Veranex Blog
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From Reactive to Predictive: The Unseen Architecture of Modern Risk Management
Feb 18, 2025How Clinical Teams Are Replacing Firefighting With Future-Proof Monitoring The Silent Efficiency Leak: Why Legacy Systems Fail In 2024, a study of...
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Medical Device Innovation: A Doctor’s Journey to Transforming Respiratory Care
Feb 10, 2025Maria Artunduaga, MD, MPH, MTM Founder and CEO of Samay In This Podcast: How and why Dr. Artunduaga created her company The challenges she faced...
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AI Medical Devices: Answering Your Burning Questions
Jan 31, 2025As artificial intelligence continues to revolutionize medical device development, the FDA's evolving regulatory framework presents both...
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AI Medical Devices: Your Comprehensive Guide to Development and Documentation
Jan 28, 2025The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers...
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Advanced CT Imaging in Preclinical Research: Pioneering Tomorrow’s Cardiovascular Innovations Today
Jan 27, 2025The evolution of medical device testing demands increasingly sophisticated imaging capabilities. At Veranex, our state-of-the-art CT scanning...
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Rescue Studies: Salvaging Clinical Trials Through Expert Data Management
Jan 23, 2025When a clinical trial faces data quality challenges, every day counts. Rescue studies have become an increasingly critical component in preserving...
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Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
Jan 21, 2025As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software...
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Critical Updates for Medical Device Manufacturers and Healthcare Institutions: Switzerland Aligns with EU IVDR Transitions
Jan 17, 2025Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This...
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Testing Medical Devices with Artificial Anatomy Models
Dec 30, 2024Whether you’re a new medtech startups or established strategic, testing new devices against realistic anatomical conditions is crucial for success....
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Five Questions to Ask When Selecting a CRO for Preclinical Studies
Dec 30, 2024Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization Below are a few...
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Optimizing PLM-OEM Collaborations: Key Strategies for a Smooth IVDR Transition
Dec 12, 2024Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under...
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Challenges for Medical Device Database Builds
Dec 11, 2024How do regulatory requirements within the medical device industry impact a database build? What are the important items to be aware of? In this...
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Giving Back
Dec 09, 2024Nicolas Borenstein, DVM, Ph.D. Co-President, Preclinical Services “We are not a veterinary clinic and our primary mission is indeed to validate...
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Ten Things to Know Before You Start Your GLP Study
Dec 05, 2024The most expensive study is one you have to repeat Good laboratory practice (GLP) studies are an essential component to medical product development...
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December Image of the Month
Dec 02, 2024You be the Pathologist! What type of implant is shown here, and in what location? Answer: This is a dental implant in the mandible! This mandibular...
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Reducing the 90% Recurrence Rate for Glioblastoma Treatment Through an Implantable Device for the Delivery of Stem Cells
Nov 11, 2024Extending Patient Lifespan with LifeSTEM What is Glioblastoma? Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign...
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What Makes a Good Preclinical Study Final Report?
Nov 08, 2024When it comes to meeting deadlines and continuing to receive investments, the timely review of your GLP preclinical final report is very important....
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November Image of the Month
Nov 05, 2024You be the Anatomist! To which species does this image of an aortic arch (red arrow) belong?Answer: This is an image of a human aortic arch! Here’s...
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How 3D Printing Can Accelerate Your Product Development Timeline
Nov 04, 2024Accelerate Your Product Development Timeline One of the biggest timeline impacts in any development program is getting the product to work. Our...
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The Ins and Outs of Using ECMO and VAD in Preclinical Studies
Nov 01, 2024ECMO Vs. VAD Ventricular assist device (VAD) and extracorporeal membrane oxygenation (ECMO) are two similar temporary techniques to bridge cardiac...
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Critical Elements of High-Quality Preclinical Study Protocols
Oct 30, 2024When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already...
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October Image of the Month
Oct 22, 2024You be the Cardiac Imaging Specialist! What cardiac structures are observable on this IntraCardiac Echocardiography (ICE) image, and what approach...
