Design and manufacturing engineers strive to develop high-quality devices in a budget-conscious and timely manner. The problem is that a variety of challenges occur in the design and assembly processes that can present functionality issues of the finished device.
In 2011, the medical device market in the US was estimated to be $105.8 billion - a market based largely upon clinical and surgical interventions administered in hospitals. However, the design and manufacture of medical devices is undergoing paradigm shifts in cost and utility, motivated largely by miniaturization, which has revolutionized consumer products.
Every medical device manufacturer accepts that in the current regulatory environment, with the Food and Drug Administration (FDA) demanding complete life cycle traceability of every product, accurate labeling is a necessity. Yet the reality is far from satisfactory: many companies have issues with label quality, not knowing what was printed, discarding pre-printed stock and needing to dispose of labeled products; whilst product recalls and field instances are endemic not due to the failure of research and development or manufacturing processes but inaccurate labeling information.
Healthcare providers should welcome the recently proposed ruling by the Food and Drug Administration (FDA), which states that medical devices distributed in the United States will be required to carry a Unique Device Identifier (UDI) as part of labeling and packaging.
Through the pre-coffee haze of your morning ritual you notice a red dot blinking on the bathroom mirror that is fogged with shower steam, “oh dear” you think “I wonder what’s wrong.” You press the illuminated mirror and a message pops up letting you know your body temperature is elevated. A menu of options appears on your mirror, and you select ‘speak to health worker.’ Welcome to the doctor’s office of 2050: your home.
As medical device companies engage in the business challenge of creating new products in a highly regulated market, two key factors slow innovation. First, companies too often rely on FDA-required compliance systems to drive innovation. These systems are focused on enabling the automated maintenance of design controls, and do not ensure creativity or good business outcomes for a business.
The globalization of design, sourcing, manufacturing, and sales of Medical Technology (Med-Tech) has created opportunities and challenges for the entire ecosystem. To assess the impact of globalization and outsourcing in the Medical Technology Industry, Axendia conducted a survey research of 125 Medical Technology Industry Executives representing 89 different companies across 16 countries. This article provides a summary of the project’s research report entitled, “Walking the Global Tightrope: Balancing the Risks and Rewards of Med-Tech Globalization.”
In today’s manufacturing environment, ergonomics and repetitive motion injuries are major issues that every business must address to insure production levels remain at expected levels and employee injuries remain as infrequent as possible. Although many of the hand assembly processes have been replaced with automated equipment over the past 20 years, there is still a surprising number of manual operations still required for many applications.
Consumers want to improve the functionality offered by sports and fitness apps through the use of sensors. A recent study conducted by IMS Research, a company recently acquired by IHS Inc. (NYSE:IHS), found that 62.3 percent of respondents with a smartphone interested in sports and fitness applications and who exercised at least once week, were prepared to purchase sensors to monitor performance and enhance the sports and fitness application on their smartphone.
Healthcare professionals and patients alike are embracing mobile medical applications for smartphones. Experts project that, by 2015, 500 million smartphone users will be using medical apps. A 2011 press release from the U.S. Food and Drug Administration indicates the FDA’s plan to regulate some smartphone medical apps, a decision that has been met by both positive and negative reviews.
How does a start-up company convince investors to help turn a bathtub idea into a warehouse full of products? That’s the question tackled by leading technology design and development firm Cambridge Consultants in a new free guide to help start-ups get their products successfully to market.
Being pro-active when it comes to mold tooling pays dividends. Even with the best of intentions, a solid maintenance program and the ability to react to mechanical breakdowns, tooling with a lot of miles on it becomes a cost and a risk to supply.
Many medical device manufacturers believe that risk has always been a cornerstone in evaluating device compliance with medical standards. The Second Edition of IEC 60601-1 covered risk management, but Third Edition is taking it up a notch – the word “risk” is included in IEC 60601-1’s Third Edition standard more than 600 times. This increased emphasis on risk is a direct result of two elements of the revised standard – the requirement to review both the risk management processes and the risk management file, and the addition of essential performance.
According to the official press release from the FCC, "Wireless devices that operate on MBAN spectrum can be used to actively monitor a patient’s health, including blood glucose and pressure monitoring, delivery of electrocardiogram readings, and even neonatal monitoring systems." Since patients are free of cables, the use of MBANs makes it easier to move patients from one part of the hospital to another for treatment. Further, from the FCC press release, "MBANs allow for ubiquitous and reliable monitoring, and give health care providers the chance to identify life-threatening problems or events before they occur."