Author Archives: Arlen Meyers

About Arlen Meyers

Arlen Meyers, MD, MBA is an emeritus professor at the University of Colorado School of Medicine, an instructor at the University of Colorado-Denver Business School and cofounding President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org. Follow along onSubstack.

Do sickcare innovation centers deliver?

GUEST POST from Arlen Meyers

If you work for a big, established company, you’ve probably been noticing the sudden rise of a new trend: the innovation lab. Companies as diverse as Delta Air Lines, Target, Google, Pfizer, Marriott, Autodesk, Fidelity Investments, Ford, Verizon, and Stanley Black & Decker are jumping on the bandwagon. Most don’t deliver.

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Open innovation labs like this bring The Garage Experience inside the four walls of the corporate business environment – freely available for everyone to use and experience.

Univerisities have joined the parade, creating undergraduate and graduate innovation and entrepreneurship centers, despite the fact that there is scant evidence that they work.

The new thing in sick care administration is to create healthcare innovation centers, modeled somewhat after other industry R/D and skunk works. Their goal, ostensibly, is to innovate our way out of the sick care and health care mess. They focus mostly on quality, cost, process improvement, patient experience, sometimes doctor experience and access to care and range in size, scope and vision. A recent review identified 50 hospital innovation centers. Steve Blank calls it innovation theater

Considering how deeply companies rely on innovation, it is astonishing how bad most of them are at finding, developing, and implementing new ideas. Global companies pour roughly $1 trillion yearly into innovation; estimates are that at least 10% of that sum — $100 billion — is completely wasted.

Here is an example of one that is successful. Some have combined designers and, can you imagine, are also asking patients what they want.

Here is a building dedicated to sick care innovation in Denver.

Now,even the AMA is in the game and has anted-up $15M.

As you would expect, there are now conferences, webinars and white papers about health innovation centers, best practices and their impact to date. Accelerators are changing to accomodate the realities of the sickcare industry. 

 It is not always a good thing for a startup to join an incubator or accelerator. Or, rather, there are multiple aspects of business incubation practices that could affect negatively early-stage companies, and founders of new ventures should be very careful when selecting a specific incubation program.

Corporations are creating innovation outposts to stay ahead of the curve.

Sick care (over 90% of the US “healthcare” spend is for taking care of sick people) innovation center leaders and participants will need to address some issues to be effective and deliver impact:

1. The last mile. All the systems engineering in the world won’t make a difference until we crack the code on how to change human behavior.

2. The rules. Most will have relatively limited impact until and unless the reimbursement rules substantially change. Rules drive ecosystems that create business models that deploy and scale innovation. Right now innovation centers are trying to use new tactics but can only deploy limited innovation strategies without a new playing field. They are living in the no man’s land between the now and the new.

3. Systems thinking overcoming silos. Healthcare is notoriously siloed at almost every level, from department to department to one sick care system to the next.

4. Patient willingness and ability to engage. The assumption is that more patient “engagement” will be mean better outcomes. That needs to be validated and we need to do a better job of targeted patient segments who want to take responsibility for their care and assume the consequences for the results.

5. Shifting value factors. Medical care is becoming commoditized. Patients can’t judge quality and cost since they are so opaque so they use service, speed, convenience and experience as proxies. There is relatively little correlation between satisfied patients and the quality of care they receive.

6. Data integration and interoperability. Resolving the protect but share dictum will be challenging.

7. Measuring and defining innovation. Big orbit change is necessary, not incrementalism. Innovation is a measure of the multiple of user defined value that results when compared to the existing competitive offering.

8. Lead innovators, don’t manage innovation. We need leaderpreneurs and followers with an entrepreneurial mindset willing to fail at low cost.

9. Innovation management systems. There are many ways to foster, package, test, validate, prioritize and deploy components of an R/D portfolio. The process needs to efficient, effective and transparent to the users .

10. Execution. Inspiration and perspiration. In the end, no idea, invention, discovery, or process is worth much without a team who can execute or deploy it.

11. Long sales cycles prolonged processes of decision making.

12. Different business models to develop digital health and process improvement products

13.Overcoming the main barriers to physician adoption: a)evidence based safety and effectiveness, b) concerns about liability, c)getting paid to do whatever you propose that d) will not interfere with workflow, take more time and further abbreviate face time with patients.

14. Entrepreneurs outperform intrapreneurs

Here is an example of a “different” model. We need scalerators, not accelerators.

Healthcare innovation centers seem to have a different focus than community based entrepreneurship centers. Yet, they should both be focused on the same thing: transfering value to patients. Physician centered value centers should have the following features:

1. Focus on creating value transfer to patients, not startups

2. Create a separate value proposition for the different kinds of physician entrepreneurs: private practitioners, technopreneurs, intrapreneurs, investors, consultants.

