In an environment that requires ever increasing cost cutting measures, supply chain stability, and manufacturing flexibility, the contract manufacturer can be a critical partner in the financial success of a legacy device that is still enjoying profitability or in the launch of a brand new innovation that has beat the competition to market.
Welcome to the Pulse, brought to you by MDT TV. Today, we're implanting an MRI-safe spinal cord stimulator, sorting blood with a microchip, building robots out of biocompatible hydrogel, and making hydrogel move with light.
When it comes to business and manufacturing, I have to admit, I’m not always the “Rah! Rah! USA!” guy. As a consumer, I believe in getting the best product for my dollar, regardless of where it is made. My mother used to continue to buy U.S. cars because she believed in “buying American” even though each and every car she got would give her some sort of mechanical problem for a significant amount of the time that she owned it.
The highly aggressive sterilization methods used on medical devices to help combat healthcare-associated infections (HAIs) are harsh and can cause color shift. Medical devices that become discolored from sterilization can comprise patient safety and public peace of mind.
Welcome to the Pulse, brought to you by MDT TV. Today, we’re patenting new biomaterial to make artificial bones, creating pain-free prosthetics, using ultrasound waves to improve your mood, and using magnets to steer stem cells.
As a manufacturer, the UDI rule allows us to take more than 30 years of experience in the development of marking and imaging technologies to satisfy a critical need in a new market. In terms of assisting our customers in their efforts to become compliant, we now offer the MPX-90M impact printer.
The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.
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.”
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.
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.
On this episode of The Pulse, a device that helps train the brain to turn sounds into images, detecting cancer by imaging the consumption of sugar, biomedical applications for a new hydrogel, and a nanofiber mesh that treats tumors with both thermotherapy and chemotherapy.
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.
There are many “hot button” issues that are of concern to medical device companies, such as infection control, the UDI rule, or the trend toward home healthcare. Since plastics are such a huge part of the design of medical devices, the molders who work with the OEMs are doing everything they can to address these same issues to help alleviate the challenges faced by designers.
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.
The exciting growth the medical telemonitoring sector has seen recently is impressive. According to Frost & Sullivan, the industry is expected to exceed double the revenues of previous years. The reason for this growth is twofold: necessity and innovation.
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.
As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
The greatest challenge [in designing for the consumer] is recognizing the limited knowledge and abilities of a home user. There needs to be an understanding that the home patient is not a medical professional and is not exposed or practiced with the multitude of technologies the designer may have previous experience with.
On this episode of The Pulse, a major step toward an artificial pancreas, detecting disease from just one drop blood, creating mature human cardiac patches from human heart cells, and a smart sock that helps runners improve their technique and prevent injuries.