Using Competitor Research Throughout the Medical Device Product Development Lifecycle

May 26, 2020 / by Kapstone Medical / 6 minute read

A Conversation With David Walsh | Director of Engineering

 

According to David Walsh, Director of Engineering at Kapstone, medical device companies really only have one goal: to “make sure their device is ultimately widely accepted in the market, easily understood, and can be used safely and effectively.” Sums it up, doesn’t it?

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

May 15, 2020 / by Kapstone Medical / 5 minute read

A Conversation With Justin Rowland | Project Manager

Bringing a medical device to market is difficult for startup and established medical device companies alike. Though the development and approval process can sometimes take years, those years are jam-packed with requirements and milestones that can challenge even the most experienced companies.

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

April 15, 2020 / by Kapstone Medical / 5 minute read

A Conversation with Kellen Hills | Regulatory Affairs Specialist, Kapstone Medical

Since 1906, the US Food and Drug Administration (more commonly known as the FDA) has protected consumers against the threat posed by adulterated, mislabeled, unsafe, or otherwise ineffective food and drug products. Regulatory affairs consultant Kellen Hills notes that before the FDA was empowered to regulate these products, “people were getting sick and dying because of unsavory characters putting things out on the market, making false claims about what they did with no oversight.” 

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

March 31, 2020 / by Justin Rowland / 4 minute read

A Conversation with John Kapitan | Founder & CEO, Kapstone Medical

Bringing a medical device to market is a challenging process, to say the least. From ideation to product classification to obtaining final approval in a target market, so many of these necessary steps can become pain points for established and fledgling companies alike. 

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European MDR: EUDAMED Database and UDI

January 16, 2020 / by Kapstone Medical / 3 minute read

Part 7 in a 7-part series on the EU’s Medical Device Regulation

The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro Diagnostics Devices Directive (IVDD) and included the Medical Devices Directive (MDD).

Under the new MDR that replaces the MDD, the European Commission recognized that to fully support the more stringent requirements for filing, reporting, and continuing surveillance, it would need to greatly expand the capabilities of the database for monitoring and data collection.

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European MDR: Post-Market Surveillance

January 8, 2020 / by Kapstone Medical / 3 minute read

Part 6 in a 7-part series on the EU’s Medical Device Regulation

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF) that moves closer to the FDA’s approach.

The FDA defines PMS as the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.”

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EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

December 18, 2019 / by Kapstone Medical / 3 minute read

Part 5 in a 7-part series on the EU’s Medical Device Regulation

Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence.

Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles, but if you also market in the US, Canada, Japan, or other countries, the new regulations will likely be familiar to you.

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European MDR: Product Portfolios and Technical Documentation

December 12, 2019 / by Kapstone Medical / 4 minute read

Part 4 in our 7-part series on meeting the new requirements under the EU MDR

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers marketing products inside the EU. One of the most taxing efforts for companies that already have CE-marked devices in the EU is the need for portfolio reviews.

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European MDR: Notified Bodies

December 4, 2019 / by Kapstone Medical / 3 minute read

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most significant differences from the US FDA system or regulatory oversight.

A Notified Body is an independent certification organization that is “notified” by an EU member state’s Competent Authority, usually the ministry of health, to certify that a product meets the applicable requirements for CE marking.

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European MDR: How do we get ready for MDR?

November 21, 2019 / by Kapstone Medical / 5 minute read

Second in a 7-part series on the EU’s Medical Device Regulation

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to medical device makers that want to market their products in the European Union.

The clock is already ticking and the three-year transition period is counting down to 26 May 2020, which is the “Date of Application” (DoA) of the Regulation.

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

November 13, 2019 / by Kapstone Medical / 4 minute read

First in a 7-part series on the EU’s Medical Device Regulation

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.

