By Robin Strongin. 2010 was a very exciting and disruptive year in the world of health care. On March 23^rd the historic Patient Protection and Affordable Care Act was signed into law by President Obama.  Disruptive Women was right in the middle, weighing in on the debate and conversation.  We also kicked up some dust on other health care issues, framing, commenting, and providing insights and perspectives. We hope you found our blog a useful resource.

Stay tuned to us in 2011, we’ve got more ebooks and events planned. As always, we love to hear feedback from our readers. Don’t be shy about letting us know what topics you want us to cover.

On behalf of all the Disruptive Women best wishes for a healthy, happy and prosperous new year.

Take a few minutes and view this video featuring Disruptive Women Regina Holliday: Remember Your Hollidays – A Message for Caregivers . We promise it is well worth your time!

Dear Internal Revenue Service Commissioner Douglas H. Shulman:

The National Consumers League has been advocating on behalf of women and children’s health since our founding in 1899. We were therefore very concerned to read about the IRS’ decision [1] to deny nursing mothers the ability to use  their tax-sheltered health care accounts to pay for breast pumps and other supplies. Under IRS regulations, eligible medical expenses under the flex programs.

According to IRS Publication 502, items that can be reimbursed  include those that aid in the  “prevention of disease.” The IRS apparently has inexplicably determined that breast-feeding does not help in the “prevention of disease.” The National Consumers League could not disagree more with this determination. We ask that you review and reverse this misguided decision. Indeed, the medical evidence is overwhelming that far more widespread breastfeeding would not only “prevent disease” in the United States, but would save our health care system billions of dollars.

Consider the following evidence about the myriad health benefits to both mother and child of breastfeeding:

• According to a Harvard study published in April of this year[2], if 90% of US families would comply with medical recommendations to breastfeed exclusively for 6 months, the United States would save $13 billion per year and prevent an excess 911 deaths, nearly all of which would be among infants ($10.5 billion and 741 deaths at 80% compliance).
• The risk of infant death due to Sudden Infant Death Syndrome (SIDS) is lowered[3], and respiratory infections such as pneumonia, and necrotizing enterocolitis is nearly eliminated if mothers breastfeed their infants until at least six months after birth.
• The US Department of Health and Human Services has found that  breastfed infants have a lower risk of contracting ear infections, stomach viruses, atopic dermatitis, type 1 and 2 diabetes, childhood leukemia, and other health problems.
• Mothers also benefit from breastfeeding because of lower risk of contracting type 2 diabetes, breast cancer, ovarian cancer, and postpartum depression (PPD).
• A former acting Surgeon General, Steven Galson, has noted that for most women, breastfeeding is biologically possible. Both babies and mothers gain many benefits from breastfeeding. Breast milk is easy to digest and contains antibodies that can protect infants from bacterial and viral infections.
• Breastfed infants typically need fewer sick care visits, Congress recently acknowledged the importance of breastfeeding in the landmark health care reform legislation it enacted this year by requiring that workplaces provide women with a private place to nurse or use a breast pump.

As  Dr. Robert W. Block, president-elect of the American Academy of Pediatrics noted in the New York Times this week “The old adage that breast-feeding is a child’s first immunization really is true … So we need to do everything we can to remove the barriers that make it difficult.”

We agree with Dr. Block. We need to encourage, not discourage, barriers to widespread breastfeeding. Unfortunately, the IRS determination NOT to allow parents to use their tax-sheltered flex accounts to cover the cost of breast pumps has the impact of further discouraging  women  from breast feeding and directly undermines what is by every measure a critical practice for improved public health.  We ask that you, as IRS Commissioner, review this decision and, in light of the overwhelming evidence, reverse it. We believe the cost of breast pumps should and must be a covered cost in these flex plans.

Thank you for your attention to our concerns.

