Kapstone Medical

Cardiovascular | Software & IT

GE Healthcare, ACC Team Up to Advance AI in Cardiac Care

Collaboration will start tackling overwhelming challenges related to AFib management.

Sam Brusco, Associate Editor 06.03.21

Contract Manufacturing

Resonetics Acquires Distal Solutions

Adds interventional medical device design and development services to Resonetics' portfolio.

Sam Brusco, Associate Editor 06.01.21

Lessons from the Lab: Testing Orthopedic Devices

Changes in testing protocols and revised regulatory demands make testing experts even more valuable than they’ve ever been.

Non-Traditional Thinking Can Help Drive Medtech R&D

Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.

Electronics

Miniaturizing Linear Motion and Measurement—A Medical Equipment Challenge

A real world example of a successful engineering challenge to develop a smaller, lighter motion control solution.

Christian Meier, Senior Product Manager, SCHNEEBERGER 05.14.21

Contract Manufacturing

A Contract Manufacturer Selection Handbook

This article will offer considerations and best practices for selecting the right partner for your medical device development project.

Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21

Contract Manufacturing

Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A

A contract manufacturer should complement the OEM in every step of the product development process, from concept to commercialization.

Chronic Disease | Digital Health

Glooko, Eli Lilly Begin Connected Insulin Pen Collaboration

Will integrate Lilly's Tempo Pen and Tempo Smart Button with Glooko's platform.

Sam Brusco, Associate Editor 05.06.21

Five Tips to Protect IP While Working with a Freelancer

Freelancers provide various benefits, but you need to be able to know how to ensure you have a degree of trust with them.

Ramya Sriram, Digital Content Manager, Kolabtree 04.29.21

Electronics

EMS Providers Play Key Role in Product Development Amid Pandemic

EMS firms acting as 'a central point' to ensure 'all the pieces come together.'

Michael Barbella, Managing Editor 04.27.21

Electronics

OEMs Increasingly Choosing EMS Providers Closer to Home

Firstronic CEO notices preference among major device firms to reshore electronics manufacturing.

Michael Barbella, Managing Editor 04.23.21

Electronics

EMS' Engineering Resources Increasingly in Demand

Unpredictable demand, the need to reduce costs, and shorter production lead times driving companies to seek earlier interaction with product engineers.

Michael Barbella, Managing Editor 04.20.21

Electronics

Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

Devices with high-speed data capabilities and high-resolution video must be rugged enough to withstand OR environment and harsh sterilization methods.

Michael Barbella, Managing Editor 04.15.21

Nagarro Achieves ISO 13485 Certification

Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.

Michael Barbella, Managing Editor 04.14.21

Software & IT

Three Future Trends and Opportunities in Quality Assurance

As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.

David Jensen, Staff Writer, MasterControl 04.09.21

The Reality of Virtual Experiences for Medtech

VR presents a great way to expose doctors and other medical professionals to new technologies.

Sean Fenske, Editor-in-Chief 04.01.21

Contract Manufacturing | Software & IT | Testing

Quality & Regulatory Solutions for the FDA Regulated Industries

EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.

Electronics

Talented Labor Pool a Challenge for EMS Providers

Workers skilled in electrical wiring and installation in medical products can be difficult to find.

Michael Barbella, Managing Editor 03.31.21

Bassetti Acquires 3DTRUST

The deal expands Bassetti’s TEEXMA for additive manufacturing solution suite.

Michael Barbella, Managing Editor 03.31.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

Sam Brusco, Associate Editor 03.26.21

Software & IT

Using Quality as an Advantage in 2021

Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.

Jon Speer, Founder, Greenlight Guru 03.25.21

BGF Invests in Vascular Closure Devices Firm

Financing marks BFG's seventh Irish investment in the past two years.

