Kapstone Medical Blog

Three Key Differences Between MDD and MDR

Medical device companies hoping to bring their products to market in the European Union (EU) will now have to [..]

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How to Develop Your Medical Device Go-to-Market Strategy

Many ideas for new or improved medical devices come from observing a problem. Maybe a wearable is too heavy. Maybe [..]

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FDA Cleared vs. Approved vs. Registered: The Difference

FDA approved vs. cleared vs. registered and what it means for your medical device The Food & Drug Administration [..]

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5 Facts About ISO 13485 Every Medical Device Manufacturer Needs to Know

ISO 13485 certification is a routine practice for medical device manufacturers. So much so, in fact, that [..]

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US FDA Q-submissions: A Comprehensive Guide for Medical Device Manufacturers

The regulatory framework around bringing a medical device to market in the United States is complex. While the US [..]

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How and When to Register Your Establishment with the FDA & Who Needs to Register

FDA registration is mandatory for all businesses involved in the commercialization of medical devices in the [..]

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Understanding 21 CFR 820.30 Design Controls for Medical Devices

Under 21 CFR 820, the US FDA lays out current good manufacturing practices (GMP) pertaining to bringing safe and [..]

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What is an ISO certification and what role does it play in the medical device industry?

In order to commercialize medical devices in accordance with international standards, medical device and [..]

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How to Determine FDA Primary Mode of Action

When a medical device operates in combination with a drug or biologic, it is known as a combination product. [..]

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Explore the Changes to Medical Device Classification Under EU MDR

The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, [..]

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4 Steps to Developing a Successful Medical Device Commercialization Strategy

An effective medical device commercialization strategy is imperative for successful product launch and scaling. [..]

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10 Tips on How to Respond to an FDA 483

FDA inspections are part of doing business as a medical device company in the United States. Sometimes, the FDA [..]

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Design Control Traceability Matrix: 5 Essentials for Medical Device OEMs

Every aspect of the medical device life cycle — from concept to post-market activities — is subject to [..]

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Implementing design controls: Medical device quality, compliance, & traceability

Let’s talk design controls – essential, but sometimes overlooked by even established medical device companies. [..]

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Using eSTAR and PreSTAR Templates

With the date for use of eSTAR for all 510(k) submissions fast approaching on October 1 2023, I decided it was [..]

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EU MDR and Post Market Surveillance: What You Need to Know

Part 6 in a 7-part series on the EU’s Medical Device Regulation The new EU Medical Device Regulation (MDR) builds [..]

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  • 08/28/2024

How Much Does it Cost to Develop a Medical Device?

How Much Does it Really Cost to Develop a Medical Device? A Conversation with Kapstone Medical's Experts Hayden [..]

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What is European MDR and Why It happened, Timelines for Compliance

First in a 7-part series on the EU’s Medical Device Regulation The European Parliament passed the Medical Device [..]

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What is an FDA 483, and How Do You Respond?

Food & Drug Administration (FDA) inspections are part of doing business as a medical device company in the United [..]

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5 Factors That Guide Successful Medical Device Consulting Partnerships

Whether the innovation of an established industry manufacturer or that of a newly formed startup, taking a medical [..]

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5 Ways a Medical Device Consultant Helps OEMs Overcome Regulatory Challenges

The breakthrough technologies and innovations behind medical devices rapidly advance the quality of patient care. [..]

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How medical device consultants guide successful 510(k) submissions

If a medical device manufacturer intends to bring a product to market in the United States, it must notify the [..]

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Annex XVI: What to do if Your Non-Medical Product is Subject to Regulation Under MDR

New Device Regulations Under MDR Annex XVI Starting on May 26, 2021, medical device companies hoping to [..]

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FDA Biocompatability: The Guide to the ISO 10993 Standards

What is ISO 10993 and what is it used for? ISO 10993 is a set of international standards for the biological [..]

