Nerac Insights and Publications

A world of knowledge and expertise at your fingertips. Custom written research and articles from our staff that you won’t find anywhere else on the web.

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.

Wine Bottles, Wine Boxes, Wine Cans….Oh My!! A Packaging Dilemma

Originally published May 23, 2022
By Rosemarie Szostak, Ph.D., Senior Analyst

Wineries are now exploring alternative packaging to the iconic 750ml glass bottle. Considerations include boxes, cartons, plastic, and aluminum cans. How might a packaging company approach development in this market space in order to meet resulting business challenges and opportunities with success? Get the article here.

Maximize Your Intellectual Property with a Patent Landscape

Originally published November 2, 2021
By Jeffrey Magee, BSME, MBA, Nerac Analyst-Innovation & IP Management

A patent landscape provides a visual representation of a large patent collection. Did you know it has applicability throughout the research, development, and commercialization process? Get the article here.

The Secret to Staying Ahead of Your Competition

By Rosemarie Szostak, Ph.D., Senior Analyst, Ben Bahavar, Ph.D., Senior Analyst, Jeffery Magee, BSME, MBA, Analyst – Innovation & IP Management
Originally published August 23, 2021
This article explores the importance of a targeted approach to stay ahead of competitors, disruptive technologies, regulatory hurdles, potential customer requirements, and supply chain issues. Get the article here.