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The America Invents Act impacts Medtech
Published on 2013-04-10 08:59:09
At least as early as the 1990s there were growing pressures to correct perceived problems in the patent system of the United States. The problems were said to relate to patent quality and the increase in patent litigation, its costs and its consequ
Trusting in the Value of Medtech Innovation
Published on 2013-02-26 11:17:23
For many of us that work in the medical device area, the constant pursuit of the next product innovation is as natural as breathing air. The U.S. economic malaise and the rapidly escalating cost of healthcare, however, have some pundits suggesting
What do you really need?
Published on 2013-02-12 03:35:55
In this blog, I have made a big deal about the difference between needs and ideas. The reality is that for a need to be more than pointing out the obvious, it has to provide sufficient definition or a problem statement. Or, as the very successful
5 Reasons for Doctors to Share Needs
Published on 2013-01-22 01:00:32
Years ago I attended a unique conference in Jackson Hole, Wyoming for physicians and invited guests from the medical device industry. The conference’s theme was to expose the worst clinical case train-wrecks with the goal of catalyzing developmen
Big MedTech Companies lose their main innovation advantage by decoupling manufacturing
Published on 2012-12-17 01:00:59
Big medtech companies have been criticized for their diminishing innovation record, especially from this blog. One of the few innovation strengths that large companies should exhibit is manufacturing. And, I’m not referring to advanced manufact
Market-driven Innovation; start your engines
Published on 2012-12-05 01:00:24
How does a medical device company improve R&D productivity when most of the industry is in decline due to regulatory and reimbursement pressures? According to Ray Swanson (partner at TCG, LLC), the best performing companies place the customer at th
Weird (regulatory) Science
Published on 2012-11-14 01:00:49
In October 2010, the FDA published the initiative “Advancing Regulatory Science for Public Health”, which has meaningful goals for developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regul
How do I get started developing my medical device idea?
Published on 2012-10-30 02:00:54
As part of the Healing Innovation blog, we have been reaching out to physician inventors to learn how we can assist them in our tutorials and postings, connecting them with resources, as well as assessing their identified medical needs. In the process, we are realizing that many clinical innovators are more naïve than expected and [...]
“All in” versus “just get started”
Published on 2012-10-16 11:20:33
In the medical device innovation space, like other industries, there are many dreamers and much fewer doers. I have previously postulated that one of the key reasons doctors never get out of the starting blocks on their medical device ideas is fear of someone stealing their idea. Whatever the reason, there is inertia working against [...]
Mind Control or Design Control
Published on 2012-10-02 08:25:11
Although veterans of the medtech industry may lament the loss of R&D and product development at major medical device companies, the reality is that big companies are just not good at it, and getting worse. I have previously pointed out some of the reasons why established medical device companies have chosen to further reduce the [...]
We never got a chance to say goodbye to Product Development
Published on 2012-09-18 02:00:36
We at Healing Innovation have mused over the years about advanced research and development at large medtech companies being squeezed out by the business development function. Now, rumblings are being heard that due to the cost of integrating business acquisitions and the impending medical device tax, large medtech will be scaling back organic product development [...]
Physician collaboration with engineers
Published on 2012-08-28 02:00:54
It seems self-evident to me that when you put an innovative physician and a creative engineer in a room together, sparks will fly, and compelling solutions to medical needs will emerge. That is if the two collaborators trust each other and understand their different approaches to problem solving. Medgadget editor Dan Buckland is an engineer [...]
Does your hospital own your idea? Part II
Published on 2012-08-06 02:00:32
A year ago we wrote about hospital systems starting to take greater ownership of physician inventions, with intellectual property rights now defined in employment agreements, even for non-research hospitals. A recent legal case has further cemented the constraints for innovative physicians. According to the Boston Globe, a state superior court judge has thrown out a [...]
How does “Convergence” affect physician innovators?
Published on 2012-07-11 09:24:26
Just returned from the Converge meeting in Philadelphia, a one day meeting to discuss the convergence of technology and healthcare. I’m a born skeptic of conferences and the carousel of speakers that are on the meeting circuit, but Converge was a refreshing change. In addition to the obvious focus on the future of healthcare technology, [...]
