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Nerac Strategist

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.
 

Sign up for the Nerac Strategist here

 


Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Press Release: Nerac Expands Innovation Practice Group

By Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Nerac is pleased to announce that Robert M. Beinstein, P.E., ENV SP, has joined our Innovation Insights and Consulting Practice as Director, Sustainability Innovation.

Read the full press release here.


Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Can Capitalism Thrive While It Saves Humanity? Finding the Economic Prize in the UN’s Sustainable Development Goals

By Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

In an emerging future world with competing interests and at times conflicting choices, choosing a path forward is challenging at best. Climate change is obviously a real threat, but so is scarcity of water supply, and threats to biodiversity and economic well-being rank high. Hunger is increasing but known solutions may worsen other crises. On long time scales, poverty is receding, but that doesn’t mitigate the crushing burden on many of the world’s most vulnerable. So, what’s a company to do? While money may not be the ideal yardstick for measuring societal progress, following the money can be highly valuable to executives steering their firms through these tumultuous times..

Read the article here.


Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

Serendipity, Science, and Systems – A Path to Business Growth and Social Impact

By Robert M. Beinstein, P.E., ENV SP, Director, Sustainability Innovation

How might serendipity drive progress on some of the globe’s most intractable problems? Can chance, informed by sagacity, combine with deep innovation and cross-sector systems approaches to create as yet unknown opportunities for large corporations? Can these companies leverage that combination to accelerate their growth around the UN Sustainable Development Goals while building shareholder value? In this first of a multi-part series, Nerac makes the case that this is, in fact, exactly where we’re going.

Read the article here.


Robert Zott, Director of Advisory Services Development 

 

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. 

 

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. 

 

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 

 

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 

 

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 

 

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.  


  

Recent Nerac Posts

Similar Devices in State of the Art

Originally Published May 4, 2023
By Priscilla S. Monarca, M.P.H.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Get the article here.

Best Practices for the State of the Art Evaluation

Originally Published April 20, 2023
By Priscilla S. Monarca, M.P.H.

This article outlines best practices for creating the state of the art evaluation under EU regulations. Get the article here.

Digital Transformation – How to Do it Right

Originally Published April 18, 2023
By Dr. Ripi Singh, Dr. Johannes Vrana, Inspiring Next

A large fraction of Digital Transformation efforts fail to deliver their promised value. This article helps to demystify Digital Transformation and build an executable roadmap. Get the article here.

The Road to IVDR Implementation

Originally Published March 20, 2023
By Sarah McLeod, M.S.

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. This article takes a closer look at the revised implementation timeline and potential impacts on certification. Get the article here.

EU MDR CER Literature Review Process: Expectations and Best Practices

Originally Published March 14, 2023
By Erica Kramer, Ph.D.

This article looks more closely at the literature review process for EU MDR compliant clinical literature evaluations. Get the article here.

Medical Device Claims and Clinical Evaluation Under the EU MDR

Originally published February 13, 2023
By Miriam Sharif-Murray, M.S.

A closer look at the requirements for medical device claims and how they impact the clinical evaluation process, subsequent Clinical Evaluation Report and eventual conformity to medical device regulations. Get the article here.

What was Old is New Again: Chemical Recycling of Plastic Waste using Pyrolysis

Originally published February 3, 2023
By Ben Bahavar, Ph.D., Richard Maldanis, Ph.D., Rosemarie Szostak, Ph.D.

This article takes a closer look at the advancements in chemical recycling, patent activity and the supply chain impacts of this emerging technology. get the article here.

Get a Grip….Get a Gecko!

Originally published January 25, 2023
By Rosemarie Szostak, Ph.D.

This article explores biomimetic and gecko-inspired technologies, and thier potential commercial applications. Access the article here.

The Use of Published Literature in FDA Medical Device Submissions

Originally Published January 13, 2023
By Miriam Sharif Murray, M.S.

This article explores the different types of published literature that can support Class III Medical Device submissions for FDA compliance. Get the article here.

Recession: The Mother of All Innovation

Originally published November 3, 2022
By Jeffrey Magee, BSME, MBA, Nerac Analyst-Innovation & IP Management

This article provides evidence-based examples of how a patent landscape can help to guide technology development, patenting, and freedom-to-operate (FTO) strategy.
Get the article here.

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