When designing a medical device, material selection can be difficult, especially with thousands of plastic material options available. While material properties, environmental effects, regulatory requirements, and cost almost always are considered, "feel" is often overlooked – despite its importance to user and patient satisfaction, as well as market success.
When outsourcing and offshoring your operations, it may seem daunting to “let things go,” but redundancy wastes time and effort. Here, we will delve into the business areas to retain and those to relinquish control of, while still maintaining the high quality expected of your products.
I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance.
An examination of warning letters issued by FDA to industry reveals trends that can help manufacturers avoid the agency’s wrath. In this column, we’ll review important sources of information on FDA enforcement activities, trends in FDA Form 483 observations, and tips to implement an effective quality management system.
Selecting the right injection molding partner is crucial for a successful project. The costs and timescales can be a significant part of a project budget.
Metallographic examination has become an indispensable tool in the testing, quality control, failure studies, and post-mortem analyses of implantable devices. This paper presents techniques and results for examination of titanium-based acetabular cups and Co-Cr-Mo femoral hip stems and knees.
Connectivity has evolved alongside the proliferation of the smartphone and the two are coming together to redefine how we manage our health. Considerations such as durability, battery life, security, user experience, and much more must be considered as you develop a connected medical solution, but the principal consideration for any smartphone is its principal purpose: Connectivity and communication.
Medical product marking and decoration is used for inventory control, process management and internal tracking, branding, and functionality. In many cases, lasers provide the preferred means of marking and identifying those products.
What is the best part about wearable technology products? You can wear them while they work! This also indicates, however, that your wearable device must be made of an appropriate material to be worn safely.
Cellnovo Group is partnering with technology company TypeZero to utilise Cellnovo’s e-connected insulin patch pump alongside its inControl AP software in an artificial pancreas program. This joint system will be in consideration for use in the International Diabetes Closed Loop Trial, which is funded by the National Institute of Health.
Becton, Dickinson and Company (BD) CEO Vincent A. Forlenza told investors recently that an ongoing partnership with Medtronic on a new insulin infusion set is on track, and unveiled the company's pipeline of new products in 2016, including a couple of new cell analyzers with faster simultaneous measurement capabilities. He also confirmed that savings from the medical device tax suspension will be re-invested into R&D.
The U.S. Food and Drug Administration (FDA) is giving original equipment manufacturers (OEMs) some additional time to remove legacy FDA labels from medical devices, citing concerns from payers and pharmacies that removing the labels prematurely would interfere with patient access. Certain medical devices manufactured before September 2018 will have until September 2021 to remove the legacy labels.
Tribogenics, the inventor of triboluminescence based X-ray technology for industrial, security and scientific applications, announced today that Nikon Americas Inc. has made a strategic investment in Tribogenics. Nikon Group’s investment will help speed the commercialization of Tribogenics’ Watson, hand-held XRF analyzer products.
Abbott has obtained CE Mark (Conformité Européenne) for the FreeStyle Libre flash glucose monitoring system indicated for children and teens with diabetes aged 4-17 years old. This means that children and young people with diabetes living in Europe are able to experience the liberation from the pain and hassle of routine finger pricks.
Edwards Lifesciences reported a strong fourth quarter performance built on increased adoption of transcatheter-based heart valve therapies, and company CEO Michael A. Mussallem believes momentum will likely continue this year as the company receives more indications for its Sapien 3 implant.
The U.S. Food and Drug Administration (FDA) has released two new draft guidances and one final guidance related to human factors in product design. One draft guidance describes the agency’s recommendations regarding human factor studies in the design of combination products; the other lists which device types should include human factors (HF) data in their premarket submissions. The final guidance focuses on applying human factors and usability engineering to medical devices.
Royal Philips is further enabling connected health by signing an agreement with Validic, a U.S.-based fast-growing company that pioneers a technology platform for connectivity and access to digital health data from clinical and remote-monitoring devices, sensors, fitness equipment, wearables and patient wellness applications.