The Myths and Facts of Manufacturing in Mexico

Deciding on the appropriate region for your manufacturing operations is a vital step.  Many US manufacturers consider Mexico when deciding on plant locations because of its proximity to US markets, access to resources and skilled labor, as well as the favorable trade agreements. But is Mexico the best decision for your organization?

To help manufacturers make an informed decision American Industries developed the eBook below which outlines the benefits, issues, myths and facts about manufacturing in Mexico.

Download the eBook below to gather the information you need to make an informed decision on whether Mexican manufacturing is the right decision for you.

Manufacturing in Mexico

Optimize Your Lean! Marry 5S Programs, Kanban Systems and Kamishibai

You may be familiar with how 5S Programs, Kanban Systems and Kaizan Events help drive your lean manufacturing processes, but how familiar are you with the Art of Kamishibai?

Once standardized work has been developed and documented, how does your company ensure that it’s sustained?  This is where kamishibai comes in.

Check out the infographic below, courtesy of Phase 2 Medical, to understand how kamishibai is implemented and how it can enhance your lean manufacturing efforts.

The Art of Kamishibai in Medical Device Manufacturingphase2medical (1)

Interested in finding out more? Contact Phase 2 Medical for more information.

If you are attending the American Medical Device Summit in Chicago this October, don’t forget to stop by Booth #30 to say hello to Phase 2 Medical in person!

Big Challenges for Testing Today’s Wearable Devices

Wearable devices have become a commodity; devices act as fitness and health trackers, work and lifestyle guides as well as medical monitors.  According to The Business Insider the “global wearables market will grow at a compound annual rate of 35% over the next 5 years”.   This growth will bring a range of lifestyle enhancing and potentially life-changing accessories directly to consumers and to the healthcare industry at large.  As the market evolves, developers and manufacturers will find themselves faced with an array of functionalities and processes that need to be rigorously tested in order to ensure consumer satisfaction, safety and regulatory compliance.  Averna, a Test Engineering Leader, generated the whitepaper “High Tech, Will Travel” to outline some of the current and upcoming challenges in testing wearable devices. A brief preview is below, click on the image or link to Download the full whitepaper!


high tech, will travel

We are thrilled to have Averna join us at the upcoming American Medical Device Summit 2016! To find out more about the summit and join the discussion this October 5-6, visit:

Legal Entity Frameworks for Manufacturing in Mexico

Setting up manufacturing operations in Mexico requires an initial assessment of the appropriate legal entity framework; manufacturers have the option to work with a shelter legal entity, or work with as own legal entity.  American Industries is a group has helped more than 200 manufacturing companies successfully establish and run operations in Mexico. The eBook below has some great insights to help manufacturers asses the right framework, and make the right decision for any Mexican operations.  If you are considering manufacturing operations to Mexico, check out the Legal Entity Framework eBook!

Manufacturing in mexico

Major Test Challenges for RF Products

Automotive consumers are demanding, and are placing OEMs under increased pressure to provide enhanced value through the use of RF technologies. Remote keyless entry, CAN/VAN networking and self monitoring operations are all considered standard in automobiles newly entering the market.  For OEMs this means an increase in the composite parts and that need to be integrated into their designs as well as months of development, integration, prototyping and testing.  Ensuring the successful installation of an RF system can enhance safety, avoid recalls and ensure consumer satisfaction.

Averna specializes in test engineering and is all too familiar with the challenges that OEMs face when it comes to the effective testing of RF products. The ebook below was created by Averna to discuss some of the major challenges in RF Product testing and highlight  key strategies to overcome them.

Check it out! Download the eBook Here!

averna 1


Whitepaper: Beyond the ID, The Value of UDI

There has been a great amount of discussion around the impact that UDIs will have on medical device developers, manufacturers and the health care system at large.  The following whitepaper takes a different approach and looks at UDI implementation from a strategic perspective to assess its true value.  Check out the whitepaper below, generated by Dassault Systèmes and Axendia, to understand where the true value in this system will be expressed.  


Beyond the ID, The Value of UDI



7 Tips for Transitioning to Electronic Medical Device Reporting

In August 2015 the FDA’s Center for Devices and Radiological Health (CDRH) implemented a requirement for manufacturers and importers of medical devices to transition away from paper reporting, and to instead submit adverse event reports electronically.  The electronic transmission of adverse event reports coupled with the mandatory reporting deadlines will allow the FDA to respond more readily to adulterated, misbranded or unsafe devices.  Pilgrim Quality Solutions, created the eBook below to help manufacturers and importers transition to electronic medical device reporting.

Check out the eMDR e-book! 7 Tips for Transitioning to Electronic Medical Device Reporting


For more medical device strategies, join Pilgrim Quality Solutions at the American Medical Device Summit taking place on October 5-6 in Chicago, IL.

Struggling with finding a fully validated Requirements Management Tool?

Quality control and regulatory compliance are paramount in medical device development.  A fully validated tool can help reduce time and effort in the initial stages of product development. Finding the right Requirements Management Tool is imperative for medical device developers operating in an extremely regulated environment.

Cognition Corporation, product and process development leaders for more than fifteen years, developed the white paper below to help medical device developers navigate this terrain.

Check out the Cognition Validation Kit White Paper!

Cognition Validation Kit

eBook: Medical Device Commercialization Best Practices

The evolving regulatory landscape and the accelerated pace of medical device innovation are increasing pressure on medical device developers to speed their time to market while providing higher quality products,  at less cost.

Navigating this shifting terrain and enabling a quick time to market can often be a challenge. In this eBook, we sat down with Cognition Corporation, compliance and medical device solutions specialists, to gather their insights on the commercialization challenges that medical device developers face and the best practices to overcome them.

Check out the eBook below:


Medical Device Commercialization Best Practices



The Benefits of Test Engineering Services for the Entire Product Life Cycle


Medical device developers are under increasing pressure to develop new features and better quality products while speeding time to market. One of the ways that developers are achieving this goal is by adopting automation software that will allow them to streamline their product development and test times without sacrificing quality. Averna, a Test Engineering leader, generated the video below to highlight the benefits of automation software and explain how it can help address some of the biggest challenges that medical device developers face.  Check out the video below: