Software Articles & Videos

Ideas on how to get foundation models and generative AI FDA cleared.

Medical device design begins with design inputs. The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’ answers questions our clients frequently ask us about design inputs and analyzes a number of poorly written example requirements.

To provide quality service to our clients, we need to do more than produce quality work.

The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and the lifecycle management of such technologies. Key points include the complexity of training data in foundation models, the risks of hallucinations in outputs, and the evolving role of post-market surveillance. Insights highlight challenges in balancing innovation with regulatory oversight and safety.

We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risks like network vulnerabilities and outdated dependencies, recommending best practices such as code reviews, automated testing, and prioritizing tool validation for critical security areas.

Yujan and David discussed the topic of FDA's performance in regulating AI medical devices, focusing on the ideal regulatory situation, the impact of AI on risk analysis, and the regulatory pathways for adding AI tools to existing software medical devices. They also explored the potential of continuous learning models in medical devices, the adoption of AI and ML in the US healthcare market, and the cybersecurity threats facing medical devices. The conversation ended with a discussion on the regulatory implications of continuous learning algorithms and the potential for a letter to file for a SAMD cleared by FDA for surgical planning.

Notes on medtech funding, covering accelerators and funding sources.

A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion.

A practical guide for integrating software with VistA, the VA’s PACS. This guide is based on our experience working through the process with our client.

Overview of SMART on FHIR and when it’s a good approach to integrating your software into the clinical workflow. It includes a few sequence diagrams and discusses when its an appropriate fit for your device.

An in-depth guide to navigating the use of off-the-shelf software (OTS) in the medical device industry. OTS software is general purpose software you didn’t develop yourself that you use in your device, e.g., open-source packages, cloud services, and operating systems. The article starts with the basics and then delves into more detailed issues, including strategies for documenting OTS software for the FDA.

A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Includes links to the relevant guidance and a few best practices.

What is the difference between user needs and requirements?

This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to researchers or companies who are repurposing existing software into a medical-device.

If you’ve ever been working on a medical-device and have thought, “this is a waste of time,” this article is for you. It will provide a framework for understanding which activities are necessary and how to proceed if you believe one isn’t.

Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on two key factors: whether the changes require regulatory submissions and the ability to produce all necessary design change documentation quickly.

This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their devices, while still ensuring continued safe and effective performance. It provides a basic set of documentation necessary for all OTS software and a detailed discussion on additional needs and responsibilities of the manufacturer when the severity of hazards from OTS software failure increases.

This article explains why regulatory consultants who understand software can save your engineers time and help get your medical device to market faster. It also provides tips for interviewing regulatory consultants.

Learn from a real-world MedTech OS software bug and explore various debugging techniques that can help you navigate through software issues and find solutions effectively.

The IEC 62304 standard requires medical device manufacturers describes their software’s structure and identify the software items, but how granular should your items be?

What is traceability? How does Notion help you handle it? How does Notion's flexibility empower medical device startups in ways that eQMS vendors can't.

This video explains why code reviews are essential for growing a 10x software engineering team and how to do code reviews well.

An example Socratic dialogue exploring various definitions of software maintenance and construction, agile, and the validity of the building/software analogy.

This FDA draft guidance document provides recommendations for the documentation that should be included in premarket submissions for device software functions. Innolitics has transcribed the draft guidance for easy access and use by clients. If you're overwhelmed by cybersecurity requirements for your SaMD, we can help with turn-key engineering solutions and regulatory consulting services.

This article explains why code reviews are essential for growing a 10x software engineering team. The first part of the article is theoretical, while the remainder uses this theory to make practical suggestions about using GitHub pull requests for code reviews.

We describe the SKUASH debugging methodology for medical device software defect investigation and documentation. We’ve used this method for several years on client projects, including an industry leading medical-device company with hundreds of installations around the world.

Completing a web form requires an investment of time and energy by the user. An accidental navigation can destroy this investment. This article implements a simple yet robust confirmation that is displayed before a destructive navigation occurs.

Should your medical application be built for the cloud, native, or a hybrid approach? In this article, we compare six deployment strategies and how each relates to HIPAA compliance.

This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their devices, while still ensuring continued safe and effective performance. It provides a basic set of documentation necessary for all OTS software and a detailed discussion on additional needs and responsibilities of the manufacturer when the severity of hazards from OTS software failure increases.

Make has been used extensively for forty years and offers incremental builds, parallelization, and a declarative syntax. In this post we’ll take a look at how the .DELETE_ON_ERROR special target helps eliminate possible downstream problems in your makefiles. You’ll also come to understand why most makefiles should include it.

Deep-learning models are ideal candidates for building image classification systems. In this article, we demonstrate how to leverage Keras and pre-trained image recognition models to create an image classifier that identifies different Simpsons characters.

Many medical applications run within a closed network. This arrangement can make investigating software bugs more difficult because the only readily available information is an (often vague and incomplete) recounting of the problem, a zip file filled with system and application logfiles, and the application source code.

Refactoring a codebase means changing its internal structure without altering its observable behaviour. Refactoring is an essential tool for keeping an evolving codebase maintainable. This article is a commentary on a book chapter about refactoring code—Chapter 24 of Code Complete.

In this article, we explore how to extend async JavaScript functions using a functional design pattern—the decorator.

In this post, we provide a set of exercises that should help you solidify your knowledge of BASH. Note that these are NOT introductory level questions, and they assume that you are starting with a working knowledge of Linux and BASH.

Poor code quality can be an extremely expensive problem to fix. This article describes what code quality is, why its important, and how to handle issues related to it.

Developers often don’t think about database connection pools until they are having connection problems. This article explains the purpose of connection pools, how they work, and how to tune them, while remaining agnostic to a particular implementation. It also discusses other types of object pools.

Picking the right programming language for a project can be an important business decision, and making the wrong choice is usually expensive. After reading this, you should have enough background to have an informed conversation with your development team.