FEATURED EDITORIAL

Industrial Metalworking 4 Steps To Kick Off Your Mold Production Project For Success

Zachi Fizik of ZF Consulting has been involved with injection molds production since the early 1990s. In the first article in this two-part article series, he'll detail the four milestones that are relevant and necessary for all mold production projects, no matter how tight your budget is or how quickly your deadline looms.

  • Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending

    Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.

  • Continuity Is The Key To Success For Your Medical Device Company

    When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.

  • The 3 Compliance Aspects For Passive Predictive Monitoring Device Success

    The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly.

INDUSTRY INSIGHTS

Micro-MIM Succeeds At Making Precise Micro Metal Parts

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.

Plan For Success With Sustaining Engineering In Medical Device Development And Manufacturing

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.

How To Uncover The Hidden Value Of Culture In Supplier Selection

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.

Taking Micromolding To the Next Level

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. 

SOLUTIONS

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.

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.

SCHOTT offers a series of high-performance glass-based diffusers designed to radiate laser light extremely homogeneously and efficiently (more than 80%) for more effective medical treatments. They are offered with various diffuser geometries, including cylindrical, front emitting, spherical, and other special shapes.

The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency. 

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.

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.

Caplugs, a global leader in protective solutions since 1948, offers extensive custom molding capabilities and a catalog of products available for same day shipment for the medical industry. With more than 1,300 medical customers, a series of ISO certifications, a Class 8 certified Clean Room and a stringent quality control process, Caplugs understands the unique challenges and needs of the medical field. Whether you need a custom molded solution or an in-stock component, our dedicated team of medical experts is available to guide you through the process.

MED DEVICE ONLINE CONTENT COLLECTIONS

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Each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.

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