Sincerely,

Sally Greenberg
Executive Director, National Consumers League

Cc:      Senate HELP Committee Chairman Tom Harkin, Treasury Secretary Timothy Geithner, Surgeon General Regina Benjamin and House Energy and Commerce Chairman Henry Waxman

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[1] http://www.nytimes.com/2010/10/27/business/27breast.html?_r=1&scp=1&sq=IRS%20wont%20reimburse%20for%20breastfeeding%20&st=cse

[2] http://pediatrics.aappublications.org/cgi/content/abstract/peds.2009-1616v1

[3] http://www.monash.edu.au/news/newsline/story/200

On December 1st Disruptive Women held its annual holiday party at The Kreeger Museum. This year the program was entitled Music and Art Therapy: A Demonstration of Healing.

The event featured:

• Concetta Tomaino, DA, MT-BC, LCAT, Executive Director and Co-Founder, Institute for Music and Neurologic Function; Senior Vice President, Music Therapy at Beth Abraham Family of Health Services; and Disruptive Women in Health Care blogger
• Judy Greenberg, Director, The Kreeger Museum and Disruptive Women in Health Care blogger

 

There was also a special musical performance by Washington DC’s Art and Drama Therapy Institute’s Inspirational Choir and Moroccan Ensemble. Attendees also enjoyed a cake designed especially for this event by Chef Duff, star of The Food Network’s Ace of Cakes.

If you were unable to join us we’ve got you covered; links to view video from the event are below.

• Highlights video
• Part 1
• Part 2

By Casey Quinlan. I have this dream. It’s about how, when I make an appointment to see my doctor – my primary care physician – the process is easy, honors my time as much as it does my doctor’s, and winds up running smoothly for both parties.

The dream starts this way: I realize it’s time for my annual physical, or any other usual-suspects periodic visit to my PCP. I open up my browser, point it to my doctor’s website, and log in to the secure patient portal. The one where I can see all my prescriptions, my personal health record, make an appointment (using the handy calendar function), request a prescription refill, ask the nurse or doctor a question via email, or download a PDF of my health record.

In my dream, using the handy scheduling function in the portal, I select a date and time for my appointment. The portal auto-populates that date and time with my name and insurance/contact information, since I logged in and it knows who I am. The system asks me if any information has changed. I click “no”. If I click “yes,” the next screen asks me to make the changes, and “submit”.

I select “annual physical” from the list of appointment types. I enter any information I need to related to this appointment request (i.e. “Doctor, I have this pain…”). Then I click “submit” and the system sends me a confirmation email or text (I picked which one I prefer when I set up my profile on the portal). It also schedules me for a blood draw in the week prior to the appointment, sending me a confirmation for a walk-in at the lab.

The scene in my dream shifts to the day of my doctor’s appointment. I’m scheduled to be seen at 11:00am. I get a text at 10:00am – or an email, whichever I selected when setting up my portal profile – saying that the doctor’s running about 30 minutes behind. I can either come in at 11:30am, or select one of the alternate appointment times in the text/email and be re-scheduled.

I select 11:30am, and I arrive a few minutes before that time. Signing in involves scanning a key tag – just like the one you get from your favorite supermarket – which lets everyone in the practice, from the receptionist to the doctor, know that I’m there, and on time.

If the administrative staff needs to talk to me for any reason, they’ll see me on their screen (usually because, in the day-before review, they checked the “confirm insurance details” or “update pharmacy info” or “collect co-pay” radio button) and invite me to have a private conversation. By using my first name only. No sign-in sheet (HIPAA violation) or yodeling my full name across a crowded waiting room (HIPAA violation). (more…)

By Robin Strongin. From all of the Disruptive Women…

By Julie Murchinson. While many have argued that health reform and other federal regulatory posturing has left true innovation in health improvement for consumers and patients nearly impossible, the “innovation” concept seems to be the buzz word du jour across the health care industry. This post focuses on innovation as it relates to how health care is delivered and paid for.   