Selecting a Patent Attorney to Protect Your Medical Device Invention
Published on 2012-06-26 02:00:46
So, you have an idea for an invention? Maybe you have made a prototype. You think it may have commercial possibilities. You know you should protect yourself and that probably will involve trying to patent the invention. Although you have the right to write and prosecute your patent application yourself, you recognize that might be [...]
A longer runway
Published on 2012-06-12 02:00:23
As a physician inventor, you likely don’t have the time or business interest in starting an “operational” company that sells medical devices. You have a great idea. You want to demonstrate its effectiveness and then find an established company to market and distribute the product. The challenge is that pre-revenue acquisitions or licensing (i.e. products [...]
Pediatric Medical Device Innovation
Published on 2012-05-14 02:00:32
Developing medical devices for pediatrics brings both engineering and business challenges. The medical device industry is beginning to understand that kids are not simply smaller adults, but have unique design requirements. Unfortunately, major medtech companies just don’t know what to do about it. Very few commercial endeavors, with the exception of Orthopediatrics and a few [...]
Medical Device Fast Failure
Published on 2012-04-24 02:00:50
We have all read entrepreneurial experts push the idea of allowing yourself to fail. They even want you to do it fast. Basically, the longer it takes, the more “wasted money”. But, for a medical device inventor or company, the more precise advice may be to challenge your weaknesses early because they might fail in [...]
The Provisional Patent Application: Money Saver or Potential Trap?
Published on 2012-04-10 02:00:43
For inventors seeking to protect their inventions, provisional patent applications can be a very useful tool. While the filing procedures are relatively simple and inexpensive, the practice is sometimes misunderstood. The mere filing of a provisional patent application is no assurance that it will provide adequate protection. The value of a provisional application depends on [...]
3 Steps to Starting an mHealth Business
Published on 2012-04-03 02:00:47
What physician inventors should understand about the patent system
Published on 2012-03-20 02:00:49
Physicians hoping to commercialize their inventions should have a basic understanding of the patent system by which those inventions may be protected. All modern patent systems rest on a foundation of some simple, yet crucial, principles and objectives and understanding them is helpful to understanding the fabric of rules and laws that build on that [...]
Lean medical device start-up
Published on 2012-03-13 02:00:51
Healing Innovation posted a blog over one year ago about medical device startup companies hiring infrastructure before needed. We have also blogged about medical device virtual companies. All medical device companies outsource some aspect of their business, but our premise is that in the early stages, medtech startups should focus on their core competency and [...]
Are post-market studies the answer to faster FDA approvals of novel medical devices?
Published on 2012-02-28 01:00:27
In most of the world, regulatory bodies approve medical devices based on safety. Seems like common sense. But, in the U.S., the FDA approves medical devices based on both safety and effectiveness. It’s the “E” word that is largely responsible for the long and protracted clinical trials that delay approval of novel medical devices. The [...]
Novelty, and we’re not talking x-ray glasses
Published on 2012-02-14 04:00:01
When most people think of novelty items, they are envisioning the trinkets you buy at a party store for a gag birthday gift. But, medical device intellectual property is no laughing matter. In patent parlance, novelty refers to whether an invention is unknown or not used before being filed with the patent office, and is [...]
Greater physician innovator collaboration with medical device companies
Published on 2012-01-31 01:00:21
The Healing Innovation (HI) blog has spent the last year making the case for greater collaboration between the medical device industry and clinicians. HI, however, has also blogged extensively about the conflicts of interests created by clinicians becoming PR mouthpieces for new products and clinical trial results. Although medical device companies spend large sums of [...]
Is Crowdfunding coming to medical device start-ups?
Published on 2012-01-17 01:00:07
I’m not sure why it has not received more attention in the medical device start-up world, but the Entrepreneur Access to Capital Act (EACA), which recently passed in the U.S. House of Representatives, has the potential to open the door to intriguing fundraising possibilities for individual medical device innovators and start-ups. Although the title of [...]
Christmas present from the FDA
Published on 2012-01-03 01:00:09
Happy New Year! Healing Innovation hopes that Santa left you a great gift under the tree that you can enjoy in 2012. Disguised as Jolly Old Nick, the FDA left Healing Innovation a present that we have been wanting for years. The promise of continuity in FDA reviews. Although it appears to have been released [...]
Medical device innovation: process or people?
