FEATURED EDITORIAL

Get Involved In The FDA Process…Or Else!
Get Involved In The FDA Process…Or Else!

As a child and student, I was mostly an academic. I got report cards with lots of “A’s” on them, but they didn’t hand out trophies for that. I did earn two small trophies for being on the first place team in kickball tournaments (it would have been way cooler if that was dodgeball instead). I did win a “Louie” as the guitar-player in the high school jazz band. I still have the little trophy for my Louis Armstrong Jazz Award and every time I lay eyes upon it – I think to myself, what a wonderful world!

  • The Internet Of Medical Things Raises Novel Compliance Challenges
    The Internet Of Medical Things Raises Novel Compliance Challenges

    The “Internet of Medical Things” (IoMT) — the network of medical devices and applications connected to healthcare information technology (IT) systems — has led to security vulnerabilities affecting medical devices, a landscape of uncertain liability, and emerging regulations.

  • 2018 – Good For The Device Industry, Good For Patients, Good For FDA
    2018 – Good For The Device Industry, Good For Patients, Good For FDA

    I recently assembled a forward-looking article for Life Science Leader magazine, blending feedback from seven medical device industry leaders, who discussed industry trends for 2018. Here, I share the full set of responses from Maureen L. Mulvihill, co-founder, owner, and CEO at Actuated Medical, Inc.

  • Incorporating Accessibility Into Medical Device Design
    Incorporating Accessibility Into Medical Device Design

    When incorporating human factors into medical device development, conducting user testing and gathering feedback from the device’s target end users is critical. To do this properly, the end user groups must be appropriately defined.

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INDUSTRY INSIGHTS

  • Improving Health Outcomes With Personalized Apps
    Improving Health Outcomes With Personalized Apps

    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.

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. 

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SOLUTIONS

Medical Micromolding Medical Micromolding

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. 

Standard Solutions and Containers Standard Solutions and Containers

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.

Drug Delivery Device Prototyping Solutions Drug Delivery Device Prototyping Solutions

Being able to create prototype injection molded components and assemblies quickly gives product developers a critical competitive edge. 

Caplugs Custom Medical Molding Caplugs Custom Medical Molding

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.

Flexible Electronic Assemblies For Medical Ultrasound Imaging Flexible Electronic Assemblies For Medical Ultrasound Imaging

Micro Systems Technologies (MST) offers an array of highly reliable flex circuit assembly solutions for ultrasound imaging used in diverse medical diagnostic areas. From 1D to 3D and beyond, the advanced flexible electronic assemblies deliver enabling capabilities in PCB manufacturing and assembly technologies.

Medical Silicone Processes Medical Silicone Processes

FMI is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, FMI is able to ensure patient safety and 100 percent inspection of every single component before it ships.

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FEATURED SUPPLIERS

FMI, Inc. FMI, Inc.

FMI 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.

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 EVENTS

Pre-Filled Syringes Europe January 17 - 18, 2018
London)
The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown January 25, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
3rd Human Factors Engineering & Usability Studies Summit February 12 - 13, 2018
San Francisco, CA)
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response February 13, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Medical Devices Summit March 26 - 27, 2018
Boston, MA)
Pre-Filled Syringes East Coast April 11 - 12, 2018
Boston, MA)
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