What Healthcare Can Learn From 5 Other Industries

There are 4 major consumer trends that are rippling through healthcare.

A recent Booze Company report analyzed how 5 industries are hitting the reset button as they emerge from the global recession. Healthcare should pay attention.

For example, the 4 trends cited in the report for the consumer products industry are frugality with a twist (paying a little more for creature comforts), an aging and health conscious population, digital customers and large, emerging markets.

All of these trends present great opportunities for bioentrepreneurs in health and wellness products and services, global care, digital and social network healthcare marketing and high value, differentiated medical products and services designed for those willing to pay more.

We have a lot to learn from telecom, consumer products, automotive , financial services and telecommunications. Innovation is almost always a visitor, not someone who lives in your house.

How To Do An Organizational Innovation Audit

Innovation in medical settings needs an environment that facilitates its development. Here's what to look for where you work.

If you had an idea for a medical device, would you know where to go at work to get help commercializing it? Most of the time, based on my experience at www.venturequestltd.com, an innovation management consulting company, the answer is no.

Given that there are a small number of hidden innovation gems on the medical staff or faculty, engaging them, getting them interested and moving them to action requires a carefully crafted and executed strategy. Whether you work in an academic or non-academic setting, here are some questions you should ask to assess your organization’s innovation IQ.

Is there structure, process and leadership in place to help me commercialize my idea?

Most major research universities have technology transfer managers and processes in place to help faculty move their commercial ideas forward. The initial steps typically involve determining whether the invention or discovery passes certain technical, legal, intellectual property ,and market hurdles. If that’s the case, then technology transfer managers work with faculty or staff to identify potential licensees, like drug or device companies, or, with business development or spinout managers, who work with inventors interested in creating a separate company.

In community hospitals and systems, even large ones with many hospitals, large R/D budgets and hundreds of staff, there is typically no innovation management system or a designated executive to lead it. At best, some of the pieces are outsourced or inventors are referred to members of the hospital network or community with some experience. Usually, though, you’re on your own.

When it comes to innovation, does my organization have a process to move the medical staff from awareness to intention to decision to action?

There are several ways to internally market to staff to make them aware of what innovation is and how to participate in the creative process. Newletters, websites, emails, educational events and other tools help to create awareness and inform the staff about intiatives and opportunities to contribute.

What has your organization done to remove the barriers to participation and create incentives to innovate?

We all can identify things that get in the way. Common ones are , “I don’t have enough time to do this given my clinical and administrative duties” or, “This is not why I became a doctor”.  However, without a culture or ecosystem that enables those who are interested, ideas will usually fade into the woodwork  or medical staff will leave.

Does your workplace celebrate success and cheer the champions?

Nothing succeeds like success… if people know about it. Awards dinners, articles and press releases and other devices are great ways to highlight the accomplishments of peers and get others excited.

Healthcare innovation, whether it is process, goods or services, is a combined bottom-up and top-down effort that requires an enabling, user friendly environment. If you think you are working in a place that is not designed for innovation, you can lead, follow or get out of the way. The choice is yours.

Biopharma Commercialization: From Discovery To Delivery

Biotechnology offers physicians opportunities to dramatically improve people’s lives.

Biotech companies develop products in stages, each with specific goals and milestones. Physicians may find career opportunities in any one or all of the stages of this process.   

The commercialization process helps companies identify the most promising potential drugs in research, develop them into innovative therapies, and then deliver them to the patients who need them. It is a dynamic process that enables companies to dramatically improve people’s lives. 

Some may think this process starts with a discovery. A scientist discovers a molecule in the laboratory—and years later, a patient receives a product made from this molecule. How did the discovery become a drug?  And why did it take as long as a decade or more? It advanced step by step. And it started even before the molecule was discovered.

Discovery and Screen. The process starts with an unmet medical need. Scientists indentify targets, or points in the course of a disease, where a potential drug may have an effect. Scientists then test hundreds, if not thousands, of molecules. The goal is to find one or more molecules with biologic activity against a target. Usually, only a small number are active.

Lead Optimization. The field of candidates narrows. Scientists evaluate all the bioactive molecules to identify the lead molecule with the most desirable characteristics. They further optimize this lead molecule to meet the criteria for a viable clinical candidate. 

Pre-Clinical. When a single molecule with the potential to be safe and effective in humans has been identified, it then progresses into preclinical testing—bringing it one step closer to testing in humans.  The product team evaluates safety, prepares to manufacture clinical materials, and seeks regulatory approval to begin Phase 1 clinical trials.

Phase 1. When there is sufficient evidence that a new molecule can be safely tested in human, it progresses to the next stage. Small Phase 1 studies of healthy volunteers or patients with disease gather preliminary data on safety, dosing, and biological activity.

