Industry Perspectives - Design & Development

11. Secure By Design And Default: Compliant Medical Device Development 1/8/2024

    The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA. 

12. The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA 12/21/2023

    The U.S. FDA, Health Canada (HC), and the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) have come together and identified 10 guiding principles, with the aim of developing good machine learning practices (GMLP) that will address the unique nature of AI/ML-driven medical devices.

13. How To Operate In The AI Compliance Vacuum 12/19/2023

    The rapid incorporation of AI into healthcare systems raises significant legal compliance concerns, particularly for technology developers, medtech companies, and users. This article focuses on implications from state practice of medicine laws; the FDA’s regulation of medical devices; the HIPAA Privacy Rule; and the recently issued Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.

14. WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

15. The Secret To Medical Device Development Success: A Mindset For Continuous Learning 12/4/2023

    We all want our development teams to get better. But when will we make time to learn and improve? It's much simpler and more available than you think. You don’t need to sign up for a course or order a book. You can learn from the work you’re already doing on development teams.

16. Human Factors Considerations For Your Emergency Use Drug Delivery Device 11/27/2023

    Emergency use medical devices have seen the autoinjector EpiPen leading the way, followed by the emergence of naloxone nasal sprays and autoinjectors for the treatment of opioid overdose, and others. There are use-related challenges in emergency situations, so you will need to give careful consideration to the human factors involved with who is using the device and how it is accessed.

17. Understanding The FDA's New Medical Device Cybersecurity Guidelines 11/20/2023

    The FDA cybersecurity requirements for medical “cyber devices” went into effect on Oct. 1, 2023. The FDA has made it clear that it cannot even accept submissions that don’t contain the cybersecurity requirements. This article shares 4 steps to navigate the new requirements.

18. How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products 11/16/2023

    This article shares pro tips related to usability studies, design controls, and other human factors engineering best practices to make the FDA happy with your combination product.

19. Harnessing Connectivity In Medical Device Design 11/15/2023

    Unfortunately, putting a datalogger in a device and connecting it to a networked database is not a panacea. You’ll need to consider the trade-offs, and you'll need to make the most of your data. And if you are thinking of using AI to help, you'll need to consider that extra layer of complexity.

20. FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products 10/31/2023

    Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.