Some organizations like Kaiser Permanente have been threading innovative approaches through aspects of their work for years with the Innovation Consultancy, the Innovative Learning Network and the Garfield Innovation Center, a living laboratory where ideas and solutions are tested in a real-world simulation.  The rest of the industry is seeing new life forms start to take hold that are inspiring and organizing innovation. For example, Health 2.0 and other conferences are showcasing and tracking the latest and greatest innovations in web-2.0 ideas and iphone apps for health care.  The California HealthCare Foundation recently started an Innovation Fund “to support entrepreneurs with business concepts that have the potential to significantly lower the total cost of delivering care or to substantially improve access to care”.  The federal government is even joining the movement through its establishment of the CMS Innovation Center to test new payment methods through new models of health care delivery, the creation of the Community Health Data Initiative that is making publicly available data more accessible and by creating financial and non-financial challenges like the VA Innovation Initiative to create new solutions around new data availability or a specific goal/problem.

So, the question is…how well are these innovations being designed for and absorbed into the current health care marketplace to actually improve the efficiency and/or effectiveness of the health care system?

One indication the industry is attempting to absorb innovative technologies and solutions is the emergence of executive-level accountability for innovation among health systems, pharmaceutical companies, health plans and other health care companies.  Following in the footsteps of Fortune 500 companies in other sectors, many large health care companies and organizations are establishing an Innovation Officer role, presumably to improve their brand and increase revenues in this time of incredible change and uncertainty.  According to 2009 research conducted by Accenture’s Innovation Performance Group, establishing an executive as an innovation leader increases a company’s chances to drive higher innovation performance and capabilities than those who do not establish such a role. This is mostly because they do not let as many new ideas languish without the proper structure and internal champion and, better yet, manage innovation as a business process.  The question is…will these innovation seekers believe the value of solutions professed by the innovators mentioned above and manage innovations well to a fruitful result or will the same macro issues stalling progress in health improvement for consumers and patients prevail? 

Innovation may be a proxy for many things, but these two ends of the spectrum demonstrate the existence of significant new idea generation with an increased focus on transforming the business of health care with new, revenue-generating or brand-enhancing ideas.  If innovation is the marriage of ideas that drive revenue with purchasers who can put them to work, then we may just be on to an opportunity to move progress in health improvement forward.  That said, it requires the ideas to prove their value and purchasers to be comfortable with a potentially non-linear, longer-term road to the new nirvana.

By Patrice Milos. Well, it seems as though I’ve made a habit of annual posts to Disruptive Women in Health Care, and in hindsight the timing seems just about right as we attempt to trace the path of innovation in genomic technologies and their application to health care. 

By stepping back, once a year, I use the opportunity to reflect on the rapid pace of technology development in the area of DNA sequencing and pose the question – “Does this rapid pace translate into something meaningful for patients?”  Hopefully as you read this synopsis you’ll come away with an understanding that technology alone isn’t enough, but the emergence of new critical success factors suggests the answer is yes!

Indeed from just one year ago, the cost of DNA sequencing has declined precipitously – a year ago, a complete human genome sequence cost somewhere between $50,000-100,000. Today, the cost is closer to $10,000 with the promise of the $1,000 genome over the horizon.  New companies have entered the market and the competition continues unabated with desktop machines promising to enable complete genome sequencing shortly.  Yet while this addresses the continued technological innovation, does it deliver impact on health care?  Not quite yet, but if you’ll allow me, I’ll digress some and tell you why I believe this will change shortly.

Having spent the better part of my career in the field of personalized medicine, I have had the opportunity to know many people who are passionate about this field and contribute in major ways to the pace at which this field is developing.  One of these individuals is Mark Boguski, an MD and PhD.  Mark is presently an Associate Professor of Pathology at Beth Israel Deaconess Medical Center and the Center for Biomedical Informatics at Harvard Medical School.  Mark has held numerous influential positions during his career including a major leadership role at the Novartis Biomedical Institute, a founding directorship of the Allen Brain Institute and was a founding scientist at the National Center for Biotechnology Information.  Mark’s and my path have crossed many times over the years but a key hallmark of Mark’s career is that he is always ten steps ahead of the field and can see well what the future holds. 

I reflect on Mark’s experiences for you as earlier this year he invited me over to Beth Israel to meet with him and Jeffrey Saffitz, MD, PhD and Chief of the Department of Pathology at Beth Israel.   We discussed the pace of technological innovation in DNA sequencing and agreed that the business investments will ultimately deliver on the promise of the $1000 genome.  (more…)

By Glenna Crooks.  I’m on the Finance Committee of my condo association. A few weeks ago, the Board accepted our recommendation to raise monthly fees by 3%, of which the majority will build a larger reserve fund. The increase will no doubt be controversial.

