FEATURED EDITORIAL

what-we-need Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise

With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

INDUSTRY INSIGHTS

  • Key Considerations For Selecting A Medical Pump

    Newcomers to medical device design may think that pressure and flow rate are sufficient parameters to consider when it comes to selecting a pump. While this may be the case in some industrial applications, medical device requirements are a bit more demanding. A thorough review of the selection criteria for a medical pump is required to ensure the correct pump is chosen for every application.

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.

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.

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.

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.

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.

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.

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

FEATURED SUPPLIERS

With more than 60 years of experience in formulation of quality aqueous cleaners, Alconox Inc. understands the cleaning needs of the medical device manufacturing industry including stringent FDA regulations and GMP compliance.

MED DEVICE ONLINE CONTENT COLLECTIONS

20_12_MDO_ProcessValidationEbook_300x200

 

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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