Michael Barbella, Managing Editor 03.19.21

FDA Making Progress With Technology and Data Action Plans

There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

Alan Rencher, Vice President, Engineering, MasterControl 03.04.21

Contract Manufacturing | R&D & Design

SteriPack Acquires HS Design

Provides flexible and responsive design, development, and contract manufacturing solutions.

Sam Brusco, Associate Editor 02.23.21

Flywheel Secures $15 Million in Series B Funding

The funding will allow the company to deepen its presence in the life sciences and AI markets.

Michael Barbella, Managing Editor 02.19.21

J. Knipper and Company Adds to its Executive Team

Trio is charged with launching the company's third-party logistics (3PL) unit for 2021.

Michael Barbella, Managing Editor 02.16.21

R&D & Design

Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.

Dawn A. Lissy, President & Founder, Empirical 02.03.21

Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase

Dr. Mark Ostwald of Freudenberg Medical speaks to the changes to the supply chain as well as the benefits realized in communication options.

Dr. Mark Ostwald, President—Minimally Invasive Solutions and Europe, Freudenberg Medical 02.03.21

Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions

The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.

Michael Barbella, Managing Editor 01.29.21

Molding

Medtech Makers: Material Science for Micromolding

Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.

MedAcuity, Fathom Partner on Human Factors Engineering Services

Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.

Michael Barbella, Managing Editor 01.25.21

Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

Michael Barbella, Managing Editor 01.22.21

New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.

B3C newswire 01.08.21

Greenlight Guru and Nelson Labs Partner

Alliance helps customers mitigate risk and go to market faster.

Greenlight Guru 01.06.21

Impact of COVID-19 on the Medtech Supply Chain

Agility, reliability, and resiliency all describe objectives of a company’s supply chain management system.

Joe McBeth, Vice President, Global Supply Chain, Jabil 12.16.20

PTC to Acquire SaaS PLM Leader Arena Solutions

PTC reaffirms its cash flow targets for fiscal year 2021.

PR Newswire 12.16.20

4D Biomaterials Awarded Funding for 3D Tissue Scaffolds

The company's new polycarbonate-based resins can be formed into materials that have good shape memory, and tuneable mechanical and chemical properties.

4D Biomaterials 12.16.20

Survey Finds On-Site Inspections Plummeted by 93 Percent

Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.

Greenlight Guru 12.08.20

3D Systems, Veterans Health Administration Collaborate to Improve Patient Care

Additive manufacturing solutions at the point of care aim to foster innovation and enhance patient care.

3D Systems 12.03.20

Wytech Industries Names Henry Burmeister as CFO

Complex specialty core wire manufacturer adds to its management team.

Wytech Industries 12.02.20

Materials

Best Practices in Venting of Medical Devices

Learn how to design the best venting solution for your medical device using custom-engineered porous polymers in this webinar for medical device engineers.

12.01.20

R&D & Design

New Project-Based Rapid Precision Prototyping Program

Your First Step Is the Most Important

Indago Appoints President and General Counsel

New leader has 15 years of experience in the life sciences industry.

Business Wire 11.16.20

Diagnostics

Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent

Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.

Frost & Sullivan 11.10.20

Veteran Medical Device Executives Named to Dimension Inx Board

New members served as startup CEOs and Fortune 200 corporate executives.

Dimension Inx 11.05.20

Chronic Disease

Pharmaceutical Focus: A Look at Combination Products

Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.

Mark Crawford, Contributing Writer 11.04.20

3D/Additive Manufacturing

The Printed World: Additive Manufacturing in Medtech

Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.

Sam Brusco, Associate Editor 11.04.20

Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

Maria Shepherd, President and Founder, Medi-Vantage 11.04.20

Advanced Technology for Staking and Swaging Medical Plastics

It reliably assembles heat- and vibration-sensitive components, and works with a wide range of plastic materials.

Priyank Kishor, Global Product Manager—PulseStaking, Branson at Emerson 11.04.20

Quality Assurance When Supply Chain Disruptions Arise

From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.

Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20

Cardiovascular

CoreMap Completes $10.5 Million Series A Financing

Round led by Qure Ventures will accelerate development of CoreMap’s technology to enable curative, patient-specific treatment of atrial fibrillation.

Globe Newswire 10.23.20

First Patients Treated in Trial for Liver and Pancreas Sealant Patch

The patch is optimized to significantly reduce fluid leakage during the critical healing period after hepato-pancreato-biliary procedures.

B3C Newswire 10.22.20

Contract Manufacturing | Electronics

Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

But many companies are hesitant to start new development projects while the coronavirus is still rampant.

Michael Barbella, Managing Editor 10.05.20

An Update on the 2020 Presidential Election and Recent Regulatory Changes

The 2020 presidential election is heating up as both parties held their national conventions in late August.

Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 10.01.20

Materials

Beyond the Status Quo: Eight Often-Overlooked Areas of Medical Textile Product Development

Companies have been successful in bringing devices to market that support MIS approaches in part because of biomedical textile materials.

Shanzeh Farooqui, Development Engineering Lead, Cortland Biomedical 10.01.20

Device Success Contingent Upon Flexible Circuit Design

Defining the requirements unique to the medical application is essential before starting the design.

Michael Barbella, Managing Editor 09.30.20

Neurological

Medtronic Gets Patent Affirmation of Sacral Neuromodulation Tech

U.S. Patent and Trademark Office rejects IPR challenge to Medtronic patent.

PR Newswire 09.28.20

Let’s Build This: Best Practices for Utilizing External Regulatory Expertise

Building a regulatory submission is much like building a house and requires recognition of the order of steps that need to take place.

Michael C. Morton, Principal, Michael C. Morton Regulatory Affairs Consulting LLC 09.25.20

Patent Issued for Single-Use or Short-Term Nitric Oxide Delivery Device

This patent will provide Nu-Med Plus the IP protection to pursue individual nitric oxide treatment options in emergency situations.

Globe Newswire 09.21.20

Beaufort CRO Names Senior VP of Regulatory and Quality

Industry thought leader and veteran strategist to lead the further expansion of global regulatory and quality services.

Business Wire 09.11.20

Machine Solutions Acquires Crescent Design

The deal marks Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.

Machine Solutions Inc. 08.28.20

SaaS Solution Introduced for Guided Compliance in Medtech Product Development

Cognition Corporation's solution is designed to automate the product development process in compliance with industry standards.

PR Newswire 08.24.20

Xenocor Issued a U.S. Patent Protecting its Surgical Scopes Offering

Company claims the patent further bolsters its intellectual property patent portfolio.

PR Newswire 08.24.20

Surgical

Olympus Buys Arc Medical Design

Underscores Olympus' commitment to expanding its offering in gastrointestinal therapeutic devices.

PR Newswire 08.07.20

Cardiovascular | Neurological

New Design Principle Could Prevent Brain Shunt Catheter Failure

Major challenge in hydrocephalus catheters—clogging—could be overcome by leveraging catheter geometry.

Mindy Blodgett, Institute for Medical Engineering and Science, MIT 07.31.20

Patent Issuance Allowed for Single-Use or Short-Term Nitric Oxide Delivery Device

The allowance could open up new patient markets for Nu-Med Plus.

Globe Newswire 07.28.20

Patent Marking: The Proper Method to Display Protection

Manufacturers should have an active patent marking program that aids in deterring infringement while minimizing potential liability for false marking.

Douglas Portnow, Principal, Schwegman Lundberg & Woessner, P.A. 07.21.20

Recent Regulatory Changes and a 2020 Election Update

As COVID-19 continues to impact the country, legislators and policy makers in Washington are keenly focused on the upcoming national election on Nov. 3.

Jeffrey J. Kimbell, David C. Rudloff, Caroline P. Tucker, and Matteson L. Beckis, Jeffrey J. Kimbell & Associates Inc. 07.21.20

IRADIMED Issued Patent for Infusion Pump Remote Control

Latest patent expands previous claims around IRADIMED’s wireless communication.

