Another surprising location for growth is Ontario—in particular, Toronto. The number of people directly employed in medical device manufacturing makes this Canadian center similar in size to the hot bed of medical technology—San Jose, California.
Dawn A. Lissy, president of Empirical Testing Corp., was a part of the staff written article, “It Begins and Ends with Testing.” She took time to present a full array of responses that were not able to be included in the article, so they are presented here.
In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.
In Part 1 of this blog, I’ll describe the background and approaches we at StarFish Medical took for more modern devices with a comprehensive technical file, with five top tips. In Part 2, I’ll describe how we recertified for older devices where the design documentation was less comprehensive, with seven top tips.
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.
These are exciting times in the drug delivery industry. A host of new delivery platforms is in development, some of which have recently reached the market. The primary goal of these developments is to create systems that optimize a drug’s therapeutic value, but it’s also believed that finding better ways to get a drug into a patient’s system in a safer and more consistent way will lead to better compliance and outcome.
In today’s modern electronic SMT assembly facilities, the design and flexibility of the workstation is critical to maintain quality, workflow, and ergonomics. Unlike the old, static, welded frame workstations of the past that were never moved or reconfigured, the modern workstations now incorporate a modular, flexible, adaptable design with a wide variety of options that allow tremendous flexibility.
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.”
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.