Medical Device Design & Development

INDUSTRY PERSPECTIVES

5 Steps To Eliminate Weak Links In Your Data Governance

Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.

FDA Vs. Congress: The Software Showdown

September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016. 

You Have A Medical Device Proof Of Concept. Now What?

No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.

3 Steps For A Smarter Medtech Supply Chain

Our medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.

WHITE PAPERS & CASE STUDIES

  • Digital Transformation In Production Planning And Scheduling

    Planning systems for manufacturers are valuable communication and coordination vehicles for breaking down interdepartmental barriers. Learn about improving your planning systems, "smart" manufacturing, production, enterprise resource planning, and more.

Back To Basics: Breaking Down The Fundamentals Of Filters

Regardless of the technology behind the filter, there are several key concepts that all filters share. Our new ebook provides a wealth of detailed fundamental filter information with the goal of helping customers simplify their future filtering decisions.

CytexOrtho Advances Implant To Clinical Trials With Textile Design And Contract Manufacturing Solutions

After CytexOrtho developed a new implant to restore joints in young patients with early joint disease, they needed the support of an experienced, quality-driven CMO for the production of the implant, which required a highly specialized 3D-printing process, along with packaging and sterilization management.

Embolization In The Treatment of Aneurysms

Coil embolization is a treatment for both aortic and cerebral aneurysms that fills the aneurysm with a coil-like material to close off the aneurysm sac and reduce the risk of bleeding or rupture.

Medical Device Design: The Benefits Of Partnering Early With An Expert Textile Supplier

Ideally, device engineers should partner with a textile component supplier as soon as possible during the earliest stages of product development. But how can a device manufacturer pinpoint the right textile partner?

DESIGN COMPONENTS & SERVICES

The OEM Spectrometers: AS-161 Microprocessor Board is a modularly designed electronics board with a 16-bit microprocessor, 2 channel 14-bit AD converter and USB/RS232-interface. The AS-161 electronics board is a part of the AvaSpec spectrometer and can control two Avabench spectrometer channels.

MicroMo Electronics, Inc. announces the addition of a metal spur zero backlash gearhead with the release of the Series 08/3

SnapQuik Series breakaway connectors are ideal for small bore applications. Their compact design delivers high-flow fluid transfer in a small profile, and their unique internal latching mechanism creates an exterior that is easy to clean and use.

The 1/4" flow PLC Series is the most popular group of couplings from Colder. Proven worldwide in thousands of applications, the PLC line offers the widest selection of sizes and configurations. PLC couplings are injection molded from acetal thermoplastic and are durable and resistant to most mild chemical solutions.

The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from their place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive, and traceable data. They offer in-depth feasibility studies, test method development, and test equipment to bring the supreme level of quality to high-value medical device applications. PTI’s inspection solutions are unique in their performance, reliability, and use of sensory technology.

ColOSSIS™ from DSM Biomedical is an injectable, settable, drillable putty designed for remodeling bones. It offers improved handling in preparation and delivery and can be mixed with saline, blood, and bone marrow aspirate, allowing for an affordable, fast-remodeling, settable, and drillable biomimetic solution to fracture repair.

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