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Using 3D Printed Parts To Make Low-cost Live-cell Imaging Microscope

3D printing doesn’t always have to be used for new, high-tech applications such as printing tailor-made medical [..]

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How GDPR Applies to Medical Devices

With the European Union’s General Data Protection Regulations (GDPR) going into effect May 2018, much of the [..]

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  • 10/07/2024

Navigating Regulatory Challenges: A Conversation with Kapstone's VP of Regulatory

Navigating Regulatory Challenges: A Conversation with Kapstone's VP of Regulatory In the fast-changing world of [..]

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4 Effective Strategies for Medical Device Development Cost Optimization

The complexities of medical device development don’t begin and end with the device. The process surrounding [..]

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How to Define and Classify Your Medical Device

FDA Medical Device Classification and Definitions Regulatory affairs can often be the most challenging part of [..]

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5 Signs Your Quality Management System Needs an Upgrade

Most medical device companies already have a QMS in place. It’s hard to track, document, and validate any of your [..]

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An Integrated vs. Piecemeal Approach to Product Development

In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to [..]

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The Pro’s and Con’s of Medical Device Materials

Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know Material selection is one [..]

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How Outsourced Regulatory Affairs Consultation Can Save Your Medical Device Company Time and Money

A Conversation with John Kapitan | Founder & CEO, Kapstone Medical Bringing a medical device to market is a [..]

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  • 08/02/2024

Streamlining FDA Review: Strategic Solutions and Expert Insights

Streamlining FDA Review: Strategic Solutions and Expert Insights In 2023, the FDA faced a significant surge in [..]

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Product Design & Development

In this video, we’ll discuss: Justin Rowland explains the range that Kapstone Medical is involved in the product [..]

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5 Simple Steps to Intellectual Property Development

Most of us would love to continuously “be innovative” and create lots of intellectual property to create [..]

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Kapstone Medical New Product Development (NPD) Roadmap

Kapstone Medical is a single-source solution for medical device companies We take a fully integrated approach to [..]

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510(k) Premarket Notifications: How to Determine Substantial Equivalence

A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical Since 1906, the US Food and [..]

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European MDR: EUDAMED Database and UDI

Part 7 in a 7-part series on the EU’s Medical Device Regulation The European Database for Medical Devices [..]

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Key to Creating Value from a Medical Device Idea

The Key to Creating Value from a Medical Device Idea? It’s YOU. Most physician inventor entrepreneurs tend to be [..]

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The Top 5 Features Medical Device Companies Request for Their Quality Management Systems

What features should you request for your ISO 13485 QMS? A Conversation With Jon Speer & David DeRam, Greenlight [..]

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4 Ways a Medical Device Design Consultancy Supports and Improves Innovation

Innovation in the medical device industry drives ideas that lead to improved patient safety and better outcomes. [..]

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ACA tax has $665 million impact on medical device industry

A new study has found the excise tax on medical devices enacted as part of the Affordable Care Act had a $665 [..]

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European MDR: Product Portfolios and Technical Documentation

Part 4 in our 7-part series on meeting the new requirements under the EU MDR Complying with the European Union’s [..]

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BioLIFE4D Has Successfully 3D Printed Human Cardiac Tissue

BIOLIFE4D announced earlier this year that it has successfully 3D printed human cardiac tissue demonstrating the [..]

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Regulatory Strategy

Carolyn Guthrie explains the process of FDA requirements and classifications of a device. Kapstone Medical is a [..]

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European MDR: How do we get ready for MDR?

Second in a 7-part series on the EU’s Medical Device Regulation The new Medical Devices Regulation (2017/745/EU), [..]

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4 Questions to Ask Before Submitting a 510(k)

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA [..]

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How a medical device consultant helps manufacturers manage quality and risk

A number of decisions about bringing a medical device to market are dictated by regulatory requirements. Chief [..]

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Why Kapstone?

