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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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.

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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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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GUEST POST from Arlen Meyers

Sign up here to join 17,000+ leaders getting Human-Centered Change & Innovation Weekly delivered to their inbox every week.

GUEST POST from Arlen Meyers

Sign up here to join 17,000+ leaders getting Human-Centered Change & Innovation Weekly delivered to their inbox every week.

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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GUEST POST from Arlen Meyers

Leadership is in crisis and the command and control model is bankrupt. In healthcare, we will need a cadre of physicians to lead us to the promised land. However, doctors don’t seem interested and are pre-occupied mostly with keeping their heads above water or putting them in the sand.

Physician executives are not necessarily physician entrepreneurs.

Knowledge technicians are different from managers who are different from leaders who are different from entrepreneurs.

Coping, let alone thriving , in this turbulent sick care environment will require an attitude change. Consider:

1. Doctors need to evolve from technicians to managers to leaders to entrepreneurs to leaderpreneurs to thrive. Some call it practicing at the top of your license. In addition, filling the C-suite with more physician managers just makes it harder to innovate and adds further clutter to the organization.

2. Millenials have no interest in leading.

3. The large majority of “leaders” are managers with no leadership skills and are examples of the Peter Principle. At best, most are managing process, safety and quality improvement, not significant and meaningful sick care innovation.

4. Leadership is about communicating vision, direction and inspiration. It is not managing. Entrepreneurship is the pursuit of opportunity with uncontrolled resources with the goal of creating user defined value through the deployment of innovation. Innovation has both a qualitative and quantitative component and is measured by user defined multiples of both.

5. Most leaders fail because they have poor communications skills. They have poor communication skills because they don’t know how to listen, engage and motivate followers.

6. Listening fails for many reasons, not the least of which is not ignoring your internal conversation and changing the lenses through which you see and hear people.

7. Who is “the leader” is not something determined by the org chart. Get rid of it and take advantage of the leadership potential of those without the titles on their office door. Navy Seals do. Israeli army officers do. You can too and it won’t be nearly as dangerous but it usually involves having as much courage.

8. Require every manager to go to leadership boot camp before they can assume any leadership position. Assign them a mentor and get them coaching.

9. Value is the coin of the realm. Leaderpreneurs have to evolve and adopt an entrepreneurial mindset. In the new world of robotic infested work, everyone has to be an entrepreneur or run the risk of losing their jobs. Just ask Watson.

10. Hire, develop, promote and reward for innovation.

Leaderpreneurship development isn’t creating leaderpreneurs whether it be those who deliver are or those who manage and lead it.

Leadership development expert, Alan Patterson, describes the four stages of leadership at it applies to technical experts like physicians:

Stage 1: Expertise derived from technical competence

Stage 2: Credibility derived from people skills

Stage 3: Execution, alignment and engagement, derived from teaching, coaching and inspiring other people , focusing on the now

Stage 4: A strategic mindset focusing on the next (making existing products and services better) and the new (making existing products and services obsolete)

One key difference between management and leadership is that the former is about you and the latter is about coaching and teaching the people you lead.

Here are 10 principles of strategic leadership:

Leadership styles depend on the situation. Here are the six leadership styles Daniel Goleman uncovered among the managers he studied, as well as a brief analysis of the effects of each style on the corporate climate:

The pacesetting leader expects and models excellence and self-direction. If this style were summed up in one phrase, it would be “Do as I do, now.” The pacesetting style works best when the team is already motivated and skilled, and the leader needs quick results. Used extensively, however, this style can overwhelm team members and squelch innovation.

1. The authoritative leader mobilizes the team toward a common vision and focuses on end goals, leaving the means up to each individual. If this style were summed up in one phrase, it would be “Come with me.” The authoritative style works best when the team needs a new vision because circumstances have changed, or when explicit guidance is not required. Authoritative leaders inspire an entrepreneurial spirit and vibrant enthusiasm for the mission. It is not the best fit when the leader is working with a team of experts who know more than him or her.
2. The affiliative leader works to create emotional bonds that bring a feeling of bonding and belonging to the organization. If this style were summed up in one phrase, it would be “People come first.” The affiliative style works best in times of stress, when teammates need to heal from a trauma, or when the team needs to rebuild trust. This style should not be used exclusively, because a sole reliance on praise and nurturing can foster mediocre performance and a lack of direction.
3. The coaching leader develops people for the future. If this style were summed up in one phrase, it would be “Try this.” The coaching style works best when the leader wants to help teammates build lasting personal strengths that make them more successful overall. It is least effective when teammates are defiant and unwilling to change or learn, or if the leader lacks proficiency.

The coercive leader demands immediate compliance. If this style were summed up in one phrase, it would be “Do what I tell you.” The coercive style is most effective in times of crisis, such as in a company turnaround or a takeover attempt, or during an actual emergency like a tornado or a fire. This style can also help control a problem teammate when everything else has failed. However, it should be avoided in almost every other case because it can alienate people and stifle flexibility and inventiveness.

The democratic leader builds consensus through participation. If this style were summed up in one phrase, it would be “What do you think?” The democratic style is most effective when the leader needs the team to buy into or have ownership of a decision, plan, or goal, or if he or she is uncertain and needs fresh ideas from qualified teammates. It is not the best choice in an emergency situation, when time is of the essence for another reason or when teammates are not informed enough to offer sufficient guidance to the leader.

Here is another way to slice the pie.

There is a growing acceptance of the practice of formally developing physician leaders to help navigate the increasingly turbulent health care landscape. Research points to the important role that clinical leadershipcan play in improving the performance of health care organizations. Growth in compensation for physician executives, particularly those with postgraduate management degrees, signals higher demand and appreciation of their value.

