In order to commercialize medical devices in accordance with international standards, medical device and development companies must be familiar with the guidelines set forth by the International Organization for Standards (ISO). Kapstone Medical is proud to have an ISO-certified quality management system (QMS)—but what does it mean to have an ISO certification? How would your company benefit from Kapstone’s expertise in this area? Read on for the answers, and please do not hesitate to get in touch with a Kapstone consultant if you have further questions.
The European Medical Device Regulation (MDR) replaced the Medical Device Directive (MDD) in May of 2017. However, many medical device development companies are still working to understand the key differences between these guiding documents. Fundamentally, the MDR differs from the MDD in terms of device classification. Companies looking to commercialize their products in Europe will need to be familiar with these updated classifications and update their internal manufacturing, testing, and commercialization procedures accordingly.
Adapting to The EU Medical Device Regulation (MDR)
Medical device companies hoping to bring their products to market in the EU will now have to comply with the Medical Device Regulation (MDR), an update from the old Medical Device Directive (MDD). Companies that were already compliant with the MDD will need to pay close attention to this updated regulation, which departs from the MDD in several key ways.
Medical Device Material Selection: Pros and Cons Medical Device Companies Need to Know
Material selection is one of the most challenging—and important—components of medical device development. No matter how strong a concept or dedicated a team, selecting the wrong material can jeopardize a device’s commercialization timeline and likelihood of regulatory approval. Fortunately, the Kapstone team of experts is well-versed in device material selection and manufacturing as well as the testing needed to go with it. Our mission is to inspire, equip, and guide our partners in bringing the highest quality medical devices to market, which includes the material safety and effectiveness.
A Conversation With John Kapitan | Founder & CEO, Kapstone Medical
Medical device development companies large and small face different hurdles when bringing a new device to market. However, no matter their size, all companies cope with the inherent unpredictability of the development process—which, due to shifting regulatory guidance, the complexity of device manufacturing, and other factors, can quickly overwhelm timelines and budgets.
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?
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.
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.”
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.
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.
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), similar to FDA’s approach for high risk devices.
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.
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.
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.
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.
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.
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:
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:
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:
The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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.
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.
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.
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:
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.
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.
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:
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.
With little fanfare in the media, researchers announced that they had successfully used 3D printing to produce the first human corneas for transplant.
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).
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:
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).
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.
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:
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.
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 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.
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.
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:
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).”
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.
The global market for 3D printed medical devices is poised for rapid growth according to a new market research report by Transparency Market Research.
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.
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:
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.
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.
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.
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:
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?
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.
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.
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:
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.
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.
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.
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:
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.
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.
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.
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.
(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 that may provide an unprecedented level of accuracy in doing breast cancer biopsies.
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.
(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 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.
FDA committed to fostering innovation in additive manufacturing.
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.
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 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.
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.
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.
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.
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.”
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.
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:
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.
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.
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:
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?
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:
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!
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:
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:
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:
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.
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.
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:
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:
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:
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.
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:
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.
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.
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...
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...
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...
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...
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...
When and how to get constructive feedback throughout the development process
The Top Ten Things to Avoid
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 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...
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...
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...
Is Your Next Product Idea Viable?
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.