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What You Missed Last Month – January Edition

February 4, 2019 / by Kapstone Medical / 1 minute read

Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing machines to the creation of 3D printed organs to more streamlined processes by the FDA to approve 3D medical devices. Here is a quick overview of what you missed:

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What You Missed Last Month – December Edition

January 31, 2019 / by Kapstone Medical / 1 minute read

From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of December. Here is a quick overview of what you missed:

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What You Missed Last Month – November Edition

December 29, 2018 / by Kapstone Medical / 2 minute read

Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of November. Here is a quick overview of what you missed:

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

December 26, 2018 / by Kapstone Medical / 1 minute read

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

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FDA's ASCA Pilot Program

December 20, 2018 / by Kapstone Medical / 1 minute read

Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment, or ASCA.

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BioLIFE4D Has Successfully 3D Printed Human Cardiac Tissue

December 11, 2018 / by Kapstone Medical / 2 minute read

BIOLIFE4D announced earlier this year that it has successfully 3D printed human cardiac tissue demonstrating the ability to 3D bio-print viable tissue for transplant.

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Heart Implant, 3D Printed to Order

December 7, 2018 / by Kapstone Medical / 2 minute read

For patients with heart rhythm disorders, current pacemakers and implantable cardioverter defibrillators are “one-size-fits- all” devices that provide narrowly limited information for cardiologists treating patients with the devices.

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

November 28, 2018 / by Kapstone Medical / 1 minute read

The MedTech Industry has been very busy with 3D printing! From the first 3D printed human corneas and custom cardiac surgical devices to 3D printing helping in the development of mobile phone based medical devices, there was a lot of exciting events that occurred in October.

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

November 20, 2018 / by Kapstone Medical / 2 minute read

Achievement advances quest for bionic eye prototype

The act of “seeing” is the result of a complex system of biological tissues that capture and focus light onto an array of photosensitive receptors in the retina that converts light into electrical signals and sends them to the brain through the optical nerve.

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3D-printed device could treat spinal cord injuries

November 5, 2018 / by Kapstone Medical / 2 minute read

The dream is to eventually 3D print a spinal cord scaffold layered with viable neurons that can be implanted into a human spinal cord and rebuild damaged neural connections and restore mobility to people with spinal cord injuries.

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FDA lists proposed guidance publications for 2019

October 30, 2018 / by Kapstone Medical / 1 minute read

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

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What You Missed Last Month September

October 29, 2018 / by Kapstone Medical / 1 minute read

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and how to handle the latest Medical Device Regulation, a woman’s collapsed ankle was restored with a 3D printed ankle implant, and a new report shows that the medical additive manufacturing field will see significant growth in the coming years. Here is a quick look at what you missed last month:

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Emerging AI Applications in Medical Devices

October 23, 2018 / by Kapstone Medical / 3 minute read

In April, the U.S. FDA issued its first marketing permit for a medical device using artificial intelligence to detect greater than mild diabetic retinopathy. While it was the first such AI approval, it promises to be just the beginning of AI medical devices.

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Shared responsibility for cybersecurity of medical devices widely recognized

October 22, 2018 / by Kapstone Medical / 2 minute read

The FDA issued a warning about vulnerabilities of medical devices to cybersecurity threats in a press release on Oct. 1, 2018 and is taking steps to help organizations improve cybersecurity of their medical devices.

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Playbook sets framework for dealing with medical device cybersecurity attacks

October 18, 2018 / by Kapstone Medical / 2 minute read

Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical devices, the FDA announced in an October 1, 2018 press release the publication of its Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.

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$10 chip changes standard ultrasound into 3D

October 3, 2018 / by Kapstone Medical / 2 minute read

In a novel adaptation of the chip in your smartphone that tracks how your phone is oriented can turn a $50,000 2D ultrasound machine into an ultrasound with 3D capabilities rivaling that of $250,000 counterparts. And here is the wow factor, the chip costs $10.

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What You Missed Last Month – August 2018

September 28, 2018 / by Kapstone Medical / 1 minute read

August was another busy month for the MedTech Industry. From the discussion on medical device taxes to the prospect of 3D printing transforming the healthcare industry, the month was filled with lots of important discussions within the industry. Here is a quick recap of what you missed in the Medical Device Industry in August:

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

September 24, 2018 / by Kapstone Medical / 2 minute read

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment from the industry prior to finalization.