President & Founder, John Kapitan explains provisions made by Kapstone Medical to create efficiency and speed to [..]

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5 Ways Medical Device Development Companies Can Save Money When Developing Products

A Conversation With John Kapitan | Founder & CEO, Kapstone Medical Medical device development companies large and [..]

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EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

Part 5 in a 7-part series on the EU’s Medical Device Regulation Among the significant changes facing device makers [..]

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Shape-shifting the Future of Medical Implants

Using 3D printing and sequential folding technology, researchers are proposing to revolutionize the way medical [..]

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How Kapstone Helps Medical Device Companies Upgrade Their QMS

No two companies can use exactly the same quality management system (QMS). These systems have to be designed with [..]

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European MDR: Notified Bodies

Part 3 in our 7-part series on meeting the new requirements under the EU MDR If you are new to obtaining marketing [..]

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World’s First Use of 3D Printing May Revolutionize Reconstructive Surgery

A Welch surgical team has performed the first jaw reconstruction surgery using 3D printed titanium specifically [..]

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5 Questions Inventor’s Need To Ask Before Developing Their Inventions

Busy clinicians often find themselves identifying a clinical need that a new product or new technology would fill. [..]

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6 Imperatives For Improving Cybersecurity in Healthcare

The House Committee on Energy and Commerce is calling on HHS to act promptly on all recommendations for medical [..]

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Using Competitor Research Throughout the Medical Device Product Development Lifecycle

A Conversation With David Walsh | Director of Engineering According to David Walsh, Director of Engineering at [..]

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3D printed Robot Fits Inside MRI For More Accurate Breast Biopsy

Stormram 4 sounds like the latest video game from Xbox, instead it is a unique robot made from 3D printed plastic [..]

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Playbook sets framework for dealing with medical device cybersecurity attacks

Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical [..]

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Developing Microspheres for 3D Printing Living Tissue

The dream of using 3D printing technology to regenerate damaged or diseased tissues faces a number of [..]

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Solving The Top 4 Challenges Medical Device Companies Face When Developing New Products

A Conversation With Justin Rowland | Project Manager Bringing a medical device to market is difficult for startup [..]

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Quality Assurance

Carolyn Guthrie discusses QMS: Quality Management System, and product related systems of a medical device. [..]

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FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with [..]

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Shared responsibility for cybersecurity of medical devices widely recognized

The FDA issued a warning about vulnerabilities of medical devices to cybersecurity threats in a press release on [..]

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A Roadmap to Success for Surgeon Inventors – Part 1: From Concept to Commercialization

Introduction Thomas Edison is quoted as saying, “Anything that won't sell, I don't want to invent. Its sale is [..]

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Manufacturing Solutions

In this video, we’ll discuss: President & Founder, John Kapitan explains provisions made by Kapstone Medical to [..]

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Reprocessing medical devices market to grow to $3 billion by 2024

The reprocessed medical devices market will rise from nearly $983 million in 2015 to $3.35 billion by 2024 for a [..]

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What You Missed Last Month August Edition (3D Printing and Healthcare)

August was another busy month for the Medical Device Industry and 3D printing is continuing its evolution in the [..]

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What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in [..]

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The Next Generation of 3D Printing

Brief roundup of medical grade 3D printing materials

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What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting [..]

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FDA Reconfirms Continued Acceptance of Single Audits

In an update to its review of the International Medical Device Regulators Forum report the FDA in December [..]

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Opportunities and Challenges in 3D Printing

SmartTech Publishing released a new study of additive manufacturing in orthopedics in May 2017. The market [..]

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How Medical Device OEMs Can Use ISO 14971 to Create a Risk Management Process

In the medical device industry, risk mitigation is non-negotiable. Device manufacturers are tasked with improving [..]

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A Roadmap to Success for Surgeon Inventors - Part 2: Is Your Next Product Idea Viable? The Case for Feasibility Studies

How does a surgeon inventor determine quickly and efficiently whether or not his idea has clinical and technical [..]

