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 […]
A presentation on Combination Products, which includes the following: Combination Products Definition FDA Guidance for Industry Case Study 1 – Insulin Delivery System Case Study 2 – Antimicrobial Eluting Catheter Technical Risk Assessment Be on the lookout for the video presentation coming shortly.
In this white paper, you’ll learn whether 3D-Printing a model will be sufficient or if a part must be hard-tooled in Micromolding. The advantages of 3D-Printing as a model and prototype-making process have excited the overall product development community. It is natural that the successes experienced by those using 3D-Printing in the “Macro-world” would inspire […]
A resource for sample submissions, test descriptions, sample requirements, and turnaround times for biocompatibility testing according to: FDA/ISO 10993 MHLW-Japan USP AAMI