Newsletter | August 6, 2022

08.06.22 -- July's Most Popular Articles & Solutions
 
Featured Editorial
Tips For Obtaining Your 510(k) FDA Clearance
 
By Rolland Carlson, Ph.D., CEO, Immunexpress

This article shares tips such as knowing when to apply for your 510(k) device clearance, mapping out an application strategy, using the presubmission process, responding to FDA rejection of your application, and more.
3 Lessons I’ve Learned: Two Decades In The Medical Device Space
 
By Meghan Scanlon, SVP and president, urology and pelvic health, Boston Scientific

Boston Scientific's SVP and president of urology and pelvic health shares her three lessons learned after working in the industry for two decades. Her takeaways have served as her guiding principles over the years and have become the core pillars of her personal and professional philosophy.
The 5 Common Medical Device Startup Challenges (And How To Overcome Them)
 
By Peggy Fasano, Boulder iQ

The medical device market is a land of both opportunity and risk for enthusiastic, innovative developers. Understanding the most common challenges device developers face, and how to successfully navigate them, can provide the competitive edge an entrepreneur needs to succeed in this environment.
Top Industry Insights
Five Considerations For Working With A Molder Early In The Product Design Phase (Dos And Don’ts)
Article | By Mike Driscoll, Carclo Technical Plastics

When developing a part or device for the medical or optic industries, the goal is always to get that part to market as quickly as possible. The key to doing just that: developing a strong relationship with a molder early in the part design process.
The Importance Of Medical Device Packaging
Article | Flexan

When designing or considering the manufacturing process for a medical device, there’s an element that often gets left until the last minute: packaging. The right packaging can reduce costs, potentially optimize the sterilization processes, and aid in the manufacturing process.
5 Characteristics To Consider When Designing An Engineered Shaft Or Delivery System
White Paper | Nordson MEDICAL

Nordson MEDICAL utilizes engineering expertise along with a software platform, SimShaft™, to balance key characteristics to optimize the performance of delivery systems. Five key features to consider will be discussed in greater detail.
Top Resources
Dassault Systèmes Engineered To Cure
Dassault Systèmes Americas
Healthcare 3PL Supply Chain Solutions Brochure
Cardinal Health, Inc.
Fiber Optics And Optical Micromolding
Accumold