Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: JjrkCh

Friday, December 21, 2012

Forbes: John Nance, Rosemary Gibson, ePatient Dave DeBronkart, Regina Holliday


http://www.forbes.com/sites/leahbinder/2012/12/20/13-to-watch-in-2013-the-unsung-heroes-changing-health-care-forever/
Leah Binder  12/20/12  FiDA highlight added to indicate my particular heroes!

When I have a health problem, I talk to my doctor or nurse. But when our nation has a collective health problem, doctors aren’t the only ones who know best. While I could write a year’s worth of blogs about inspirational physicians or nurses who are transforming our health care system from the inside out, today I want to highlight some of the largely unsung heroes changing health care from the outside in: these are influential leaders who don’t wear stethoscopes or see patients, but have some important answers for us, from pilots and business leaders to game show titans and soccer moms.
Their influence comes through social media, conferences, publishing and even some peer reviewed medical journals. My prediction: they will make some history in 2013.
1. John Nance
Did you know that a checked bag on an airline flight is still exponentially safer than a patient in an American hospital? John Nance is a former airline pilot and veteran, who has taken lessons learned from airline safety to dissect hospital safety – and found the latter wanting. His books on the subject, most recently, “Charting the Course,” co-authored with his wife Kathleen Bartholomew (a national change maker of major influence herself, but a nurse so not on this list of outsiders), create a fictional situation where hospitals are run with the same safety rules and procedures as airlines. The entertaining book challenges almost everything we assume about proper hospital administration.
2. Al Lewis
This Harvard-educated policy specialist is considered by many the father of “disease management” — and like all good parents, he’s the first to note when his offspring are misbehaving. Now he’s imposing some discipline. He’s concerned that the benefits of prevention initiatives are often oversold by overzealous consultants and vendors, so he wrote a category bestselling book “Why Nobody Believes the Numbers” to show how the rosy scenarios don’t always add up.
3. Suzanne Delbanco
Many self-insured employers have an astonishing little provision buried in their contract with their health plan: they aren’t allowed to reveal the prices they are paying for health services. The employers are allowed to pay the bills, of course, but they just can’t tell employees how much they paid. Thanks to Suzanne Delbanco, and her organization Catalyst for Payment Reform (CPR), ridiculous restrictions like that will soon be a thing of the past. CPR helps purchasers — large employers and unions — set rules for health plans on issues like pricing and quality of care.
4. Francois de Brantes
Your hospital usually makes money if a patient gets an infection during their stay and your doctor stands to gain financially if he gives you the wrong care. As a businessman, Francois de Brantes was outraged by the perverse incentives in health care that drive costs up and drive quality down. He formed a non-profit called the Health Care Incentives Improvement Institute to try to deal with the incentives problem, and his terrific collection of essays highlights his blunt and logical ideas for addressing them. Although de Brantes is not alone in calling for better economic incentives in health care, he is unrivaled in piecing together and even applying detailed strategies to the health care system, undaunted by the complexity involved.
5. Rosemary Gibson
A study by the Harvard School of Public Health and the Rand Corporation concluded that one-third of people who were told they needed heart bypass surgery did not need it. Studies have also shown inappropriate CT scans, other heart surgeries, back surgery, pap smears, carotid surgery to prevent strokes and among others. Rosemary Gibson is a quiet and highly effective opponent of these rampant practices that harm millions and cost billions. Her much-discussed book, “The Treatment Trap” had a significant impact in the health policy world and put the issue of overtreatment into the spotlight where it belongs.
6. Dave deBronkart
Often better known as e-Patient Dave,” Dave deBronkart survived stage 4 kidney cancer and today is a social media superstar who speaks nationally and internationally on how patients should be treated in the U.S. health system. His compelling TEDx Talk, “Let Patients Help,” is in the top half of most-watched TED talks of all time. He tends to turn health care’s conventional wisdom on its head. “Why is it when patients do the right thing it’s called ‘compliance,’” he asks, “But when doctors do the right thing it’s called ‘quality?’”
7. David Goldhill
If you are raised to think the combination of TV and health care equals Marcus Welby, meet David Goldhill, whose day job as head of the Game Show Network (GSN) belies his other self, a controversial thought leader in health care who is getting a ton of attention. Watch for Goldhill’s book to be published in the New Year: “Catastrophic Care: How American Health Care Killed My Father.” Until his father’s death, Goldhill never considered why the normal market competition rules that apply in other industries don’t apply in health care. He recommends some unusual policy ideas.
8. Tom Emerick
When Tom Emerick was a global benefits executive for Wal-Mart, he discovered (with advice from Mayo Clinic and other leading medical experts) that thousands of his employees had been given transplant procedures when they didn’t need them, an unfathomable amount of suffering for people to endure. I wrote about the improvements that Tom made in a previous post, but it’s worth calling out again – Tom is a leading crusader for employers to protect the American public from unnecessary and dangerous procedures. There is no disagreement in the medical community that such harm exists; a recent consensus report from the Institute of Medicine found that one third or more of health services are wasteful. Tom helps employers address this issue.
9. David Knowlton
David Knowlton is a highly influential behind-the-scenes guy in New Jersey, who is a maverick in the best sense of the word,  and has gained national attention as a result. He’s a leading advocate for transparency, safety and quality and has been awarded numerous national appointments in recognition of the respect he’s earned in his home state and the value of his ideas — and his ability to turn them into policies. For instance, he’s the co-chair of The Leapfrog Group’s Hospital Safety Score Committee. In addition to being a key influencer behind significant New Jersey legislation on quality and transparency over the years, he’s been unafraid to do what was right. He published prices of common hospital services long before anyone else in the country was doing so, and he did a survey of New Jersey nurses to get their reputational ratings of hospitals. Keep an eye out; he has plans for 2013.