Phase 2. Patients with the disease are studied. The company assesses the safety and efficacy of the molecule and dosing in patients. They begin to assess the value of the product to patients, physicians, and payers—as well as the company.

A portal or gate review at the end of Phase 2 determines whether the scientific and medical evidence and commercial value of the product warrant a significant investment in large clinical trials. The company determines whether it has met regulatory requirements and is prepared to file a marketing application with regulatory agencies. 

Phase 3. Testing involves large numbers of patients. Large-scale studies confirm safety and effectiveness, and the product team plans the submission to regulatory agencies for product approval.

Regulatory Filing. The product team submits a marketing application to regulatory agencies, answers their questions, finalizes labeling and plans for launch. After regulatory approval, the team proceeds with reimbursement submissions in each country.

A portal or gate review determines whether the company is confident in the product’s ability to meet safety, efficacy, and reimbursement requirements. 

Launch. After a decade or more, a molecule has become a product. A discovery—and all those involved its commercialization—can make a difference for patients. To launch a new product, companies must ensure enough supply to meet demand and begin marketing the newly approved product according to the approved label.  

To learn more about biopharma commercialization and related career opportunities, check out the websites for some of the leading biotechnology companies: amgen.com, gene.com, merckserono.com, biogenidec.com, and ucb.com.  This could give you a framework to explore specific opportunities or extend your network to other firms in the industry.

Change Creates Opportunity. Here's Where To Look.

Looking for love in all the right places.

Many years ago I was the ENT doc seeing patients at the Gates Clinic. The clinic was an on-site healthcare facility for employees of the Gates Rubber Plant in Denver and I worked there one day a week as a contract doc. The clinic is now gone, the plant became condos next to a light rail station and I moved on. The other day I received a request from someone asking me if I know anyone offering on-site care to employees. Henry Kaiser would have been proud.

None of us needs to be told that the US healthcare system is undergoing change. Designed for yesteryear and  showing signs of dysfunction and age, our system is cracking under the strain of an aging population, escalating costs and technological progress.

Things have changed in several important ways:

• Health Insurance Reform and changes to the Reimbursement model
• Decentralized patient –centered care
• Downsizing /rightsizing the healthcare workforce
• Electronic medical records, healthcare information exchanges and data analytics/BI
• Acute to preventive care
• Disconnected to integrated care
• Medical travel: The search for value-based care
• Mobile health
• The emergence of non-US markets for biomedical innovation
• Increasing regulatory scrutiny
• The changing intellectual property landscape
• New healthcare delivery models : telemedicine, concierge medicine, hospitalists
• Physician-industry conflict of interest and transparency requirements

These market shifts can be lumped into four categories, each an opportunity for you to make a difference.

The first is healthcare information technology. The infrastructure emerging has four basic components: electronic medical records, health information exchanges, data analytics and business intelligence and telehealth/telemedicine. They all serve as elements of a rapidly evolving national healthcare information architecture that will be second nature to your doctor wannabee daughter who is now in high school. Using the system will be as easy as putting your card in an ATM machine in Nairobi and getting US dollars.

The second category are those changes and models designed to deliver care more efficiently and effectively than the present face-to-face model, where the patient has to come to a structure to see the doctor. Examples include on-site clinics located in businesses, disease management facilities, intermedicate care clinics and pharmacy based offices.

The third group attempts to make billing and collection better, faster and cheaper. Processes like identity verification and authorization, real time benefits verification, dependent validation and benefits comparisons are designed to make sure the right person is getting paid the right amount for the right reasons.

Finally, the ground is shifting under the biomedical innovation infrastructure. Changes in regulatory rules concening manufacturing, marketing, FDA approval and intellectual property are but a few of the manifestations.

If you are searching for a non-clinical career and have been unsuccessful so far, you might be looking for love in all the wrong places. Check the action in industry, healthcare IT, alternative care delivery and revenue cycle managment and you are likely to find it.

The 12 Steps To Biomedical Innovation

The 12 step path from an idea to a successful innovation or commercial venture.

We’ve all had great ideas. Whether the insight comes to you in the shower, while driving to work, or in a dream, a new concept or thought pops into your mind and begs for attention. Very few ideas, however, actually see the light of day. The difference between an idea and innovation is what happens after you think of the new idea. Innovation is about inventing something that can create economic value in the marketplace. Ideas are commodities, but innovation is about finding and validating the business opportunity that both the leadership of the organization and its culture embrace and commit to and which is connected to its business strategy.   Implementing innovation is the hard work that goes into conceptualizing an idea to take advantage of a market opportunity and executing a commercialization plan that gets results.

 Today in health care, whether it be drugs, devices, diagnostics, healthcare IT or alternative care models,  successful innovation is about both predicting and observing patients’ wants and needs and satisfying them with new products and services.

