September 2013 - Real competition is coming to Healthcare... with Health Insurance Exchanges

In the first week of September 2013 the news started breaking on the actual costs for the new healthcare exchange insurance programs.  On average, a young single person in Minnesota could expect to pay ~ $300/month for insurance, for an annual cost of $3600.  There are various plan levels to choose from as well, and variables for age, family plans, etc.

Key to the operation of the whole system will be to enroll "young invicibles" into the insured pool to round out the risk base. For folks who haven't experienced any health problems in their lives, all of a sudden taking on a new expense for health insurance may not be all that easy to swallow.  I wish I could find the article in the StarTrib that quoted some people reacting to the rates - "why is health insurance so expensive?"  "I am just going to get the minimum coverage necessary."  etc.

I predict that the consumer-driven behavior of individuals required to buy health insurance will be the real force that moves the needle with the underlying cost of healthcare.  People will drive the premium payments down by choosing cheaper insurance options, insurers will compete with savvier plans, providers will need to re-engineer their operations to provide care at lower cost and compete for insurance company contracts, and service providers in the healthcare industry will revolutionize the way healthcare is delivered.  All due to the forces of market competition that happen when CONSUMER chooses how much they will PAY.

We are living in exciting times in healthcare.

June 24, 2013 - A rare opportunity to hear about medtech from Omar Ishrak, Medtronic CEO

We are fortunate to have LifeScience Alley (LSA), a non-profit organization dedicated to the medtech and biological industries, right here in Minnesota to stimulate discussion, education, and networking among the lifescience community.  Earl Bakken was a wise soul when he founded Medical Alley for the Minnesota / midwest region, a spinoff of the term "Silicon Valley," to brought our lifescience industry community together and then grew into LifeScience alley under Governor Tim Pawlenty's term.

I was reminded of how fortunate we are to have this group when LSA sponsored an interview forum on June 24, 2013 with the relatively new CEO of Medtronic, Omar Ishrak who hailed once from GE Medical.  Here is the LSA post-event email (and if you'd like, you can join MassDevice and listen to the podcast):

On June 24th, Medtronic CEO, Omar Isrhak, sat down for a live one-on-one interview with MassDevice.com publisher, Brian Johnson, to discuss the future of the medical device industry, emerging markets, the medical device tax, and what comes next for Medtronic. Thank you to everyone who joined LifeScience Alley, AdvaMed, and MassDevice.com this past Monday to hear Ishrak's interview live in St. Paul. In case you missed it, follow the link below for audio of the interview: Podcast: Medtronic CEO Omar Ishrak on emerging markets, economic value and the medtech tax

Wearing a pink shirt and tan suit that didn't really go with it, in my view, and with his bald head, glasses, and wide smile, my impression of Omar Ishrak is that he is a confident leader who reflects on how the moves he makes affects Medtronic as well as the world at large.  My main takeaways from the interview are:

• The "symbolic gift" Bill Hawkis received as CEO of Medtronic was a sword; Omar said his "symbolic gift" was the globe.  Very cool to think of medtech evolving in a truly global marketplace.
• The importance of data is growing in healthcare, and data sharing will get us to a place where everyone can benefit from it. (Yale Infuse study.)
• Time to leverage the assets we've grown under our country's financial support of the medtech industry to go to other places.  
• What is economic value?  All of those approaches.  Translation of clinical value to economic value in very granular terms.  Through that, the focus of R&D is figuring out where the value is captured.  What $ to bring to market.  Everything we do has a clinical value and a corresponding economic value.  Provide it in a way that hospitals and Doctors and Patients can relate to.  Granularity is important; generality can't do.
• I was reminded of my summer intern Zac Dalton's work at Guidant when we developed the value framework for heart failure sensors; as a brilliant former Intel engineer, he brought order to this equation with the following process diagram, which I have evolved in my work with MedLinX and WMDO:

• Helath care outcomes WW are incredibly different, but cost - if we improve outcomes, cost comes down, not up.  Improve care so we can bring cost down.
• Global markets?  We have to see what the markets want.  We have to know the value technology brings to those markets.
• What kind of better?  "Ending desire for better healthcare."
• Emerging markets: not technologies, but solutions in line with what people can afford (only 15% of people can afford Medtronic technologies now in emerging markets.)  But a $5 bn/year opportunity.  Remaining 85% - as middle class rises, government provides more so MDT's cost goes down; then there will be even bigger opportunities.
• How does the patient get the Rx?  Awareness - then Market Development!  (ala Dymedex Medical's market development methodology:

• Hospitals are around; training and awareness is missing.  (and referral development & care pathways.)
• What knowledge are you bringing back to the U.S.?  Learning the healthcare systems - the end market in China is way bigger than what we can do.
• When you leave Medtronic, what do you want the company to look like?  Transform from device co. to Healthcare Solutions company.  Pay for value better understood.  Equal access around the world.  Markets will be bigger, but not challenge the level of care that developing countries have.  