10. Maureen Corry
Maternity care in the U.S. has serious problems, including a rapid growth in the rate of Cesarean sections, now comprising more than 30 percent of all births in the U.S. Procedures that are known to be unnecessary or even harmful – like scheduled deliveries prior to 40 weeks gestation – remain
common in American hospitals. Maureen Corry and her 94 year old organization, Childbirth Connection, bring together researchers, clinicians and patients to come up with solutions. Maureen is a strong policy advocate, but also a thoughtful and purposeful researcher who brings all sides together in very constructive ways, which is why many of the issues she has raised over the years are now on the top of the policy agenda in Washington. Look for her report next year on mothers’ perceptions of the childbirth experience.
11. Regina Holliday
My fellow Forbes.com blogger Michael Millenson has called Regina Holliday the “Rosa Parks of health care.” A young widow with two small children, Holliday speaks eloquently of her husband’s cancer and the terrible ways the health care system added to his suffering. Her cause: all patients should have immediate access to their medical records. She wouldn’t move to the back of the bus when the hospital refused to share her husband’s records, and we shouldn’t be forced to either. This effort is getting traction, with a group of leading physicians now launching a movement called “open notes.”
12. Wendy Lynch
Wendy Lynch is a respected thought leader in the world of health benefits executives, and she’s a bit fed up. Now leading a unit of the think tank The Altarum Group, Wendy wants to see more boldness by employers in incentivizing employees to seek quality providers. Lynch and Altarum are likely to have significant impact in 2013.
13. Gary Taubes
This science journalist and author spent five years of his life plowing through every known study linking lifestyle factors to conditions like heart disease, diabetes and obesity, and he then wrote a book detailing all of it, “Good Calories, Bad Calories: Fats, Carbs, and the Controversial Science of Diet and Health.”
The bottom line: the science doesn’t support conventional wisdom on saturated fat, diabetes, obesity, diet and exercise. With his remarkable colleague, Dr. Peter Attia, he started a new organization called Nutrition Science Institute to support more research and assure that Americans hear directly from the scientists. Given the heavy emphasis on lifestyle and wellness under Obamacare — including a provision allowing employers to incentivize employee wellness with up to 30 percent of their health insurance premium — look for Gary to help dispel some unscientific myths that undermine these programs.
So as you clink your glasses and wish your loved ones a Happy New Year, remember to look out for these trailblazers who will likely make a true impact on health care in 2013.

