Introduction If FDA does not need to review your device before you sell it, how much of a quality system do you [..]
Introduction Scope creep is usually treated as a failure of planning. While this can be the case, we on the [..]
Introduction Early dialogue with the FDA has long been one of the most valuable tools in a device developer's [..]
Introduction On February 2, 2026, FDA's Quality Management System Regulation (QMSR) took effect, aligning 21 CFR [..]
Introduction Choosing an electronic quality management system (eQMS) is one of the higher-stakes decisions a [..]
Introduction A medical device concept can look great in CAD and still leave important questions unanswered. Does [..]
How generative AI challenges medical device regulation — validation, risk ownership, and the future of Regulatory [..]
Bringing Pulmera's CBeam™ to Market "Bringing a new technology to market takes a great team, and Kapstone [..]
Redefining the Medical Device Partnership The majority of medical device startups never reach commercial scale. [..]
Introduction You have a CE Mark. Your device is compliant under the EU Medical Device Regulation, it is on the [..]
Introduction: Content of Human Factors Information in Medical Device Marketing Submissions On May 29, 2026, FDA [..]
Our Shared Mission This picture, one of my favorites, always reminds me of our mission at Kapstone Medical and [..]
Introduction: The Crucial Early Steps of Medical Device Development If you want to bring an innovative medical [..]
Introduction For many clinical professionals, the inspiration for a new medical device comes directly from the [..]
Introduction Wondering how best to demonstrate substantial equivalence for your implantable device? FDA’s 2023 [..]
The Risk of Fragmented Development In the traditional medical device development model, regulatory strategy and [..]
Introduction The rapid expansion of robotics and artificial intelligence (AI) in orthopedics is transforming both [..]
Introduction For decades, the medical device industry operated under two distinct quality frameworks: the FDA’s 21 [..]
Watch: U.S. SBA Administrator Kelly Loeffler & CEO John Kapitan on Domestic MedTech Manufacturing Introduction The [..]
Our Visit with Kelly Loeffler, the 28th Administrator of the U.S. Small Business Administration We were thrilled [..]
Introduction For medical device startups, the path to market is often managed through a phase-gate approach: [..]
Introduction Design transfer is one of the most consequential moments in a medical device startup’s journey. It is [..]
The intent of this article is to consider the differences between flexible partnership models and venture equity [..]
For medical device startups and OEMs in Europe and Asia, the United States has always been an important [..]
Kapstone Medical offers flexible and customized Phase 0 Feasibility Studies to many startups and inventors. The [..]
Key Takeaways The Change: The FDA is replacing the legacy 21 CFR 820 with the Quality Management System Regulation [..]
Key Takeaways - Terminology Matters: The FDA does not "approve" all devices. Using the wrong term (e.g., claiming [..]
Key Takeaways: How Much Does It Really Cost to Develop a Medical Device? A Guide for Founders There are Many [..]
Key Takeaways: How to Evaluate a Medical Device Partner Require End-to-End Integration: Choose a partner who [..]
For a medical device startup, every decision impacts valuation. You're in a constant race to manage innovation, [..]
Key Takeaways Bridge the Gap to Funding: A Phase 0 Feasibility Study transforms a speculative clinical idea into a [..]
In the medical device industry, risk mitigation is non-negotiable. Device manufacturers are tasked with improving [..]
Innovation in the medical device industry drives ideas that lead to improved patient safety and better outcomes. [..]
Design transfer is an integral part of successful medical device production, yet on its face the one-sentence [..]
Navigating Regulatory Challenges: A Conversation with Kapstone's VP of Regulatory In the fast-changing world of [..]
Streamlining FDA Review: Strategic Solutions and Expert Insights In 2023, the FDA faced a significant surge in [..]
Every aspect of the medical device life cycle — from concept to post-market activities — is subject to [..]
If a medical device manufacturer intends to bring a product to market in the United States, it must notify the [..]
An effective medical device commercialization strategy is imperative for successful product launch and scaling. [..]
