In Part 1 , we discussed why not to procrastinate in your packaging design. The next step to protect your device and get it approved is to have a packaging expert take a look. Experts in ISO11607 can ensure that the material and design will meet or exceed your needs—and increase validation confidence. These are the […]
Part 1: It’s Only Packaging: What Could Possibly Go Wrong?
May 4, 2022 by
No medical device startup will hear any argument from us that the development of your device is Job One—as it should be. It is what drives you and your team, and if it goes well, that device could provide new care for the patients you’re trying to reach, while elevating your corporate and individual roles […]
Project Management during the Great Resignation
March 7, 2022 by
People are leaving companies for many reasons: Better pay, a position where they get more perks, better benefits, better prestige. They could also be looking to escape any number of issues with their role, coworkers or even the culture of the company with which they do not align. We are going to look at three […]
3 Package Testing Methods to Ensure the Quality of your Product
February 17, 2022 by
There are many ways to test your package or pouch for imperfections. Each method provides a unique output and can help identify crucial data for improving your finished package. We asked our Project Engineering Manager, Brian Nissen, to highlight 3 testing methods commonly used for medical device packaging. 1) Tensile Testing Tensile testing is used […]
Medical Technology International Business Opportunities
February 8, 2022 by
Trade Mission to the UK and Finland In November 2021, I had the honor to represent the MDRG and the state of Minnesota on the Governor’s Trade Mission to the UK and Finland. Our mission of 70 was comprised of four tracks: Medical Technology, Environmental Technology, Food and Agriculture, and Education. MedTech Track The Medical […]
Consider Cybersecurity Early When Developing Your Medical Device Design
January 24, 2022 by
Three Important Questions to Ask: Will this Medical Device be connected to a network? How would a breach of this Medical Device affect patient safety along with corporate negative publicity? What role will labeling play in the overall security of this Medical Device? The answers to these questions should be well-thought out, reviewed, and have […]
How to Maximize Customer Value by Implementing Operational Excellence within your Organization
April 26, 2021 by
Operational Excellence (OE) is all about using your tools and engaging your team every day to make improvements that maximize customer value. It focuses on individual processes to find opportunities for enhanced efficiency. Operational Excellence is not specific to any job function and can be applied to any role within an organization to drive productivity, […]
The Integrity Meeting
March 18, 2021 by
A subject came up with some members of our team about a practice we have adopted: The Integrity Meeting. In some workplaces it might be called a verbal warning. We use the term Integrity Meetings because people want to be known as having integrity. We all mean to do what we say and don’t usually […]
COVID’S impact on connected health – developing your value strategy
March 10, 2021 by
Connectivity Enables a Continuum of Value – from the device to holistic, patient-centric services. COVID-19 has changed our world in many ways. The medical device industry has been changing as well. The urgency and direction of most of the changes we see coming to medical devices were already in motion before COVID. Now, connectivity is […]
UK Conformity Assessment (UKCA) marking comes into effect
February 5, 2021 by
Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will not be transposed into law in Great Britain. In this context, it is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom, which comprises Great […]