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Leveraging 3D Printing For Small Hospitals and Device Developers

September 13, 2018 / by Kapstone Medical / 2 minute read

The Society of Manufacturing Engineers’ (SME) 2018 Annual Report took a deep dive look at medical additive manufacturing, more commonly referred to as 3D printing.

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What You Missed Last Month July Edition

August 29, 2018 / by Kapstone Medical / 1 minute read

Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as a threat to additive manufacturing, the FDA is urging companies to go paperless, and there has been a recent development in 3D printing that will allow biological tissues to be created. Here is a short overview of what you missed in the month of July:

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How GDPR Applies to Medical Devices

August 17, 2018 / by Kapstone Medical / 3 minute read

With the European Union’s General Data Protection Regulations (GDPR) going into effect May 2018, much of the attention has been on its impact on Internet websites and applications that gather personal information, but it also affects makers of medical devices that offer goods or services to, or monitor the behavior of EU data subjects, according to the EU GDPR organization.

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British Researchers Report First 3D Printed Human Corneas

August 9, 2018 / by Kapstone Medical / 2 minute read

With little fanfare in the media, researchers announced that they had successfully used 3D printing to produce the first human corneas for transplant.

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

July 31, 2018 / by Kapstone Medical / 2 minute read

The reprocessed medical devices market will rise from nearly $983 million in 2015 to $3.35 billion by 2024 for a 14.9 percent CAGR according to a report by the market research firm Transparency Market Research (TMP).

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What You Missed Last Month June Edition

July 28, 2018 / by Kapstone Medical / 1 minute read

With the beginning of summer, there have also been many updates in the MedTech Industry in the month of June. There has been a 3D printing technique that has the capability of printing biological tissues from multiple tissues, the FDA is now encouraging companies to use electronic systems to move towards a paperless manufacturing process, and the new EU Medical Device Regulation has shown potential to threaten the use of additive manufacturing in medical device creations. Here is a quick recap of what you missed last month:

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NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical / 1 minute read

The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical device industry in the five countries participating in Medical Device Single Audit Program (MDSAP).

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ACA tax has $665 million impact on medical device industry

July 24, 2018 / by Kapstone Medical / 2 minute read

A new study has found the excise tax on medical devices enacted as part of the Affordable Care Act had a $665 million impact on the medical device industry, according to an Iowa State University researcher.

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What You Missed Last Month May Edition

June 29, 2018 / by Kapstone Medical / 2 minute read

Lots went on in the Medical Device, Manufacturing, and 3D Printing fields in the month of May. Luckily, we are here to keep you up-to-date. From 3D printing replacing injection molding to discussions on boosting medical device safety, there is a lot to share that went on last month. Here is a quick overview of what you missed:

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What You Missed Last Month April Edition

May 31, 2018 / by Kapstone Medical / 1 minute read

Along with springtime showers, April brought a lot of interesting news in Medical Device Manufacturing and 3D Printing. In case you missed it, here are a few highlights of what happened in the MedTech Industry in April.

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FDA’s Strategic Policy Roadmap for 2018

April 25, 2018 / by Kapstone Medical / 2 minute read

FDA Commissioner aims to streamline review and beef up technical support

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

April 20, 2018 / by Kapstone Medical / 0 minute read

3D printing, also known as “additive manufacturing”, is a growing industry, specifically in the spinal surgery area. The anatomy of the spine is complex, and the nature of the surrounding structures are extremely delicate. Three-dimensional printing has shown the potential to aid surgical planning and enhance procedural accuracy.

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Fast 3D Printing of Living Cells While Maintaining Viability

April 17, 2018 / by Kapstone Medical / 2 minute read

A major challenge to 3D printing living tissues is that many 3D printing techniques are based on using heat or ultraviolet light, which can damage or kill living cells.

To address this challenge, researchers at the University of Twente (UT) in Enschede, Netherlands are taking a page from biochip technology that adapted microfluidics for a variety of biocompatible applications.

