2024-04-16 20:21
In healthcare, understanding the regulatory landscape for in-vitro diagnostics is paramount. Compliance with these regulations not only upholds standards but also directly impacts patient sa… Read More
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Nerac Insights And Publications - Nerac Blog
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Nerac Analysts write about a new topic every week! If you want to learn about anything from patenting best practices to tumor cell development, you've come to the right place.
2024-04-09 20:03
In today’s volatile business environment, developing an effective risk mitigation plan is essential for minimizing potential disruptions and safeguarding operations. A well-structured… Read More
2024-04-05 18:48
Literature and Data Appraisal in Clinical Evaluation ReportsBy Miriam Sharif-Murray, M.S., RAC, Nerac Analyst
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Substantiating the safety and performance of your medical de… Read More
2024-04-04 19:48
In today’s complex business landscape, comprehensive risk assessment stands as the cornerstone of effective risk mitigation strategies. This in-depth process equips enterprises to navi… Read More
2024-04-02 18:14
In today’s rapidly evolving business landscape, effective risk mitigation is crucial for safeguarding assets and ensuring organizational resilience. As enterprises face a multitude of… Read More
2024-03-26 17:48
The global energy landscape is undergoing a profound transformation driven by the emergence of disruptive technologies and a growing consensus on the need for sustainable energy solutions. R… Read More
2024-03-21 17:40
The automotive industry is at a pivotal crossroads, propelled by the rapid evolution of disruptive technologies. Among the most transformative are the developments in electric vehicles (EVs)… Read More
2024-03-19 17:33
The financial sector is undergoing a profound transformation, driven by disruptive technologies that redefine how services are delivered and consumed. Innovations in fintech, bolstered by bl… Read More
2024-03-14 15:55
In recent years, the healthcare industry has witnessed a technological revolution that is reshaping patient care, making it more accessible, efficient, and personalized than ever before. Inn… Read More
2024-03-12 15:38
In an era where technological advancements occur at an unprecedented pace, disruptive technologies are at the forefront of shaping and transforming industries across the globe. From artifici… Read More
2024-03-07 19:04
In the fiercely competitive landscape of product development, the key to success often lies in the ability to unlock and harness the potential of new products through meticulous research and… Read More
2024-03-07 19:03
Navigating the journey from a spark of innovation to securing a patent can be as complex as the invention process itself. For inventors, understanding the pathway to patent success is crucia… Read More
2024-03-07 18:55
For inventors navigating the complex world of intellectual property, understanding and leveraging patent research services is crucial. These services not only illuminate the path to patentin… Read More
2024-03-06 19:11
The pharmaceutical industry operates in one of the most dynamically challenging environments, where innovation, regulation, and market forces converge. Achieving success in this complex land… Read More
2024-03-06 18:49
In today’s competitive business landscape, intellectual property (IP), particularly patents, plays a crucial role in securing a company’s innovations and maintaining a competitiv… Read More
2024-03-06 18:28
The pharmaceutical industry is characterized by intense competition, stringent regulatory requirements, and an ever-evolving market landscape. In this complex environment, achieving success… Read More
2024-03-06 17:24
Expanding your business into global markets is an ambitious and potentially rewarding endeavor. However, it’s also fraught with complexity, especially when it comes to navigating the d… Read More
2024-03-05 18:09
Biotechnology stands as a beacon of innovation, merging biology with technology to address some of the most pressing challenges in healthcare, agriculture, and environmental sustainability… Read More
2024-03-05 18:02
The biotech industry stands at the forefront of scientific innovation, transforming how we approach healthcare, agriculture, and environmental sustainability. Navigating product development… Read More
2024-03-05 17:55
In the digital age, where technology evolves at an unprecedented pace, Research and Development (R&D) stands as the beacon guiding tech companies towards innovation, market leadership, a… Read More
2024-02-23 13:29
How Regulatory Compliance Accelerates Medical Device InnovationShare this article!
