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.
Specialty Coating Systems (SCS) offers a variety medical coatings and technologies to support a range of medical device applications, including elastomeric seals, forming mandrels, pacemaker components, and stents. The biocompatible, biostable SCS Parylene coatings provide excellent moisture, and chemical dielectric barrier protection. These coatings also feature a low coefficient of friction for applications where lubricity is important.
Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.
SCHOTT Electronic Packaging and Primoceler Oy have joined forces to expand current hermetic packaging portfolios with pioneering glass micro bonding technology. This process enables the manufacture of vacuum-tight, ultra-miniature electronic and optical devices with superior reliability. This bonding method is based on laser technology and can be completed without any heat or added materials.
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.
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.
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.
Dassault Systemes Americas provides a scientific collaborative environment for advanced biological, chemical and materials experiences that help science- and process-driven companies develop better products faster and more cost effectively in regulated and non-regulated environments.
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.