A number of decisions about bringing a medical device to market are dictated by regulatory requirements. Chief [..]
Let’s talk design controls – essential, but sometimes overlooked by even established medical device companies. [..]
Medical device companies hoping to bring their products to market in the European Union (EU) will now have to [..]
Food & Drug Administration (FDA) inspections are part of doing business as a medical device company in the United [..]
Under 21 CFR 820, the US FDA lays out current good manufacturing practices (GMP) pertaining to bringing safe and [..]
The regulatory framework around bringing a medical device to market in the United States is complex. While the US [..]
ISO 13485 certification is a routine practice for medical device manufacturers. So much so, in fact, that [..]
The complexities of medical device development don’t begin and end with the device. The process surrounding [..]
Whether the innovation of an established industry manufacturer or that of a newly formed startup, taking a medical [..]
The breakthrough technologies and innovations behind medical devices rapidly advance the quality of patient care. [..]
With the date for use of eSTAR for all 510(k) submissions fast approaching on October 1 2023, I decided it was [..]
Many ideas for new or improved medical devices come from observing a problem. Maybe a wearable is too heavy. Maybe [..]
FDA inspections are part of doing business as a medical device company in the United States. Sometimes, the FDA [..]
FDA Medical Device Classification and Definitions Regulatory affairs can often be the most challenging part of [..]
FDA registration is mandatory for all businesses involved in the commercialization of medical devices in the [..]
What features should you request for your ISO 13485 QMS? A Conversation With Jon Speer & David DeRam, Greenlight [..]
New Device Regulations Under MDR Annex XVI Starting on May 26, 2021, medical device companies hoping to [..]
When a medical device operates in combination with a drug or biologic, it is known as a combination product. [..]
Most medical device companies already have a QMS in place. It’s hard to track, document, and validate any of your [..]
No two companies can use exactly the same quality management system (QMS). These systems have to be designed with [..]
How does a surgeon inventor determine quickly and efficiently whether or not his idea has clinical and technical [..]
What is ISO 10993 and what is it used for? ISO 10993 is a set of international standards for the biological [..]
Kapstone Medical is a single-source solution for medical device companies We take a fully integrated approach to [..]
In previous installments of this eBook series, we touched on pointers for optimizing your chances of success as a [..]
This series of articles focuses on a different paradigm for bringing new ideas to market, one in which you as a [..]
Where do you start? How many different angles are involved? Here again there is no set formula, but the following [..]
Carolyn Guthrie explains the process of FDA requirements and classifications of a device. Kapstone Medical is a [..]
Carolyn Guthrie goes over the process of getting a 510k for your company. Kapstone Medical is a single-source [..]
Carolyn Guthrie discusses QMS: Quality Management System, and product related systems of a medical device. [..]
President & Founder, John Kapitan, speaks on the topic of Intellectual Property (IP), patents, and guiding a [..]
In this video, we’ll discuss: President & Founder, John Kapitan explains provisions made by Kapstone Medical to [..]
In this video, we’ll discuss: Justin Rowland explains the range that Kapstone Medical is involved in the product [..]
President & Founder, John Kapitan explains provisions made by Kapstone Medical to create efficiency and speed to [..]
Busy physicians often find themselves identifying a clinical need that could be satisfied with a new product or [..]
In order to commercialize medical devices in accordance with international standards, medical device and [..]
So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA [..]
The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, [..]
Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know Material selection is one [..]
A Conversation With John Kapitan | Founder & CEO, Kapstone Medical Medical device development companies large and [..]
A Conversation With David Walsh | Director of Engineering According to David Walsh, Director of Engineering at [..]
A Conversation With Justin Rowland | Project Manager Bringing a medical device to market is difficult for startup [..]
A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical Since 1906, the US Food and [..]
A Conversation with John Kapitan | Founder & CEO, Kapstone Medical Bringing a medical device to market is a [..]
Part 7 in a 7-part series on the EU’s Medical Device Regulation The European Database for Medical Devices [..]
Part 6 in a 7-part series on the EU’s Medical Device Regulation The new EU Medical Device Regulation (MDR) builds [..]
