The welding of plastics using laser technology enables the rapid, clean result medical device manufacturers want. However, when welding clear or translucent plastics, additives must be used in order for the bond to occur. That is, until now. New laser technology enables these types of plastics to be welded without any additives being used.
Rapid prototyping must accurately portray what a completed design will entail, and how a completed design will function. The product may even need to mirror injection molded parts. Enter cast urethanes. This article highlights the benefits of using this technology for prototype parts as well as short run productions.
While options may be limited overall, selecting the right package testing laboratory can still be critical for a medical device manufacturer to ensure a timely and on-budget product launch. Therefore, keeping the following five considerations in mind when going through the selection process can make a significant impact on a company’s success.
Micro molding can provide an excellent alternative for designing and manufacturing medical devices used in minimally invasive surgery. Micro manufacturing processes overcome the limitations of established technologies, facilitating smaller components, incorporating complex features, reducing the number of components, eliminating outdated processes, reducing manufacturing costs, and increasing production yields.
Medical device product development teams are often asked to develop new features for new devices or updated generations of existing devices. Often, due to cost or resource restrictions, a decision needs to be made between including one feature versus another.
Today’s medical staffs increasingly rely upon wireless networks and devices to conduct critical-care applications, access electronic medical records and test results, and to share information throughout facilities. At the same time, Wi-Fi networks in healthcare facilities are being pushed to the limits by the Bring Your Own Device (BYOD) trend among patients and guests.
The FDA and Department of Homeland Security recently issued an alert urging medical device makers and medical facilities to upgrade security protections to protect against potential cyber threats. This came in response to an ICS-CERT publication of a list of more than 300 devices with hard coded passwords.
Acquiring equipment through leasing and other financing methods is more flexible and customizable to meet unique business needs than most funding options. This makes medical equipment finance a perfect fit, especially for start-up and small businesses, which may have trouble getting traditional bank loans.
Since June 2009, all drug listing submissions have been done electronically using Structured Product Labeling (SPL) files. Now, devices can be listed using SPL as well. While the FDA does not require that devices be listed using SPL, the ability to do is there, with benefits including providing product exposure on sites such as the National of Library of Medicine’s (NLM) DailyMed.
While regulators are understandably focused on compliance, industry needs to focus on quality. The terms are often used interchangeably, but there’s a big difference between quality and compliance. Think of quality as the processes, procedures, and culture that permeate an organization—enabling it to consistently develop and produce high-quality medical device products that will meet or exceed regulatory requirements.
The IEC has made a change to the Recovery Test, 60601-2-34. Issue 3 offers modifications that make it more beneficial for engineers as a custom test system is no longer required for this specific test. This article reviews the full breadth of the test and how it can impact medical device manufacturers.
As flexible manufacturing becomes a more attractive option to medical device manufacturers, ensuring that the processes involved with it all work in sync is critical. With leak testing in this system, there are a number of factors that need to be considered. This article reviews the areas that engineers need to keep in mind when adapting to this option.
Medical device engineers rely on an array of testing instruments and equipment to verify the safety and efficacy of their products. An axial-torsion testing system is just one of them; however, it has a variety of indications across various device sectors. This article looks at two products for which this testing instrument is invaluable.
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.