Thursday, October 22, 2015

Managing Risk in Institutional Innovation Programs

By John Mattison

Chief Medical Information Officer
Assistant Medical Director

Kaiser Permanente, SCAL

The ascent of rapid innovation is changing our culture and planet in historic proportions.  The exponential pace of innovation challenges our imagination, and it’s often a matter of how quickly we can introduce radical change.  As every institution races to create or enhance their innovation programs, there are several avoidable pitfalls. Institutions whose primary mission is operational services, such as healthcare, appear to be at higher risk of these pitfalls.  The skills and experience required for high performance are not necessarily abundant, and recruiting experienced talent is difficult. Further, existing incentive models within healthcare can clash with models better suited for rapid innovation.  This brief reports highlights common pitfalls and is not intended to be comprehensive.

Focusing On The Principles—And Pitfalls—Noted Below Can Help You To Manage the Inherent Risks in Institutional Innovation:

1)  Principle:  Focus on important problems
  • Confusion of ideation with innovation.  Generating large portfolios of ideas without aligning them with strategic priorities is hazardous.   
  • ‘Spray and Pray’ approach (aka acute and chronic pilotitis):  Assuming that a few big successes will emerge out of a plethora of innovation pilot projects is risky.  While this strategy may appear similar to early phase Venture Capital portfolios, healthcare institutions generally don’t have the variety and flexibility of capital investment vehicles available to entrepreneurs in the open market.   When many innovation projects ‘fail’ it can discourage intrapraneurs, strategic partner entrepreneurs, and the overall culture of innovation.
  • “Vision without action is a daydream. Action without vision is a nightmare." – Japanese Proverb  

2)  Principle:  Dedicate the right resources
     (People, Processes, and Technology)

  • Confusing enthusiasm for competence.  Enthusiasm is necessary but not sufficient.  Skillful support resources are critical to channel that enthusiasm.  
  • Delay in securing effective sponsorship:  Securing sponsorship can be more difficult later in the life cycle, when it is most needed.

3)  Principle:  Understand the full life cycle of innovation from ideation to scale

  • Premature death of early pilots:  Every innovation follows certain patterns during the evolutionary life cycle of iteration and enhancement, but each one also has its own unique pathway.  It is critical to recognize milestones that warrant a transition in approach or resources to progress through the next stage and eventually reach scalable solutions.
  • Underestimating the time needed for success:  Some innovations can be completed in months, but many require many years.  Recognizing when more time will help or not is critical.  As Einstein said, “Innovation is 1% inspiration and 99% perspiration”.  

4)  Principle:  Exploit platforms (especially open modular and open source):

  • Allowing innovation to occur across competing platforms is unnecessarily costly for both initial development and support.  Furthermore, downstream integration of user experience is impaired when ‘platform jumping’ is required.

5)  Principle:  Fail early, adjust, iterate, and remove ego from learning

  • Innovation is increasingly a team sport, relying on acquiring skills and resources from across the multi-platform ecosystems or ‘plecosystem’.  Teams must embrace the tension of conflicting ideas.  Celebrating success is helpful unless it focuses too much on individuals.  A focus on individual credit risks individual blame and impedes the critical pace of rapid iteration.    

6)  Principle:  Empathic design  (a user-centered design approach focused on
     the user's feelings toward a product)

  • Failure to distinguish empathic design from democratic design is dangerous.  Leadership and support is critical to avoid design by consensus.  Consensus-bound decisions often threaten the best opportunities.

7)  Principle:  Recruit key leadership with deep experience in innovation

  • Versatility in experience and leadership:  Large institutional models of promoting leaders often focus disproportionately on political skills at the expense of more basic entrepreneurial skills and track records of success. Versatility is critical in any leadership role for innovation.  Since different types of innovation require different approaches and skills, knowing what skills, resources, and processes to apply at different project stages is critical.  A single innovation success is not a sufficient predictor of versatile leaders.
  • Critical review of candidate resumes:  Key leadership must have experience across the full life cycle of multiple innovations.  Beware of resume claims of multiple successes when each success requires more time than the tenure of that individual in their role on that project.
  • Avoid the “articulate incompetent”.  The CEO of a large tech company once described this term and her series of screening and interview tools to determine whether the representations made by a candidate were justified by the evidence for those claims.  She attributed her low employee turnover rate to this thorough screening process.

