As medical devices are increasingly connected to central systems within hospitals, numerous cybersecurity challenges have emerged for medtech manufacturers. For example, networked medical devices need to be secured from risks, including hacking and malware. The FDA, as a part of its Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, recommends that manufacturers […]
Medical Grade Qualification Class VI Regulatory Requirements Biocompatibility Defined ISO 10993 Testing Test Strategy Determination Sample Preparation Test Category Descriptions & Assays Case Study Conclusion
For smaller CV device companies seeking to launch or expand their clinical research programs, this paper reviews seven areas of focus for the safest and most expedient path to market. This paper, from clinical research organization Novella Clinical, addresses key factors for smaller device companies to consider when bringing a cardiovascular product to market.
The continuing growth of Point-of-Care (POC) In Vitro Diagnostic (IVD) testing is supported by technology improvements and the recognition that rapid test results offer economic benefits. The integration of frangible seal reagent blisters into various technology platforms holds promise for more precise and reproducible results compared to currently accepted methods – an important consideration for […]
How technology companies can manage the risks of wearables to reap the rewards At one time, people scoffed at the idea of a personal computer in every home. Today, we not only have high-speed Internet available in our homes, but we also connect to the Internet at will with a variety of mobile devices from […]
Many design engineers express interesting, but incorrect, perspectives relating to Micromolded parts. Because Micromolding is an emerging technology with a shortage of accurate information in existence, this information vacuum creates fertile ground for myths and misconceptions. Most myths relate to the designers’ prior experience with “normal” or sometimes called, “macro” injection molding.
Brace yourself for another year of opportunities and challenges in the medical device industry. For 2014, we predicted that longer life expectancies, emerging markets, increased regulatory scrutiny and health care reform would drive industry change. As we move into 2015, we see many of those trends continuing to evolve, and some exciting new trends emerging. […]
Speed to market is everything when it comes to development of medical components and devices. This ebook examines various rapid manufacturing options available to today’s medical design engineers and product developers. From 3D printing to injection molding, explore the strengths and weaknesses of each process as well as material options best suited for your particular […]
The medical device business landscape is changing rapidly in response to a wide range of socioeconomic and government pressures. As the U.S. population continues to age, by 2030 20% of U.S. residents will be over 65, compared with 13% in 2010 and 9.8% in 1970, the demand for better and more cost-effective medical care is […]
This paper looks at key issues and costs drivers in this equation and the industry-driven systems that can help minimize the additional costs associated with the necessary due diligence. It also looks at the choices SigmaTron International, a publicly-traded U.S. EMS provider, has made in developing a compliance system that meets both its needs and […]
Product design and development is a journey with unexpected twists and turns. People often ask, “how can I make my design process more predictable?” In our 25 years of experience designing medical devices, we’ve found that you can’t always predict all the twists, but there are things that can be done to increase the certainty […]