3 Include rapid prototyping facilities

4. Integrate non-MDs from other industries to create a larger, more eclectic community of interest

5. Include patients and others who might help with the customer discovery and development process

6. Include human subjects trial support

7. Accomodate the schedules of practicing clinicians

8. Use state of the art teaching technologies

9. Have an active and effective mentoring process

10. Create a business model that doctors will buy

A recent study provides details for the 10 top success factors for hospital innovation:

1.      Use a clear step-by-step innovation method

2.      Establish an Advisory Group to guide innovation concepts and proposals

3.      Focus on consumer needs, rather than technologies to direct the innovation

4.      Generate Big ideas by focusing on core outcomes, not the symptoms

5.      Minimize early funding by focusing on a minimal viable product

6.      Support projects with innovation experts (design, engineering, business)

7.      Utilize an iterative prototyping to quickly build and test the best product

8.      Nurture publicity and storytelling to raise visibility, excitement and funding

9.      Include industry experts/ vendors/ investors to support commercialization

10.  Develop power users to give hands-on training and coaching for innovations to build key behaviors and practical experience

“What is the source of this hostility to innovation?”, “Is the under-performance in innovation episodic or systemic?” and, “What is causing this value-destroying gap between stated intent and actual reality?” Here are 3 reasons.

In fact, like many industry innovation centers, my guess is that few sickcare innovation centers are creating much impact and should be closed, particularly if they are just high priced, high tech suggest boxes. Here are five reasons why they should be shuttered.

In addition, the establishment of university-affiliated incubators is often followed by a reduction in the quality of university innovations, according to a new study co-authored by a Baylor University entrepreneurship professor.

Here are some reasons why it is so hard for BIG MEDICINE to innovate

Most don’t and that’s part of the reason doctors have been disintermediated and marginalized from the value creation process.

We need to rethink accelerators and incubators given their marginal success record of creating scaleable companies. Scale up expert Sherry Coutu believes that most innovation facilities today are failing in their duty to help startups and corporates work effectively together and bring products to market at scale. Whether in terms of running successful proof-of-concepts, giving access to talent and finance, or even providing the hardware required to scale up their work, these things are traditionally lacking from the modern incubator.

The challenge for enterprises looking to make strides then is to back up their innovation strategy with the organizational capability to scale up the experiment i.e minimally viable pilots.. Hagel and Seely Brown advocate a seven-step process:

  1. Locate your edge, which is likely to be an emerging business opportunity that has great potential to scale up rapidly.
  2. Identify your changemaker/s who fully understand and will embrace this opportunity.
  3. Position this individual/s outside the core of the organization.
  4. Take a lean startup style approach and experiment relentlessly in order to accelerate learning.
  5. Deprive the team of much in the way of support or resources.
  6. Encourage the team to connect and partner with other parties outside of the organization to gain the support they need.
  7. The new venture should look to create a new product or service and not cannibalize the core business, at least to begin with

Sick care organizations can also learn some lessons from other industry corporations that are trying to partner with startups.

Sick care innovation centers might be a fad or an important tool for fixing what’s broken. We’ll have to see. In the meantime, enjoy yourself at all those conferences.

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Welcome to Amedzon…huge selection at great prices, delivered to your door

GUEST POST from Arlen Meyers

Welcome to Amedzon.com where we intend to transform the sick care business as much as we will transform the grocery business after our recent acquisition of Whole Foods. Just imagine discounted prescription prices delivered to your door in two hours for Prime members. No more Whole Paycheck. No more Whole Bank Account forcing you into medical bankruptcy. Are you nervous?

In case you have been confused about our recent activities, this might help explain the method to our madness.

Take advantage of :

  1. The mother of all analytics that can help you choose your medical needs and raise your health IQ as well as DIY decision support. If you are a “provider”, take advantage of our advertising that targets your patients based on what they have bought.
  2. AmedzonRx that provides online drugs at a fraction of the cost you pay now. Check outour line of OTC drugs.
  3. AmedzonDME for all your durable and DIY medical needs
  4. AmedzonLabs for online blood tests without the hassle of having to go through those annoying and inconvenient doctors to get them and the results
  5. AmedzonPrime for our special members who want premium priced sick care services from our pre-screened, high value network . Just click and book using Amedzon Insurance.
  6. Drone services to deliver medicines to difficult , out of the way places during vacation or an emergency
  7. One stop shopping for home delivery foods, special dietary needs and nutritional advice from our trained staff who understand how hard it is to stick with that Mediterranean diet. Unfortunately, Nestle has beat them to the punch.
  8. Health kiosks in all of our Whole Foods stores. We will even install places to charge your cell phone or laptop since most of our stores will be tap and go and last thing we want is for your cell phone battery to die before you buy that last box of quinoa
  9. Discounts on video streaming services when bundled with your Prime account
  10. Free two-day shipping with Prime when you order business and office supplies from Amedzon Business.
  11. No more of those ridiculous directories in the middle of the store that does have listed what you want . Just use our AmedzonGo app to search and buy.
  12. Get bonus points and use them for your next clinic visit at AmedzonCare at a facility near you.
  13. Alexa enabled medical devices, just like your Kenmore washer Health technology company Saykara is building an artificial intelligence-powered voice scribe with the goal of becoming Amazon Alexa for hospitals. Developed by a group of former Amazon, Microsoft, Google and Nuance employees, its solution uses voice recognition and machine learning to transcribe physician voice data and simplify EHR entries.
  14. The Amedzon Colostore, where you can shop online for your CT or MRI scan, mammogram or colonoscopy or other sick care diagnostic commodity
  15. Medical devices. We have teamed up with brand consultancy business Arcadia Group to launch a brand of consumer-use medical devices for diabetes and hypertension management. Now you have Alexa powered Choice.
  16. We will mine your records on the EMR

17. Amedzon smart homes and apartments come prewired with Alexa, your new roomate, to monitor your health. Amazon is partnering with the NHS to bring Alexa to patientsThe NHS pitches the service as being especially useful to elderly patients, blind patients and those who cannot access the internet through traditional means.