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The Steps to a 510k

Carolyn Guthrie goes over the process of getting a 510k for your company. Kapstone Medical is a single-source [..]

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How Intellectual Property Brings Value to an Inventor

Surgeon inventors need to invest in intellectual property. The following dialogue outlines how a typical inventor [..]

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Heart Implant, 3D Printed to Order

For patients with heart rhythm disorders, current pacemakers and implantable cardioverter defibrillators are [..]

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FDA's ASCA Pilot Program

Agency publishes details for conformity assessment The US Food and Drug Administration’s Center for Devices and [..]

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Systematic Review of 3D Printing in Spinal Surgery: The Current State of Play

3D printing, also known as “additive manufacturing”, is a growing industry, specifically in the spinal surgery [..]

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What You Missed Last Month November Edition (3D Printing)

November proved to be a busy month in the MedTech Industry. From a custom 3D printed shoulder implant helping a [..]

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Market Researchers See Double-digit Growth in 3D Medical Device Market

The global market for 3D printed medical devices is poised for rapid growth according to a new market research [..]

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Go Further with Your Idea with Project Manager, Justin Rowland

President & Founder, John Kapitan explains provisions made by Kapstone Medical to create efficiency and speed to [..]

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Staying Focused: Using A Framework For Your Competitive Research

(Second in a series of posts on doing competitive research)

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Emerging AI Applications in Medical Devices

In April, the U.S. FDA issued its first marketing permit for a medical device using artificial intelligence to [..]

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A Roadmap to Success for Surgeon Inventors - Part 1: From Concept to Commercialization

Busy physicians often find themselves identifying a clinical need that could be satisfied with a new product or [..]

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How to Identify and Navigate Medical Device Design Transfer Complexities

Design transfer is an integral part of successful medical device production, yet on its face the one-sentence [..]

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A Roadmap to Success for Surgeon Inventors - Part 5: The Top Ten Things to Avoid

In previous installments of this eBook series, we touched on pointers for optimizing your chances of success as a [..]

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Intellectual Property Insights from John Kapitan

President & Founder, John Kapitan, speaks on the topic of Intellectual Property (IP), patents, and guiding a [..]

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What You Missed Last Month (Apr 2015 Edition)

It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with [..]

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FDA’s Advice for Medical Device Interoperability

The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers [..]

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What You Missed Last Month (September 2015 Edition –Medical Device & 3D Printing)

As summer drew to a close and the leaves began to turn to vivid shades of orange, red, and yellow, Team Kapstone [..]

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What You Missed Last Month May Edition

Lots went on in the Medical Device, Manufacturing, and 3D Printing fields in the month of May. Luckily, we are [..]

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3D-printed device could treat spinal cord injuries

The dream is to eventually 3D print a spinal cord scaffold layered with viable neurons that can be implanted into [..]

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How Useful Are Pre-sub Meetings With the FDA?

Making the most of your Q-submissions How important is the FDA Pre-sub meeting? If saving time and money is [..]

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What You Missed Last Month – November Edition

Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to [..]

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Four of the Top 3D Printing Stories in Orthopedics in 2014

The 3D printing industry is taking the orthopedics world by storm. Here at Kapstone, we’ve been watching the [..]

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Medical 3D Printing is Pushing Metrology Labs to Keep Pace

It is probably safe to say that the advancements in additive manufacturing of medical devices have come at a pace [..]

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What You Missed Last Month (May Edition)

As usual, time is continuing to fly by and as time soars right by us so can the news! May has come and gone in the [..]

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FDA Approves OSSDsign’s 3D Printed Cranial Implant

The FDA has approved OSSDsign’s new cranial implant that uses an innovative and patented composite material [..]

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Three Considerations for 3D Printing of Medical Devices in 2015

In late October, Medical Innovations Labs of Austin, TX announced their new 3D printing hub. They plan to provide [..]