We have insurance against the usual risks but can foresee events that insurance won’t cover, like work that will improve the ‘street appeal’ of the property or upgrades required by changes to city building codes. I agree with the approach; it’s better to be prepared than to be caught short and ‘paying as you go’ to build reserves is less painful than the alternatives.

Leadership of other buildings in our neighborhood were not thoughtful and owners were caught short when  city inspections required roof repairs or new fire codes required new alarm systems. As a result, owners faced multi-year assessments – in the range of $30,000-40,000 annually for up to three years. Many people, but especially the elderly on fixed incomes, could not afford the amounts. They had no choice but to sell, placing a large number of units on the market, driving prices down and finding prospective buyers reluctant to buy property encumbered by special assessment price tags.

I was one of those prospective buyers and so one item on my list of property specifications was the quality of condo leadership. I wanted a Board that was smart and visionary, with a President willing to act like a leader. Better to invest small amounts along the way than to deal with disastrous consequences from the failure to do so. 

Does this relate to innovation in health care? You bet it does. Plenty.  Where health care innovation is concerned, we have many needs but precious few reserves and leaders don’t seem to notice.

Perhaps you don’t care about US-based innovation. I do. For many decades, the US has been the source of most of the world’s health care science-driven, venture-supported innovation. I’d like that to continue, but it appears those days are over. I’m declaring that the US innovation patient has a terminal illness, likely to be dead within my lifetime unless a miracle happens.

How did this happen? We not only helped rebuild the health care infrastructures in Europe and Japan after WWII, we built our own and then we reached out to others in the world. Some magician did not pull today’s health care capacity from his hat. The ‘Great Generation’ came home from the war and went to work. Clinicians, hospitals, diagnostics and medicines are here for us today because taxpayers, employers, investors, entrepreneurs, philanthropists and patients did the hard work of making it happen. They invested in it and paid for it. They took risks. Sometimes they succeeded; sometimes they failed. Or more likely, what they set out to do did not work, but they learned something from that failure. In a very real sense, then, they did not ‘fail.’

They made the US the source of the world’s innovation. Yes, we paid for it. Yes, health care was more expensive here. Yes, lots of the world got a free ride. So what? It was an investment in our lives and productive capacity and it paid off well in the highest standard of living anywhere. ‘A car in every garage and a chicken in every pot’ promise became multiple cars, multiple houses and more food discarded in a meal than many of the world’s people eat in a day. (more…)

The following post is by guest blogger Leah R. Kendall. Leah is a Senior Associate in the Health Care and Life Sciences Practice of the law firm Epstein Becker & Green and is a Senior Advisor with EBG Advisors, Inc.  Leah counsels medical device, biotechnology, and pharmaceutical companies on the requirements of the U.S. Food & Drug Administration and other healthcare regulatory issues impacting them throughout the product lifecycle.

By Leah R. Kendall.

Everything changes and nothing remains still. -Heraclitus, as interpreted by Plato 

Scathing letters from disgruntled FDA scientists, revamping enforcement policy and pillars of regulatory paradigms, communications from Congress suggesting the need for and then questioning said revamping, rescinding market clearances, promises to seek criminal sanctions on executives[i] …. The sky is falling!  Or is it?

It’s easy to sound like Chicken Little in today’s regulatory world.  Over the past year, those of us in the medical device and biotechnology sector have watched our U.S. Food & Drug Administration (FDA) transform before our very eyes.  We have grappled with stalled marketing application reviews, an Agency that seems suddenly skittish to give informal feedback, and the reality of a “new FDA”.  Some of us are enduring Warning Letters, consent decrees, or more informal methods of regulatory scrutiny. 