Our value propositions are a virtual grab bag of benefits:

  1. Supply chain management
  2. AI driven decision making
  3. Quality outcomes measurement
  4. Information exchange interoperability
  5. Better patient experience
  6. Reduce costs
  7. Improved back office efficiency and workflow
  8. Cheaper insurance and employer benefits costs
  9. Better doctor experience
  10. More transparency

Just imagine being able to shop and take care of yourself online without having to get off your couch and interrupt episode 7 of House of Cards. You are going to love kale and coumadin in a box.

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The courage to innovate

GUEST POST from Arlen Meyers

Being an innovator takes courage, confidence and conviction. You are a guerrilla fighter waging war against the status quo, vested interests and corporate bureaucracy that have sophisticated defenses against intruders that seek to threaten their cash flow, culture and business models. You are fighting for the hearts and minds of patient customers ,payers, providers and non-users alike and will need to overcome your fears, willing to sacrifice and do the hard work. But, would you push someone who is afraid of flying into an airplane?

Here are some tips on how to overcome your fear of failure. You can also try these tips to overcome your other fears. What will you do today that scares you?

Attachment theory might help explain your fears and help you find a safe place to confront them.

Entrepreneurship, the pursuit of opportunity with uncontrolled, scarce resources has its goal the creation of user defined value through the deployment of innovation. Entrepreneurs confront the unknown with not just a mindset, and entrepreneurial habits but with courage based in their hearts. The very act of entrepreneurship involves embracing uncertainty. often living in darkness. After all , the English word for courage is connected to the heart, coming from the Latin word cor, which means heart.

Courage. Encourage. Two words, same origin. Heart. You gotta have heart. Miles and miles and miles of it. There’s no bravery or boldness without heart. There’s no spirit or support without heart. There’s no sacrifice or soul without heart. Nothing great ever gets done without heart. You gotta have heart.

And at the heart of leadership is caring. Without caring, leadership has no purpose. And without showing others that you care and what you care about, other people won’t care about what you say or what you know. As a relationship, leadership requires a connection between leaders and their constituents over matters, in the simplest sense, of the heart. It is personal and it is interpersonal.

But, to get stuff done, you need to have the power to do it. Feldman writes that according to French and Raven (1959), and later Raven (1974), there are six bases of social power:

  1. Reward Power
  2. Coercive Power
  3. Referent Power
  4. Legitimate Power
  5. Expert Power
  6. Informational Power

Author and psycotherapist Estelle Frankel offers some perspective on confronting and accepting the unknown in her book, The Wisdom of Not Knowing. There are many similarities between the spiritual lexicon and the entrepreneurial one, for example, walking through the valley of death, going to the dark side, embracing the journey instead of the destination and having faith in how failure in one thing will open the doors to success in another.

Frankel further notes that the basis of creativity is often suspending your concepts of reality and entering the unknown as if in a dream or mindful state. For example, did you know that the brain scans of jazz musicians during improvisational work resemble those found during deep states of REM sleep?

Former Surgeon General Vivek Murthy noted that, “In the end, two emotions drive the decisions we make: love and fear. Everything else is a manifestation of one or the other, Murthy said. Love manifests itself as generosity, kindness and compassion. Fear shows itself in jealousy, anger and rage. “When fear drives our decisions, more often than not it tends to lead us to darker places. It tends to have negative impacts on our health and it tends to drive us apart, separate us and isolate us,” he said. “When love is driving our decisions, and informing our interactions with each other, it tends to be nourishing, it tends to be good not only for our health but it also builds that connection, that cohesion in society that we ultimately need.”. Drive out fear. Do something every day that scares you.

Here are some lessons from the cowardly lion.

Confronting the uncertainties of customers, products and markets is child’s play compared to having the courage to confront your inner demons or the ultimate uncertainty, death. And yet, do it you must if you are to have enough courage to live your life as an entrepreneur. Remember Steve Jobs at the Stanford graduation.

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Ladder your career portfolio

GUEST POST from Arlen Meyers

A career used to describe your roles in one company throughout your working life, like a career at Monsanto, Deloitte, a university or IBM. But, the workplace and generational attitudes have changed, along with a prolonged life expectancy, so careers now mean something different. Now,a career includes all the roles you undertake throughout your life – education, training, paid and unpaid work, family, volunteer work, leisure activities and more.

