself at the forefront of the biotech industry in the early 1990s. His passion for medical innovation has led him to co-found, govern, and take to the public market several life science companies, including BioSig Technologies, Inc. BioSig aims to improve the outcomes of cardiac ablations for the treatment of arrhythmias .

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