Thursday, December 13, 2012

End Secrecy, Save Lives: Consumers Union patient stories

Steven Baker profiled by Consumers Union Safe Patient Project.
Information on growing patient harm is suppressed by powerful interests that benefit from underfunded research and regulation.  Taxpayers and consumers deserve to know which medical devices are safe and effective.  (Especially now when joint replacements are the #1 expenditure of Medicare!)  Patients deserve to know more about an implant device than they do about a toaster oven they are considering for purchase.  Informed consent must include a discussion about the FDA 510(k) clearance debate and medical device Supreme Court pre-emption (Riegel v Medtronic) and tort reform that weakens patient protections when a device fails.  The epic failures of various ICD's, surgical mesh and metal-on-metal hips were preventable.  The device industry is not entitled to profit without accountability.
Please support Consumers Union Safe Patient Project!  These patients are bravely telling their stories to benefit us all!  




Wednesday, December 12, 2012

Rep. Erik Paulsen (R-MN): Stop Cheerleading!


"Our elected leaders must rethink in their endorsement of corporate interests over public health.  Failed implanted medical devices are a huge taxpayer expense.  Joint replacements have become the #1 expenditure of Medicare and on 7/29/2011 the Institute of Medicine (in an FDA-commissioned study) determined that the majority of these implants were marketed through a flawed legislative process called 510(k).  "Revision" surgeries are extremely expensive and subject patients to untold dangers including job and home loss.  Cheerleading for more "innovation" may be profitable to legislators and the industry, but without balance, it will be a drag on our economy.  Congressman Erik Paulsen's constituent services to patients with failed implants:  FDA MedWatch #5009052   -silence-" 
Joleen Chambers-patient advocate-

http://post.mnsun.com/2012/12/guest-column-i-agree-with-president-obama-keep-manufacturing-jobs-in-america/
December 2, 2012 at 6:00 am
BY ERIK PAULSEN – MINNESOTA THIRD CONGRESSIONAL DISTRICT

Paulsen
I agree with President Barack Obama.
During the past year’s campaign, the president stated his support for keeping domestic manufacturing jobs in America. As he said in the first presidential debate, “That’s why we have to invest in advanced manufacturing. That’s why we’ve got to make sure that we’ve got the best science and research in the world.
I agree with the president that we need to invest in manufacturing, and research and development. And, it is my sincere hope that he will work with members of Congress on both sides of the aisle to institute policies that will spur innovation, increase job creation, and keep manufacturing jobs here in America.
A key sector where America’s global leadership is threatened is the medical technology industry.  While other countries, especially Asian and European nations, are providing tax incentives for medical technology firms to do research, invest, and manufacture, U.S. policy makers are actively driving American innovators overseas.
Unfortunately, some of the president’s policies are already causing dramatic jobs losses in medical innovation.
Over the past two years, news headlines have highlighted thousands of jobs being eliminated from this dynamic industry: 1,050 from Stryker, 1,000 from Medtronic, 700 from Abbot, 595 from Covidien, 450 from Zimmer, 300 from St. Jude Medical, 275 from Welch Allyn. In Minnesota alone, 400 device companies, which sustain 35,000 high paying jobs, could be in jeopardy.
The question must now be asked: What is driving these jobs away?
The answer is a new $30 billion tax on medical devices in the president’s new health care law. It’s a 2.3 percent tax on revenue, not profit, and equates to a $30 billion burden being placed on the backs of medical technology companies around the country.
A new study by Ernst & Young, released in mid-November, shows that the new excise tax will actually add another 29 percent per year in taxes to the amount the medical device industry already pays in federal income tax. Estimates from Congress’ bipartisan Joint Committee on Taxation already show that medical technology companies will pay about $8.7 billion in overall federal income taxes next year, with the device tax adding another $2.5 billion to that tab.
The reality is if the tax goes into effect, the medical device industry will face one of the highest effective tax rates of any industry in the world.
This tax will cripple job creation in an industry that has become a true success story for made-in-America manufacturing. The layoffs are proof that companies are no longer investing and innovating here in America. Instead, they are cutting operations, and in some cases, sending those jobs overseas.
American manufacturers need a government that will partner with them to bring jobs back home and jump start our economy, not a government that builds barriers and prevents growth.
I know that medical device innovation and high-tech manufacturing is important to Minnesota, and that’s why I’m working across the aisle to stop this onerous tax. The House has already passed legislation to repeal the medical device tax – with the bipartisan support from the entire Minnesota delegation. But, the bill still waits for action in the Senate.
It is essential that U.S. medical device manufacturing remains a vibrant, innovative and successful industry that employs thousands of Americans. During the campaign, President Obama said he believes in American manufacturing. I do too.  The president has an opportunity to help American manufacturing by working together with Congress on pro-growth policies that will prevent jobs from going overseas and help create new jobs here at home. It’s my hope that the president recognizes that the medical technology industry is one of those opportunities and will support the repeal of this burdensome tax.
Erik Paulsen is the Republican congressman representing Minnesota’s Third U.S. Congressional District.

