Kapstone Medical Blog

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. [..]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Brief roundup of medical grade 3D printing materials

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 [..]

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

(Third in a series of posts on competitive research)

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

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

When and how to get constructive feedback throughout the development process

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

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

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

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

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

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

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

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

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

FDA Commissioner aims to streamline review and beef up technical support

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

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

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

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

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

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

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

(First in a series on developing competitive research skills)

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

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

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

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

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

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

The Top Ten Things to Avoid

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FDA committed to fostering innovation in additive manufacturing.

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

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

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

The Top Ten Things to Avoid

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

Is Your Next Product Idea Viable?

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

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

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

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

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 [..]