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Fast 3D Printing of Living Cells While Maintaining Viability

A major challenge to 3D printing living tissues is that many 3D printing techniques are based on using heat or [..]

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What You Missed Last Month - October (3D Printing)

The MedTech Industry has been very busy with 3D printing! From the first 3D printed human corneas and custom [..]

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Competitive Analysis: Determining Your Competitive Position

(Third in a series of posts on competitive research)

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Continuing Challenges Facing IP Valuation for Medical Device Innovations

An industry analysis by Grant Moss of Adapt IP Ventures and reported in IAM online magazine, suggests that IP [..]

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Leveraging 3D Printing For Small Hospitals and Device Developers

The Society of Manufacturing Engineers’ (SME) 2018 Annual Report took a deep dive look at medical additive [..]

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What You Missed Last Month – January Edition

Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing [..]

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8 Trends For 3D Printing in Spine

According a systematic literature review in the Journal of Spine Surgery, the fast-growing 3D printing industry [..]

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MedTech in the US Healthcare Industry

Will 2017 be a good year for MedTech in the US Healthcare Industry? Signs point to yes. Looking at the uncertain [..]

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What You Missed Last Month January Edition (3D Printing & Cybersecurity)

Lots has happened in the MedTech Industry in the beginning of the New Year! The FDA has made statements concerning [..]

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$10 chip changes standard ultrasound into 3D

In a novel adaptation of the chip in your smartphone that tracks how your phone is oriented can turn a $50,000 2D [..]

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FDA lists proposed guidance publications for 2019

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed [..]

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Ebook - Roadmap to Success for Surgeon Inventors - Part 4

This series of articles focuses on a different paradigm for bringing new ideas to market, one in which you as a [..]

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A Roadmap to Success for Surgeon Inventors - Part 3: Surgeon as Entrepreneur

Where do you start? How many different angles are involved? Here again there is no set formula, but the following [..]

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What You Missed Last Month (April Edition)

The month of April was another busy one, especially in the Medical Device industry! April was jam packed with news [..]

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FDA Exempts More Than 1000 Medical Devices from 510(k)

FDA exempts more than 1000 devices from 510(k) premarket submissions.

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What You Missed Last Month (June 2015 Edition- Medical Device & 3D Printing)

Each month, as our team digs through the array of medical device, 3D printing, and orthopedics stories on the web, [..]

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FDA’s Strategic Policy Roadmap for 2018

FDA Commissioner aims to streamline review and beef up technical support

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FDA Sets Priorities for 2016: What Does It Mean for Medical Devices?

It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory [..]

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What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway [..]

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Researchers 3D-print light receptor array on a curved surface

Achievement advances quest for bionic eye prototype The act of “seeing” is the result of a complex system of [..]

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What You Missed Last Month December Edition (3D Printing)

3D printing is continuing to make major steps in the healthcare and MedTech Industry. From creating high business [..]

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A Roadmap to Success for Surgeon Inventors, Part 4: The Cost of Developing Your Idea

This series of articles focuses on a different paradigm for bringing new ideas to market, one in which you as a [..]

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Competitive Research: Do It In-house or Outside? The Answer May Surprise You!

(First in a series on developing competitive research skills)

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What You Missed Last Month (Jan 2015 Edition)

While you were busy drawing up your latest medical device invention during the month of January, here are a few [..]

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What You Missed Last Month (January 2017 Edition)

Stay up to date with the latest medical device manufacturing news. Here’s a recap while you were getting a start [..]

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A Roadmap to Success for Surgeon Inventors, Part 3: Technologies for Development of Your Ideas

Traditionally, as a surgeon inventor, you may have waited for one of the large implant companies to recognize the [..]

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Making the Case for Industrial Design and Human Factors

An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to [..]

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A Roadmap to Success for Surgeon Inventors, Part 5 (installment 1 of 2)

The Top Ten Things to Avoid

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What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D [..]

