Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development.
This article is the first in a series drawing on highlights from the LATAM Medtech Leaders podcast, with guests imparting advice on topics like commercialization strategy in Latin American markets, pricing, and more.
The United Kingdom’s plan to leave the European Union now has PM Boris Johnson at the helm and (seemingly) a hard deadline of Oct. 31, 2019. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Aug. 1, 2019.
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
REVOX has put together a team comprising engineers, chemists, microbiologists, project managers, business consultants, and quality and regulatory professionals that are subject matter experts with strong expertise and experience in their fields. REVOX can work to enable sterilization technology to work to its fullest potential for medical devices. The company offers rapid 30-day sterilization development, materials and microbiological laboratory testing, supply chain optimization services, and regulatory development expertise.
The new FLIR Research Studio is a powerful, yet simple to use software for analyzing how thermal imagery changes over time. Designed to work the way you work, the software makes thermal analysis faster, more convenient, and enables better teamwork. Whether a Windows, MacOS or Linux user, Research Studio provides customers with an easy way to quickly and efficiently display, record, and analyze accurate thermal data on their machine in any one of the available 22 languages.
PRISYM 360 is the ONLY labeling solution dedicated to Medical Device and Life Sciences. PRISYM 360 provides organizations with complete label integrity to meet the strictest compliance requirements for FDA and EU regulations.
By focusing on the data, rather than the label/artwork, PRISYM 360 provides a revolutionary 360° outlook of your master data assets and gives the ability to control and optimize them to create a fully integrated approach across the full label lifecycle.
Due to the information being data driven, it lets you to find out where content sits quickly and easily, allowing you to deal with mass change. This feature has annually saved customers multi- million dollars on global label change, while reducing the risk of the label carrying old data or using the wrong version.
SIMULIA’s solutions for medical device development provides a framework for engineering teams to integrate the tools they use into re-usable, deployable processes. This reduces time-consuming and error prone tasks to improve productivity and consistency, while enabling design exploration studies to find better designs and democratization to expand the user-base for simulation. Lastly, capturing these processes in the 3DEXPERIENCE® platform provides the traceability organizations need when making critical business decisions.
SCHOTT Lighting and Imaging delivers medical light sources to help redefine the boundaries of medical innovation, and provide deeper insights in helping medical experts see more of what is relevant to their diagnoses and therapies.
Whether you need a few pieces or a few thousand, Donatelle's highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of their integrated services, they work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on their expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.
We were among the first to work in the arena of minimally invasive techniques for revolutionary procedures such as neuromodulation. Our PEEK drawn fiber offers a non-metallic replacement for stainless steel. And when a major aircraft manufacturer needed an immediate design change on a harness assembly, Zeus delivered in record time.
Flexan is dedicated to producing medical-grade silicone components for Class II and Class III medical devices. In fact, custom silicone moldings are the only products we manufacture and health care is the only industry we serve. That singular focus allows us to provide the highly customized components that medical device manufacturers depend upon for patient safety, efficacy and reliability.
What is our readers’ greatest shared concern? Demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Learn more in this free collection of articles highlighting how regulatory confusion can be time-consuming, costly, and damaging to your brand.
