FEATURED EDITORIAL

Piggy Bank Overcoming Funding Challenges For Innovative Medtech In Germany: Learnings From The NUB Process

This article explores how medtech companies should approach the reimbursement pathway for their devices when seeking to enter the German market. By understanding the strengths and challenges of Germany's NUB process, you'll have a better understanding of how to navigate it.

  • While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.

  • The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the MHRA. Discover the 10 actions you should take to prepare for the U.K. Conformity Assessment process.

  • The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.

INDUSTRY INSIGHTS

  • Why Use A Medical Grade Silicone For Your Component?

    Using medical-grade silicone offers a number of benefits for medical components, including meeting FDA regulations, superior gas permeability, excellent bonding and overmolding capabilities, as well as high flexibility and tear resistance. 

Manufacturing Process: Tools For A Successful Startup

Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts. 

Elements Of Design: Dealing With Suspect Parts

Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process. 

Helium Leak Detection Technology Solves Cold Supply Chain Challenges

Vaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.

Managing Cost And Speed — DFM Considerations For Plastic Medical Products

Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.

SOLUTIONS

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

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.

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

As the global life expectancy continues to get longer, the demand for electronic medical implantable devices is growing. Knowles offers a variety of capacitor solutions for the medical implant industry.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

FEATURED SUPPLIERS

MTD is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products. Our experienced team will consult with you to help you refine and develop your design, using the most advanced materials and micro molding technology. We’re here to help our customers it right – from design through production – so companies can produce a high quality device, and get it to market quickly.

Proto Labs, Inc., through its Firstcut and Protomold services, utilizes proprietary computing technologies and automated manufacturing systems to provide prototype parts and short-run production services. All parts are made by standard production methods, delivered at affordable prices, and can be delivered in as fast as one day.

MED DEVICE ONLINE CONTENT COLLECTIONS

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This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. Each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique.

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