Regulated industry, public health groups, and the government alike are intensively monitoring the proposals for reforming the FDA’s medical device marketing clearance (“510(k)”) process and the use of science in decision-making.  The purpose of this blog post is not to analyze the specific content of those proposals (that would require a book, not a blog post).  Suffice it to say that they have been the topic of numerous public comments, passionate discussion and debate, not to mention significant media coverage.  While some proposals seem to have general support, others have received significant pushback.  Indeed, several weeks ago, several members of Congress (which, as you may remember, originally called for reform of the market clearance process) wrote to Margaret Hamburg to express concern with the implementation of some of the proposals in the FDA report. 

What does this FDA regulatory reform mean for innovation?  Is the reform colliding with innovation, unnecessarily impeding its growth?  Should FDA continue on its previously well worn path, simply interpreting existing requirements to ever-increasing innovative technologies? 

That’s one possibility, but on the other hand, there exist convincing reasons to think about innovation in broader terms – terms that embrace not only medical or technological innovation, but also innovation with respect to the health regulatory paradigms that support (dare I say, foster?) medical product and treatment innovations.

So what are those reasons?  Here’s some food for thought. (more…)

The following is a guest post by Rosa M. Abrantes-Metz, PhD. Rosa is a principal with LECG’s antitrust, securities and international arbitration practices based in New York City, and a visiting scholar at Leonard N. Stern School of Business, New York University, where she has previously taught industrial organization.

By Rosa M. Abrantes-Metz. There is nearly universal agreement that changes are needed in the US health care system. The price of health insurance is high and continuing to rise, and many are priced out of the market. There is certainly room for reform. But reform must be discussed in the right way, using the right measures. Total spending (or “total costs,” as some call it), is simply the wrong way to frame the problem.

Much of the health care reform debate focused on containing costs. A common approach to attain this goal is limiting medical innovation, which will reduce the quantity and quality of health care in the future relative to what might otherwise have been.

Critics of the U.S. system note that the US spends a greater share of its GDP on “health care” than does any other advanced economy. Even those skeptical of many reform proposals accept this as intrinsically undesirable. Everyone seems to agree that the level of health care spending is too high, and its rate of growth unsustainable, despite evidence by several renowned economists that the benefits from this spending have been worth while.

In my view, this metric – total expenditures – is a very poor guide for policymakers. It is easy to imagine good, positive changes which every consumer of health care would welcome but which increase – not decrease – total costs.  And it is easy to imagine policies which are designed to curb costs but which result in less (and less effective) health care for all. Controlling costs should not be the main objective of policy.

But we must be very careful to distinguish costs (total spending) from prices. Prices inform the relative expense of one item or procedure over another. It is perfectly reasonable to lament the high price of health care. Most of us would prefer to face lower prices than higher, and most of us would welcome a general decline in the price of health care since that would mean, all else equal, that more people could more easily afford more of it.

Costs, on the other hand, are total expenditures – the total dollars spent. Cost is price times quantity. The price of an aspirin is $1, and we might feel that this is too high since some can’t afford it. When we buy 10 aspirin, the total cost becomes $10.  But if the price falls to $0.75 and we then buy 20 (either because some of us buy more than we did before, or because new people are able to afford it for the first time, or both), the total cost rises to $15. Once we realize that a decline in price could lead to an increase in total expenditures, we are forced to question whether expenditure is as useful a metric for policy as many people would suggest. (more…)

By Lynn Shapiro Snyder. I have been a managed care, Medicare and Medicaid attorney for over 30 years. Although this focus includes compliance and enforcement work, I also do a lot of work helping entrepreneurs bring new ideas to the health care marketplace. Providing strategic, legal and regulatory assistance for some of these innovations has been some of the most rewarding work for me.

It used to be the case that when an innovator wanted to launch a new drug or device in the United States, the key regulatory tollgate was the federal Food and Drug Administration (FDA). That standard focuses on safety and efficacy. Once that tollgate was satisfied, the company could promote its product, and the product would enjoy general distribution in the marketplace. Those days are over.

Two new additional tollgates include access to identifier codes – especially for certain medical devices and coverage for the innovation. The focus of this blog is on the new coverage challenges to innovation.