Part 5 in a 7-part series on the EU’s Medical Device Regulation Among the significant changes facing device makers [..]
Part 4 in our 7-part series on meeting the new requirements under the EU MDR Complying with the European Union’s [..]
Part 3 in our 7-part series on meeting the new requirements under the EU MDR If you are new to obtaining marketing [..]
Second in a 7-part series on the EU’s Medical Device Regulation The new Medical Devices Regulation (2017/745/EU), [..]
First in a 7-part series on the EU’s Medical Device Regulation The European Parliament passed the Medical Device [..]
Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing [..]
From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for [..]
Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to [..]
The FDA approved last July the first continuous glucose monitoring system that could free millions of people with [..]
Agency publishes details for conformity assessment The US Food and Drug Administration’s Center for Devices and [..]
BIOLIFE4D announced earlier this year that it has successfully 3D printed human cardiac tissue demonstrating the [..]
For patients with heart rhythm disorders, current pacemakers and implantable cardioverter defibrillators are [..]
The MedTech Industry has been very busy with 3D printing! From the first 3D printed human corneas and custom [..]
Achievement advances quest for bionic eye prototype The act of “seeing” is the result of a complex system of [..]
The dream is to eventually 3D print a spinal cord scaffold layered with viable neurons that can be implanted into [..]
The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed [..]
September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and [..]
In April, the U.S. FDA issued its first marketing permit for a medical device using artificial intelligence to [..]
The FDA issued a warning about vulnerabilities of medical devices to cybersecurity threats in a press release on [..]
Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical [..]
In a novel adaptation of the chip in your smartphone that tracks how your phone is oriented can turn a $50,000 2D [..]
August was another busy month for the MedTech Industry. From the discussion on medical device taxes to the [..]
The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in [..]
The Society of Manufacturing Engineers’ (SME) 2018 Annual Report took a deep dive look at medical additive [..]
Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as [..]
With the European Union’s General Data Protection Regulations (GDPR) going into effect May 2018, much of the [..]
With little fanfare in the media, researchers announced that they had successfully used 3D printing to produce the [..]
The reprocessed medical devices market will rise from nearly $983 million in 2015 to $3.35 billion by 2024 for a [..]
With the beginning of summer, there have also been many updates in the MedTech Industry in the month of June. [..]
The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory [..]
A new study has found the excise tax on medical devices enacted as part of the Affordable Care Act had a $665 [..]
Lots went on in the Medical Device, Manufacturing, and 3D Printing fields in the month of May. Luckily, we are [..]
Along with springtime showers, April brought a lot of interesting news in Medical Device Manufacturing and 3D [..]
FDA Commissioner aims to streamline review and beef up technical support
3D printing, also known as “additive manufacturing”, is a growing industry, specifically in the spinal surgery [..]
A major challenge to 3D printing living tissues is that many 3D printing techniques are based on using heat or [..]
According a systematic literature review in the Journal of Spine Surgery, the fast-growing 3D printing industry [..]
7 questions to ask before submitting 501(k) The FDA recently issued updates to its guidance for its “Refuse to [..]
February was a lovely month and has passed quickly as we celebrated Valentine’s Day and continued to work hard on [..]
The global market for 3D printed medical devices is poised for rapid growth according to a new market research [..]
3D printing doesn’t always have to be used for new, high-tech applications such as printing tailor-made medical [..]
Lots has happened in the MedTech Industry in the beginning of the New Year! The FDA has made statements concerning [..]
Busy clinicians often find themselves identifying a clinical need that a new product or new technology would fill. [..]
The House Committee on Energy and Commerce is calling on HHS to act promptly on all recommendations for medical [..]
In an update to its review of the International Medical Device Regulators Forum report the FDA in December [..]
3D printing is continuing to make major steps in the healthcare and MedTech Industry. From creating high business [..]
Did Republicans forget the medical device tax? When all the dust had settled following the passing of the Tax Cut [..]
