As a packaging professional in the healthcare industry, it’s important to understand the basics of adhesive coatings, including why they’re important, and their impact on packaging materials. A better understanding of adhesive coatings will help you design and troubleshoot your sterile barrier system. Pouches (Coated vs. Uncoated) There are tradeoffs when using coated and uncoated materials […]
Why conduct formative evaluations?
May 8, 2023 by
We interact with interfaces all the time: our smartphones, the gas pump, online bank accounts. And we all experience times when these daily interactions are confusing, inefficient, or just plain frustrating. But when we’re using medical devices, these interactions can turn into an expense or even a dangerous situation. Consider the following three imagined but […]
Vendor selection: How does a small medical device company select their vendor(s)?
February 28, 2023 by
The Problem: Medical Device start-ups in general, and small business executives in particular have many competing priorities for their time and resources and selecting the “best” vendor for the components and assembly of a Medical Device system can be very time consuming. It is always a consequential effort in which few are experienced. Hiring a […]
Watch: Current Realities Reshaping Global Supply Chains for US Medical Device Companies
July 21, 2020 by
Watch a moderated discussion with former Congressman Erik Paulsen regarding the new tensions surrounding the supply chain issues impacted by COVID-19 and how the US government is responding. The global pandemic has revealed an interest to address U.S. healthcare’s reliance on non-domestic suppliers. The risks of this over-reliance came into sharp focus during the build-up of the COVID-19 […]
Shelf Boxes: Three Best Practices & Tips
May 8, 2020 by
Written by Brian Nissen, CPP Shelf boxes are an integral and functional component of Medical Device Packaging. It is very important to consider the protection they provide, the ease of use as well as the esthetic appearance of the product. There are many techniques on how to best protect your device and its packaging while maintaining […]
COVID-19 Continues to Impact Medical Device Manufacturing in China
April 20, 2020 by
Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. We can see that in China alone, many medical device companies have manufacturing sites, utilize contract manufacturing sites, and get medical device components. The disruption in this supply chain will impact device companies and can […]
Project in chaos? Don’t Panic!
March 18, 2020 by
Project chaos / crises can be caused by several factors, from a complete breakdown of direction, a lack of performance on key activities, or even misguided leadership. Sometimes it’s outside factors that throw everything into disarray. This last cause may be relevant to our current work environments. There are four key elements of rescuing a project […]
Great opportunities for U.S. Medical Device Companies Abroad
February 25, 2020 by
The U.S. produces the most medical devices, and also consumes the most medical devices in the world. U.S. medical device companies are well positioned and are highly regarded globally for their innovations and high-technology products. Why Expand your Exports • Access to new markets has never been easier • Demand, 70% of purchasing power is outside the […]
Does your person responsible for regulatory compliance meet the required criteria?”
January 16, 2020 by
Article 15 of both the Medical Device Regulations and the In Vitro Medical Device (IVD) Regulations have requirements for appointing a ‘person responsible for regulatory compliance’ (PRRC). Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one PRRC. The Medical Device Coordination Group has recently endorsed and made available guidance on this topic. It should be noted […]
DFU Extended
November 18, 2019 by
Most people have heard the product development term “DFX”, where the “DF” stands for “Design For” and the “X” stands for just about everything, most commonly “M” (Manufacturability), “A” (Assembly), “S” (Serviceability), etc. In this way of thinking, a product designer considers all the processes a device will encounter during its entire lifecycle and adds […]