Medical Devices, Usability, and Human Factors: What you Need to Know
Usability is a must-have in the medical device industry. But are you perplexed about how to start incorporating usability into your development plan? Not to worry! Our three-part webinar series will walk you through the concept of usability step-by-step. Whether you are just starting out in the medical device development field or looking for ways to improve your current design process, this series is a must-watch!
The three-part series includes:
Usability: Where to Start
Industrial Design Best Practices
Human Factors FDA Requirements
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Why you should care about Usability and Human Factors
Product use errors are part of more than one third of device incidents reported to the FDA. That is why human factors studies are required for most medical device submissions. But beyond regulatory requirements, developing a device that is easy to use and developed with the user in mind will result in a device that users will enjoy working with.
If you start your development and then talk to end users, the probability of a redesign increases. If you fail summative testing, costs escalate, and timelines increase. Incorporating usability into your design plans early will lead to a better and safer product, reduced time to market, and reduce your capital burden.
"Developing Medical Device Software," New Med Device Online Article Series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device...
Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
Sterling Medical Devices designed and developed a Class III pain medication delivery system for patients with spinal injuries. The system is comprised of three devices: an implantable pump, a handheld Clinician Programmer, and a handheld Patient Therapy Controller. The pump is surgically implanted into the patient, and the two handheld devices each communicate with the pump when held within close proximity of it....
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