In today’s world the term career is seen as a continuous process of learning and development. For physicians, those activities that contribute to a career can include:

  • training
  • education
  • employment
  • work experience
  • community activities
  • enterprise activities
  • employment
  • different life roles
  • volunteer work
  • leisure activities

Investment advisers often suggest bond laddering as an investment risk management strategy. A bond ladder is the name given to a portfolio of bonds with different maturities. For example, you buy bonds with maturation dates that are 1 year, 3 years,5 years and 10 years with variable returns. When one matures, you retire it and buy another on the ladder. Physician entrepreneurs should consider doing the same with their careers as a way to hedge career risk. Doctors, like most everyone, need some side gigs. But, you don’t want to quit your day job until the time is right.

Instead of putting all of your eggs in one basket, diversify your interests and job roles, gradually retiring one to assume another. For example, while clinical practice is the focus of most doctors, take time to build your interest portfolio and dedicate the requisite time and attention to those roles to build value in them . Such roles can be teaching, volunteering, advising, writing, consulting,entrepreneurship or many others. Then, when it’s time, prune or retire one of the roles to assume another on the ladder.

The strategy also applies to advising or consulting. At some point, if you have done things right, people will be coming to you to ask for help instead of you marketing to them. In that case, like everyone else, you will have to prioritize your time and build your portfolio to meet your needs, not just those of potential clients. For example, you might want to apply these criteria to whether you accept your next gig based on fit:

  1. Does it meet your personal and professional needs?
  2. Do you trust the people ?
  3. Do you think the business is viable and how long will it take?
  4. What are the next critical success factors and do you have the knowledge, skills, attitudes and competencies to deliver them?
  5. Are you satisfied with the compensation being offered?
  6. Is there a conflict of interest with other projects?
  7. How much will this intrude into your non-work life and other commitments?
  8. Is the problem the company wants to solve important to you?
  9. How much time, effort and travel is expected?
  10. How much liability is there?

Don’t get stuck in the three boxes of life. Laddering jobs during your career, including after traditional retirement age as an encore career, is a great way to keep you engaged and satisfied.

Here is the case against early retirement. Many of these studies clearly show that health problems intensify after workers qualify for retirement benefits and abate after policies encouraging work are introduced. In addition, there are financial and social consequences.

The word is out. For the first time in 57 years, the participation rate in the labor force of retirement-age workers has cracked the 20 percent mark, according to a new report from money manager United Income (PDF). Some work longer because they want to. Most do it because they think they have to.

What’s more, since social security costs will exceed income in 2020, by delaying retirement ,you will be doing your part for your country’s budget.

You don’t have to do all this full time. Instead you can be a digital nomad or follow the 10/20/30 plan.

Some cities or towns will pay you to move there.

Create a career portfolio and rethink your encore career: You lower your risk, increase your return and can wake up with a smile on your face having made a wise investment.

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Fundamentals of Digital Health Entrepreneurship

GUEST POST from Arlen Meyers

Bioscientists, engineers, non-sick care entrepreneurs and health professionals have many ways to practice biomedical and clinical entrepreneurship e.g. in biopharma, medical device and diagnostics, small business medical practice, educational technologies, social entrepreneurship and intrapreneurship. Digital health entrepreneurship is another pathway.

Digital health is the application of information and communications technologies to exchange medical information. Like all other areas of biomedical entrepreneurship, digital health entrepreneurs pursue opportunities with scarce resources with goal of creating user/patient/customer/stakeholder defined value through the design, development, testing, validation and deployment of digital health products and services.

In some instances, digital health products and services can be stand alone offerings, usually providing the intended user with information, a communications interface and education, that are not defined as drugs or devices and therefore not subject to regulatory clearance requirements. Some, on the other hand, become a new part of a drug or device e.g.a remote sensor in an orthopedic implant or a “smart” pill or other innovative drug delivery device.

Much like the medtech innovation roadmap, the digital health innovation roadmap has several stops along the way including :

Early stage or prototype product development, customer discovery and development and validating the parts of the business model canvas. If you don’t do his right, there is not much point in moving to the next steps. In fact, not having a viable business model is the main reason companies, including digital health companies, fail.

Design and reduction to practice using established quality system controls, including technical validation and verification

The terms Verification and Validation are commonly used in software engineering to mean two different types of analysis. The usual definitions are:

  • Validation: Are we building the right system?
  • Verification: Are we building the system right?

In other words, validation is concerned with checking that the system will meet the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-free, and so on. Verification will help to determine whether the software is of high quality, but it will not ensure that the system is useful.

The distinction between the two terms is largely to do with the role of specifications. Validation is the process of checking whether the specification captures the customer’s needs, while verification is the process of checking that the software meets the specification.

Following the appropriate regulatory approval pathway, when appropriate

Following the appropriate intellectual property protection pathway, when appropriate

Following the appropriate business model

Translational and human subjects research, when appropriate

Launch, marketing and sales 

Post market surveillance

Exit

While the path may be clear, the journey is difficult and filled with hazards. Here are some posts, blogs and commentaries that might help you find your way:

1.Here’s how digital health entrepreneurship is different from other types of biomedical and clinical entrepreneurship.