8)  Exploit and spread existing internal successes

  • Overlooking existing successes is a serious hazard, and reflects both “not-invented-here” as well as competition between institutional silos.  Applying ‘positive deviance’ as a discipline will bear many fruits.

Each of the above pitfalls is compounded by the presence of any other. The most critical asset to prevent these problems is to select leaders who already have established track records of several successes over the full life cycle of ideation, prototypic iteration, operationalization, funding, and scale.  Once these uncommon skillsets are recruited, they can be effectively leveraged across the innovation infrastructure.  Avoiding these pitfalls not only saves money, but more importantly avoids lost time in a world where rapid disruptive innovations are increasingly necessary to just stay ‘in the game’.

Monday, October 19, 2015

The Future of Our Market

By Jeff Champagne
Director of Business Development
MPR Product Development Group

Astronomers say that in 4 billion years, our Milky Way galaxy will collide with the Andromeda Galaxy to produce a super galaxy. The post merger integration will take about 2 billion years.  Medtronic and Covidien should be fully integrated by then.

There are similar yet smaller collisions that are happening today in real time, right under our noses.  Massive consumer and medical technology companies are colliding every week.

So what does that mean for the future of the life science industry?

Mega deals seem to be in the news on a weekly basis.  Some of the largest medical device companies around are converging with little overlap between them. Much of the value that is being created today in the life sciences industry is a result of the convergence of technologies.  Telecommunications colliding with Rapid Diagnostics will produce real time monitoring and mediated remote treatment of patients. The miniaturization of devices, not previously possible, is happening with an increasing frequency.

Batteries that last for almost a decade are being placed inside the body to create safer and less cumbersome answers to our most challenging health problems. One example that illustrates where we are headed is the Micra, a leadless pacemaker from Medtronic, the size of a Mike and Ike® with a 9 year battery life. 

The rapid changes  and solutions that we see all around us are the result of the connecting of technologies from multiple, seemingly disparate industries.
In recent studies of the collisions that seem to spark serendipitous innovation, it’s clear there are a number of factors contributing to them. One of the largest factors is the diverse talent pool that our industry draws from. Individuals are being hired from adjacent industries because of a technical know -how but with zero previous exposure to life sciences. Talent is moving across industries with ease, full of transferable job skills and a fresh outside perspective. This collision of outside talent and new industries creates many meaningful products.

Maybe “collision” is too dramatic. As suggested in this blog post about “what happens when galaxies collide?” it is perhaps more of a merger. There is so much whitespace in our industry that it does not necessarily mean that direct competition is created as these giants of industry become closer together. Not too long ago, Medtronic and Samsung announced a joint partnership to develop future solutions for diabetes patients to better manage their disease. The product of this collaboration will create a new ecosystem for patients to learn about their condition and improve their health outcomes.

Other tech players that have jumped from Tech to MedTech have had some growing pains and you will continue to see those missteps. Qualcomm, well known in the Medical Technology world for its 2Net solution, is seeing trouble with adoption, as hardware solutions in a connected environment become increasingly obsolete. Bluetooth Low Energy has become widely adopted as an alternate way to connect devices up to the cloud, collecting patient data for eventual predictive modeling.

Because of the smaller, cheaper, faster, models that collide with the established regulatory bodies there is still a bottleneck that forms downstream in the innovation process, especially in biotech and medical device space. If we are to truly develop breakthrough products that utilize cutting edge technology, this bottleneck will have to be solved.

The FDA, USPTO and other regulatory bodies around the world are re-evaluating priorities, to help fast track key developments that can help vast patient populations. The race to develop an artificial pancreas is just one example of this special class of development that merits a fast track.