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Tackling Postpartum Hemorrhage: Innovations on the Horizon
Oct 15, 2024Postpartum hemorrhage (PPH) remains a significant global health concern as the leading cause of maternal mortality worldwide. According to the World...
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Exploring the Assay Development Pipeline for In-Vitro Diagnostics (IVDs)
Sep 25, 2024Establishing a Strong Assay Foundation Before we can conceptualize IVD product configurations, we must establish assay inputs which include, but are...
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5 Keys to Successful Partnerships: Building Stronger Collaborations to Support Medtech and Pharma
Sep 24, 2024Successful business partnerships within the life sciences industry are often the cornerstone of thriving drug development. Here are five essential...
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Best Practices: Preparing for a Patent
Sep 20, 2024Bob BouthillierDirector, Electrical Engineering, VeranexIn this post, our director of electrical engineering Bob Bouthillier covers the importance...
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September Image of the Month
Sep 16, 2024You be the Pathologist! What intervention caused the lesions shown in this ovine artery?Answer: Application of heat generated the collateral damage...
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Common Costs in Preclinical Testing Programs
Sep 16, 2024All preclinical study estimates are not created equal and they can get expensive. Medical device innovators need to know what goes into the making...
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Identification, Engagement and Commitment of Key Players for a Successful Preclinical Study
Sep 09, 2024Assembling a team for an efficient preclinical studyWhen it comes to kicking off your preclinical study, assembling the right team will help you...
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How to Design an Efficient Preclinical Testing Study
Sep 03, 2024A medical device's pathway from concept to commercialization can be fraught with pitfalls, setbacks, and a need to recurring, significant...
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Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Aug 28, 2024Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality...
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August Image of the Month
Aug 28, 2024You be the Anatomist! To which species does this CT scan image belong?Answer: This is an image of an ovine (sheep)! Here’s how we know: The kidneys...
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How Confounding Forces Impact Medical Device Development
Aug 12, 2024Bob Bouthillier Director, Electrical Engineering, Veranex We live in a time where we have easy access to biometrics that help both our clinicians...
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What is Fast to Proof-of-Concept?
Aug 09, 2024We see a continued need from our clients, both large and small, to partner with organizations that can deliver meaningful and actionable solutions...
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Leveraging AI and ML in Medical Products – Part 3
Aug 07, 2024Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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Leveraging AI and ML in Medical Products – Part 2
Aug 07, 2024Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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Achieving Regulatory Clearance for a Novel Device – Provisio Medical
Aug 06, 2024Provisio™ SLT IVUS™ System Creating a novel medical device typically includes innovation around treatment, capabilities, cost reduction, or...
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Leveraging AI and ML in Medical Products – Part 1
Aug 05, 2024Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence...
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Building Blocks of Quality: The Role of Design Control in Medical Device Development
Jul 24, 2024Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
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Playing Defense: Cybersecurity for Diagnostic Devices
Jul 19, 2024No industry or device is immune from the risk of cyber attacks. And it’s especially important that medical devices including diagnostic instruments...
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Expert Insights: Project Management with Matt Perry
Jul 02, 2024Matt PerryVP of program management at VeranexRecently we sat down with Matt Perry, VP of program management at Veranex, to talk about common project...
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Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity
Jul 01, 2024New guidance from the FDA replaces similar, but now obsolete, guidance. Some of the guidance was issued in response to the PATCH Act, which is a...
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Clinical Utility Evidence Planning: Framework, Assessment Techniques, and Case Study for a Diagnostic Test
Jun 21, 2024Clinical utility describes the usefulness of a medical product (device, diagnostic/prognostic, or therapeutic) for physicians and/or patients, and...
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Appropriate, early planning for medical device development could help outshine the darkness of Alzheimer’s disease
Jun 15, 2024Exciting developments in the area of medical devices for the diagnosis, prognosis, treatment/management, and monitoring of Alzheimer’s disease (AD)...
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Document Review: A Nuanced Process in Medical Writing
Jun 13, 2024Veranex is determined to provide complete support to our healthcare partners to reach our shared goal of advancing medical care and improving...