The common perception among many in the medical device industry is that regulatory compliance is a barrier… Read More
2024-02-23 13:18
The Top 5 Challenges in Medical Device Regulatory Compliance and How to Overcome ThemShare this article!
Navigating the regulatory compliance landscape is a pivotal and challenging aspect of… Read More
2024-02-22 13:55
Understanding Medical Device Regulations: A Beginner’s GuideShare this article!
In the complex world of healthcare innovation, navigating the regulatory landscape is a critical step fo… Read More
2024-02-22 13:53
Global Market Entry Strategies for Medical Devices: Overcoming Challenges and Seizing OpportunitiesEntering the global medical device market is an ambitious goal for manufacturers, offering… Read More
2024-02-21 13:40
Balancing Creativity and Compliance in MedTechShare this article!
Navigating the intricate landscape of medical technology (MedTech) innovation requires a delicate balance between fostering… Read More
2024-02-21 13:32
The Future of Healthcare: How Wearable Tech is Shaping Medical DevicesShare this article!
The healthcare industry is witnessing a revolutionary shift, largely propelled by the advent and int… Read More
2024-02-20 17:20
Why DIY Market Research Might Not Be EnoughShare this article!
In today’s fast-paced business environment, understanding the market is crucial for any company aiming to launch new prod… Read More
2024-02-20 17:19
Understanding Your Market: The Key to Innovation and GrowthShare this article!
In an era where markets evolve at an unprecedented pace, the ability to keenly understand and adapt to these ch… Read More
2024-02-20 13:38
Navigating the FDA Approval Process for Medical Devices: Step-by-StepShare this article!
The journey to FDA approval for medical devices can be intricate and challenging. Understanding the s… Read More
2024-02-19 17:19
Understanding Customer Needs: The Key to Successful Product DesignShare this article!
In the ever-evolving landscape of product development, one principle remains unchanged: understanding cu… Read More
2024-02-12 19:03
Leveraging Research and Development for Competitive AdvantageShare this article!
In today’s rapidly evolving technological landscape, staying ahead of the competition requires more tha… Read More
2024-02-12 18:55
Navigating the Complex Landscape of Medical Device ComplianceShare this article!
The medical device industry is a critical component of the healthcare sector, driving innovation and improvin… Read More
2024-02-12 18:27
The Role of Market Research in Successful Product LaunchesShare this article!
In the dynamic world of business, launching a new product is both an exciting opportunity and a considerable cha… Read More
2024-02-12 16:08
Intellectual Property Strategy in the Age of InnovationShare this article!
In today’s fast-paced world of technological advancement, intellectual property (IP) stands as a critical ass… Read More
2024-02-12 15:09
The Future of Medical Device Innovation: Navigating Regulatory ChallengesShare this article!
In the rapidly evolving landscape of healthcare, the medical device sector stands at the forefron… Read More
2024-01-12 16:58
Considerations and Tips for Conducting Intellectual Property Research – A Few Things You Need to KnowBy Ben Bahavar Ph.D.,
Rosemarie Szostak Ph.D.,
Jeffrey Magee BSME, MBA
Senior Nerac… Read More
2024-01-12 16:28
Clinical Literature Reviews for Regulatory Submissions: Not Just for the EUBy Erica Kramer, Ph.D.
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Systematic clinical literature reviews are essential for achieving and m… Read More
2024-01-04 21:19
Disruptive Technology: Assessing its PotentialBy: Rosemarie Szostak, Ph.D.