While satisfaction scores might be high, unfortunately, only about 10% of leadership development programs are successful. They fail for 3 basic reasons:

“The first is a gap in motivations. Organizations invest in executive development for their own long-term good, but individuals participate in order to enhance their skills and advance their careers, and they don’t necessarily remain with the employers who’ve paid for their training. The second is the gap between the skills that executive development programs build and those that firms require—particularly the interpersonal skills essential to thriving in today’s flat, networked, increasingly collaborative organizations. Traditional providers bring deep expertise in teaching cognitive skills and measuring their development, but they are far less experienced in teaching people how to communicate and work with one another effectively. The third reason is the skills transfer gap. Simply put, few executives seem to take what they learn in the classroom and apply it to their jobs—and the farther removed the locus of learning is from the locus of application, the larger this gap becomes. To develop essential leadership and managerial talent, organizations must bridge these three gaps.”

Politicians,whether in your company or in the upcoming elections, promise change. Leaders make it happen. They lead innovators, they don’t manage innovation. There just seems to be fewer and fewer of them wearing white coats and physician leadership and MBA programs are not working.

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GUEST POST from Arlen Meyers

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GUEST POST from Arlen Meyers

Every entrepreneur who has succeeded or failed (is there a difference?) has advice about how to get the right people on the bus. What questions should you ask at the interview? What character traits should you seek and how do you do that? How much is science and how much is just going with your gut and whether you click?

What Google found was that interview scores had no correlation with performance, of those who got hired.

Likewise, advisors or potential employees want to find the right fit as well. The rules are somewhat different when it comes to the board of directors, the management team, employees, consultants and advisors.

Maybe flipping a coin or a job lottery would save a bunch of time and money and get the same results.

I’ve been on both sides of the table so allow me share my two cents on how to staff your startup:

1. Hope for the best and expect to fire fast. Give yourself lots of wiggle room.

2. Don’t hire hood ornaments (doctors with fancy credentials that you parade on your website and pitch deck) unless you simply need one for credibility and really don’t expect them to do much more.

3. Clarify expectations, timelines and benchmarks

4. Rent advisors, don’t buy them

5. Barter, don’t rent, if possible

6. Expect most people to put a hand up, not show up

7. Define your next critical success factor (like raising 2M dollars in seed money) and find people who can help get it done. Once it’s done, stop and empty the bus, and reload. For example, suppose your company has achievements to date that include FDA 510(k) submission, provisional and non-provisional patent filing (there is no such thing as a non-provisional patent granted by the USPTO), and patent attorney freedom-to-operate letter (here’s what that is). You have raised $200,000 from angel investors and are currently raising $1.5M in the current seed round with a valuation of $10M. Who do you want to help, how and how much will you compensate them and for how long?

8. Don’t give away the store early in the game. If you are successful, you’ll have to give it away to get the money anyway so keep your powder dry

9. Hire people who are card carrying members of the Get Shit Done Club  

10. Evolve as fast as you can from a knowledge technician to manager, to leader, to entrepreneur to leaderpreneur i.e. work on the company, not in it.

11. Be careful about hiring interns since there are practical and labor law issues that can make your life more complicated than it already is or is going to be. Internships are supposed to be about helping the intern. You want people who primary purpose is to help your company as much and as soon as possible

12. Don’t overhire for quality or quantity. Do you really need to hire that expensive CFO when what you really need is someone to keep the books and do payroll at this stage of the game? What about business development, sales and marketing?

13. Figure out whether you are hiring someone, or joining someone, to help with strategy or tactics. At the beginning, it is usually a cacophany of both. As the company validates its model, though, there is the risk of the distraction of traction. For a surgical benefits management company, for example, you need to focus and define your SCOPE.

14. The single most important question you can ask yourself is, “Do I like and trust these people?” The second is, “Can I deliver what they want, or am I just doing this to stroke my ego and make some bucks?”

15. If you had one more day to live, would you spend it in a co-working space wearing a hoodie? How about training and hiring felons?

16. Promote intergenerational collaboration

17. Don’t hire doctors to sell your products. They don’t know how to do it.

18. Here’s some advice on who should be on your board

Here are some tips on hiring sales people and avoiding the mistakes.

This on-demand talent model, dubbed SPEED by the author (Success, Plan, Execute, Evaluate, Decide), is good for the company, and good for all specialized, dedicated, and high performing people in the workforce today. Your company gets the flexibility to adapt quickly to the needs of a rapidly changing marketplace, and workers get to broaden their experience in the work they love.

One empirical analysis shows that companies that are equipped with both business and technical skills are disproportionately more likely to introduce new-to-the market innovations than firms that have only one of these skills. However, not all firms that are equipped with both types of skills are able to profit from them. Firms profit disproportionately from a mix of business and technical skills when the founder has technical knowledge and employs additional business experts. By contrast, we find no evidence of complimentary either when business and technical skills are balanced within a founding team, or when a founder with business skills hires employees with technical skills.

Entrepreneurial startup success is about entrepreneurial startup TEAMwork i.e.finding the people:

1. Who have Talent
2. Who can Execute
3. Who can Articulate a vision, mission, values and strategy
4. Who know how to raise, manage, protect and make large sums of Money

That means you will have to find people who play some skill positions like problem seeker, problem solver, money finder, score keeper, product developer, business builder, dot connector, risk manager and story teller.

The startup lineup should also have people in it with these skills and abilities.

How do you compensate these people without breaking the startup bank? Here are some ideas.

Hiring the right people makes the difference between fun and misery. Plan to make lots of mistakes and fire fast. Pivoting often means taking casualties.

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GUEST POST from Arlen Meyers

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