In the United States, we have a wide variety of payers of health benefits. There are publicly funded payers such as Medicare and Medicaid. There are privately funded payers such as self-funded employers and private health insurance plans. Traditionally, the scope of covered benefits focused more on illnesses. The new benefits focus on prevention and population health management. There are enumerated benefits, enumerated exclusions and general coverage phrases like covering what is “reasonable and necessary.”

More and more payers will be offering similar benefits as Title I of federal health reform is implemented. This is because a proposed federal regulation will be issued soon by Department of Health and Human Services to define the “Essential Health Benefits Package” for individual and small group health plans. This benefits package is supposed to be comparable to coverage by existing employer plans.

Who decides whether an innovation fits within an existing covered benefit or whether a new coverage decision is needed so that patients can get access to the innovation? And, what is the criteria for confirmation of coverage? Is it enough that the innovation is comparable to existing options? Does it have to be breakthrough? While there is a whole body of literature about randomized control trials and other data points needed to establish FDA approval, what should be the study protocol to establish a positive coverage determination by the payer? Finally, should the new cost of the innovation even play a role in the coverage decision-making process?  These are the key questions across payers.

Centers for Medicare & Medicaid Services (CMS) uses the MEDCAC – the Medicare Evidence Development & Coverage Advisory Committee- to provide independent guidance and expert advice on specific clinical topics.  In its deliberations, the MEDCAC reviews and evaluates available evidence, including medical literature and technology assessments, and listens to public testimony.  The Committee then makes coverage recommendations to CMS based on its review.  Private payers usually have some type of technology assessment processes. (more…)

By Tine Hansen-Turton.  In the face of an acute primary care physician shortage, and the steady reduction in the number of physicians who are willing to accept Medicaid and Medicare, it is unclear whether our existing primary care system will be able to meet the needs of the 30 + million Americans who shortly will become insured as a result of national health reform.

Health care delivery is strained under tremendous pressure from the demands of chronic health issues, downward trends in third party payments, and while insurance coverage will address some of these issues, many of these problems may persist even when near universal insurance coverage is achieved in the United States. So what else needs to happen to make health care reform a success? 

In recent years, a series of “disruptive innovations,” (as coined by Harvard Business Professor, Clayton Christensen, PhD), in the health care sector have capitalized on non-physician providers, such as nurse practitioners. Their ability to provide high-quality primary and preventive care in retail-based settings such as Convenient Care Clinics (also known as retail-based clinics) and in community-settings, such as Nurse-Managed Health Clinics has been well documented.

Research by RAND Corporation and publications in Health Affairs, the Institute of Medicine and Robert Wood Johnson Foundation’s Future of Nursing report and peer-reviewed journals have documented that retail-based clinics and Nurse-Managed Health Clinics provide safe, accessible, affordable care to millions of Americans without threatening continuity of care.   Nurse practitioners practicing in these independent settings already touch 20 + million or more people annually. Consumers gravitate to both models because they are accessible, affordable, provide quality care but most importantly, they are convenient in their locations, hours and ease of use.  For health care reform to be successful, we need to embrace these and many other disruptive innovations.

Disruptive innovation does not happen overnight or without a strategy – rather, innovation is built on a series of innovations that happen over time; time needed to grow and mature outside the limelight.  Neither the convenient care clinics nor Nurse-Managed Health Clinics would exist without the nurse practitioner in the primary care service seat. 

The nurse practitioner workforce, 150,000 strong today, with an annual growth rate of 5,500, was first established in the late 1960s as a response to a physician shortage and a belief that nursing could play a critical role in primary care.  It grew slowly over a 30 year period.  Like Thomas the Little Tank Engine, it stayed focused and gained steam as the number of providers grew. 

First, nurse practitioners proved their worth by silently filling the health care needs of underserved populations in rural and urban settings. Over time, and thanks to national and state legislative and regulatory reforms that have taken place over decades, including those recently led by governors in Pennsylvania and Massachusetts, nurse practitioners gained public support, were defined in law as primary care providers, and now are legally authorized to prescribe medications and provide care that is a comparable in scope to that of a primary care physician in all 50 states. Today, they are known by most Americans and have become a household name and provider of choice.

* This post is part of the Disruptive Women series on innovation.