2.Here are 12 trends in physician digital health entrepreneurship.

3.Here are 10 bumps along the digital health innovation road

4.Here are 10 digital health gaps and how to close them

5.Here is how to measure your digital health cluster

6.Here is how and why we need to get real about digital health

7. Not enough bioscientists, engineers and health professionals have an entrepreneurial mindset.

8. Too many sick care entrepreneurs are problem solvers, not problem seekers

9. Here are 10 reasons why non-sick care entrepreneurs fail

10. Here are the problems with data, data everywhere.

11. T2V is the new normal

12. Why your idea is not investor ready

13. How to create a flawed business model

14. Horizon 3 sick innovation

15. When will Google be in the clinic

16. How to measure a digital health cluster

17. The elusive medical business model

18. Prototype and simulate to verify and validate

19. How to build a VAST business model

20. How to close the doctor-patient eCare gap

21. How to overcome regulatory market barriers

Digital health entrepreneurs have a big challenge. Digitizing sick care, while inevitable, has already seen its share of failed products. bad rules and dysfunctional ecosystems. Most have failed because they did not achieve the 3Vs of sick care innovation, they set the bar too low or they quit too soon.

We are in the early stages of digital health entrepreneurship , trying to figure out what works and what won’t, what rules and regulations we need and which we should revise and the impact on society and the medical profession. I have confidence that digital health entrepreneurs will get it right soon, despite the efforts of many who are getting in the way.

 

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Make it personal, but don’t take it personally

GUEST POST from Arlen Meyers

There are a lot of things that motivate (bio)entrepreneurs. Some come from inside (intrinsic) and others come from outside (extrinsic). Most think that it’s a good idea to have passion for your cause, product, technology or objective. Others think that that “passion” can cloud your judgement, further obscure your blind spots, and lead you to be pig headed or obstinate in the face of truth.

Creativity is what happens when mood has sex with thinking.

Sometimes, though, it is a good idea to hide your ugly side, even though that’s what keeps you going.

Many entrepreneurs create products because of personal circumstances or that of a family member. They are driven by the desire to solve a problem that eats at them and they do not want others to have to deal with same thing. Its personal.

As recently reported, when Jeff Dachis suddenly and unexpectedly learned he had Type 1 diabetes at the age of 46 in September 2013, he was stunned. After all, he ran marathons, followed a healthy diet and never had an inkling of any medical troubles during previous annual physicals.

“I went to the doctor, got about six minutes with a nurse practitioner, an insulin pen, a prescription and a pat on the back, and I was out the door,” Mr. Dachis said. “I was terrified. I had no idea what this condition was about or how to address it.”

Feeling confused and scared, he decided to leverage his expertise in digital marketing, technology and big data analytics to create a company, One Drop, that helps diabetics understand and manage their disease.

The One Drop system combines sensors, an app, and a Bluetooth glucose meter to track and monitor a diabetic’s blood glucose levels, food, exercise and medication. It uses artificial intelligence to predict the person’s blood glucose level over the next 24 hours and even suggests ways the person can control fluctuations, such as walking or exercising to offset high sugar levels — or eating a candy bar to raise low glucose levels. Users can also text a diabetes coach with questions in real time.

Patient entrepreneurs join engineers, healthcare professionals and service providers leading the 4th sick care industrial revolution.

Fundamentally, entrepreneurs are driven by emotions, not thinking. At its core, it is about feelers who happen to think . The range of emotions can be encyclopedic, or they can be reduced to a few categories.

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Of course, describing an emotion and the triggers that evoke it and the entrepreneurial behaviors, be they constructive or desctructive, that result are the lore of capitalism.

On the other hand, they have to maintain an objective distance from the realities they confront. It is a common mistake to have blind spots when creating and running a business. They can’t take it personally.

When entrepreneurs face the inevitable rejection, here’s how they cope with it.

One of the enduring factors in creating an agile and innovative business is purpose. Purpose answers the question: why do we do what we do? It gives a sense of determination to your ambition and direction. It gives a different flavour to your work then a vision, mission or strategy. To me a vision provides a point on the horizon, the guiding light for your ambition. A mission directs the task that will lead you to your vision. And a strategy is a process or road map to realize your vision.

Entrepreneurial psychopathology is a fickle beast. Controlling what drives you, accepting the truth and not letting it get the best of you is a key part of entrepreneurial emotional intelligence. Be sure you know the difference when you feel it.

and Co-editor at Digital Health Entrepreneurship

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Mentors, Sponsors, Coaches and Colleagues Help with Burnout

GUEST POST from Arlen Meyers

Physician burnout is pervasive and appears to be worsening. In fact, in some specialties, residents are burned out even before they have spent their first day in practice. But, they are not alone since burnout happens in many industries other than medicine.

Burnout is considered to have a range of symptoms. There is no agreement which of those are part of it and which ones are not. But all definitions given so far have in common that the symptoms are regarded as being the consequence of stressful activities in or outside the job. One possible source of stress outside the job is caring for a family member, for example.