Monday, December 10, 2012

Patients: Improving Safety

Mary Brennan-Taylor (Consumers Union, Safe Patient Project)  provides UB medical students access to the patient harm story that ended her mothers' life.  Patient safety requires vigilance by medical staff to identify patient harm and investigate the source of the harm so that it can be corrected/eliminated.   Unrealistic litigation fears have interfered with this partnership between patients and their health providers.  Medical schools that recognize this conflict have invited harmed patients/families/advocates to speak.  The conversations are poignant and appreciated by doctors-in-training.  Inviting patients as stakeholders is essential and we all benefit from this balanced approach to improving healthcare.  Harmed patients should not abandoned as lepers, but should be provided additional attention/care to help design a healthcare system that honestly benefits mankind.  Young medical doctors in training want to join a profession where their ethical choices will be respected and valued.

Wednesday, December 5, 2012

Rheumatoid Arthritis Study: Hip, Knee Replacement


http://www.emaxhealth.com/11306/caution-advised-rheumatoid-arthritis-patients-considering-hip-or-knee-replacement


By Robin Wulffson Md on November 30, 2012 - 5:26pm  for eMaxHealth
                Arthritis Pain Treatment Current News


Victims of rheumatoid arthritis can develop problems with their joints throughout the body, including the knee and hip. These joints can be replaced with an artificial one with a procedure known as arthroplasty. Researchers affiliated with the University of Toronto (Toronto, Ontario, Canada) conducted a study to evaluate the complication rate of a total hip or knee arthroplasty among patients with rheumatoid arthritis, compared to patients with osteoarthritis. They published their findings online on November 28 in the journal Arthritis & Rheumatism.
The researchers noted that most of the evidence regarding complications following total hip arthroplasty and total knee arthroplasty is based on studies of patients with osteoarthritis; thus, little information regarding the outcomes in patients with rheumatoid arthritis has been published. Therefore, they conducted a study with the objective of reviewing the current evidence regarding rates of total hip and knee arthroplasty complications in rheumatoid arthritis patients compared to osteoarthritis patients.
The researchers reviewed data from Medline, EMBase, Cinahl, Web of Science, and reference lists of articles. They included reports published between 1990 and 2011 that described studies of primary total joint arthroplasty of the hip or knee and contained information on outcomes in 200 or more rheumatoid arthritis and osteoarthritis joints. Outcomes of interest included revision, hip dislocation, infection, 90-day mortality, and venous thromboembolic (blood clot) events. Two reviewers independently evaluated each study for quality and extracted data. Where appropriate, meta-analysis was performed; if this was not possible, the level of evidence was assessed qualitatively.
The review comprised 40 studies. The investigators found that patients with rheumatoid arthritis are at increased risk of dislocation following a total hip arthroplasty (2.16 times greater risk). In addition, the found fair evidence to support the concept that risk of infection and risk of early revision following total knee arthroplasty are increased in rheumatoid arthritis, compared to osteoarthritis. There was no evidence of any differences in rates of revision at later time points, 90-day mortality, or rates of venous thromboembolic events following total hip replacement or total knee replacement in patients with rheumatoid arthritis versus osteoarthritis. Rheumatoid arthritis was explicitly defined in only three studies (7.5%), and only 11 studies (27.5%) included adjustment for covariates (i.e., age, sex, and comorbidity
The researchers concluded that the findings of their literature review and meta-analysis indicate that, compared to patients with osteoarthritis, patients with rheumatoid arthritis are at higher risk of dislocation following total hip arthroplasty and higher risk of infection following total knee arthroplasty.
Arthritis is inflammation of one or more joints, which results in pain, swelling, stiffness, and limited movement. There are over 100 different types of arthritis. Rheumatoid arthritis is considered an autoimmune disease. The body's immune system normally fights off foreign substances, such as viruses. But in an autoimmune disease, the immune system confuses healthy tissue for foreign substances. As a result, the body attacks itself. Osteoarthritis is related to aging. In osteoarthritis, the cushioning (cartilage) between the bones wears away in the joints. As osteoarthritis gets worse, the cartilage disappears and bone rubs on bone. Bony spurs or growths usually form around the joint. The ligaments and muscles around the joint loosen and become weaker.