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8 Trends For 3D Printing in Spine

April 6, 2018 / by Kapstone Medical / 1 minute read

According a systematic literature review in the Journal of Spine Surgery, the fast-growing 3D printing industry could lead to enhanced spine implants, decreased surgical time, and improved patient outcomes in spine surgery. Here are eight trends in the spine surgery industry for 3D printing:

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FDA Announces Updates to “Refuse to Accept Policy”

April 2, 2018 / by Kapstone Medical / 2 minute read

7 questions to ask before submitting 501(k)

The FDA recently issued updates to its guidance for its “Refuse to Accept Policy for 510(k)s” for Center for Biologics Evaluation and Research-regulated (CBER) devices and for “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).”

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

March 28, 2018 / by Kapstone Medical / 1 minute read

February was a lovely month and has passed quickly as we celebrated Valentine’s Day and continued to work hard on our New Year resolutions. In case you haven’t had the chance to catch up, here is what happened last month in 3D printing and the Medical Device Industry.

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

March 16, 2018 / by Kapstone Medical / 1 minute read

The global market for 3D printed medical devices is poised for rapid growth according to a new market research report by Transparency Market Research.

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

March 7, 2018 / by Kapstone Medical / 1 minute read

3D printing doesn’t always have to be used for new, high-tech applications such as printing tailor-made medical devices. Researchers at Uppsala University have used 3D printing to create an inexpensive tool to make live image videos of living cells.

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

February 28, 2018 / by Kapstone Medical / 1 minute read

Lots has happened in the MedTech Industry in the beginning of the New Year! The FDA has made statements concerning the future of 3D printing in medicine as well as provided recommendations for medical device cybersecurity, which has become an increasingly popular topic in healthcare. Take a quick look at what you missed in the month of January:

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

February 22, 2018 / by Kapstone Medical / 2 minute read

Busy clinicians often find themselves identifying a clinical need that a new product or new technology would fill. If you think you have a marketable idea, you need to know there is a long and winding road to bringing an invention to market.

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6 Imperatives For Improving Cybersecurity in Healthcare

February 20, 2018 / by Kapstone Medical / 1 minute read

The House Committee on Energy and Commerce is calling on HHS to act promptly on all recommendations for medical device security suggested by the Healthcare Cybersecurity Task Force.

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FDA Reconfirms Continued Acceptance of Single Audits

February 9, 2018 / by Kapstone Medical / 1 minute read

In an update to its review of the International Medical Device Regulators Forum report the FDA in December reconfirmed that it will continue to accept results of the Medical Device Single Audit Program (MDSAP) for medical device regulatory approval.

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

January 29, 2018 / by Kapstone Medical / 1 minute read

3D printing is continuing to make major steps in the healthcare and MedTech Industry. From creating high business value in the Healthcare Industry and revolutionizing personalized healthcare, 3D printing is continuing to make a major impact in healthcare. Here’s what you missed in additive manufacturing in the month of December:

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What You Missed With the New Year Tax Reform

January 17, 2018 / by Kapstone Medical / 2 minute read

Did Republicans forget the medical device tax?

When all the dust had settled following the passing of the Tax Cut and Jobs Act, the $1.5 trillion Republican tax overhaul, the medical device industry was left scratching its collective head and asking what happened to the medical device excise tax repeal?

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How Useful Are Pre-sub Meetings With the FDA?

January 3, 2018 / by Kapstone Medical / 1 minute read

Making the most of your Q-submissions

How important is the FDA Pre-sub meeting? If saving time and money is important, then taking advantage of the FDA Pre-submission meeting program is key.

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FDA’s Advice for Medical Device Interoperability

December 29, 2017 / by Kapstone Medical / 2 minute read

The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers insight into what the agency is looking for in terms of safety and effectiveness for medical devices that are connected to each other and to other technology.

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

December 29, 2017 / by Kapstone Medical / 1 minute read

November proved to be a busy month in the MedTech Industry. From a custom 3D printed shoulder implant helping a patient overcome the wounds of a shooting tragedy to the world’s first jaw reconstruction surgery using 3D printing. Here’s what you missed last month:

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Developing Microspheres for 3D Printing Living Tissue

December 20, 2017 / by Kapstone Medical / 1 minute read

The dream of using 3D printing technology to regenerate damaged or diseased tissues faces a number of technological and biological challenges, not the least of which is providing the new tissues with just the right amount of a complex mix of proteins referred to as growth factors needed for development of stem cells after implantation.