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Key Insights on the Challenges of Whitespace Innovation
May 29, 2024We recently sat down with three big-picture thinkers at Veranex to talk about whitespace innovation — its challenges, how we’ve seen it done...
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Risk Management in Pharmacovigilance
May 15, 2024It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits...
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Avoid These Four Medical Device Supply Chain Woes
May 03, 2024Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and...
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The Promise of Pulsed Field Ablation and the Critical Role of Preclinical Science in its Advancement
May 02, 2024CT Image of Pulmonary VeinsAtrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While...
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The Power of Generative Artificial Intelligence in Medical Writing
Apr 29, 2024The use of artificial intelligence (AI) in clinical trials is evolving quickly. According to the research and consulting firm, Gartner, the life...
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Harnessing AI Technology to Identify Adverse Events with Great Accuracy and Efficiency
Apr 29, 2024The use of technology in clinical trials, including artificial intelligence (AI), is evolving rapidly. According to the consulting firm Gartner,...
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Amending Regulation for MDR / IVDR: Key Takeaways for the Diagnostics Industry
Apr 26, 2024Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the...
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Five Advantages of Veranex’s Quality Management Systems
Apr 22, 2024Our approach to Quality Management ensures that we’re always speaking the same language. When it comes to needing a Quality Management Solution,...
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2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
Apr 17, 2024In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
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Built to Fit Your Needs: Our CDMO Capabilities
Mar 19, 2024Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
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Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions About Medical Device Software
Mar 13, 2024Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
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Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices
Mar 08, 2024In January, the MHRA released a regulatory framework – Roadmap towards the future regulatory framework for medical devices. Learn more in this...
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Strategies for Successful Clinical Data Management Rescue Studies
Mar 05, 2024What is a rescue study? A rescue study is a clinical trial that is being conducted by a new vendor after having previously been conducted by another...
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Preclinical Insights #40 — Have a Heart
Feb 28, 2024Preclinical Paris Founders Nicolas Borenstein and Luc Behr discuss their 25-year legacy.
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Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
Feb 21, 2024On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...
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Automation and the Future of Clinical Data Management
Feb 01, 2024Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by...
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New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
Jan 26, 2024The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming...
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A Bird’s Eye View of the Nuclear Medicine and Radiopharmaceuticals Market in China
Jan 12, 2024Part 1: Providers and Regulators Getting information on the nuclear medicine market landscape, regulations, and market access environment in China...
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Preclinical Insights #39 — 25 Years of Preclinical Paris: A Conversation with Our Founders
Dec 20, 2023Preclinical Paris Founders Nicolas Borenstein and Luc Behr discuss their 25-year legacy.
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The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Nov 29, 2023Why search the scientific and medical literature? “Scientific and medical literature is a significant source of information for monitoring of the...
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Preclinical Insights #38 – What Sets Us Apart: Our In-House Pathology Department
Nov 27, 2023Veranex is proud to share the latest issue of our Preclinical Insights publication. In this issue we talk with Dr. Laurence Fiette, Head of...
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Key Insights from NMPA Guidance Draft 01 & 02 from Our Human Factors Team
Nov 14, 2023The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We're committed to...
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Opportunity Ahead in the Cardiovascular Devices Market
Nov 13, 2023Panel Recap: Industry experts share deep-level analysis at LSI Europe ’23
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Event Recap: Biocompatibility Insights 2023
Oct 24, 2023We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you...
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Bridging Design and Manufacturing
Oct 16, 2023For growth-stage companies, finding a contract manufacturer to take on low volume runs and bridge the gap between design and manufacturing can be a...
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Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment
Sep 28, 2023Nanomaterials, due to their small size and high surface area, present distinctive physico-chemical properties. However, these properties also entail...
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Grounding Your Investment in Human-Centered Design With a Foundational Needs Assessment
Sep 19, 2023We sat down with leaders from top life sciences companies to discuss foundational needs assessments – how to do them, what can go wrong when you...
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Challenges for Medical Device Database Builds and Strategies to Overcome Them
Sep 13, 2023What are some of the challenges with database builds for medical device studies, given the current regulatory requirements? What are the important...