Published on 2011-12-12 01:01:30
The recent VdE debate on the Healing Innovation blog forced me to reconsider what drives innovation in medical devices. A reduced pool of money clearly hurts innovation, which is our current situation due to the lack of regulatory visibility and healthcare reimbursement concerns. But, under the same financial constraints, what has a greater impact on [...]
Will VdE change the U.S. medical device industry? ABIA responds.
Published on 2011-12-05 09:30:50
Last week the Healing Innovation website posted a blog asking whether Value-driven Engineering (VdE) is the solution to the recent challenges to innovation in the medical device industry and whether the PR on the initiative overstates the impact relative to the content of the movement. And, fundamentally is the process in itself actually innovative? The [...]
What is VdE? And, will it change the U.S. medical device industry?
Published on 2011-11-29 01:00:58
Anyone been following the Value-driven Engineering movement (VdE)? In response to President Obama’s “Winning the Future” initiative, the Austen BioInnovation Institute in Akron (ABIA,) has launched a national effort in VdE. According to ABIA’s website, “VdE Incorporates product design with targeted content,” which ABIA suggests will safeguard the U.S.’s leadership position in medical device innovation [...]
We never got a chance to say goodbye to R&D
Published on 2011-11-01 15:12:01
I grew up in the medical device industry when revenue-producing companies actually had internal R&D groups (and, I don’t even have any gray hair). Not “commercialization teams” or “New Product Development”, but actual investigation of novel medical device candidates. Also referred to as Advanced R&D, New Ventures or an Antenna Group, these dinosaurs of the [...]
The new orthopedic sales rep; the surgeon
Published on 2011-10-19 08:23:45
No physician inventor should apologize for making money off an innovation that improves medicine. Certain orthopedic surgeons, however, have pushed a tenuous ethical line in how they distribute their own devices. Entrepreneurial surgeons have formed medical device companies to develop, manufacture and distribute implantable plates, rods and screws used to fix maladies such as spine [...]
Seeing the FDA in the Mirror
Published on 2011-10-04 04:56:42
The title of Scott Gottlieb’s Wall Street Journal article “How the FDA could cost you your life” is not only sensational, but misguided. I am no apologist for the FDA’s poor execution, weak resources and lack of transparency; however, the agency’s existence and culture are a direct response to what American society values. Almost every [...]
Are we yelling too loud at the FDA?
Published on 2011-07-05 09:05:31
I don’t want to become an FDA basher. It just seems like every year it is getting harder to push the medical device rock up the FDA hill. Speaking with peers, their perception has been similar, but last week the speculation was confirmed. I hav
J&J stent saga ends with a fizzle
Published on 2011-06-20 16:52:23
Last week’s news that J&J is abandoning their coronary stent business was sad, but provided several lessons about poor product development execution and the need for constant innovation. J&J created the coronary stent market, managing the f
My Idea was stolen by a Medtech company
Published on 2011-06-06 09:00:39
We have all heard stories from doctors about some medical device company stealing their idea for a new product. Perhaps, there are real medtech bandits on the prowl, but in the vast majority of cases, it’s more a matter of misconceptions and misc
Are you too small for stage-gate discipline?
Published on 2011-05-23 09:26:13
Despite the many challenges that larger companies have in developing new products, to their credit most medical device companies have mastered the process of Stage-gate portfolio management. Start-ups and single product development efforts don’t ty
Pre-IDE meetings. Know when to hold’em, and when to walk away
Published on 2011-05-09 09:18:41
An Investigational Device Exemption (IDE) approval is necessary before conducting FDA sanctioned medical device clinical trials. Companies often (around 200 times per year) utilize an informal pre-IDE process as a pre-cursor to the IDE application fo
The future of medical device innovation
Published on 2011-05-02 09:04:31
How do you build a community of clinicians looking to solve medical challenges with improved devices, diagnostics, equipment, or implants? Why not via the Internet? www.scrubstorm.com launched on April 26th at the annual conference, SAS11, of the
Market-driven Innovation; start your engines
Published on 2011-04-18 08:37:24
How does a medical device company improve R&D productivity when most of the industry is in decline due to regulatory and reimbursement pressures? According to Ray Swanson (partner at TCG, LLC), the best performing companies place the customer a
How medical device companies can win with open innovation
Published on 2011-04-14 07:27:44
Companies typically pursue open innovation programs with the goal of collecting new ideas more quickly than internal resources can accommodate. Medical device companies share this same goal, but due to fears of intellectual property issues, they to
Why are early clinical studies performed offshore?
