In reference to the UDI rule, the FDA estimates more than 1,200 companies are in need of equipment or have already implemented direct part marking into production. Of the 1,200 companies, roughly 700 are medical implant manufacturers, while the remaining 500 produce multi-use devices, such as surgical instruments.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”
Encouraging compliance is a critically important—and often overlooked—aspect of a product’s design. Compliance is relegated to a discussion between patient and caregiver, but I believe the device should play an active role. First, the user experience must be friendly.
From a test engineer’s perspective, understanding final requirements, application, and quantifiable goals for testing before a protocol or test plan is executed is crucial to the success and efficacy of a device used directly by the patient.
One recurring challenge in designing products for use directly by the patient is the difficulty in predicting long term aspects and the impact of a given medical device on a diverse group of users due to their varied characteristics and sensitivities, as most new medical technologies have limited information related to their long term results and side effects.
The biggest challenge for many medical device designers is selecting sensors that can help them optimize designs for size, cost, and complexity. A modular sensor design provides a single device that can be optimized for a variety of markets or customers, enabling a designer to select the right sensor with the appropriate functionality.
In today’s global market, lack of effective communication through the value chain is the greatest obstacle to successful home device design. To gain an advantage in the market, OEMs are continuously outsourcing component design and procurement. By doing so, OEMs increase the number of different entities involved in the value chain.
While legal enforcement dates for RoHS2 compliance is July 22, 2014, Northwire, a leading OEM, is alerting their valued customers in medical equipment manufacturing of the critical details to make certain they comply with CE-mark. Originally published in July 2011, the Recast RoHS Directive dictates that all medical devices, electrical and electronic OEMs comply with new standards.
Imagine what could happen when medical and chip experts team up. Would it be possible for chips to revolutionize healthcare in the same way they have revolutionized the electronics industry? Let’s dream: a cheap technology that allows accurate and reliable diagnostics for everyone, at any place and at any time.
As medical systems move from hospitals to homes and onto human bodies, designers need to realize their users are not professionals anymore. These new at-home users do not understand conditions that could impact measurements and the validity of measurements.
Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.
Consumer-driven user requirements for home-use devices increasingly require more than just usability, safety, and efficacy; strong insight into why the consumer needs the device is also required. From backyard sheds to universities and research groups to small and large companies alike, bright minds have no shortage of invention of medical products designed for home use.
I regularly run into manufacturing engineers and other support staff throughout Europe who do not clearly understand the basic principles of leak detection for the medical device industry. As a result, they continue to run compromised assembly lines.
Designers should look for a company that not only provides the right silicon, but also development tools, software, and support that are tailored for two main phases of a typical smartphone/tablet-based medical design. The first phase consists of the smartphone interface, and the second phase is the design of the medical device itself.
To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.