Monday, December 3, 2012

Righteous Indignation!


Righteous indignation is typically a reactive emotion of anger over perceived mistreatment, insult, or malice. It is akin to what is called the sense of injustice. In some Christian doctrines, righteous indignation is considered the only form of anger that is not sinful.


ReginaHolliday, the Walking Gallery, just completed this amazing jacket for my brother, Steven Baker.  "Don't Tell Me To Zip It!" 

 What you see in our eyes is not disappointment, but righteous indignation!

The righteous indignation stems from research (my blog is an aggregate of that research) that easily uncovers a continuing systemic abuse of our government by elements of the entitled implanted medical device industry.  The indicators are patient harm (mutilation, torture) and futile class action lawsuits that do not stop the perpetrators from exploiting others. 

This morning the Senate Medical Technology Caucus was briefed  (with the FDA/CDRH) about the new “Medical Device Innovation Consortium” an unnecessary and redundant platform for the industry to influence regulators and legislators.


Patients are the primary stakeholders.  Patient engagement is a term that is not being honored.  I am witness as a patient advocate who has dedicated much of my life the last 5 years to following protocol to determine why my brother’s elbow implant failed and to get him the care that he needs.   It is clear to me that our government (FDA) is unable to assure that implants are safe and effective and subsequently unable to provide justice/assistance to correct the system so this does not happen to others. 

The cost of this failure to U.S. healthcare consumers is staggering, but the profit of the device industry is driving exploitive legislation and status quo medical practice.  Public education and public indignation is coming.  Ethical CEO’s must get out in front and lead the US medical device industry to embrace patient adverse event reports as an essential, timely mechanism to improve product. 

Dear MDIC founders,
 "Maura Donovan, PhD" <maura.donovan@medtronic.com>  
Dale Wahlstrom <dwahlstrom@biobusinessalliance.org>
Please accept this as my application for MDIC membership.  Please waive the $5000 annual fee.  I represent patients harmed by failed implants with the goal of making implants safer and more effective.  FDA/OSHI has interviewed me, I attended a FDA Patient Representative workshop and testified at 2 CDRH Town Hall meetings and the first MDUFA meeting 1/2011.  I understand that MDIC is interested in inclusion of all stakeholders in this new 501(c)3 nonprofit partnership.  I look forward to working with you.

http://www.washingtonpost.com/business/technology/fda-pledges-to-work-with-medical-device-industry-consortium-to-speed-up-product-approvals/2012/12/03/0c9e4c10-3d64-11e2-8a5c-473797be602c_story.html
           
By Associated Press, Updated: Monday, December 3, 10:11 AM
WASHINGTON — The Food and Drug Administration says it will collaborate with medical device manufacturers on a public-private partnership designed to speed up the development of new medical technology.
The agency says it hopes to offer guidance to the Medical Device Innovation Consortium, a new industry-backed group that aims to simplify the design and testing of medical devices.
Medical device makers have criticized the FDA for an overly burdensome review process, which they claim slows down development of important new therapies. Congressional Republicans have held several hearings to scrutinize the agency’s system.
Faced with criticism from industry and Capitol Hill, the FDA has been highlighting efforts to slash red tape and accelerate review times.
The new consortium was created by LifeScience Alley, a Minnesota-based industry group that includes leading manufacturer Medtronic Inc.



Friday, November 30, 2012

Astroturf Lobby Group? Where is the Patient Engagement?


Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues.  Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration


---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building
Announcing: “Medical Device Innovation Consortium”
Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).
The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science.  It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.
The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.
Speakers will include:
Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom



http://www.deviceconsortium.org

The Medical Device Innovation Consortium is a public private partnership whose mission is to improve health through the application of shared knowledge in regulatory science.
Focused on the Medical Device Industry
The MDIC is the only public private partnership focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the private sector can partner with the FDA’s Center for Devices and Radiological Health to solve technical issues that affect the industry.
Focused on Regulatory Science
Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Focused on Improving Health
The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.
Founding Members
FDA
Medtronic
Life Science Alley

About Us
The MDIC is the first ever Public Private Partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.
                The PPP relationship was formalized with the signing of a Memorandum of Understanding between LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December 7, 2011. In August 2012, Articles of Incorporation were filed to formally establish the MDIC.
                Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.
Governance Structure
The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees and assist in identifying sources of funding. Subcommittees will represent industry sectors or technology areas (eg. Modeling, interoperability, orthopedics, neurological devices).
                Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.
                The working groups will bring forward project plans for prioritization and funding allocation.
What We Do
Strategies
The MDIC will pursue several strategies in support of its mission:
1.            Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the different industry stakeholders including FDA.
2.            Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support the MDIC’s mission.
3.            Provide tools to drive cost effective innovation, emphasizing education and the development of new methods and approaches with well documented data and details to enable implementation.
Value
The activities and output from the MDIC will:
                Ensure innovative technology is readily available to U.S. patients
                Make the medical device regulatory process more expeditious, transparent and effective
                Reduce the risk and expense of clinical research
                Reduce the time and cost of medical device development
Projects
The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.
After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.
                The subcommittees will organize working groups to develop rigorous project plans for prioritized topics.
                Detailed project plans will be used to solicit project specific funding from companies who will benefit from their outcome and foundations interested in supporting the initiative.
The advantages of conducting research within the MDIC include:
                Involvement of the FDA at all stages of the work thereby building awareness of and support for specific product development tools and approaches.
                The ability to share best practices across industry and academia.
                Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.
                A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.
TOP

Join
The core operations of the MDIC are funded through contributions from members.
                Pricing for annual membership is determined based upon the operating expenses for the MDIC.
                The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.
                It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.
Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.
                $150,000 contribution annually: Companies with annual revenue >$10 B
                $100,000 contribution annually: Companies with annual revenue between $5–10 B
                $50,000 contribution annually: Companies with annual revenue between $1–4.9 B
                $10,000 contribution annually: Companies with annual revenue <$1 B
                $5,000 contribution annually: Nonprofit Sector
Benefits of Membership
The MDIC will provide its members with:
                A mechanism through which to influence the future of the medical device industry by virtue of direct, collaborative discussions and projects with FDA.
                A process for identifying, documenting, prioritizing and removing issues affecting the industry.
                Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the industry.
                Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.
                Searchable databases and links to relevant reports and methods.
                Regular updates on the status of the MDIC’s activities and opportunities for involvement.
TOP

Contact Us
To receive further information and to discuss next steps and membership details, please contact:
Maura Donovan, Ph.D.Interim Executive Director, MDIC763-505-4515maura.donovan@medtronic.com
or
Dale WahlstromCEO of LifeScience Alley952-542-3077dwahlstrom@biobusinessalliance.org
TOP

Press
Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science
Regulatory Intelligence | Posted: 8 December 2011
Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science. Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, formalizing more than a year of joint effort toward developing regulatory science — a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance. (Mass Device)
Join the discussion on Regulatory Exchange








http://www.massbio.org/news/181-sen_brown_co-chairs_medical_technology_caucus/news_detail

Sen. Brown co-chairs Medical Technology Caucus
April 4, 2011

WASHINGTON, DCU.S. Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today that they will serve as co-chairs for the new Senate Medical Technology Caucus in the 112th Congress. The caucus aims to increase awareness about issues facing the medical technology sector, an industry that creates life-saving and life-enhancing innovations that improve patient care.
In Massachusetts, we have more than 200 medical device companies and hundreds of bio and pharma companies, all of which provide good-paying jobs to thousands of citizens,” Brown said. “It is critical that we provide a business environment for them to innovate, grow and thrive. I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resources they need to continue their important work.”
“These businesses not only spark medical breakthroughs, they save lives,” Klobuchar said. “Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy. I will continue to work to make sure that Minnesota remains a leader in health care innovation by developing innovative products while maintaining patient safety.”

The United States is the world’s only net exporter of medical devices, with a $5.4-billion annual trade surplus. Minnesota is home to 400 medical device practices that support over 50,000 jobs in the state. The industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect employment exceeding two million.
Klobuchar has led the effort to cut red tape that threatens innovation in this industry. After a December report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar and Brown pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and plans to hold a hearing to examine the medical device approval process and to examine ways to improve export options.