While safety and efficacy are prime drivers, a med-tech product’s form and its function have a much deeper and stronger relation than one might assume.
The results of usability testing and expert reviews can be inconsistent across evaluators. How can we make these more reliable?
As with other aspects of medical device design, medical packaging has its own unique set of challenges. Taking a big step back and reconsidering our assumptions can help us make the kind of impact necessary to ensure our future.
Whether you are designing an autonomous surgical robot, a patient-specific knee implant, or a paperweight for all the new regulations, volumes of data are useless without the proper specification framework to filter and process it.
Aging has important implications on design, the most significant of which puts emphasis on graphic and product user interfaces.
Ideation sessions can provide an effective platform for creating novel and innovative ideas. With so much material and so many ideation methods available, however, one of the biggest challenges is selecting the most appropriate ideation method. How do you go about selecting a method to ensure you are addressing a problem in the most effective way?
Viewing product development from purely a calendar perspective will limit the real view of success.
While an apple a day may not always keep the doctor away, a wireless patient monitor just might.
Integrating industrial design results in relevant and prioritized function, form, and features—whether in designing a suitable human interface, creating a consistent brand language, or ensuring that products are safe and effective.
Distribution and installation are extremely important processes that ensure approved, safe, and effective medical devices make it into the hands of healthcare practitioners. In this edition of Devine Guidance (DG), Dr. D continues with his guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically 820.160 (Distribution) and 820.170 (Installation).