Welcome to the Nerac Strategist, a publication dedicated to providing relevant, up-to-the-minute, and in-depth business perspective on rapidly developing industries, along with guidance on how to meet resulting challenges and opportunities with success.
Nerac’s analyst team of subject matter experts, scientists, and engineers deliver timely, leading-edge, cohesive custom research, analysis, and advisory services essential to strategic planning for protecting and growing business. They collaborate with industry leaders to drive product innovation through comprehensive assessments of technology development opportunities, competitive landscaping, intellectual property strategies, regulatory compliance requirements, and more. Further, Nerac’s Medical Device Practice Group is highly specialized in regulatory affairs and quality assurance solutions that span all domestic and global markets.
In these articles Nerac analysts explore the latest and greatest in valuable executive strategies across all industries and regulatory compliance challenges faced by the medical technology regulatory industries. Also access all Nerac analyst authored articles, white papers, webcasts, case studies and more by clicking the links to the right under Nerac Insights. And don’t forget to sign up to receive this valuable content direct to your in-box.
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Robert Zott, Director of Advisory Services Development
The New Post-Market Surveillance Regulations for Europe, Part 1: What to Know and Where to Go
By Robert Zott, Director of Advisory Services Development
At the time of this writing, there is 1 year, 8 months, and 18 days—that’s 626 days or 15,024 hours—before the new European Medical Device Regulation (MDR) will become the law of the land. For those affected by the tighter scrutiny of high-risk devices, changes in classification or the technical challenges of unique device identification, layers of complexity will be added in the name of safety to an already-burdensome process. But the one subject on the minds and hopefully the agendas of nearly every quality and regulatory professional is the codification of requirements for Post-Market Surveillance (PMS): the system, plans and reports that proactively collect and review experience from devices in the field. It is your eyes and ears, monitoring for signs that immediate corrective or preventive actions must be taken, and it is without question the most critical feedback mechanism in all of medical device regulation.
This article (part 1 of a 3-part series) takes a closer look at the requirements for the PMS system. Read the article here.
Rosemarie Szostak, Ph.D.
UNTETHERING ELECTRONICS: Disruptive Power Technologies
By Rosemarie Szostak, Ph.D., Nerac Analyst
Running out of battery power in a cell phone is annoying. For a medical device, it can be life-threatening!
Technology has come a long way since the 1890s when Nikola Tesla first envisioned a wireless power transmission system. Twenty years ago, WiFi was first introduced to transmit voice and data wirelessly to consumers and the consumer market never looked back. Will recharging electronics wirelessly become as ubiquitous? A handful of start-up companies are working to do just that.
This report summarizes the state of the art in through-air distance wireless power, and the impact of these disruptive technologies on the market. Read the article here.
Skye McClain, Ph.D.
How a Prior Art Search Will Actually Save Your Company Money
By Skye McClain, Ph.D., Nerac Analyst
One of the main hurdles an invention must clear before becoming a patent is that it must prove to be unique. If the concept for an invention has been published anywhere in the world prior to patent filing, it will preclude that invention from being granted a patent.
This article explores how to determine if there is any “prior art” out there which will prevent your company’s invention idea from being patentable, and how this can save you time and money! Read the article here.
Robert Zott, Director of Advisory Services Development
Mastering the Basics: A Primer on 510(k) Submissions
By Robert Zott, Director of Advisory Services Development
If you mention a “401(k),” everyone knows you’re talking about a retirement savings plan. But few people know that the name refers to the U.S. Code of Federal Regulations (CFR), Title 26, Subtitle A, Chapter 1, Subchapter D, Part I, Subpart A, Section 401(k) of the laws governing the Internal Revenue Service.… And if you work with medical devices, chances are the same is true of a “510(k).” Everyone knows the name, but few people know that it refers to Section 510(k) of the Federal Food, Drug, and Cosmetic Act of 1938, which authorized the US Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
This article takes a closer look at 510(k) submissions for FDA clearance. Read the article here.
Kevin Closson, M.S., MBA, Nerac Analyst
Using Competitive Intelligence for Advantage in the Aerospace and Automotive Industries
By Kevin Closson, M.S., MBA, Nerac Analyst
Competitive intelligence (CI) is useful no matter the industry, but it is absolutely critical in the aerospace and automotive sectors. More than that, simply having a competitive intelligence program of some sort isn’t enough. If you are in the aerospace or automotive businesses, competitive intelligence can give you a distinct competitive edge. This article shows you how. Access this article here.
Mary Becher, Nerac Analyst
Established and Emerging Applications of 3D Printing in the Medical Field
By Mary Becher, Nerac Analyst
Three dimensional printing (3D printing), also known as additive manufacturing (AM) has revolutionized industries across the manufacturing world for over 30 years, and 3D printing technology has exploded in the last decade. There are endless applications of additive manufacturing and although there are numerous market areas this intriguing technology is capturing, the most innovative industry is in the medical field.
This article explores current applications of 3D printing in the medical arena as well as what’s out on the horizon. Read the article here.
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