The forum also included a panel discussion by CEOs from the medtech industry including John Russell, my former boss at Guidant who is now CEO of Corventis, and the CEO of Orthocor Medical and Debra xxx from Advamed.  In general, my takeaways from this panel discussion is that regulatory and reimbursement challenges, in addition to the medical device tax, are squeezing small company's ability to innovate.  Their stories brought these messages home.  I hope we as a country can find the right balance to make innovation the cure for what ails our healthcare system.

Thank you again, LSA, and Omar Ishrak and the panel members.  A great evening.

2013 0410 Design of Medical Devices Conference - "The Future of Medical Devices", by Randy Schiestl, VP of R&D, Boston Scientific

The University of Minnesota hosts a world-class Design of Medical Devices conferences, targeted at inventors and engineers, near campus each year in April.  I was fortunate to attend one of the Luncheon Keynotes, an address by Randy Schiestl, VP of R&D (and rabid Gopher fan, being a graduate of both the undergraduate and MBA programs; and he is coaching his granddaughter Stella to be a future Gopher as well!) on "The Future of Medical Devices."

Mr. Schiestl's talk focused more on the process of innovation than the "what" in the future of medical devices, discussing the importance of a global approach to understanding markets & regulatory requirements, and collaboration being key to success.  He provided a glowing testimony to the value of collaboration between industry and the U of MN, through the "Medical Device Innovation Consortium" which allows industry to fund research and contract for future royalty value of technology that is developed.

One technology he highlighted was 3D computational modeling, specifically a heart model that can be constructed via MRI and CAT-scan images, that allows for a detailed understanding of navigational opportunities within the heart.  The work between BSC and the U of MN in this area was published in a recent IEEE article.  Technologies such as these, he said, will advance both quality and speed of device development, and reduce costs.

Although the talk was light on the "what" of what the future of medical devices will bring, Mr. Schiestl concluded with an insightful recap of what's important in the conceptualization and development process:

• Follow the $ --> Know the Payers
• Connect with Big Data --> Hospital Networks
• Recognize the demographics --> Assess Worldwide Markets (people are different around the world)
• Collaborate --> Develop Global R&D and Operations capabilities
• Partner with Regulators --> Ensure a Global Approach
• Drive Quality, Speed, and Efficiency --> for a Winning Culture

We are lucky to be in a place where so much wisdom about medical devices exists.  Thank you Randy Schiestl for sharing yours, and for doing so much to contribute to the community!

Jan. 31 2013 - Design Thinking Workshop by expert Ryan Armbruster, Dir. Innovation UHG

One of the greatest perks to being on the faculty as an Adjunct Instructor at the University of St. Thomas is being invited to wonderful faculty seminars and Health Care MBA program events.

This post comes from a faculty seminar which featured Ryan Armbruster (ryan.ambruster@gmail.com), Director of Innovation at United Health Group, who taught us the broad definition of Design Thinking and then led us through an exercise with a partner to design a better gift-giving experience.  I'll just post the slides I created as notes from this experience here to share with you; it was the easiest way for me to capture my learning.  THANK YOU RYAN - VERY INTERESTING AND FUN EXPERIENCE!

Dec. 5th, 2012 Annual Life Science Alley Conference

LifeScience Alley (LSA), a great non-profit industry group here in the Twin Cities, held its annual conference in Feburary at the Mpls. Convention Center on Dec. 5th.

Earl Bakken started "Medical Alley" likely in the 70's-80's to help industry professionals establish career networks; he recognized the importance of this when big computer firms like Control Data and Honeywell had layoffs and people needed to find new careers (in fact, Medtronic and other device firms probably benefited from the skilled labor pool in MN from those industries.)  When Pawlenty was governor in the mid-90's, the name was changed to reflect a broader-based view of the medtech industry to include biotech and perhaps even agritech.

Often, I feel that LSA's meeting reflects the themes of the times.  Over the years, the keynotes and presenters have focused less on clinical benefits of individual technologies to broader healthcare system issues, and the presenters, panelists, and conference-goers have evolved over time as well.  This year, there was even greater involvement on the part of insurers and providers, offering the medtech world a deeper view into those stakeholders needs and challenges.

LSA makes note-taking easy, and has posted the keynote lectures from the session:
http://www.lifesciencealleyconference.org/2012-keynote-speaker-videos-2

Videos from the 2012 Conference are now available online.  Click here for speaker videos.
Morning Keynote: Julie McHugh, MBA, COO, Endo Health Solutions	Luncheon Keynote: Véronique Roger, MD, MPH, Director, Center for the Science of Health Care Delivery, Mayo Clinic	Afternoon Keynote Panel: Rob Clark, Vice President, Healthcare Modernization, Optum Brent A. Del Monte, JD, Vice President, Federal Government Relations, Biotechnology Industry Organization (BIO) Raymond Frost, Vice President, Public Policy & Government Affairs, Bayer HealthCare Mark Leahey, President & CEO, Medical Device Manufacturers Association

Here are my takeaways as well.