Hopefully these special cases will help the FDA to develop a new norm that leads to faster approvals and clearances. Recently, the FDA announced that a number of devices would be downclassified, from class III to class II, creating a faster pathway to clearance as there are a number of predicate devices now that satisfy their need for safety and efficacy.  This trend to break down barriers for innovation should continue.

In this picture of colliding worlds, we have a unique view of recently developed, breakthrough products in medtech, consumer, and industrial applications.  This helps us to find synergies and make connections.  For example, helping medical device companies are currently leveraging cloud computing and big data analytics to get better metrics on health outcomes.  Connecting low cost automotive sensors with wearables for on-the-go health monitoring Is another interesting pairing.  We'll see more of these gravitational attractions going forward.

Over the next few years, you will continue to see more mergers, more collaborations, more breakthrough products and a lowering of barriers for speed. It is an exciting time to be in the medtech space. Hold on tight. This is gonna be fun.

So You Want to Do a Telehealth Pilot Program…

By Nancy T. Rector and Hugh Rector
Chief Operations Officer and Chief Executive Officer

Kickstand Business Concepts, Inc.

Decisions….decisions…decisions. Telehealth is all the buzz right now. Plenty of “toys” exist in the marketplace for not only wellness & fitness but also for true medical devices. For right now, we’re going to focus on medical devices for vital sign measurement.

The Beginning

Where do you start? There are many starting points: you may have had a request by your team or you recently read that your facility outcomes could use some improvement and you want to try a tangible process to measure the possibility of real benefits. Wait--but first, what are the state and federal regulations that will affect your reimbursements? Before you consider a pilot, check the following link to familiarize yourself with your state regulations:

A Process, Not a Product

The first important aspect of a telehealth pilot requires that you remember that it is a process, not a product, and that the right team is essential to overall, sustainable success.  Then what?  You must ascertain what questions need to be asked and answered when setting up the pilot.  During this stage, the following should be thoroughly considered and analyzed:

Identify your goals. What do you want to achieve?

A few quick thoughts:

  • A process change or quality initiative to measure basic process improvements: after-hours monitoring in a skilled facility or the implementation of a new process for home monitoring for your practice or facility
  • A non-scientific study with specific measureable objectives that will be utilized to institute broader change or utilized for facility marketing purposes
  • A peer-review study with a scientific protocol for the purpose of publication in a professional journal

Pilot Team

Who will participate in the study? Who will be a part of the team? Once you have determined what pilot type is right for your type of facility, it is necessary to develop the team you wish to use. These members will need to be detail-oriented, forward-thinkers. They will need to understand the process and specifically how to develop and execute a process. Without Process and Team there is no success. This team will need to set specific goals and goal time frames; they will need to understand how to put the goals into motion and further how to continue to motivate others to assist in the implementation of the How and What, which is discussed later in this article.

Patient Population

One of the most critical aspects of the process is determining the “where?” and/or the “who?”.  Specifically, where is the desired impact and/or what patient population will be utilizing the new process? In coming to this determination, it can be broken down to a specific patient DRG (Diagnosis Related Group), a segment of facility population (e.g., wing, floor, etc.), or any other defined set of patient circumstances. Once you identify this critical aspect, it will guide you in identifying the appropriate process and equipment.

Current Process vs. New Process

Now we revisit the How and What in greater detail. How do you envision changing your current process? Understanding what you want to change and where that change will enter into the current processes is critical to understanding the specific product requirements for accomplishing your identified objectives.

Consider the following examples:

  • If your goal is RPM (Remote Patient Monitoring) only, this will impact the system you choose. Specifically, RPM won’t require 2-way HIPAA secure video.
  • If you want active patient/clinician interaction, you’ll need a video system, but not necessarily one that is built into an RPM system. 
  • If your clinician’s process is cardiac-related, the process will typically require specific devices, such as a stethoscope.

Telehealth Tools

After identifying the How and What, you’ll need to identify the specific tools required to achieve your stated objectives.  So you must ask yourself: What telehealth tools do I need for the process? You have already assembled your team, analyzed your patient population, and identified your process goals and initiatives.