Three main areas of symptoms are considered to be signs of burnout syndrome:

  • Emotional exhaustion: People affected feel drained and exhausted, overloaded, tired and low, and do not have enough energy. Physical symptoms include pain or problems with the stomach or bowel.
  • Alienation from (job-related) activities: People affected find their jobs increasingly negative and frustrating. They may develop a cynical attitude towards their work environment and their colleagues. They may, at the same time, increasingly distance themselves emotionally, and disengage themselves from their work.
  • Reduced performance: Burnout mainly affects everyday tasks at work, at home or when caring for family members. People with burnout regard their activities very negatively, find it hard to concentrate, are listless and experience a lack of creativity.

Burnout can also be described as “the extinction of motivation or incentive, especially where one’s devotion to a cause or relationship fails to produce the desired results,” and is a stress-related state and there are multiple causes.

Burn out interventions and prevention programs both at the personal and organizational level are successful 80% of the time. However, both personal and organizational interventions are better than either alone, and the results tend to fatigue over time.

Mentors, coaches, sponsors and colleagues might help, but , you need to understand the roles each one plays and when and how to engage them. Here is what to do when your boss refuses to be your sponsor.

Mentors are accountability partners who help you stay on track to meet your goals. They are hard to find and the lack of a mentor is an oft quoted reason for entrepreneurial failure. Many entrepreneurs have a hard time finding the right mentor for various reasons. Mentors help your personal development.

Here are some tips on being a good mentor. It starts with building a genuine relationship.

Sponsors are different from mentors. Their job is to run cover for you in your organization and help you find the scarce resources intrapreneurs need to succeed. They are making an investment in your idea, and, like every investor, they expect a return within a defined time.

They are also called “rabbis” and you should find and be one yourself. Many who consider themselves to be sponsors are acting more like mentors. To claim the title of sponsor, a senior leader should be an active advocate for their protégé — a more junior professional who the sponsor sees as a top performer, with tons of potential, who deserves to move up in their career. A sponsor has three primary responsibilities: to believe in and go out on a limb for their protégé; to use their organizational capital, both publicly and behind closed doors, to push for their protégé’s promotion; and to provide their protégé with “air cover” for risk-taking.

Colleagues are people you work with that you admire and can emulate. They are not friends, but rather a honest sounding board. They set an example by their actions. There are many reasons why colleagues make good mentors or confidantes.

Coaches The goal of the coach is to facilitate learning, focus, and results. Coaches are trained in the strategies for achieving the results specific to their domain of coaching. Although they may not have experience generating the results you are looking for in themselves, they should have experience generating these results in other people or organizations. Coaches teach you a skill.

Many of you who are reading this don’t have a mentor. But, here are some ways to change that.

Here are some best practices for mentors and mentees.

You might be a member of the miserable professional class. Whether you are an employed physician, a community practitioner, a budding CEO of a biomedical or health startup or an intrapreneur, you need help as an antidote to the stress. Take the time to cultivate the right relationship with the right person in the right role and thank your lucky stars you found them.

 

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Fundamentals of medtech biodesign and commercialization

GUEST POST from Arlen Meyers

Much like drug development and commercialization, medical device design, development and commercialization follows a defined pathway to patients. While less expensive and less time consuming than getting a drug to market, getting a device to market requires the same regulatory, IP, market-product mix, reimbursement and business model rigor.

Here’s the secret sauce, at least according the director of the Stanford Biodesign Program.

There are several differences between biomedical (biopharma and medtech) innovation compared to clinical innovation.

Here are the Cliff’s Notes. Read them before reading the rest of this article. Yes, it will take more than the usual 2 minutes to read the post so prepare yourself.

Now, let’s move on.

Here are the stages:

Understanding customer needs and designing a product to satisfy them

Here’s how to do that

Biodesign: Once you have identified a customer need and created a solution to solve their problem, reducing an idea to practice involves following the standards set by international regulatory agencies. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

For more information about how to get an IDE, go to the FDA website.

Here are the parts of the design control process.

Creating a prototype is one thing. Being able to manufacture it at scale is another. Here are the issues and some caveats.

Following the appropriate regulatory approval pathway: There are two primary pathways for medical device clearance or approval-the 510(k) pathway or the PMA (premarket approval) pathway. 

Medical devices that do not require FDA review before the devices are marketed are considered “510(k) exempt.” These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) (named for a section in the Food, Drug, and Cosmetic Act) to provide a reasonable assurance of safety and effectiveness.

These devices are exempt from complying with premarket notification requirements subject to the limitations on exemptions; however, they are not exempt from certain general controls. For example, 510(k) exempt devices must

  • be suitable for their intended use
  • be adequately packaged and properly labeled
  • have establishment registration and device listing forms on file with FDA
  • be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements)

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Here are 10 regulatory traps that kill valuation.

Did you know that 69 percent of 510(k) submissions were rejected the first time between January and June of 2015? Here are some tips to prevent that from happening.

Here is a useful link describing the differences between the US and European clearance processes.

Getting a CPT code, coverage and enough payment to generate a profit

Translational and human subjects research

Launch, marketing and sales after regulatory clearance: Medtech, like biopharma, is facing many challenges that is forcing them to reconsider their business models and sales and marketing approach.