Nerac Senior Analyst
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The technology landscape is dynamic, challenging companies to determine wh… Read More
2023-12-08 16:10
Nerac Announces New Global Tech Watch Alert SeriesFree trial of Nerac’s automated alert service delivering the latest market news and technology developmentsShare this article!December… Read More
2023-09-07 13:09
Next-generation sequencing (NGS) assays sequence the genes in human biological samples making them a unique subset of in vitro diagnostic devices (IVDs). Unlike other IVDs, NGS test results… Read More
2023-08-18 13:31
Exploring emerging technologies and commercial applications in the field of therapeutic ultrasound
The history of ultrasound devices goes back to the start of the twentieth century, when… Read More
2023-08-10 15:22
Pediatric medical devices are critical for proper medical care of children.
The connection between innovation and realization of pediatric medical devices is a challenging one as th… Read More
2023-07-03 16:17
Artificial Intelligence (AI) is touted as an enormous opportunity for all industry segments, from consumers to businesses to healthcare and beyond. A recent introduction of “ChatGPT,&r&hell…Read More
2023-07-03 15:50
Making a clinical diagnosis without a definitive blood draw or tissue sample sounds like science fiction but current trends in AI/ML (artificial intelligence and machine learning)and their u… Read More
2023-07-03 15:00
Under the EU MDR, literature reviews are recommended components for clinical evaluation, post-market surveillance, post-market clinical follow-up, and PSURs. The need to review scientific li… Read More
2023-05-04 15:09
The state of the art evaluation is a necessary component of Clinical Literature Evaluations (CERs) based on the European Union (EU) Medical Device Regulation (MDR), In Vitro Diagnostic Regul… Read More
2023-04-20 17:27
Have you struggled to develop your search strategies for the state of the art evaluation? Are you finding yourself sorting through large amounts of data? This article outlines best practice… Read More
2023-04-18 12:44
A large fraction of Digital Transformation efforts fail to deliver their promised value. Many of them cause frustration, anger, and distrust. Leadership accepts several reasons, rarely inclu… Read More
2023-03-16 14:32
Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. Some of the most impactful changes include a new classification of IVDs, an expa… Read More
2023-03-14 15:10
Medical device literature reviews for EU CERs present a challenge to many manufacturers. The literature review component of your CER will undergo robust scrutiny by the Notified Bodies… Read More
2023-02-10 19:48
The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance. Device claims are… Read More
2023-02-03 14:56
Mechanical recycling of plastic has been the primary approach to recycling, yet it remains to have serious issues. Recycling plastic using mechanical techniques (shredding, grinding, melting… Read More
2023-01-25 12:55
It has been two decades since scientists learned to mimic the ability of the gecko to adhere to any surface reversibly. The critical question is whether this biomimetic technology has found… Read More
2023-01-12 19:14
When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s… Read More
2022-11-03 15:02
This article provides evidence-based examples of how a patent landscape can help to guide technology development, patenting, and freedom-to-operate (FTO) strategy. More than just a patent la… Read More
2022-05-23 13:19
This article explores how an in-depth market study of alternative consumer packaging including target audiences, sustainable practices and social values, can arm companies with the insight t… Read More
2021-11-02 20:46
Clients trying to understand how their business is evolving can benefit from taking a step back to look at the current state of intellectual property. A patent landscape analysis helps N… Read More
2021-08-22 16:46
What keeps you up at night? Staying on top of your industry sometimes feels like you are drinking water from a fire hose. It is a Herculean task to keep up with all the information that is o… Read More
2021-06-03 18:54
