Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

Medtech Conference Season - An Outlook on Medical Device & Manufacturing Markets

Launch Team and Novatek discuss current trends in the medical device industry.Michele Nichols, President of Launch Team, Inc. and Amy Castronova, President of Novatek Communications, are teaming up again this fall to bring you the latest in product launch, technical documentation, and marketing in medical devices and industrial manufacturing. In a series of blog posts, we’ll share industry and economic trends, emerging regulatory and business challenges, and best practices for overcoming those barriers to new product launch and adoption.

October marks Manufacturing Month, and at the kickoff summit in Buffalo, also home of many emerging medical device companies, speakers Gardner Carrick, VP of Strategic Initiatives at the Manufacturing Institute in DC, and Dr. Jay Walker of Niagara University, shared economic trends and barriers to growth for advanced manufacturers in this region, and throughout the US.

Two major trends that impact manufacturing were clear:

1. Manufacturers face a changing economic landscape

79.5% of US manufacturers name regulations as a top challenge to growth

The top challenge named by US manufacturers is an unfavorable business climate, namely taxes and regulations. As regulations increase, manufacturers will continue to struggle to meet the documentation and reporting requirements.

While manufacturing growth stalled in August, the Purchasing Managers Index rebounded in September. Despite the strengthening US dollar, making US goods more expensive to purchase overseas, many companies will be moving their manufacturing back to the US. Why? The single biggest change is that “natural gas has changed manufacturing in the US.” Our energy costs are now 1/3 the energy costs of China.

Experts expect that onshoring will exacerbate our existing skilled workforce gap. Currently 82% of manufacturers cannot find the skilled workers they need.

2. Workforce training will be critical to growth

In 2015-2025, an estimated 2 million jobs are expected to go unfilled

In many of the trades critical to advanced manufacturing, a mass exodus is expected as Baby Boomers retire. Apprenticeship programs can help, as can ‘ambassador’ programs aimed to educate junior high and high school-aged kids about manufacturing career paths, increasing companies’ workforce pipeline. STEP Ahead, which promotes Women in Manufacturing, looks to increase the total population of people choosing manufacturing as a career path by increasing interest among young women.


Both of these major industry trends will impact your work: increased regulation increases the need for documentation of quality systems, standard operating procedures (SOPs), and manufacturing processes to meet FDA, ISO, and other regulations.

Workforce skill gaps will put a greater strain on training and documentation managers, as it will become increasingly critical to capture and transfer expert knowledge and quickly ramp up new hires.

Novatek works with medical device and industrial manufacturers to create training and documentation that can provide these workers with the information they need, including:

-       Product training

-       New hire training

-       Standard operating procedures

-       Quick reference guides and other job aids

Novatek’s expertise in documentation required for FDA and ISO regulated industries can also help you overcome the burden of increasing regulation.

Watch for next week’s post to learn more about trends impacting the medical device industry, as we share key learnings from the MedTech conference.

For more on the manufacturing economic forecast, and how to compete and win in 2015 and 2016, click here.

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Topics: trends