 Now, more than ever, industry and health care entities need physicians to help them innovate to stay competitive. Our post-capitalist economy is driving leaders to harvest new ideas and the intellectual capital of their knowledge workers. Success depends on using processes for creating and analyzing new ideas.  Limited time and competition for resources requires prioritization.

The 12 Step Roadmap to Innovation

The path from an idea to a successful innovation or commercial venture is lined with mine fields that can sabotage success at any step. At Venturequest (http://www.venturequestltd.com ), my colleague, Courtney Price, and I have worked with multiple organizations in industry, academia and government labs.  We have developed and applied a 12 step process to increase the success rate for implementing innovation and creating new revenue streams. http://www.ncbi.nlm.nih.gov/pubmed/16615405 The process is designed to quickly eliminate ideas that don’t have a high likelihood of market success, that don’t fit with the strategic mission of your health care organization, or that involve too high a level of market, technical, intellectual property or implementation risk for the proposed return on investment. Our 12 Step Innovation Roadmap provides a framework for screening, incubating, commercializing, and benchmarking the success of new ideas and tested including tools and protocols for health care providers.  At each step of the process, a Go or No-Go decision is made about the opportunities. Sometimes the opportunity skips some of the steps based on the market and stage of development.  Below is a brief description of each step.

Idea generation consistent with the strategic plan

Ideas are a dime a dozen.  The challenge is finding ideas that match the business strategy, connect with senior management, and are embraced by the organization’s culture.  Such ideas leverage the core competencies of the organization as well as build on its intellectual assets including intellectual property, branding, new technologies, etc.  They both build upon sustainable core competencies as well as forecast future breakthroughs. Brainstorming or collecting new ideas that don’t match your facilities culture or its strategic plan will have a limited chance of success. 

Concept development and initial testing

Once ideas are selected that meet the above criteria, it is necessary to describe their uniqueness and determine if there could be a sustainable competitive advantage. A clear value proposition, i.e. the worth, importance or usefulness to your customers, should be clear early in the process.  As you obtain more information about the opportunity, the business concept will change over time in response to newly discovered market, competitive, and patient information. The next steps involve a series of iterations designed to refine your idea.

Seven-Step Opportunity Evaluation

After the concept is developed, it is time to quickly assess the potential opportunity by using a quick Seven-Step Opportunity Evaluation which takes less than 30 minutes to complete.  It addresses the problem being solved, the potential opportunity, and the market for the opportunity, potential revenue, required funding, intellectual property creation and protection, and stage of development.  It also identifies potential customers, competitors, and commercialization viability.  This quick analysis will help you define whether the business, industry or markets you propose to enter are appropriate. It will also help you define what kinds of people you will need to make your venture successful.

Model Opportunity

Once the concept is evaluated using the Seven-Step Opportunity Evaluation, it is time to discover the inherent strengths and weaknesses of the opportunity.  This software tool is based on 24 distinctive characteristics to objectively evaluate the opportunity.  The purpose of this protocol is to identify the Achilles’ heel of the concept. It was designed to assist physicians and researchers without a business education to objectively evaluate the opportunity.  As weak areas of the concept are improved, the better chances it has for success. If you identify potential risks or threats that cannot be address, then the idea should be abandoned. 

Business Opportunity Assessment

The  Business Opportunity Assessment is a more in-depth review of the opportunity including market research and due diligence that includes IP analysis, opportunity development timing, legal liability issues, applications of the opportunity, barriers to entry, industry trends, growth potential, market positioning, competitive analysis, financial projections and pricing, resource requirement analysis, and licensing potential to name a few.   These are the important considerations to address if it looks like the opportunity has a strong commercialization potential.  This software tool is designed in a question and answer format which make it easy to complete a 360 degree assessment.

Market Validation

Once you have completed the Business Opportunity Assessment and have decided to proceed, the Market Validation process focuses on obtaining feedback on how the opportunity addresses specific market needs as well as taking a hard look at your competition. This step helps differentiate the opportunity from competing opportunities based on patient needs.  This process maximizes perceived patient benefits and eliminates extraneous features that increase costs.  This experience-based market learning is critical to market success and helps develops better business judgment for a Go or No-Go decision.

Revise Business Opportunity Assessment

Based on the results of the Market Validation, you can now revise your Business Opportunity Assessment and build a commercialization strategy.

Finalize the Commercialization Plan

By this time, you should have a good idea about whether you have a viable innovation. Since your idea will be competing for resources with other ideas, however, you will need to prioritize and decide which has the best odds for success. You will need to carefully hone your business model. You will now write your business plan that succinctly describes the story of your proposed business.   The good news is that by this time approximately 70 % of your business plan has been written.  

Write the Business Plan

Now it’s time to write your final business plan. Unfortunately, most entrepreneurs go immediately to this step first without using appropriate filtering systems.  This results in a business plan that has unvalidated assumptions and is rejected or leads to an enterprise that fails.