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Medical 3D Printing is Pushing Metrology Labs to Keep Pace

December 18, 2017 / by Kapstone Medical / 2 minute read

It is probably safe to say that the advancements in additive manufacturing of medical devices have come at a pace that has outstripped the visions of even the most ardent supporters. 3D printed devices have already been implanted into people’s backs, skulls and jaws.

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Shape-shifting the Future of Medical Implants

December 14, 2017 / by Kapstone Medical / 2 minute read

Using 3D printing and sequential folding technology, researchers are proposing to revolutionize the way medical implants are produced and implanted.

The technique called, “shape-shifting” is being pioneered by Professor Amir Zadpoor and his research team at Delft University of Technology in the Netherlands.

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

November 24, 2017 / by Kapstone Medical / 2 minute read

Another busy month has passed in the MedTech Industry; especially with 3D printing. From using custom 3D printed valve models for heart surgery to the FDA presenting its case for regulating 3D printed technology, lots of exciting things happened in the month of October. Here’s what you missed last month:

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

November 24, 2017 / by Kapstone Medical / 1 minute read

A Welch surgical team has performed the first jaw reconstruction surgery using 3D printed titanium specifically designed for the patient, resulting in much more natural result.

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FDA Recommendations For Medical Device Cybersecurity

November 22, 2017 / by Kapstone Medical / 2 minute read

The topic of cybersecurity for medical devices became a hotter issue this past year amid several high-profile hospital cybersecurity breaches, and the FDA is paying close attention.

In a blog post on the FDA’s site, Suzanne B. Schwartz, the FDA’s Associate Director for Science and Strategic Partnerships at the Center for Devices and Radiological Health, she outlined the FDA’s approach to medical device cyber safety.

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

October 25, 2017 / by Kapstone Medical / 1 minute read

September was another demanding month for 3D printing and the Medical Device Industry. In case you missed it, here are some of the highlights of what happened last month from new patents to advances in 3D printing and design.

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

September 25, 2017 / by MedTech Momentum / 1 minute read

August was another busy month for the Medical Device Industry and 3D printing is continuing its evolution in the healthcare industry. Here is a quick look of what happened last month from 3D printing and robotic surgery to the transformation of biomedical research and healthcare.

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Competitive Analysis: Determining Your Competitive Position

September 11, 2017 / by Kapstone Medical / 2 minute read

(Third in a series of posts on competitive research)

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Staying Focused: Using A Framework For Your Competitive Research

August 31, 2017 / by Kapstone Medical / 2 minute read

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

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

August 28, 2017 / by MedTech Momentum / 2 minute read

Stormram 4 sounds like the latest video game from Xbox, instead it is a unique robot made from 3D printed plastic that may provide an unprecedented level of accuracy in doing breast cancer biopsies.

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

August 25, 2017 / by MedTech Momentum / 2 minute read

The Medical Device Industry is continuing to evolve, especially in the area of 3D printed technology. The global medical device market is set for growth and 3D printed medical models are now being used to help surgeons better plan and execute surgeries. In case you missed it, here is a quick recap of what happened in 3D printing and the medical device industry in July.

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

August 21, 2017 / by Kapstone Medical / 1 minute read

(First in a series on developing competitive research skills)

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KAPSTONE MEDICAL CELEBRATES 10TH ANNIVERSARY

August 15, 2017 / by Kapstone Medical / 1 minute read

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

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

August 10, 2017 / by MedTech Momentum / 2 minute read

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

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What You Missed Last Month (June Edition)

July 24, 2017 / by MedTech Momentum / 2 minute read

A lot happened in June; from the progression of joint cooperation between India and Japan for the development of an international regulatory ecosystem to a wide range of updates in the 3D printing world. Here’s a quick recap of some of the top stories in the 3D printing and MedTech Industry.

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

July 5, 2017 / by MedTech Momentum / 1 minute read

FDA committed to fostering innovation in additive manufacturing.