The COVID-19 pandemic shook the world, and forced scientists to develop a vaccine rapidly, foregoing all normal protocol. Post-Market Surveillance of adverse events became a critical element… Read More
2021-05-05 16:27
The “vigilance” aspect of the pharmacovigilance process can be very challenging. Always being on guard and knowing all of the places to look can be difficult. With so much inform… Read More
2021-03-15 14:22
How do you identify potentially disruptive technologies in your market space? In an adjacent market space? How do you identify opportunities for expansion of your existing product line? Let… Read More
2021-02-26 14:31
How do you identify potentially disruptive technologies in your market space? In an adjacent market space? How can you identify threats to your essential product portfolio or the potential b… Read More
2021-02-11 18:50
Perhaps the smartest way to be prepared to serve customers in the future is by anticipating their needs. Being a few steps ahead of a client can be a recipe for success and arriving at this… Read More
2021-01-15 17:11
How do you identify potentially Disruptive Technologies in your market space? In an adjacent market space? How can you identify threats to your essential product portfolio or the potential… Read More
2020-12-10 16:02
By Robert Beinstein, P.E., ENV SP, Director Sustainability InnovationOriginally published December 10, 2020
Humanity has lately been presented with growing evidence that the problems we… Read More
2020-12-10 15:40
By Ripi Singh, Inspiring Next
Originally published December 10, 2020
The Nerac/Inspiring Next Purposeful Innovation workshop series is designed to bring innovation to your organization. I… Read More
2020-10-26 16:01
By Robert Beinstein, P.E., ENV SP, Director Sustainability InnovationOriginally published October 26, 2020
So much has been written as the Covid-19 pandemic as it continues its rampage… Read More
2020-07-27 20:00
By Nerac IP Analysts
Originally published July 28, 2020
Changing industry demands and new business challenges are also offering unprecedented opportunity. Whether it’s sudden disrupti… Read More
2020-07-23 17:40
Early this year, just when the pandemic gripped the nation, CareerPath® was invited to participate in XcellR8, the brainchild of Kevin Bouley and Warren Fisher, designed to help Connecti… Read More
2020-07-23 17:28
XcellR8! What a terrific tool, especially for the fledgling entrepreneur who may not have a thorough understanding regarding the playing field he or she is about to enter, armed only with h… Read More
2020-07-16 18:52
By Helga Weires, Nerac Analyst
Originally published July 16, 2020
XYZ Industries is a world-leader in the development and manufacturing of specialty foods and ingredients. With a marked incr… Read More
2020-06-30 14:20
By Erica Kramer, Ph.D., Senior Nerac Analyst/Medical Writer
Originally Published: June 30, 2020
In May 2017, the European Parliament and Council published Regulation (EU) 2017/746 on in vitr… Read More
2020-06-12 15:05
This Sample Research Report explores the dynamic supply chain changes and disruptive technologies evolving in this market, and provides analysis and recommendations for adjacent market oppor… Read More
2020-05-11 18:26
By Helga Weires, Nerac Analyst
Originally published May 12, 2020
The world is facing unprecedented disruption due to the COVID-19 pandemic. Regardless of industry, companies are reacting qu… Read More
2020-04-24 16:05
By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published April 24, 2020
The unforeseen COVID-19 crisis brings changing industry trends and new business challenges which can render you… Read More
2020-04-22 20:10
By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published April 23, 2020
Your 2020 strategy and plan was in place, and suddenly your market has changed completely. This unforeseen cris… Read More
2020-03-19 14:14
During this unprecedented time, we wish to extend our heartfelt prayers for health and safety to our global client community, and let you know that our thoughts go out to everyone impacted… Read More
2019-11-01 13:59
Agreement sets stage for Innovation Ecosystem approach to address business growth….and social responsibility. Read the full announcement here.