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What You Missed Last Month September Edition (3D Printing and New Patents)

September was another demanding month for 3D printing and the Medical Device Industry. In case you missed it, here [..]

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What You Missed Last Month July Edition (3D Printing)

The Medical Device Industry is continuing to evolve, especially in the area of 3D printed technology. The global [..]

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What You Missed Last Month - April News on 3D Printing Advancements

Along with springtime showers, April brought a lot of interesting news in Medical Device Manufacturing and 3D [..]

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What You Missed Last Month – August 2018

August was another busy month for the MedTech Industry. From the discussion on medical device taxes to the [..]

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FDA Recommendations For Medical Device Cybersecurity

The topic of cybersecurity for medical devices became a hotter issue this past year amid several high-profile [..]

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What You Missed Last Month September

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and [..]

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What You Missed Last Month (Mar 2015 Edition)

Welcome to the latest round of Kapstone Medical’s “What You Missed Last Month” in the Medical Device industry. [..]

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Key In-sight news: 3D Printing Corneas

With little fanfare in the media, researchers announced that they had successfully used 3D printing to produce the [..]

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What You Missed Last Month October Edition (3D Printing)

Another busy month has passed in the MedTech Industry; especially with 3D printing. From using custom 3D printed [..]

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Roadmap to Success...Does Your Design Need a Second Opinion?

When and how to get constructive feedback throughout the development process

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What You Missed Last Month (July 2015 Edition –Medical Device & 3D Printing)

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, [..]

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What You Missed Last Month February Edition (3D Printing)

February was a lovely month and has passed quickly as we celebrated Valentine’s Day and continued to work hard on [..]

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What You Missed Last Month (February 2017 Edition)

February was a busy month for the MedTech world. From the FDA approval of a 3D printed cranial implant to the [..]

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FDA Seeks Feedback on Draft Guidelines For 3D Printing Medical Devices

FDA committed to fostering innovation in additive manufacturing.

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What You Missed Last Month (June Edition)

A lot happened in June; from the progression of joint cooperation between India and Japan for the development of [..]

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FDA Announces Updates to “Refuse to Accept Policy”

7 questions to ask before submitting 501(k) The FDA recently issued updates to its guidance for its “Refuse to [..]

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What You Missed With the New Year Tax Reform

Did Republicans forget the medical device tax? When all the dust had settled following the passing of the Tax Cut [..]

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What You Missed Last Month – December Edition

From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for [..]

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A Roadmap to Success for Surgeon Inventors, Part 5 (installment 2)

The Top Ten Things to Avoid

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Manufacturing at Home: Advancements in 3D Printing

No matter where you turn, you are bound to run into a news headline expounding on the wonders of 3D printing. From [..]

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A Roadmap to Success for Surgeon Inventors, Part 2: Is Your Next Product Idea Viable?

Is Your Next Product Idea Viable?

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What You Missed Last Month - June News - 3D Print Advancements

With the beginning of summer, there have also been many updates in the MedTech Industry in the month of June. [..]

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KAPSTONE MEDICAL CELEBRATES 10TH ANNIVERSARY

Kapstone adds staff and expands services to continue guiding, equipping and inspiring the MedTech community

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What You Missed Last Month July Edition

Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as [..]

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What You Missed Last Month (March Edition)

The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections [..]

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What You Missed Last Month (Feb 2015 Edition)

It’s that time again—from the current catalysts behind the hand and wrist market to material innovation in [..]

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Creating Exponential Value, Part II: What is Your Idea Worth?

While it may be enticing to look for possible suitors soon after inception of your idea, chances are that the full [..]

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NSF International offers online learning for MDSAP program

The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory [..]

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Creating Exponential Value, Part I: How Far Should You Take Your Idea?

Our series of articles for the physician inventor continues with a three-part look into the business side of [..]

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