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Opportunities and Challenges in 3D Printing

June 26, 2017 / by MedTech Momentum / 2 minute read

SmartTech Publishing released a new study of additive manufacturing in orthopedics in May 2017. The market research company says their paper “Additive Orthopedics: Markets for 3D Printed Medical Implants 2017,” is an in-depth look and analysis of the opportunities specific to the use of additive manufacturing or 3D printing technology for medical applications.

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Next Generation 3D Printing: Era of Individualized Implants

June 22, 2017 / by MedTech Momentum / 2 minute read

Brief roundup of medical grade 3D printing materials

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What You Missed Last Month (May Edition)

June 20, 2017 / by MedTech Momentum / 2 minute read

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 blink of an eye and has given us great updates in International Regulations and 3D printing news. Here is a quick recap of what you missed in the Medical Device Industry in the busy month of May.

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What You Missed Last Month (April Edition)

May 26, 2017 / by MedTech Momentum / 1 minute read

 

The month of April was another busy one, especially in the Medical Device industry! April was jam packed with news about the latest outlook of the medical design and manufacturing fields, the advancements of 3D printing technology in surgical training, and the key risks in product development. So, in case you missed it, here are a few highlights of medical device news from April. 

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What You Missed Last Month (March Edition)

April 26, 2017 / by MedTech Momentum / 1 minute read

The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections were filed, regulations were proposed for the medical device industry, and research was conducted on the effects of 3D printing on the pharma and medical device markets. So, in case you missed it, here is a quick recap of what you might have missed in the Medical Device Industry last month.

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5 Simple Steps to Intellectual Property Development

April 12, 2017 / by MedTech Momentum / 3 minute read

Most of us would love to continuously “be innovative” and create lots of intellectual property to create exponential value for our companies.  But saying that is a whole lot easier than doing it. As with anything, having a basic framework and process for creating an intellectual property (IP) pipeline is vital to getting where you want to go with your company. Much like the way Google Maps works, an Intellectual Property Development Process provides a sort of roadmap for generating value.

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MedTech in the US Healthcare Industry

March 28, 2017 / by MedTech Momentum / 2 minute read

Will 2017 be a good year for MedTech in the US Healthcare Industry? Signs point to yes.

Looking at the uncertain healthcare landscape under the new Trump administration, predicting future healthcare markets seems like an exercise in magic 8-ball prediction. You know the toy that answers any yes or no question with some ambiguous answer like, “Luck is on your side.”

Bloomberg reported that in a conference call, AstraZeneca Plc CEO Pascal Soriot pointing to the daily uncertainty over repeal and replacement of the ACA, financing care, and in rule setting for everything from how hospitals operate to which drugs can be sold said, “You really cannot predict the unpredictable.”

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Key to Creating Value from a Medical Device Idea

March 23, 2017 / by MedTech Momentum / 2 minute read

The Key to Creating Value from a Medical Device Idea? It’s YOU.

Most physician inventor entrepreneurs tend to be “idea people” and often their business experience is in practice management, while their intellectual property development experience is more limited. This often leads to a kind of paralysis as an “idea person” fears losing their idea by working with others with business development experience. By placing too high a priority on protecting and monetizing the idea too quickly, the entrepreneurs often stall out long before they can turn their idea into reality.

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What You Missed Last Month (February 2017 Edition)

March 15, 2017 / by MedTech Momentum / 1 minute read

February was a busy month for the MedTech world. From the FDA approval of a 3D printed cranial implant to the evolution of the Medical Device Industry in 2017, here is a quick recap of what you missed last month in the Medical Device Industry in February:

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Continuing Challenges Facing IP Valuation for Medical Device Innovations

February 23, 2017 / by MedTech Momentum / 1 minute read

An industry analysis by Grant Moss of Adapt IP Ventures and reported in IAM online magazine, suggests that IP valuation within the medical device industry appear to be declining. The analysis based on a study of identified licensing transactions and royalty rates, suggests that increasing IP values will face continuing challenges in the coming year.

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FDA Approves OSSDsign’s 3D Printed Cranial Implant

February 20, 2017 / by MedTech Momentum / 0 minute read

The FDA has approved OSSDsign’s new cranial implant that uses an innovative and patented composite material printed to exact patient needs with a 3D printer.