Morning Keynote with Julie McHugh, COO Endo Health Solutions

• Key now for medical device manufacturers is to focus on CARE PATHWAY OPPORTUNITIES.  We need to comprehend and look a the healthcare market a different way.  Having electronic data remains a key gap.
• Economic value is a must.  Innovations must improve outcomes while taking cost out of the system.  Innovation is being redefined by what is needed in healthcare delivery and information technology, (not in meeting unmet clinical needs with new technology solutions - exactly my thinking with the industrialization of healthcare!)
• 5-10 years from now, Julie sees a time when the industry has dismantled the old model and built a new one.

Luncheon Keynote with Veronique Roger, MD, MPH, Director of the Center for the Science of HC Delivery, Mayo Clinic

• Basic though this is for all of us MBA's out there, after reviewing a lot of wonderful history of Mayo and how care has evolved there, Dr. Roger outlined (in a lovely French accent) the Mayo's "new" foundation for re-engineering healthcare delivery: the Patient-Physician-Payer triangle, and the concept that Value = Quality (in terms of Outcomes, Safety) over Cost.  Old news to some of us, but I guess it's new to healthcare!
• She also introduced the idea of "Design Thinking," which again, is an old concept to industry (particularly high-tech companies like Apple) but is mission-critical to the age-old healthcare industry as it seeks to develop new solutions that will WORK for its multiple constituents.

Afternoon Keynote Panel: 2012 Election Results

I found this session to be a bit deep in the weeds of singular issues with FDA & reimbursement, but perhaps some good points to take away....

• FDA needs to be appropriately funded to manage user fee program across med device, pharmal, biosimilar, generic drug
• Most pressing issue from Affordable Care Act  / Blind Spots:
• More unknowns that knowns - 9 proposals since election
• What do small employers do in 2014? Exchanges or offer the benefit?
• How will states deliver?  Commission and independent advisory group...
• For Optum, cost, quality, and access are key, as is the escalation of Accountable Care Organizations (ACO's)
• Sunshine Act...
• 2013 Cost of Care is issue.  What is the solution?  Tech is the solution to the HC problem, not he cause.  4% of the cost, vs. 70% of the cost is labor (one could argue the point that the labor is there to utilize the tech...).  Have to think of new ways to skin the cat.
• Data from devices such as EHR; value vs. fee for service.  MDT, BSX, STJ --> how about # of times lives are saved?
• More work between companies and payors - what do they define as value?
• 2d --> 2 yr plan.  Drive consistency in FDA approval.
• Ideas: Risk sharing contracts between payor and ACO
• Get Payers involved in clinical trial design and patient advocacy (oncology)
• Concern - lack of importance we have on Physicians.  Vital communication between Dr.'s and industry reps.  Shortage of PCP's.
• Need to recognize tha tfor a new technology to be adopted, there has to be a bridge between collecting data and reimbursement.

Dec. 4th, 2012 MidAmerica Healthcare Venture Forum

A luxury meeting for me, I plopped down $650 to attend this event at the Hyatt in Mpls. to hear the stories from entrepreneurs who are starting companies and running startups these days.

My 2012 client, Steve Anderson, the CEO of Preceptis Medical Inc., presented, and it was fun to be there to hear how he described the vision of the company, market opportunity, and next steps to this audience.  I met one of his BoD members, Michael Dale, the President & CEO of Medical Device Innovations, and also enjoyed running into Guido Neels, former COO of Guidant, where I had benefitted as an employee from his great leadership.

The main themes of the conference and a few highlights:

• Mobile technology is disrupting traditional healthcare business models.  We now have the ABILITY through TECHNOLOGY to provide intelligent insights and have real applications for prevention.
• Serial Entrepreneurs: Landscape today vs. 5-10 years ago.  Michael Dale put it straight up: it's COST that matters now, not incremental clinical performance.  He's a man after my own heart: in the course I teach at UST, I tell my students, there is a four-letter word in healthcare and it's not CARE!  A decade ago medical device manufacturers talked to doctors, now they talk to payers.  New innovation has to demonstrate COST SAVINGS to provide value in this environment.
• The Healthcare Investment trend is shifting from Medical to Industrial
• Economic Value Analysis: Innovation and How we Pay for it
• Investing in AgriHealth
• New Models of Financing in BioPharmaceutical Product Development

Nov. 13, 2012 Collaborative IMPACTS in healthcare and medtech

From The Collaborative Reform Series, another great event on IMPACTS in Medtech Innovation, Health, Wellness & Technology, Regulatory & Reimbursement, and Care & Delivery.