Globe Newswire 07.13.20

Engineering and Manufacturing Partnerships: The Key to Successful Combination Products

Competent manufacturing partners can help combo product creators successfully develop any type of combo product.

Ursula Nollenberger, Product Line Director; Kevin Ehlert, Segment Manager, Trelleborg Healthcare & Medical 07.13.20

How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Sam Brusco, Associate Editor 06.09.20

Packaging & Sterilization

Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169

Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.

Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20

Emory, Georgia Tech Create COVID-19 Barrier Protection Devices

Aerosol box is designed to contain droplet spray.

Emory University

Forefront Medical Technology Changzhou, PRC Facility Capabilities Overview

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Hasbro, Cartamundi Partner to Produce Personal Protective Equipment

Companies to donate 50,000 face shields per week to local hospitals in Massachusetts and Rhode Island.

Business Wire 04.27.20

Mike on Medtech: FDA Pre-Sub Best Practices

Mike Drues and Sean Fenske discuss the most important factors to keep in mind when preparing to meet with the FDA during a pre-sub meeting.

Sean Fenske, Editor-in-Chief 04.24.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

The Medtech Supply Chain and COVID-19

How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?

Sean Fenske, Editor-in-Chief 04.22.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

Diagnostics

Blood Test May Help Doctors Catch Pancreatic Cancer Early

Penn study shows liquid biopsy may be viable option for both diagnosis and disease staging.

Penn Medicine 04.16.20

Patient Monitoring

PulseCam Maps Blood Flow

New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.

Rice University 04.13.20

Diagnostics

BD Gains Second EUA for CE-Marked Molecular Diagnostic Test

New test uses BD Max System to augment supply from existing collaborations; test results in under three hours.

BD 04.13.20

Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

Tolomatic 04.13.20

Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.

Sean Fenske, Editor-in-Chief 03.30.20

R&D & Design

Rice Joins U of U-Led Human Factors Consortium

Brings new expertise to the consortium, led by University of Utah.

University of Utah 03.30.20

Medtronic Shares Ventilator Design Specifications

The company aims to accelerate efforts to increase global ventilator production amid COVID-19.

Medtronic 03.30.20

FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test

Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.

Globe Newswire 03.30.20

Battelle Develops Decontamination System for Medical Protective Equipment

Organization receives FDA emergency use authorization to reprocess previously worn PPE.

Business Wire 03.30.20

Prent Supports the Fight Against COVID-19

The company is manufacturing and donating face shields.

Prent Corporation 03.30.20

Packaging & Sterilization

Mike on Medtech: EtO Sterilization Concerns

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.

Sean Fenske, Editor-in-Chief 03.30.20

Southern New England Design-2-Part Show

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01.02.20

Revenue-Based Financing: A New Form of Growth Capital

How revenue-based financing helped Xoran bring a new medical device to market.

John Borchers, Co-Founder and Managing Director of Decathlon Capital 11.25.19

Flambeau Appoints VP of Engineering and Technical Development

Wayne Laning joins the company.

Flambeau Inc. 11.22.19

Event info

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11.14.19

Packaging & Sterilization

Surgical Instrument Manufacturers: Stop Making Assumptions!

How assumptions are undermining your innovation and reputation.

Aaron Lieberman and Mark Hagerty, CCSVP 09.19.19

Patient Monitoring

Actiste Receives CE Mark

World’s first unified IoT diabetes care device.

Brighter 09.19.19

Current Health Names Chief Operating Officer

New hire will oversee product development and lead the company’s scaling strategy as it expands in U.S. and U.K. healthcare systems.

Business Wire 09.10.19

Customized Connections: A Discussion on Custom Electronics

Demand for more complex, traceable, integrated solutions are driving innovation in the fast-changing medical electronics market.

Michael Barbella, Managing Editor 09.09.19

R&D & Design

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