Your next step? Now you must investigate the various products that you feel would be a possible fit into your program.  Sounds easy, right? Sure; until you realize you have no concrete information on the specific product or the company you’re investigating. Enter: FDA registration. During your investigation, FDA registration will come into full view. Why? Because no products utilized in these programs or processes should be utilized without the government’s approval, or without being FDA cleared or registered, unless your program is a “wellness only” program.

As there are different devices utilized to perform an array of tasks, it is important to understand what type of “clearance” will be required. For example, “Class I clearance” is required for devices that will be performing “observation only” functions, while “Class II clearance” is required for devices that will be used to assist with “clinical decisions”, or diagnoses. Each of the foregoing clearances have varying requirements. A quick review of classifications can be found at the two following FDA web links:, 

By way of illustration, if the product is a “Class I” device/product, it is imperative, or at least to your great advantage, to verify that the product was developed within “Good Manufacturing Practice” or GMP guidelines, a set of standards aimed at ensuring a controlled manufacturing process based on quality and safety.

Once the quality has been assured, you must then determine whether the functionality of the devices will work within the pre-determined parameters of the pilot. “Trial and Error” rules this aspect of the process, I’m afraid. So be sure to choose carefully and attend conferences and tradeshows such as ATA, HIMMS, and the mHealth Symposium, in order to increase your knowledge and to further network with others who are trying to accomplish the same, or similar, goals as your Team has established.

Most manufacturer-based telehealth systems will not have everything you require for your process. Don’t be afraid to use several different companies together. One of our studies in progress utilizes 3 different products for the program that run together seamlessly.

On To Pilot Execution!

Ultimately, the key aspects to success are “Process and Team.” The products you choose will be improved upon quickly by the manufacturers, and new telehealth sensors and software are introduced into the market on a routine basis. As with the weather, those telehealth tools will be ‘ever-changing” with the lightning speed advances in technology. Your success is dependent on your team, your goals, and the identified process.

What Comes After The 'Uber For Healthcare' Model?

By Reenita Das

Partner and Senior Vice President
Transformational Health

Frost & Sullivan


New model can save time and money when treating chronic care patients 

Much has been written on the “Uberization” of healthcare and the potential benefits this model could provide in terms of cost reduction, improvement in efficiency of care, and judicious use of both manpower and resources. The prevalent consensus thus far is the Uberization of healthcare will be one of the defining healthcare trends of the 21st century.

The core objective of this model is widely assumed to be the facilitation of primary care physician home visits. These home visits expect to benefit patients who are not ambulatory because of a disability or ailment. With two-thirds of the American population using a smartphone, coupled with network connectivity and high rate of Internet penetration, healthcare providers can target this large home care market. Patients can access custom apps allowing them to view doctors in the area, select a visit from a particular general physician (GP) and make an appointment.

However, use of the Uber model for primary care home visits is debatable. A survey conducted by the American Academy of Family Physicians in 2013 shows home care visits declined from 19% a week in 2010 to 13% in 2013. This trend indicates patient mobility may not play as large a role in home visits as previously thought.

Another major issue limiting Uberization of primary care is the current physician shortage in the U.S. Despite the number of primary care physicians increasing over the past five years, the number of primary care visits a year is a staggering 1 billion annually, making an average of 3,000 patient visits per physician. Conservative estimates expect the primary care physician shortage to go as high as 12,000 by 2025, with other estimates projecting a shortage of 31,000. The most acute shortages are currently seen in rural areas, with a current deficit of 4,000 primary care physicians. Only 10% of primary care physicians in the U.S. practice in rural areas, home to one-fifth of America’s population.

With an existing primary care physician shortage expected to widen over the next decade, using physicians for house calls would adversely impact time between consultations and make a poor case for smart utilization of primary care physicians.

Virtualization – Healthcare’s New White Knight?

While Uberization of primary care through use of smartphone technology does not seem viable, the same technology can be leveraged toward virtual health services. A survey conducted by the American Hospital Association two years ago shows 76% of responders prioritized access to care over the need for human contact with providers. This survey showcases strong potential for growth in virtual healthcare.