Making the most of your Q-submissions How important is the FDA Pre-sub meeting? If saving time and money is [..]
November proved to be a busy month in the MedTech Industry. From a custom 3D printed shoulder implant helping a [..]
The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers [..]
The dream of using 3D printing technology to regenerate damaged or diseased tissues faces a number of [..]
It is probably safe to say that the advancements in additive manufacturing of medical devices have come at a pace [..]
Using 3D printing and sequential folding technology, researchers are proposing to revolutionize the way medical [..]
A Welch surgical team has performed the first jaw reconstruction surgery using 3D printed titanium specifically [..]
Another busy month has passed in the MedTech Industry; especially with 3D printing. From using custom 3D printed [..]
The topic of cybersecurity for medical devices became a hotter issue this past year amid several high-profile [..]
September was another demanding month for 3D printing and the Medical Device Industry. In case you missed it, here [..]
August was another busy month for the Medical Device Industry and 3D printing is continuing its evolution in the [..]
(Third in a series of posts on competitive research)
(Second in a series of posts on doing competitive research)
Stormram 4 sounds like the latest video game from Xbox, instead it is a unique robot made from 3D printed plastic [..]
The Medical Device Industry is continuing to evolve, especially in the area of 3D printed technology. The global [..]
(First in a series on developing competitive research skills)
Kapstone adds staff and expands services to continue guiding, equipping and inspiring the MedTech community
FDA exempts more than 1000 devices from 510(k) premarket submissions.
A lot happened in June; from the progression of joint cooperation between India and Japan for the development of [..]
FDA committed to fostering innovation in additive manufacturing.
SmartTech Publishing released a new study of additive manufacturing in orthopedics in May 2017. The market [..]
Brief roundup of medical grade 3D printing materials
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 [..]
The month of April was another busy one, especially in the Medical Device industry! April was jam packed with news [..]
The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections [..]
Most of us would love to continuously “be innovative” and create lots of intellectual property to create [..]
Will 2017 be a good year for MedTech in the US Healthcare Industry? Signs point to yes. Looking at the uncertain [..]
The Key to Creating Value from a Medical Device Idea? It’s YOU. Most physician inventor entrepreneurs tend to be [..]
February was a busy month for the MedTech world. From the FDA approval of a 3D printed cranial implant to the [..]
An industry analysis by Grant Moss of Adapt IP Ventures and reported in IAM online magazine, suggests that IP [..]
The FDA has approved OSSDsign’s new cranial implant that uses an innovative and patented composite material [..]
Stay up to date with the latest medical device manufacturing news. Here’s a recap while you were getting a start [..]
It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory [..]
Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting [..]
As summer drew to a close and the leaves began to turn to vivid shades of orange, red, and yellow, Team Kapstone [..]
It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D [..]
While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, [..]
Each month, as our team digs through the array of medical device, 3D printing, and orthopedics stories on the web, [..]
Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway [..]
It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with [..]
Welcome to the latest round of Kapstone Medical’s “What You Missed Last Month” in the Medical Device industry. [..]
It’s that time again—from the current catalysts behind the hand and wrist market to material innovation in [..]
While you were busy drawing up your latest medical device invention during the month of January, here are a few [..]
In late October, Medical Innovations Labs of Austin, TX announced their new 3D printing hub. They plan to provide [..]
The 3D printing industry is taking the orthopedics world by storm. Here at Kapstone, we’ve been watching the [..]
Surgeon inventors need to invest in intellectual property. The following dialogue outlines how a typical inventor [..]
In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to [..]
No matter where you turn, you are bound to run into a news headline expounding on the wonders of 3D printing. From [..]
While it may be enticing to look for possible suitors soon after inception of your idea, chances are that the full [..]
Our series of articles for the physician inventor continues with a three-part look into the business side of [..]
When and how to get constructive feedback throughout the development process
The Top Ten Things to Avoid
An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to [..]
Traditionally, as a surgeon inventor, you may have waited for one of the large implant companies to recognize the [..]
Is Your Next Product Idea Viable?
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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