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Biocompatibility of Medical Devices: Process, Detailed Steps and 7 Hot Topics to Crack the Code of Medical Device Safety
Sep 13, 2023Behind every successful medical device lies a crucial consideration that forms one of the cornerstones of its success: biocompatibility.
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Preclinical Insights #37 – Prof. Alexandre Carpentier
Sep 12, 2023Veranex is proud to share the latest issue of our Preclinical Insights publication. In this issue we talk with Prof. Alexandre Carpentier about his...
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Automation and the Future of Clinical Data Management
Aug 29, 2023Automation in clinical data management (CDM) is becoming increasingly popular due to the increasing volume and complexity of data being generated by...
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Centralized Risk Reporting, Escalation, and Governance (CRREG) Platform
Jul 20, 2023According to the most recent draft of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) E6(R3), “The aim...
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Webinar: Digital Health – Embracing Human-Centered-Design to Create Impactful Digital Experiences
Jul 20, 2023In this webinar, featured speaker Brandon Bogdalek will interview Greg Silvesti from Sage Therapeutics. Brandon and Greg will discuss how to use...
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Webinar: Point-of-Care Diagnostics – Best Practices for Bringing Novel Solutions to Market
Jul 20, 2023In this webinar, featured speaker Brandon Bogdalek will interview three industry leading panelists in the diagnostics industry. The panelists will...
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Webinar: Drug Delivery — Evaluating Off The Shelf and Novel Drug Delivery Solutions
Jul 13, 2023During this session, featured speaker Brandon Bogdalek, will interview three industry leading panelists. The panelists will discuss important...
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Deriving Value From Strategic Relationships and Tailored Solutions: Our Takeaways From PCT Summit – Amsterdam 2023
Apr 21, 2023The 19th Precision in Clinical Trials (PCT) Summit – Amsterdam brought together a wide range of representatives from the life sciences industry,...
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Celebrating Autism Awareness Month
Apr 13, 2023Susanah and Tucker, A Mother-Son Duo In 2016, Susannah Ashcroft drove home from an appointment at St. David’s Center for Child and Family...
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Medical Device Vigilance: Important Considerations to Comply With the EU MDR
Apr 07, 2023Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
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Meet the Team: Eric Matckie, SVP and GM of Commercial Strategy and Market Access
Mar 20, 2023In this installment of Meet the Team we’ll be getting to know Eric Matckie, the Senior Vice President and General Manager of Commercial Strategy and...
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Growth of the life sciences and medtech industry in India was apparent at BioAsia 2023
Mar 13, 2023A team from Veranex Data Management & Analytics recently traveled to Hyderabad, the capital of the Indian state of Telengana, for BioAsia 2023....
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Meet the Team: Danita Harris, SVP and General Manager of Data Management and Analytics
Mar 08, 2023In this installment of our “Meet the Team” blog series, we talk to Danita Harris, Senior Vice President and General Manager of Data Management and...
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Meet the Team: Sakthivel Sivam, Senior Director, Biostatistics
Mar 02, 2023In this installment of our “Meet the Team” blog series, we talk to Sakthivel Sivam, Senior Director, Biostatistics, about his industry experience,...
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Agile vs. Regulatory: How the Two Coexist and Contribute to Successful Medical Device Software Development
Feb 27, 2023Software is gaining relevancy in a broad range of medical devices, as it either enables the control or influence of their operation, or because...
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Insights Into the Needs of Chinese Hospital Lab Customers
Feb 27, 2023We recently analyzed a report prepared by Ding Xiang Yuan (abbreviated as DXY; Ding Xiang Yuan is one of the largest and most influential online...
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Meet the Team: Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance
Feb 17, 2023In this installment of our “Meet the Team” blog series, we talk to Aarekh Shrestha, Senior Manager, Drug Safety and Device Vigilance,...
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Celebrating Black History Month at Veranex
Feb 17, 2023Veranex is honored to celebrate our Black teammates today and everyday. Throughout February, we’re connecting with employees to learn more about...