An international survey conducted in the U.S. shows only 29% of physicians indicated their practices made arrangements for ensuring after-hours care for patients, other than automated phone referral to the emergency department. Only 30% of patients in this survey described getting care on nights and weekends as “very” or “somewhat” easy.

In another national parent survey conducted by Joseph S. Zickafoose, only 47% of patients reported access to their child’s primary care office on the weekend, 23% reported access to primary care after 5 p.m., and only 13% reported access to primary care physicians via email. Creation of virtual platforms enables patients to contact primary care physicians over video calls 24 hours a day will ensure greater real-time access to physicians.

Virtual care could also reduce cost per consultation to about $40 to $50 over time and eliminate doctor visits. This would benefit insurers looking to reduce costs and improve efficiency of care provision. Primary care physicians could see more patients on a daily basis, as well as manage patients more effectively.

For example, patients who are scheduled to see physicians for regular check-ups can do so over a virtual video call, while more serious patients can visit the doctor’s office in person. This practice allows primary care physicians to allocate more time and effort on patients requiring in-person care to improve health outcomes.

This, of course, does not mean virtualization will completely replace the Uberization of healthcare. Virtualization can work with Uberization to create comprehensive patient management solutions, which will greatly benefit chronic care patients.

Virtualization and Uberization of Healthcare – A Hybrid Solution to Patient Management in the 21st Century

Chronic care management is perhaps the most critical component in the U.S. health system. Chronic diseases are on the rise and expect to kill approximately 64 million people each year in the U.S. Four-fifths of healthcare spending is driven by chronic conditions, most of which are lifestyle diseases. Chronic care requires continuous patient management as opposed to one-off surgical or medical intervention. Currently, 71% of chronic patients are managed through face-to-face meetings with primary care physicians and specialists, while 50% of chronic patients are also supported by home visits.

To facilitate efficient patient management, it is essential to monitor patient health in real time and share this information along the care continuum. While wearable technology is currently used to monitor and share a range of health parameters such as blood pressure, heart rate, oxygen saturation, etc., without requiring a doctor or caregiver to be physically present, monitoring for some chronic conditions will require high-end imaging solutions.

In such a scenario, Uberization of health can create an extension model of care provision. In this model, specially trained diagnosticians can partner with ride-sharing services to bring portable imaging services to the patient’s home. Portable ultrasound, MRI and CT devices can be leveraged to improve efficiency of diagnosis, with results transmitted via encrypted networks to doctors and patients post-analysis. Doctors can then make an appointment with the patient either in person or virtually, based on the results.

The Tricoder – From Star Trek to Med Tech

For fans of the Star Trek series, the Tricoder needs no introduction. For the uninitiated, the Tricoder is a handheld device used to record, store and analyze data. To this end, there has been interest in creating a medical Tricoder allowing patients to self-diagnose, store and analyze health data. While there has been resistance to the idea of patient self-diagnosis, including from the FDA, there is tremendous potential for medical Tricoder adoption among care providers.

Care providers can work with device firms to create Tricoders that capture multiple parameters of health data and store for later analysis. Diagnosticians can partner with ride-sharing services to reach patients who are unable to visit the diagnostic lab. Tricoders can be used to record health data not already captured by wearable technology. Data on these devices can then be transmitted to cloud-based servers for analysis and then to the doctor.


Virtualization of health has and will continue to revolutionize the way care is provided. However, physical human presence will remain the backbone of the care provision spectrum. To this end, Uberization will have a huge role in connecting caregivers and patients outside of doctor’s offices, hospitals and diagnostic labs.

With a shift in focus from intervention to patient management, aggressive monitoring without putting a strain on already limited resources and manpower is necessary. To achieve this goal of aggressive monitoring, it is essential caregivers utilize both virtualization and Uberization to create hybrid solutions to meet current and future demand.

This article was written with contribution from Sowmya Rajagopalan, Research Manager with Frost & Sullivan’s Transformation Health Program.