Industry Perspectives - Design & Development

41. 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.

42. 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.

43. 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.

44. 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.

45. 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.

46. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2 10/27/2023

    This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

47. The Positive Impact Of The Voluntary U.S. Cyber Trust Mark On IoMT Devices 10/17/2023

    The recently proposed U.S. Cyber Trust Mark is a voluntary cybersecurity labeling program operated by the FCC. It will initially provide IoT manufacturers with a certification label that signifies their compliance with cybersecurity guidelines and best practices.

48. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1 10/6/2023

    All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a 3-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

49. A Risk-Based Approach To Assess Particulate Generation For Cardiovascular Devices 10/3/2023

    The therapeutic and/or diagnostic uses of cardiovascular devices are broad, and the total length of time that a device remains within the cardiovascular system can range from minutes to the patient’s lifetime. This article examines risk evaluation of particulate matter generated by a device and introduced into the circulatory system.

50. Two Key Security Precautions To Protect Your Device — And Your Patients 9/25/2023

    A physically secure device doesn't ensure data security, just as shoring up data connectivity vulnerabilities doesn't preclude bad actors from physically damaging a device. But, a vulnerability assessment and penetration test can greatly improve your understanding of how safe a device is from a cybersecurity standpoint.