The Uppsala, Sweden-based designer, manufacturer and distributor constructs individually designed and printed cranial implants using the patient's computer tomography (CT) information. The OssDsign system combines advanced computer-assisted design (CAD) with a proprietary calcium phosphate composite as a 3D printing material, which is reinforced by a titanium skeleton.

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What You Missed Last Month (January 2017 Edition)

February 6, 2017 / by MedTech Momentum / 1 minute read

Stay up to date with the latest medical device manufacturing news. Here’s a recap while you were getting a start on the New Year with some of the top stories in the manufacturing and the MedTech world. Here’s what you missed last month:

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

March 16, 2016 / by MedTech Momentum / 1 minute read

It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory science and introduce revised data quality standards.
From leveraging Big Data for regulatory decision making, to enhancing diverse population data for clinical trials and studies, the agency’s 2016 goals are guided by the medical device industry’s call for increased participation, transparency, and overall quality. What do these changes mean for medical devices?

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

January 7, 2016 / by Kapstone Medical / 2 minute read

While you were enjoying your holiday vacation, Team Kapstone compiled some of the best stories to Inspire, Equip, and Guide you in 3D printing and the latest in emerging world of technology. So here’s what you missed last month:

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

November 13, 2015 / by Kapstone Medical / 2 minute read

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

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

October 22, 2015 / by MedTech Momentum / 2 minute read

As summer drew to a close and the leaves began to turn to vivid shades of orange, red, and yellow, Team Kapstone was busy exploring the most educational and inspirational stories in 3D printing, medical device, and orthopedics. We are proud to provide our season-changing September “What You Missed” articles that inspired, equipped, and guided us through the end of summer and the advent of autumn:

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

September 16, 2015 / by Kapstone Medical / 1 minute read

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading list - three articles to Inspire, Equip, and Guide you through the last month:

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

August 12, 2015 / by Kapstone Medical / 2 minute read

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, medical devices, and orthopedics. Catch back up with three articles to Inspire, Equip, and Guide you through what you missed in July:

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

July 10, 2015 / by Kapstone Medical / 2 minute read

Each month, as our team digs through the array of medical device, 3D printing, and orthopedics stories on the web, a theme seems to emerge and dominate the MedTech headlines. Throughout June 2015, the most-read stories surrounded 3D printing of tissues and 3D printing’s overall potential in healthcare, now and beyond.

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

June 10, 2015 / by Kapstone Medical / 3 minute read

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most inspiring and thought-provoking topics of 2015.

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What You Missed Last Month (Apr 2015 Edition)

May 2, 2015 / by Kapstone Medical / 2 minute read

It’s time to catch up, and Kapstone Medical is ready to equip and guide you through the month of April 2015 with some of the most interesting, engaging, and inspiring news from the FDA, biomedical, and 3D printing communities. Read on for what you may have missed last month:

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What You Missed Last Month (Mar 2015 Edition)

April 17, 2015 / by Kapstone Medical / 2 minute read

Welcome to the latest round of Kapstone Medical’s “What You Missed Last Month” in the Medical Device industry. Here’s what you missed in Med Device and 3D Printing industry for the month of March:

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What You Missed Last Month (Feb 2015 Edition)

March 11, 2015 / by Kapstone Medical / 1 minute read

It’s that time again—from the current catalysts behind the hand and wrist market to material innovation in orthopedic implants, here’s what you missed in the Medical Device Industry during the month of February:

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4 Questions to Ask Before Submitting a 510(k)

March 5, 2015 / by Kapstone Medical / 2 minute read

So you’re an inventor who wants to develop a medical device and use the invention in practice. You know the FDA regulates medical devices, but that’s about as far as your knowledge takes you.

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What You Missed Last Month (Jan 2015 Edition)

February 18, 2015 / by Kapstone Medical / 1 minute read

While you were busy drawing up your latest medical device invention during the month of January, here are a few interesting industry stories you may have missed:

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Three Considerations for 3D Printing of Medical Devices in 2015

January 12, 2015 / by Kapstone Medical / 1 minute read

In late October, Medical Innovations Labs of Austin, TX announced their new 3D printing hub. They plan to provide a hands-on lab environment for medical device inventors and clinicians to launch a new generation of innovation.

