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A blog about important topics for medical device and healthcare innovators.


HFE/UE reports that only summarize HF usability validation evaluations won’t pass muster with FDA reviewers...

Last year, the Center for Drug Evaluation and Research (CDER) released the draft guidance Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. It was written with the intent to provide guidance on using packaging design and labeling to determine medical dosage strength. The guidance acknowledges that the use of colored labels can be effective in drawing the user’s attention to important information, but emphasizes that the color is more of a supplement to—rather than a replacement for—the information gained by actually reading the label. For this reason, CDER cautions that all labels must be properly evaluated to minimize the occurrence of medication errors.

Several Ximedica experts weigh in on their thoughts on the patent for Sony's SmartWig.

The US has one of the largest healthcare markets in the world, but the average hospital barely breaks even due to rising costs and shrinking revenue. Day-to-day operations are reigning in supply costs by reprocessing, renting, using generics, and streamlining purchasing in an effort to improve margins. Stricter payment regimens from federal and commercial health plans and a recessionary mindset among patients further complicates these economics creating an emerging value system never before seen...

Slides from Jeff Morang's presentation at Medical Device Summit, Boston now available for download.

Three common challenges continuously bubble up in our conversations with academic startup ventures. While these challenges can be a hindrance, keen entrepreneurs can turn the following into opportunities-here's how.

If you missed CES earlier this month you can watch Aidan Petrie and panelists discussing strategies to engage patients and providers across multiple channels online now.

There is no shortage in tech at a show like CES, and this year in particular Digital Health made a number headlines-but ever more the opportunity for health wasn’t just what one might find in that particular hall-the expo floor at-large proved to have ample opportunity and applications for the medical device industry.

Looking back on CES 2014, while Digital Health was front and center is the size of the opportunity fully understood?

Manufacturers of medication (drug or biologic)-delivery devices (i.e. combination products having a medical device constituent) are now being asked to include risk assessment and usability testing to ensure that the product packaging and labeling is effective in mitigating or reducing incidence of use-errors that could result in patient under-treatment, overdosing or otherwise receiving an incorrect treatment (i.e. dispensing of the wrong medication). The following explains key areas of HF testing impacted by DMEPA draft guidances.

Featured Posts

  • How to Prepare a Successful Human Factors Engineering and Usability Engineering (HFE/UE) Report Posted last week
    HFE/UE reports that only summarize HF usability validation evaluations won’t pass muster with FDA reviewers...
  • Incorporating Dosage Strength into Packaging Design & Labeling Requirements Posted 2 weeks ago
    Last year, the Center for Drug Evaluation and Research (CDER) released the draft guidance Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. It was written with the intent to provide guidance on using packaging design and labeling to determine medical dosage strength. The guidance acknowledges that the use of colored labels can be effective in drawing the user’s attention to important information, but emphasizes that the color is more of a supplement to—rather than a replacement for—the information gained by actually reading the label. For this reason, CDER cautions that all labels must be properly evaluated to minimize the occurrence of medication errors.
  • Technology Review #1: The Sony SmartWig Posted 2 months ago
    Several Ximedica experts weigh in on their thoughts on the patent for Sony's SmartWig.
  • Powerful Tech Trends that Will Fuel Activity in Medical Product Development Posted 7 months ago
    There is no shortage in tech at a show like CES, and this year in particular Digital Health made a number headlines-but ever more the opportunity for health wasn’t just what one might find in that particular hall-the expo floor at-large proved to have ample opportunity and applications for the medical device industry.
  • New HF Regulatory Requirements Impact Usability Validation Studies on Combo Products Posted 8 months ago
    Manufacturers of medication (drug or biologic)-delivery devices (i.e. combination products having a medical device constituent) are now being asked to include risk assessment and usability testing to ensure that the product packaging and labeling is effective in mitigating or reducing incidence of use-errors that could result in patient under-treatment, overdosing or otherwise receiving an incorrect treatment (i.e. dispensing of the wrong medication). The following explains key areas of HF testing impacted by DMEPA draft guidances.
Read More »

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Tom Varricchione

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