By Candace Littell.  One of my favorite techniques in movies and television is the “flashback” – a scene that takes the main story back in time in order to recount events leading up to the present.  Often viewed in chronological order, flashbacks form and develop the present story, scene or character.

The concept of flashback came to mind as I recently reviewed a new, innovative medical technology which I refer to here as NewPro. While I could of course understand NewPro as it existed today, I had no background in how it had come into being.  What were the events leading up to its introduction?  Out of the thousands of medical device and diagnostic products that are developed each year, why did NewPro make it to market while others did not? What factors were responsible for its development? 

Experience tells me that the circumstances and events leading to the development of NewPro are likely similar to those surrounding innovation for the vast majority of other medical technologies. 

Like many other medical technology innovations, especially breakthrough or new technologies, NewPro would likely have found its origin in a small or start-up company.  Backed by venture capital and sometimes in partnership with larger companies, these smaller firms often play a unique role in early stage development.  As efforts to bring NewPro to market progressed, the company may have been acquired by a larger firm that could navigate the later stages of the innovation process and introduce the product into medical practice.  A larger firm would also possess the necessary resources for ongoing product refinements and improvements.

NewPro would likely have followed a process of innovation consisting of four elements.  It began with an invention, an idea that medical care could be improved or performed in an entirely different way.  Invention led to development of a model of the product, a so-called prototype. Then development began, where clinicians and company engineers performed testing and evaluation, and refinements were discovered and integrated into product design.  This stage concluded upon regulatory approval for marketing.  Once cleared for marketing, adoption into clinical practice began.  Here, in the process of product diffusion, health care providers and payers determine that NewPro is worth adopting.  Finally, as adoption occurs, innovation begins anew, as the process of feedback yields product refinements and new clinical applications.

Behind this apparent structured process, however, I expect there was much variability in the development of NewPro. Lines between the stages of innovation would blur, and the process would proceed in a non-linear fashion.  Innovation might not proceed smoothly and continuously from concept to product.  It might start and stop.  Product testing would generate new information that redirects the course of product development.  More data, more experience, and more interaction with users could yield information vital to NewPro’s refinement.  And the uncertainty surrounding this process may have resulted in skepticism and resistance, both within the company developing NewPro, as well as among product users, government regulators, payers, and investors.  Close collaboration among many parties was critical – perhaps clinicians, researchers, universities, government agencies, company or industry experts and others – in order to transform what was an idea into a viable medical product.  Through this “dialogue of device innovation” NewPro emerged in form and clinical application. (more…)

The following is a guest post by the President of the Council for American Medical Innovation, Debra Lappin.

By Debra R. Lappin. A recent survey of 6,000 people across six countries found that a majority believe that the United States will lose its billing as the most innovative country in less than 10 years.  Aside from the competitive and reputational repercussions of such a drop, losing ground in innovation, especially medical innovation, means significantly less hope to discover cures, invent devices, and fundamentally bend the cost curve for health care, thus having a positive impact on the nation’s deficit.

America’s medical innovation enterprise will lead our nation out of the current economic recession. It provides excellent jobs in the public and private sectors, and improves health for all Americans. Medical innovation industries continue to be an important source of high-wage jobs, and while other sectors have been negatively impacted by the recession, medical innovation sectors have fared better and appear to be rebounding more quickly than other sectors from the economic downturn.  Health care and biomedical fields are expected to generate more new jobs than most other industries between 2008 and 2018.

From a health perspective, a single discovery in the world of chronic diseases resulting from investment in medical innovation today has the potential to save billions – if not trillions – of dollars tomorrow. This is what I call the new ROI, or return on innovation. And it is something I am advocating for through my role as president of the Council for American Medical Innovation (CAMI).

This past summer, CAMI commissioned a study by Battelle that offered a road map on what the U.S. needs to do to retain its leadership position in medical innovation. In particular, continued American leadership in medical innovation will require strong presidential vision, new public-private partnerships to promote medical innovation, a better investment climate, a smarter regulatory infrastructure and a stronger educational system.

Let me focus on two of those areas that where I believe we have the best opportunity to enact change in the near term. (more…)