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5 Tips When Designing Accessible Covid-19 Home Tests
Feb 16, 2023Veranex partnered with Rapid Acceleration of Diagnostics (RADx®) and the National Institute of Health (NIH) to help support the creation of a Best...
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Basics of Drug Safety: Importance of Case Processing in Pharmacovigilance (PV)
Feb 09, 2023Case processing in pharmacovigilance is a fundamental activity to support safety surveillance in clinical trials. Along with an anticipated...
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Meet the Team: Jim Maciariello
Jan 26, 2023In this installment of our “Meet the Team” blog series, we talk to Jim Maciariello, General Manager of Product Design and Engineering (PD&E)....
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On Time and on Target – Challenges and 5 Tips from a Biometrics Contract Research Organization (CRO)
Jan 20, 2023It should come as no surprise that conducting a clinical trial is expensive. Just how expensive depends on the phase and design of the trial, with...
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Addressing Inequity in Healthcare – A Case Study of Tackling Liver Cancer in New Zealand
Jan 17, 2023The following article illustrates how inequities arise in healthcare, one disease at a time. It highlights insights from a program we are currently...
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The New Normal for Market Access in China: Volume Based Procurement
Jan 17, 2023Our previous update1, Analysis of China’s First National Tender on Coronary Stents, discussed the first national-level centralized tender for a...
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Meet the Team: Meghana Kapoor, Manager, Clinical Data Management
Jan 03, 2023In this installment of our “Meet the Team” blog series, we talk to Meghana Kapoor, Manager, Clinical Data Management, about her background, her...
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Meet the Team: Soma Sekhar Koramatla, Associate Manager, Statistical Programming, Biometrics
Dec 08, 2022In this installment of our “Meet the Team” blog series, we talk to Soma Sekhar Koramatla, Associate Manager, Statistical Programming, Biometrics...
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5 Compelling Reasons to Go Functional Service Provider (FSP)
Nov 22, 2022Given the shifts that Contract Research Organizations (CROs) and the pharma industry have gone through with the COVID-19 pandemic and subsequent...
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Plan to Mitigate Challenges in Pharmacovigilance and Drug Safety
Oct 28, 2022Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...
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The Regulatory Constraints in Making Your LDT/CDx Partnership Choices in China
Oct 11, 2022Our previous blog discussed the emerging trends for the companion diagnostics (CDx) regulations in China. There have been several developments since...
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HHS Declares Emergency Use Authorization for Use of In Vitro Diagnostics for Detection of Monkeypox Virus
Sep 16, 2022WHAT DOES THIS MEAN? Monkeypox virus is a zoonotic infection, caused by Orthopoxvirus genus of the Poxviridae family like variola virus (the...
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Veranex Risk Based Monitoring Business Delivery Model – A Case Study
Aug 29, 2022Veranex has successfully designed and implemented a “5D Framework” to support its Risk Based Monitoring service delivery model. The 5 components...
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Veranex Risk Based Monitoring (RBM) Business Delivery Model With 5D Framework
Aug 23, 2022Veranex has successfully designed and implemented a “5D Framework” to support its RBM service delivery model, in order to create a better...
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A Data Management Perspective: How Are Device Trials Different from Drug Trials?
Aug 08, 2022The many articles discussing the difference between drug and device trials are often coming from a regulatory perspective on how device trials are...
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Risk Based Monitoring & Technology Driven Solutions – Veranex Hosted Sponsor Visit at Bangalore, India Office
Aug 01, 2022Veranex is pleased to have hosted a key meeting with a Generics & Biosimilars Sponsor at the Bangalore, India office on May 31st, 2022. This...
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Understanding the ROI of Human Factors Engineering
Jul 27, 2022By Matt Gottschalk Designing a medical device or combination product requires immense expertise in risk management to ensure compliance and control...
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Meeting Early Phase Study Challenges – a Data Management Perspective
Jul 20, 2022First-in-Human studies are a discovery point, which can decide the fate of a compound as well as lay the groundwork for subsequent phases of a...