Related PostsNERAC TALKS INNOVATION I… Read More
2019-09-30 14:51
By Robert Beinstein, P.E., ENV SP, Director Sustainability InnovationOriginally published October 1, 2019
How might serendipity drive progress on some of the globe’s most intracta… Read More
2019-09-30 14:43
By Robert Beinstein, P.E., ENV SP, Director Sustainability InnovationOriginally published October 1, 2019
In an emerging future world with competing interests and at times conflicting cho… Read More
2019-09-30 14:21
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 announ… Read More
2019-09-25 16:31
Nerac’s Innovation Insights & Consulting Practice Lead, Tim Maurer, talks about Nerac’s history as a JV with NASA to commercialize the Apollo Program IP and IT for business… Read More
2019-09-11 14:43
Tim Maurer, Practice Lead, Innovation Insights & Consulting Practice Group and Bob Beinstein, Director, Sustainability Innovation at Nerac, spoke with MetroHartford Alliance Content Mana… Read More
2019-06-24 20:47
Watch this informative video of a recent panel discussion hosted by Kevin Bouley, CEO, Nerac and David Souder, Interim Dean, UCONN School of Business with Panelists Ripi Singh, Chief of Inno… Read More
2019-06-24 14:21
By Minh Han, MD, FAAFP, Nerac Analyst
Originally published June 24, 2019
On the weekend of April 26, 2019, the Marvel Cinematic Universe (MCU) released Avengers: Endgame, which became the hi… Read More
2019-06-24 14:12
By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published June 24, 2019
Social media mining of consumers trends is not just for your marketing department anymore. It should be part of… Read More
2019-03-05 21:16
Tim Maurer, Innovation Insight & Consulting Practice Lead
Taps globally recognized innovation leader, Tim Maurer as Practice Lead
March 6, 2018, Tolland, CT. Nerac is pleased to announ… Read More
2019-02-15 20:00
By Skye McClain, Ph.D.
Originally published February 15, 2019
It is important for companies working in areas of high technology to constantly be aware of new advances which may be disruptive… Read More
2019-02-15 19:06
By Dr. Ripi Singh, Chief Innovation Officer, Inspiring Next, Nerac Partner
Originally published February 15, 2019
“Industry 4.0” is a short name for the fourth industrial revolut… Read More
2019-02-15 18:28
By Rosemarie Szostak, Ph.D.
Originally published February 15, 2019
Viewed through the eyes of an innovation manager, quantum dot technology could either represent the best thing since sliced… Read More
2019-02-15 18:15
By Robert Zott, Director of Advisory Services Development
Originally published February 15, 2019
In this final installment of the new Post-Market Surveillance (PMS) requirements from the for… Read More
2019-02-12 16:34
XcellR8 welcomes Alice Turner, Founder and CEO of Urban Tekk
February 12, 2019, Tolland, CT. Nerac is pleased to announce that the next XcellR8 meeting will be held Thursday, February 14th… Read More
2019-02-06 20:57
XcellR8 welcomes the Roast Me team
February 7, 2018, Tolland, CT. Nerac is pleased to announce that the next XcellR8@UConn meeting will be Monday, February 11th – 6:00 pm at the Werth… Read More
2019-01-11 15:22
Originally published January 11, 2019.
According to a recent 2017 survey conducted by The Association of University Technology Managers (AUTM) about the state of licensing and related activi… Read More
2018-11-13 16:38
By Robert Zott, Director of Advisory Services Development
Originally published November 13, 2018
There is now 1 year, 6 months and 20 days until the application date upon which the new Europ… Read More
2018-11-13 16:18
Skye McClain, Ph.D.
Originally published November 13, 2018
Efforts to replace fossil fuel-based energy sources with cleaner more environmentally friendly sources have been progressing for a… Read More
2018-11-13 15:53
By Rosemarie Szostak, Ph.D.
Originally published November 13, 2018
As creepy as Hal was in “2001: A Space Odyssey” to the cuteness of Pixar’s “Wall-E”, the scie… Read More
2018-10-23 19:21
Please join me in welcoming Innovation Quest winners and CCEI Summer Fellowship participants Daniel Yasoshima and Thomas Cotton, two recent Biomedical Engineering graduates (MS 2018). Dan an… Read More
2018-10-18 13:58
Brittany Molkenthin, CEO – Lactation Innovations
An XcellR8 member since 2017, Brittany and her team at Lactation Innovations are developing novel solutions to address barriers f… Read More
2018-09-26 15:26
Alex Ciccio, CEO Snipit, LLC.
An XcellR8 member since August 2018, Alex and his team at Snipit are developing a mobile application that provides users an opportunity to efficiently discover… Read More
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