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

January 1, 2015 / by Kapstone Medical / 1 minute read

The 3D printing industry is taking the orthopedics world by storm. Here at Kapstone, we’ve been watching the developments all year, and expect much more innovation and regulation news to come in 2015.

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How Intellectual Property Brings Value to an Inventor

December 22, 2014 / by Marc von Amsberg / 0 minute read

Surgeon inventors need to invest in intellectual property. The following dialogue outlines how a typical inventor works with engineering and IP to maximize return on investment. Read More...

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An Integrated vs. Piecemeal Approach to Product Development

December 4, 2014 / by Stuart Lindquist / 0 minute read

In this article, I’d like to focus on another important aspect of maximizing the value of your idea—the need to consider and integrate all aspects of product development from the very onset, regardless of how far you plan to go. Read More...

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Manufacturing at Home: Advancements in 3D Printing

November 20, 2014 / by John Kapitan / 0 minute read

No matter where you turn, you are bound to run into a news headline expounding on the wonders of 3D printing. From medical devices to guns and even to food, it seems that possibilities are endless and our appetites are growing for the technology. Read More...

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

November 2, 2014 / by John Kapitan / 0 minute read

While it may be enticing to look for possible suitors soon after inception of your idea, chances are that the full value of that idea has not yet been realized. Could you have garnered interest from multiple companies if you had prototyped and tested it? What would it have been worth if you had gained regulatory approval first? Read More...

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

October 23, 2014 / by Stuart Lindquist / 0 minute read

Our series of articles for the physician inventor continues with a three-part look into the business side of developing and commercializing your ideas. Part One, presented here, introduces a few common situations that you may face when choosing a course of action for your idea. These hypothetical scenarios seek to answer the all-important question, “How far should I take my idea on my own?” Read More...

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

September 26, 2014 / by admin / 0 minute read

When and how to get constructive feedback throughout the development process

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

September 26, 2014 / by John Kapitan / 0 minute read

The Top Ten Things to Avoid

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

September 15, 2014 / by John Kapitan / 0 minute read

The Top Ten Things to Avoid

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Making the Case for Industrial Design and Human Factors

August 27, 2014 / by Ryan Lewis / 0 minute read

An all too familiar dilemma: a physician has a great idea, but can only take it so far. A new device, a change to a procedure, a way to save time in the OR; medical technology is driven by physicians on the front lines of medical practice. How can ideas be harnessed for the benefit of patients and physicians? Read More...

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

August 20, 2014 / by John Kapitan / 0 minute read

This series of articles focuses on a different paradigm for bringing new ideas to market, one in which you as a surgeon inventor retain control over designs, aggressively pursue milestones on your own (such as issuance of a patent, testing of prototypes or obtaining a regulatory clearance) and build value before presenting them to industry for possible licensing or sale. Why would you consider this option? Why not just take your sketch straight to a big company? One of the best reasons to pursue development on your own is that the value of your idea can increase exponentially compared to the costs of development—if the process is managed properly. Read More...

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

July 18, 2014 / by John Kapitan / 0 minute read

Traditionally, as a surgeon inventor, you may have waited for one of the large implant companies to recognize the value of your new product idea. Then the game began by negotiating timelines, team structure and ultimately, your royalty agreement. While this process has been rewarding for some, it has proven to be disappointing for others. Is there a better way? What would it look like to maintain control of your design, timeline and budgets while hitting milestones and advancing your idea? And what if you could do this while creating intellectual property along the way to build exponential value? Read More...

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

July 1, 2014 / by John Kapitan / 0 minute read

Is Your Next Product Idea Viable?

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

June 1, 2014 / by John Kapitan / 4 minute read

Introduction
Thomas Edison is quoted as saying, “Anything that won't sell, I don't want to invent. Its sale is proof of utility, and utility is success.” Busy physicians often find themselves identifying a clinical need that could be satisfied with a new product or new technology. In fact, many of the best ideas are born on those difficult days when surgical cases present unique challenges.

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