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How COVID Changed the Diagnostic Industry – for Better
Jul 19, 2022It goes without saying that the pandemic has disrupted all aspects of our lives especially the healthcare system, including the diagnostic industry....
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Looking Forward – AACC 2022 Round Up
Jul 06, 2022Only a few weeks until AACC 2022 in Chicago, the largest clinical diagnostics conference in the world. Ahead of the conference, I share some...
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Medical Writing in Early Phase Studies
Jul 05, 2022Is specialized knowledge needed for Medical Writers working on early phase studies? Based on the characteristics and needs of Phase 1, 1a, 1b,...
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Three Key Points to Prepare for an Early Phase Clinical Trial
Jun 20, 2022Companies preparing for an early phase study must deal with an array of challenges and decisions for biometrics, pharmacovigilance and regulatory...
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Plan to Mitigate Challenges in Pharmacovigilance and Drug Safety
Jun 15, 2022Biopharmaceutical companies worldwide are developing better and most cost-effective medicines at an unprecedented rate. With billions of dollars...
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China Reveals Its 2025 Coverage Goals for Publicly Funded Healthcare
Mar 23, 2022In September 2021, China’s National Healthcare Security Administration (NHSA), the government agent in charge of publicly funded healthcare...
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Provider and Patient Preference Studies: Demonstrating Product Demand for Drugs, Medical Devices, and Diagnostics
Mar 21, 2022Pharmaceutical manufacturers, medical device companies, and advanced diagnostic manufacturers are increasingly incorporating patients’ and...
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MedTech Pioneers – Genesis MedTech Group: An Ascending Leader in Emerging Market MedTech Innovation
Feb 21, 2022Warren Wang, CHAIRMAN AND CHIEF EXECUTIVE OFFICER Tal Wenderow, VENTURE PARTNER Tal Wenderow and I connected at Life Science Intelligence’s Emerging...
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China Aims to Complete Transition to DRG Payment Model for Inpatient Care by 2024
Feb 01, 2022In November 2021, the Chinese government announced its 3-year (2022-2024) payment reform plan with the end goal to fully implement a diagnosis...
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MedTech Pioneers – MedTech Innovator, The Largest Global MedTech Accelerator, From Inception To Scale
Jan 05, 2022Paul Grand CEO, MEDTECH INNOVATOR (MTI) I have had the pleasure of serving as a judge, advisor and mentor to Medtech Innovator over the past few...
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Selling the Science Is a Must to Secure Research Funding
Jan 01, 2022If you cannot sell the science, it is like it was not discovered (#provocativeoverstatement) “Gut science” became a thing during the last decade. I...
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Consumable vs. Instrument, the Creative Tension in Diagnostics Technology
Dec 15, 2021By Juan F. Roman You know how the diagnostics industry relies on the “razor blade” model: give the instrument for free and make the profit with the...
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MedTech Pioneers – Intuitive Ventures: Convergent Technologies, Beyond the Robot, in Minimally Invasive Care
Oct 06, 2021Oliver Keown MD DIRECTOR, INTUITIVE VENTURES I met Oliver Keown MD, Director of Intuitive Ventures through Paul Grand’s Medtech Innovator ecosystem;...
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MedTech Pioneers – Digital Surgery 4.0 & The Power of Go, Go, Go
Jul 12, 2021Scott Huennekens CHAIRMAN OF THE BOARD, VIDA FLASH ACQUISITIONS, MEDTECH SPAC Scott Huennekens is one of the inspirations for this Medtech Pioneers...
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MedTech Pioneers – The Future of Digital Surgery at the Mayo Clinic
May 10, 2021Janani S. Reisenauer, MD GENERAL THORACIC SURGERY/INTERVENTIONAL PULMONARY MEDICINE, VICE CHAIR, INNOVATION, DEPARTMENT OF SURGERY Mark Wehde CHAIR,...
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How Policy is Driving Digital Health in Germany
May 05, 2021Several recent national-level policy changes highlight an accelerating digital transformation of healthcare in Germany, building on the Digital...