Published on 2011-04-04 08:37:48
Many, if not most, medical device companies perform pilot clinical studies outside of the U.S. Cost reductions, avoiding a protracted FDA Investigational Device Exemption (IDE) approval process, and the ability to make design changes during the study
Is FDA and Innovation like Oil and Water?
Published on 2011-03-17 16:03:23
If you haven’t heard, the FDA has been publicizing their newly launched Medical Device Innovation Pathway. Besides the standard press releases, FDA’s Center for Devices and Radiological Health (CDRH) has created a 53-minute video starring Dr. J
5 steps to starting clinical studies earlier
Published on 2011-03-03 18:30:01
Incorporating clinical studies prior to design “freeze” into a medical device product development plan is foreign to some organizations, including supposedly nimble start-ups. Changing a company’s clinical research philosophy requires well-de
When should a device undergo clinical study?
Published on 2011-02-21 13:02:02
The current state of medical device product development has relegated clinical trials to achieving two goals: 1.) reaching a milestone for funding or exit, or 2.) supporting regulatory submissions. Unfortunately, what has been lost is the pursuit
Taking the plunge into Internet-based Innovation
Published on 2011-02-14 09:31:02
A little over 1 year ago the medical device start-up company I was managing was in a holding pattern due to funding constraints. Perhaps out of boredom, and in some respects to have a Plan-B, I started to brainstorm new ideas for a start-up busines
Medical Device Virtual Reality
Published on 2011-02-03 16:33:41
In a recent post on PEHUB (Private Equity Hub), John Lonergan, Managing Member of Mach Ventures, made the case for virtual medical device product development. Mach Ventures’ business model is “we sell our medical devices just after we’ve
Let’s talk. Healthcare Innovation.
Published on 2011-01-23 14:33:30
I just found out, thanks to Thomas Sullivan at the POLICY AND MEDICINE website, that national leaders from all sectors of healthcare recently formed the National Dialogue for Healthcare Innovation (NDHI). At first, I thought this was another bureau
10 Innovation Resolutions for Doctors in 2011
Published on 2011-01-03 16:54:11
For the New Year, here’s a list of ten resolutions for clinicians to further medical device innovation: 1. Commit to every day asking yourself whether the procedures or medical steps you are performing could be done faster, cheaper, or better. 2. B
Great Concept! Is it Feasible?
Published on 2010-12-27 03:15:55
Developing medical devices is an expensive proposition, compounded by the long odds of a novel product having commercial success. The risks are not only technical, but include regulatory, reimbursement, intellectual property, and changing medical p
You don’t have to be a doctor to be a clinical innovator
Published on 2010-12-20 08:30:25
Physicians are clearly the primary clinical innovators due to their education, experience, and specialization. That said, a broad spectrum of non-physician clinicians (e.g. nurses, surgical technologists, surgical assistants, etc.) have the capacit
Doctors collaborating with engineers
Published on 2010-12-06 11:37:49
Are you a doctor with a great idea, but don’t have the technical skills or know-how to turn your concept into a working medical device? Think about finding an engineer in your area that has experience developing medical devices. You may not quite
Running before you can walk
Published on 2010-11-15 09:25:53
The standard for start-up companies these days, even prior to demonstrating feasibility, seems to be hiring a full operational management team. Considering the long clinical and regulatory pathway for novel medical devices, is there a justification
No Fear!
Published on 2010-11-05 09:23:44
There are many reasons why a doctor may let a great medical device idea gather dust and never see the light of day. Time has to be the greatest culprit, since doctors are busy and developing an idea is like a second job – a job with no traini
Just pain, no gain
Published on 2010-11-01 14:55:41
I went to the dentist today and had annual x-rays taken. I hate when they stick those stiff plastic plates, called periapicals or bitewings, in my mouth. They are painful and cumbersome and I can’t be the only person that has these feelings.
We never got a chance to say goodbye to R&D
Published on 2010-10-26 19:42:01
I grew up in the medical device industry when revenue-producing companies actually had internal R&D groups (and, I don’t even have any gray hair). Not “commercialization teams” or “New Product Development”, but actual investigation of
Low class and happy about it
Published on 2010-10-19 17:48:26
There are three FDA regulatory classes of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of FDA control. The lowest category of devices (Cl