Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.
Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.
The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.
Critically ill patients present a number of challenges to effective monitoring. Various disease states complicate blood chemistry, compromise perfusion, and cause fluctuating blood pressure levels, heart rates, body temperatures, available oxygen, and pH. Furthermore, the pharmaceuticals used to treat these conditions can skew body chemistry and vital signs, adding to the complexity.
Glenn Smith celebrates his 40th anniversary with global distributor Mouser Electronics as the company’s president and chief executive officer. Smith recently took a moment to discuss disruptive technologies, the electronics industry’s inevitable slowing, and how some companies still inconceivably refuse to embrace the internet.
Until recently, there was one method using dye to test for seal leaks in porous medical packaging. Now there are three methods manufacturers can select from for their product’s packaging. Which one should be used and why? This article attempts to tackle that question.
Cellular machine-to-machine communications are opening the door to a world of innovative new healthcare applications. With the ability to collect real-time data from people and devices anywhere, and at any time, healthcare organizations and technology vendors are creating useful applications that improve people’s health and well being.
There are many “hot button” issues that are of concern to medical device companies, such as infection control, the UDI rule, or the trend toward home healthcare. Since plastics are such a huge part of the design of medical devices, the molders who work with the OEMs are doing everything they can to address these same issues to help alleviate the challenges faced by designers.
Warehousing products can be a costly proposition for medical technology and device manufacturers. It requires leasing and management of a facility, as well as the overhead that goes along with that proposition. Using a warehousing provider can offer a more cost-effective and hassle-free way to fulfill orders.
The exciting growth the medical telemonitoring sector has seen recently is impressive. According to Frost & Sullivan, the industry is expected to exceed double the revenues of previous years. The reason for this growth is twofold: necessity and innovation.
Enabling the delivery of a drug directly to the treatment area significantly enhances effectiveness. Today, innovative new devices incorporating drug-loaded fibers into implantable textile structures have the potential to deliver this type of benefit to an array of therapeutic treatments.
As more therapies are able to indicate implantable devices for treatment, incorporating drug delivery into them can be a significant additional benefit. Even when drug delivery is the primary function, implantable devices can be preferable. This article reviews some representative applications that device designers can leverage in developing new products for the implantable drug delivery market.
As medical devices continue to get smaller in size, the assembly of the internal electronics becomes more critical. Like a puzzle, fitting all the necessary pieces together in a smaller space is no simple task. When outsourcing is involved, synergy between teams is critical. The earlier a medical device manufacturer’s design team and their contractor’s team begin working together, the better.
Selecting the best contract manufacturing partner can be a tricky process, especially for start-ups or companies new to the process. Since significant cost savings can be realized from working with a quality service provider, it is important for OEMs to identify key areas to make the process more efficient. This article outlines eight criteria to use during selection proceedings.
The Society of Women Engineers, along with the American Society of Mechanical Engineers recently honored Noha S. El-Ghobashy with the Kenneth Andrew Roe Award. El-Ghobashy is an inspiring humanitarian working tirelessly to bring opportunities and advancement to underdeveloped nations.