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MedTech Pioneers – Promaxo: The Future of MRI Guided Diagnosis and Treatment
Apr 02, 2021Amit Vohra, PhD, MBA FOUNDER, CEO & PRESIDENT OF PROMAXO Dr. Amit Vohra is a visionary leader, serial entrepreneur, and technologist with a...
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NCCN 2021 Conference Highlights: Elevating Racial Equity in Cancer Care
Apr 01, 2021The National Comprehensive Cancer Network (NCCN) 2021 Annual Conference convened virtually March 18-20, drawing attendees from more than 40...
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MedTech Pioneers – Cala Health’s First-to-Market Bioelectronic Medicine for Hand Tremors
Mar 16, 2021Renee Ryan CEO, CALA HEALTH Renee Ryan, CEO of Cala Health, is a dynamic, active leader in our medtech community. Mike Neidert and I originally met...
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MedTech Pioneers – MedTech Innovation: Go Big and Bold in 2021
Feb 16, 2021Chris Velis FOUNDER & EXECUTIVE CHAIRMAN, MIRAKI INNOVATION Scott Pantel CEO of Life Science Intelligence & Emerging Medtech Summit Chris...
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MedTech Pioneers – MedTech Color: Bringing New Leaders Forward to Shape the Future of MedTech
Feb 08, 2021Kwame Ulmer Founder and Executive Director of MedTech Color Kwame Ulmer wears many hats in our medtech community; he serves as Principal at Ulmer...
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Is China a 300 Million or 1.4 Billion Healthcare Population Market?
Feb 03, 2021A reflection on the 2019 capability development progress report of the county hospitals in China The Veranex (formerly Boston Healthcare Associates)...
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MedTech Pioneers – Next Gen Robotic Wearable for Knee Osteoarthritis
Jan 25, 2021Roam Robotic’s Tim Swift, Founder, and CEO with Sujit Dike, VP Health San Francisco-based startup, Roam Robotics, is advancing robotic exoskeleton...
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MedTech Pioneers – Moray’s Robotic Trans-Catheter Mitral Repair System
Jan 19, 2021Co-founders: Mark Barrish BSME, JD, CEO and Phillip Laby, MSME, CTO Moray Medical, a Silicon Valley-based medtech startup, is developing a...
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A Year in Review and Looking to the Future: Four Key Healthcare Megatrends
Jan 06, 20212020 has been a bit of a year, to say the least. It has also, though, been a year of invention, opportunity, and possibility for life science...
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MHRA Issues Guidance on New Medical Device Regulation in UK
Jan 04, 2021As a result of Brexit, the In Vitro Diagnostic Medical Device Regulations (IVDR) will not apply to Great Britain (England, Wales and Scotland)....
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Veranex Partners with Alcon to Conduct Real-World Study Highlighting Efficiencies of Optical Biometer in Cataract Surgery
Dec 09, 2020Alcon, a global leader in eye care, collaborated with Veranex (formerly Boston Healthcare Associates) to conduct a Time-and-Motion Study to support...
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Analysis of China’s First National Tender on Coronary Stents
Dec 09, 2020In previous newsletters (Aggressive National Programs To Drive Down Drug Costs, published in January 2019 and Medical Disposables & Consumables...
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MedTech Pioneers – MedTech Innovator’s 2020 Grand Prize Winner, Rhaeos
Dec 08, 2020Anna Lisa Somera Founder & CEO of Rhaeos, 2020 Grand Prize Winner of Medtech Innovator The largest global medtech-only accelerator, Medtech...
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China Payment Reform: 2020 Update
Nov 01, 2020The pilot of implementing a diagnosis related group (DRG) payment model to inpatient hospital care, a major initiative of China’s ongoing healthcare...
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MedTech Pioneers – Cleveland Clinic’s Mission to Advance Surgical Robotic Innovation
Oct 28, 2020Akhil Saklecha MD, Managing Director, Ventures Jihad Kaouk MD, Director, Center for Laparoscopic & Robotic Surgery, Cleveland Clinic A leader in...
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Veranex Participates in the 3rd Annual Leaders in Life Sciences Breakfast Roundtable
Oct 05, 2020Eight leaders in Life Sciences came together for a virtual breakfast roundtable devoted to leading Life Sciences organizations through these...