Here are some differences between marketing and selling drugs and marketing and selling devices.

Post market surveillance: Here are the requirements

Here is the milestone map for developing a medical device.

In some instances, your product might be a hybrid of a drug and a device and a digital health product. Having such a combined product has a somewhat different pathway. Here are the basics.

For every stage of device development, there are career opportunities for biomedical, engineering and medical entrepreneurs and ways to add value.

You will also need to have partners and service provider relationships to help you. Here are the main ones. Don’t forget your reimbursement strategy.

Here are 5 Steps To Faster-To-Market, More Profitable Medical Devices

Here is my list of the top medtech entrepreneur mistakes:

1. They don’t think they have a “device” as defined by the FDA so they forgo the process. A new category of digital therapeutics, sitting somewhere between drugs and devices, has introduced a new set of commercialization challenges

2. They don’t incorporate a reimbursement strategy from the beginning

3. They create something that is not patentable

4. They miscalculate the total addressable market

5. They don’t price the product properly

6. They start selling without a marketing or strategic communcations plan

7. They grossly underestimate the time and money it will take to sell their product

8. They create a product that is really not that much better than the competition. It just costs a whole lot more.

9. They don’t have a supply chain, sales or distribution plan

10. They don’t pay attention to quality system and good manufacturing processes

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/

Here are some tips on how to work with BIG DEVICE.

Getting a device from bench to bedside to boardroom requires careful planning and execution and simultaneous efforts to minimize not just clinical risk, but regulatory, IP, market and reimbursement risk as well.

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What if Private Equity Ran Medical Schools?

GUEST POST from Arlen Meyers

Dear Miss. Robertson,

Thank you for responding to our solicitation for a new Dean of our medical school. We are intrigued by your past experience and background in private equity. As you are well aware, things are changing quickly in sick care and the medical education establishment has been slow to adapt. You’ve no doubt heard about large healthcare companies and hospital systems being purchased for staggering sums by private equity firms.We intend to shake things up and are seriously considering alternative, non-traditional candidates like yourself.

The most recently dust up is happening in the world of dermatology, where private equity firms are buying and rolling up highly profitable practices.

Given the uncertain trajectory of basic research funding, dwindling state support for higher education, a broken medical school business model and threats to our clinical enterprise, it is clear that the model of recruiting academic triple threats that excel in research, teaching and clinical care is a dying model. Instead, we are looking for a person with a combination of leadership, entrepreneurship and innovation skills- the new triple threat.

Private equity is fixing and flipping sick care and medical services at an astounding rate and we can see why your skills should be applied to medical education.

More specifically:

  • As pressure mounts on companies to maintain top-line organic growth and sharpen focus, more are looking to sell unwanted or noncore units. In certain situations, such as to win regulatory approval for a merger, companies are required to sell some assets. Divesting makes sense for companies; our research has shown that corporates that actively reallocate capital produce total returns to shareholders of 10 percent annually, versus 6 percent for companies that reallocate only infrequently. Healthcare companies seem to be catching on. Excluding businesses that were spun out as stand-alone companies, corporate companies divested a record $115 billion of healthcare assets in 2015. The value of such divestitures was twice as high in 2013–15 as in 2010–12.
  • Price is often not the only factor in divestitures, which often require the buyer and seller to negotiate two agreements, one governing the purchase and one the transition of services. Many buyers are not equipped to manage these types of complex deals; others are unwilling. Sellers also find it preferable to move quickly toward negotiation with a single bidder. Private-equity firms skilled in managing these negotiations have an advantage. Furthermore, private-equity firms can also cultivate relationships with healthcare companies that strategic buyers (that is, other healthcare companies) would find difficult to achieve. In this way, private buyers may get a head start on divestiture opportunities and avoid a multibidder auction.
  • Many private-equity firms have capabilities well suited to transform underperforming business units into stand-alone companies and improve their finances. Active private owners can add value through effective management changes (for example, adding leaders with a proven track record of success in running healthcare companies) and establishing regular and challenging dialogue with management through a new board of directors. Private-equity firms can introduce some discipline to the capital-allocation process and help their acquisitions pivot from capital preservation to funding ambitious growth and long-term strategic bets. These could include vertical integration (as seen, for example, in the acquisition of Nordion by GTCR’s Sterigenics in 2014) or growth through highly strategic acquisitions (for example, under JLL Partners ownership, Patheon acquired a series of companies to broaden its service offerings).

Some of the possibilities we envision include:

1. Divesting our medical school from state control since they provide miniscule financial support.

2. Cut costs to the bone

3. Re-examine our tuition model

4. Explore ways to securitize the future incomes of graduates to attract investment capital

5. Recruiting a new team with skill sets compatible with our financial objectives

6. Creating IT systems and innovation management systems that add value instead of costs

7. Looking to consolidate and roll up other medical schools that share our perspective and vision

8. Focusing on supporting those who are successful instead of wasting resources on trying to rehabilitate those who clearly do not have what it takes to succeed.

