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.
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.
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.
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.
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.
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.
When designing a medical device that is meant to be used directly by patients in their home, the designer has to keep in mind that the environment of a patient’s home is likely going to be dramatically different compared to a medical facility.
The greatest obstacle to success in the design of a device is that, often times, the design engineer overlooks the need to keep electromagnetic interference in mind when he designs his device. When a product is not in compliance, it can be interfered with by radio waves emitting from other electronic devices in the home, causing the product to malfunction.
Will the OR of the future see robots completely replace human surgeons? While there are some ways in which robots can replace human involvement during surgery, it’s unlikely that robots will completely replace human surgeons. This is because human intuition, reasoning, and experience will continue to be invaluable.
Will the OR of the future see robots completely replace human surgeons? Robotic technologies combined with improved sensors and sophisticated intelligence will make inroads into many aspects of medical care, including surgical centers and operating rooms.
Would you please comment on the medical device industry as we move into 2013? Contract manufacturing continues to shift from just “manufacturing” to include a full road map of your finished products, including design, test, manufacturability, and distribution.
Would you please comment on the medical device industry as we move into 2013? The need for medical device manufacturers to have product recall plans in place was reaffirmed by the release of the latest figures on medical device unit recalls. According to the quarterly ExpertRECALL Index released August 22, 2012, over 123 million medical device units were recalled in the second quarter of 2012...
The next evolution is the focus on the supply chain and ensuring the detailed processes are in place and that products/processes provided by downstream suppliers are validated and real. With globalization as the post facto now, it will require more stringent supplier controls from the initial selection of suppliers through the monitoring phases. How will suppliers select and monitor their supplier base?
As external industry influences like excise taxes, longer approval process time, and reimbursement pressures bear down on device manufacturers, development partners must look to areas of opportunity and how to best support medical firms in these pursuits. While opportunities such as the growing and aging population and emerging markets are getting a lot of play, it’s also important to realize that progress (i.e., technological advances) poses perhaps the most significant area of opportunity in transforming healthcare.
As medical devices migrate from the hospital to the patient’s home or workplace, two concepts will become increasingly important: manageability and security. Remote medical devices must often provide continuous care, regardless of their location. Consequently, IT teams will need to manage and control the devices remotely...