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MedTech Pioneers – Dr. Maria Artunduaga Discusses Her Wearable Technology for Monitoring Lung Health and COPD
Sep 11, 2020Dr. Maria Artunduaga Founder and CEO of Respira Labs Dr. Maria Artunduaga is the founder and CEO of Respira Labs, a Mountain View-based startup with...
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CMS Proposes Changes to Part B Medicare Reimbursement for Physician-Administered Drugs Approved Under the 505(b)(2) Approval Pathway
Sep 11, 2020The Centers for Medicare and Medicaid Services (CMS) intends to alter assignment of Healthcare Common Procedure Coding System (HCPCS) Level II codes...
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MedTech Pioneers – Redesigning Healthcare Amidst a Pandemic
Aug 24, 2020Desert Horse-Grant and Dr. Jennifer McCaney, Co-Executive Directors, UCLA Biodesign This female dynamic duo founded UCLA’s Biodesign program in 2019...
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MedTech Pioneers – SV Health Investors Discuss the Firm’s New $90M Early-stage Medtech Convergence Fund
Aug 10, 2020Paul LaViolette Managing Partner & COO, SV Health Investors Forging where others are tentative to trod, SV Health Investors, in partnership with...
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Medicare Clarifies Confusion Over Tests Covered by the NGS NCD
Aug 04, 2020The Medicare NGS NCD grants national coverage for somatic testing in patients with advanced cancer if the test has FDA-approval or -clearance as a...
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G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case
Aug 04, 2020In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without...
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CMS New Technology Add-On Payment FY 2021 Proposed Rule
Jul 08, 2020The Centers for Medicare and Medicaid Services’ (CMS) New Technology Add-On Payment (NTAP) program is a system enacted by Congress and implemented...
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China Establishes a Regulatory Pathway for Companion Diagnostics
Jul 08, 2020The Chinese government has implemented a series of efforts to improve access to novel oncology therapies, one example of this is the significant...
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ICER Quietly Moves to a Pure Digital Health Assessment
Jul 07, 2020In March, leaders from our health economics team, Tom Goss and Jordan Hinahara shared insights on health technology assessments in the US under the...
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EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices
Jun 03, 2020As a result of the new European Union Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark...
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An Overview of Digital Health in China
May 06, 2020We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health...
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FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics
Apr 21, 2020April 2020 On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro...
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The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?
Apr 06, 2020In early March, lawmakers in the U.S. House of Representative and U.S. Senate introduced the Verifying Accurate, Leading-edge IVCT Development ACT,...
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German Draft Executive Order Provides Clarity for Reimbursement of Health Apps
Mar 03, 2020Towards the end of 2019, the German Federal Parliament introduced a simplified process for approval and reimbursement of digital health apps...
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DTx Part II: Building Evidence-Based Value Propositions for Digital Therapeutics
Feb 04, 2020In DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics we identified several potential payment models for monetizing the value...
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Navigating the Italian HTA Process: Essentials to a Favorable Review
Jan 06, 2020From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28...
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ICER Set to Evaluate Non-Drug Products in 2020
Dec 03, 2019The Boston-based Institute for Clinical and Economic Review (ICER), an independent research organization that conducts health technology assessments...
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DTx Part I: Identifying Optimal Payment Models for Digital Therapeutics
Dec 03, 2019According to the Digital Therapeutics Alliance (DTA), digital therapeutics (DTx) are products that deliver “software-generated therapeutic...
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Germany Paves the Way for Reimbursement of Digital Health Care Apps
Oct 24, 2019In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill...
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Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators
Sep 11, 2019As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China...
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Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany
Sep 11, 2019Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in...
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Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators
Aug 01, 2019As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China...
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First Meeting of the Italian Regional Purchasing Centers
Jun 25, 2019Italian public healthcare structures can buy medical devices only via tenders. Up to 2016, competitive pricing was the main rule for tender winners....
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New Independent Medical Review Board for Germany
Apr 01, 2019For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could...