Solicit feedback and revise the Business Plan

After the business plan has been written, it is time to solicit feedback from respected advisors who will provide realistic options about the potential of commercializing the new opportunity.  Their opinions and suggestions should be incorporated into the final business plan. 

Present the Business Plan.

It is now time to present the Business Plan and get stakeholder approval and resources to launch new venture.

Execute the Business Plan

Congratulations. You’ve got the go ahead for your new idea. Now the work begins. Fortunately, your winning business plan based on the 12 step pathway will provide an operational road map to track and benchmark the efforts to commercialize the opportunity.  Your plan will provide you with the timelines and metrics for success. A strong Executive Summary should be distributed to the review board before the presentation and a succinct Elevator Pitch should be developed. 

Whether you are considering a product or service or process improvement, the 12 Step Plan is a useful guide to getting your idea to market quicker, for less cost and with more success.

Being A Medical Entrepreneur Is Risky Business: Spotting The Landmines

Your job as an medical entrepreneur is to kill your idea early and often.

The innovation landscape is littered with buzzwords describing the impact of new ideas: earth-shattering, killer-app, disruptive, blockbuster, game-changer. Your idea, invention or discovery might be one of them. However, before you get ahead of yourself, or full of yourself, take time to do a high-level risk assessment. In this exercise, your goal is to kill your idea early and often and continually ask "Why shouldn't I kill this idea now?"

In bioinnovation, the risk categories generally include:

1. TECHNICAL RISK: Will my invention or discovery do what I claim it will do?

2. FUNDING RISK: Will I be able to get the money to do what I want to do when I want to do it?

3. INTELLECTUAL PROPERTY RISK: Will I be able to protect the intellectual property I create, control it,  and defend it?

4. EXECUTION/TEAM RISK: Will I be able to surround myself with experienced exectives who wil be able to execute our business plan?

5. MARKET RISK: Is their a large enough unmet need that will continue to grow and be profitable?

6. INDUSTRY RISK: Will the industry continue to grow and be immune from threat of substitutes, competitors, shifting supplier and buyer power?

7. BUSINESS MODEL RISK: Will your proposed business model, i.e., how you will make money, work?

8. REVENUE MODEL RISK: Are your assumptions about number of leads, conversion ratios, units sold, revenue/unit and repeat business valid, or are you betting on "only" .1% of the China market?

9. COST RISK: Are your fixed and variable cost projections reasonable?

10. REGULATORY AND REIMBURSEMENT RISK: Will you be able to get FDA approval and get someone to pay for your drug , device or diagnostic before the money runs out?

Give yourself 1-10 points for each category.

70-100: You've got a shot

50-70: Sounds like you have more work to do

<50: Don't give up your day job.

Performing this risk analysis before moving ahead with a formal feasibility plan (forget the business plan, dude, you are SO not there yet) will help you avoid spending time, effort and lots of money on an idea that was DOA from the beginning. The last thing you want to hear is your spouse telling you "I told you so".

Life Science Entrepreneurship: It's Not Just About The Patents

Life science entrepreneurship and commercialization is about much more than creating and exploiting the elements of intellectual property- patents, trademarks, copyrights and trade secrets.

There are several additional ways to work with industry and other partners in biomedicine. While licensing and spin outs seem to grab most of the headlines and get most of the attention from technology transfer and licensing managers and the investment community, biomedical entrepreneurs, whether they are academics or community-bsed, consult with industry, participate in research and development collaborations, design and contribute to clinical trials, and engage in knowledge transfer or knowledge exchange programs with industry.

Knowledge exchange programs create a platform where academics and industry scientists can work with each other. The three pillars of knowledge exchange are dissemination (pushing out information from the research base), research use (identifying a clinical problem, market need, or supplement a technological capability in the company) and knowledge brokering.

For example, at Kings College London, graduate life science students can elect to spend time with local bioscience companies, including such companies as Glaxo Smith Kline, Astrazeneca, and others, under the supervision of a company research and development expert and a faculty mentor. In addition, Kings faculty can spend a sabbatical working on a targeted problem in industry, while their counterpart in industry spends time at the the College.

Knowledge exchange programs, particularly for those with an academic basic or clinical research background, are a great way to build your networks , experience and knowledge base. To that end, the Society of Physician Entrepreneurs is organizing several bioentrepreneurship fellowships for those who want a better understanding of how devices and drugs are developed and get to market. This six month experience, sponsored by drug and device companies , will last for six months and costs will be shared by the company and the fellow. They are designed to provide the fellow with a wide breadth of experience in product design and management, regulatory affairs, sales and marketing, finance and all the other elements that result in biomedical innovation.

Innovation erupts when disciplines intermix. Knowledge transfer programs, whether internal or external, are a useful way for people to get a different view and get their creative juices flowing.