Spotlight On... FDA says drug delivery devices need human factors validation testing; Flex partners with Enable on drug delivery device development; Delayed-release aspirin company delays IPO; and more...

Several drug delivery devices are on a draft list of med tech that will be subject to a final guidance calling for the application of human factors and usability engineering to medical devices. The guidance calls called for validation testing of devices, to be collected through interviews, observation, knowledge testing, and in some cases, usability testing of a device under actual conditions of use. The drug delivery devices on the list include anesthesia machines, autoinjectors, dialysis systems, infusion pumps (including implanted ones), hemodialysis systems, insulin pumps and negative pressure wound therapy devices intended for home use. Studies have consistently shown that patients struggle to properly use drug delivery devices such as autoinjectors, which are becoming increasingly prevalent due to the rise of self-administered injectable biologics. The trend toward home healthcare is another driver of usability issues on the patient side, while professionals sometimes struggle with unclear interfaces or instructions for use. More from FierceMedicalDevices

> Enable Injections is partnering with Singapore's Flex on product development and manufacturing of wearable injector systems. More

> PLx Pharma, the developer of a clinical-stage delayed-release formulation of aspirin, postponed its IPO, which it had hoped would raise $68 million through the sale of 3.8 million shares. More

> 3M ($MMM) is launching the Scotchpak 9709 Release Liner for transdermal patches. The new product is recommended for formulations that require resistance to interactions with amines in silicone adhesives, such as those containing buprenorphine, fentanyl, methylphenidate, rivastigmine, and rotigotine. More

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