Session One: MedTech Innovation Impacts:
Dr. Stephen Oesterle, SVP of Medicine and Technology and Medtronic, opened the panel discussion with observations that MN is a good place for medtech innovation: best cluster of companies, good hospitals, great people examples to follow (Bob van Tassel, Manny Villafana), and a central airport - we can get to and from either coast in a day.

Where will innovation happen?  Where there is a positive, better economic argument.  Areas:

1. Remote patient management.  HF sensors --> PA pressures.  Diabetes. Hypertension.
2. Drug Delivery / Biologics.  Proteins don't go across the blood/brain barrier.
3. Spine.

China will spend 8% on healthcare in 5 years, vs. India at 1.2% on healthcare, in a chaotic market which by necessity will have consumers paying out of pocket --> China is a better bet.   To note a key technology trend, in India, there are more cell phones than SHOES, and yet only 75 Electrophysiologists.  A NEW MODEL is required to serve that country.  For Brazil, medical devices will have to be made there to be accepted; same with Russia. 

Ed Spencer, Chairman of Affinity Capital, noted that two areas have changed dramatically in medtech in the past few years: FDA and Reimbursement.  But also key to positioning is to understand that our demographics will significantly increase the utilization of healthcare, and 90 million+ people will be newly insured under Obamacare.

Session Two: Health, Wellness & Technology Impacts:

Rick Jelinek, CEO of OptumHealth, United Health Group discussed the evolution of the healthcare system, drawing an analogy to banking with ATM's and then online banking.  In healthcare, paper records might be ok with singular conditions, but most people have multiple conditions.  Now, we are using data to connect. In the fragmented HC system, consumers and providers are caught in the middle.  New solutions need to fit together, not just offer innovations of point solutions.  "Meaningful Use" is key in Electronic Health record use, and $ are flowing into incentivising Electronic Health records (i.e. government payment program for Medicare patients.)

Dan Ryan, CEO of Redbrick Health, also provided insights into consumer health engagement technology.  He cited the work of Dr. Vijay Fogg in behavioral research as well.

Session Three: Regulatory and Reimbursement Impacts

Representative Erik Paulsen (another St. Olaf grad) discussed progress and setbacks to repealing the medical device tax, and brought up "user fees" for utilizing FDA review services.

Susan Alpert, M.D. PhD, former FDA reviewer as well as corporate regulatory executive for Medtronic and CR Bard, discussed the changes at FDA and also mentioned that mobile health ("m-health") is a big issue in the regulatory domain.

Session Four: Care & Delivery Impacts

Vance Opperman, Chair of the BoD at BCBS of MN, outlined the impact of the election on healthcare:

• In March 2013, the rollout of Health Insurance Exchanges
• May 17th - final approval of the PRODUCTS in the plans (see the disconnecct there!)
• Oct - registration
• State needs regulations to know how to roll these out!  So far, no detailed directions.  Most states will likely offer the Federal Government exchanges.
• Outcomes based medicine with consolidating provider/payer groups will prevail.
• Proud of the work BCBS did with the war on tobacco.  We can do the same to create a cultural shift around obesity - for example, the bike rental stations, "Do" campaign, ads with grocery stores.  We can make a difference through prevention!

Last but not least, Tony Miller, managing partner of Lemhi Ventures and previous co-founder of Definity Health one of the first high-deductible insurance plans, shared his views on where healthcare is going.  (and another St. Olaf grad!  in my class, though that alone doesn't make me famous, I suppose.)  Healthcare is the single largest market in the U.S.  Now, the industry is in the process of creating a free market where insurance used to reign!  Systems that design and incentivize members around health through good COVERAGE decisions, CONDITION management thru social media; and CARE will succeed.  Individually, the question is, how do we create SHOPPING in each one of those categories for the consumer, so that real market forces revolutionize healthcare? 

Reform itself - three bets on the primary drives for how it will take place:

1. How much volume of employer-based insurance will shift to exchanges?  Unionized Fortune 100 companies are going to get out of the insurance business for their employees and pay the penalty in 2014-5.
2. COST --> Reimbursement.  Really Bad for cost control and Relative Value System.  Base from which everything comes off is backwards from which which every other industry builds efficiency.  ACO law, bundled episodes may be a starting point.  Tony believes that this time around, the Accountable Care Organization will transform the U.S. healthcare system, as well as the huge shifts in behavior at the payer level that influence consumers. 
3. Pure increase in regulation.

It will be fascinating to watch these forces play out over time.  THANK YOU to the Collaborative and to all of the wonderful panelists for sharing their knowledge, wisdom, and insight.