9. Using private equity networks to find the executive talent we need to scale our ventures

10. Using innovative financial products, like crowd funding and other securities instruments to assure an adequate return on investment at exit.

11. Offering online courses in a certificate program designed for potential biomedical entrepreneurs and others who want a more advanced understanding of basic and clinical sciences, medical technologies, innovation opportunities and healthcare systems.

12. A special program for veterans interested in acquiring advanced skills and training funding a new version of the GI bill

13. Integrating health policy, economics, innovation and entrepreneurship into our curriculum

14. Creating a second pathway for MD’s who do not want to practice clinical medicine.

15. Replacing our current MD/MBA program with an MD/MBE program

16. Rethinking our admissions process to improve equity, diversity and inclusion to include admissions by lottery, eliminating the MCAT requirement, eliminating admission interviews and eliminating bias against those who attend community colleges or foreign medical schools.

17. Educating our students to win the 4th industrial revolution

18. Creating a cyberczar to integrate computer and data science, engineering and sick care professional programs

19. Fixing the 5 big problems we have with our medical school

20. Graduating every student with an entrepreneurial mindset

21. Being textbook free to lesson the already onerous student debt burden and take advantage of open educational resources.

We might also be interested in a divestiture,which we define as the sale of a business unit or division from a corporate parent, such as our departments of family practice or rehabilitation medicine, which have always been a drag on our earnings

To that end, you should be aware that effective next semester, we will be eliminating the 4th year of medical school in an effort to make it better, cheaper and faster. We will be eliminating “audition rotations”, cutting back on non-essential basic science course requirements, making clinical rotations mandatory in the first year and making clinical skills competency a requirement for graduation. Simply put, we are changing the 100 year old model of medical education to conform to the times.

Thank you again for your interest and we look forward to hearing your thoughts.

and C0-editor of Digital Health Entrepreneurship

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Don’t confuse passion with anger

GUEST POST from Arlen Meyers

There are a lot of things that motivate (bio)entrepreneurs. Some come from inside (intrinsic) and others come from outside (extrinsic). Most think that it’s a good idea to have passion for your cause, product, technology or objective. Others think that that “passion” can cloud your judgement, further obscure your blind spots, and lead you to be pig headed or obstinate in the face of truth.

The problem is that passion can cause burnout.

Truth be TOLD, most entrepreneurs can attribute their success to talent, seeing opportunities, luck and determination or grit. The source of that grit comes from satisfying some subconscious or apparent psychic need. Best case, the results are positive. Worst case, it results in entrepreneurial psychopathologies.

Anger or revenge are other entrepreneurial hot buttons. You’ve heard it before. “Don’t tell me I can’t do something”. “Success is the best revenge”. “I’ll show you”. There are many examples of people who, frustrated at work, decide to buck the system, instead of fleeing or sabatoging it, with impressive results.

Some have ruminated on the differences. Here’s my take:

1. Entrepreneurial motivation resides in three places: the head (cognitive), the heart (emotional responses) and the soul ( where passion resides). In the Happiness Equation, author Neil Pasricha proposes that it comes from sales, society and self. Self-satisfaction is a much stronger motivator than sales (commercial) or social (peer acceptance and validation). Self satisfaction derives from self confidence.

2. There is an anatomy and physiology for each, driven by the fight or flight stress response and hormones, mostly in your brain and your adrenal glands.

3. Your biggest strength in any of these areas can be your biggest weakness and you need to control and balance when exercising one makes sense and is in your best interest.

4. Thoughts drive emotions and emotions drive behaviors. Toxic behaviors derive from toxic thoughts.

5. In most instances, how you think and how you respond to stress are learned behaviors that can be modified

6. When someone gives a pitch and the response is “I can hear the passion in your voice”, don’t confuse that with anger, lack of emotional intelligence, or worse, a personality disorder or entrepreneurial psychopathology.

7. There is a season for everything, including rational analysis, anger and passion.

8. Behaviors and passion are contagious so be sure you quarantine them if you don’t want injurious ones to spread.

9. Trying to extinguish someone’s passion is a fool’s errand and potentially dangerous.

10. If you get angry a lot, create a space between the stimulus and the response and be mindful of the triggers.

Now, it turns out, in a movement that some experts are calling “the second wave of positive psychology,” many psychologists are recognizing that negative feelings that make us uncomfortable or unhappy may sometimes be good for us. If we pay attention to them, they can help us identify what is wrong in our life and motivate us to seek change. Research even shows that people who have negative thoughts along with positive ones are healthier.

Adopting an entrepreneurial mindset, as the name implies, resides in the head, not the soul. Many times, though, the heart and the soul can determine, rightly or wrongly, technology adoption.

Anger is not the only one of the seven deadly sins that motivate entrepreneurs. There is more than enough greed and envy.

There’s nothing wrong with being angry about how things are and wanting to change them. In fact, recent research indicates that anger can be constructive in business and negotiations.For the most part, that is the history of the world. But, the key to building something new is more about using the right tool than being a carpenter who uses a hammer for every job. Doing something that you love can have many sources.

and Co-edotor of Digital Health Entrepreneurship

 

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