Software Meets Healthcare

FountainBlue’s August 8 Life Science Entrepreneurs’ Forum, on the topic of Software Meets Healthcare, featuring:
Facilitator Dipankar Ganguly, CEO, BioTelligent
Panelist Ted Driscoll, Technology Partner, Claremont Creek, Member, Life Science Angels and Founding Director, Sand Hill Angels
Panelist John Sotir, Senior Manager, Medical & Test Group, Altera
Presenting Entrepreneur Rohan Coelho, CEO, Rexanto
Presenting Entrepreneur Parvati Dev, PhD, FACMI, President, Innovation in Learning Inc., Distinguished Visiting Scholar, Media-X, Stanford University, Former Director, SUMMIT Lab, Stanford University School of Medicine
Presenting Entrepreneur Marco Smit, President, Health 2.0 Advisors

Please join us in thanking our sponsors at KPMG for sponsoring this event and this series. Thank you also to our speakers for taking the time to share their advice and thoughts. Below are notes from the conversation.
Our panelists shared many different ways of implementing software meets healthcare solutions: from pharmacy prescription management to simulations and training, from development tools to mobile monitors and sensors. Regardless of the application, the focus is on serving the customer, by improving efficiency through software automation, by training and learning new behaviors in a safe environment, by reducing development time, by better monitoring behaviors and symptoms, or by providing more accurate, personalized and timely products and services.
Software meets healthcare offers huge opportunities, but there are also many barriers to entry. Solutions must serve a market and customer need, and meet policy, reimbursement and regulatory requirements which are ever-changing. Some of the advances in the technology world, including business analytics, cloud computing and mobile applications, are being leveraged in the software-meets-healthcare space, in the areas of sensors and monitoring, personal genomics, electronic medical records, and other areas. Indeed, we are moving to a world of intelligent agents, which would assume a more active monitoring role than a typical nurse or doctor, in a much more cost-effective, automated and efficient way. This becomes so much more important as demand increases for a variety of reasons, including the aging of the population in general, the increasing health care costs, and the ever-increasing demand for real-time, inexpensive solutions from patients, hospitals, care-givers, providers and insurers alike.
Below are some examples of upcoming opportunities in the software-meets-healthcare space:
– Intelligent agents will help monitor, track, report on and inform others regarding basic indicators from glucose to heart rate to ocular pressure. There is an opportunity for automating hardware and software agents and generating actionable reports to people who would pay for it, and making it easy to spread the word through social media.
– Training and education which would help people make positive lifestyle changes and creating tightly-knit, easily-expandable communities can not only help raise the overall health and quality of life for all in the community, but also create revenues for those managing and creating those communities.
– Adopting software and database solutions into the healthcare spaces offers opportunities in electronic medical records, diagnostics, genomics, and many other areas which require rapid processing of huge amounts of data, and generating reports that inform, educate, and facilitate decision-making.
– There is a drive from the patient side and the provider side for patients to assume more responsibility for their care, and training and education, automation and monitoring solutions which are easy to manage and easy to use for laypeople will be in high demand.
– Solutions which inform the patient and their select network will empower and inform, and ultimately help patients live more independently for longer period of time, which is less expensive and more satisfying for all.
– Mobile devices and solutions will be in high demand, if they are readily available and easy to use. But to ensure ready adoption, make it easy for customers to leverage social media to spread the word and IT departments to approve and support them.
Below is advice or entrepreneurs innovating in this space:
– Develop a solution which your target customer can easily navigate and utilize with minimal training. Take into account, for example, the dexterity, visual acuity, flexibility, etc. of your customers, particularly if they may be limited by physical ailments/diseases, aging, etc.
– Consider the security and data integrity standards for the industry overall.
– Protect patient-sensitive information as people are as sensitive and protective of that as they are of their personal financial information, where there are high standardized requirements for security.
– Serve an existing and passionate market, dont just create a technology looking for a problem.
– For many reasons, the adoption rate is much slower in the software-meet-healthcare space. Invest time in building relationships with hospitals, insurers, providers, etc.
– Build your credibility by having a great solution for a ready, proven market, having an experienced team, developing a scalable solution, and delivering based on milestones.
– Consider who will ultimately pay for the solution, which may not be the end patient, and build a business case on why it is in the best interest of the payor to do so.

The bottom line is that there are huge opportunities for those who are persistent, work with all the key stakeholders and deliver solutions to an eager customer base willing to pay for it.

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Robotics in MedTech

FountainBlue’s December 12 Life Science Entrepreneurs’ Forum, was our final life science forum and was on the topic of Robotics in MedTech. Below are notes from the conversation.
By definition, Robots are devices that automatically perform complicated, often repetitive, tasks or are a mechanism guided by automatic controls. These tasks are ones where human activities are augmented or replaced by automatic or semi-automatic devices. The robotics field can be broken down into areas of body interaction (which would include surgical robots, prosthetics, end-effect robots) Power Source (which includes luggable and fixed robots), Movement Detection (which includes programmed movement and myoelectric), as well as Patient Benefits (which includes vertical wheelchairs, stance control). See the attached chart on the medical robotics landscape, courtesy of Tibion.
Tibion offers a wearable robotic device for augmenting muscle and balance functions through sensors and software, and represented the movement detection category on our panel. Restoration Robotics, which is developing and commercializing a state-of-the-art image-guided system (ARTAS™ System) that enables follicular unit extraction and represents the body interaction space, Accel Biotech, which does product development for medical, diagnostic, biodefense and biotech products and represents products from the movement detection, patient benefits and body interaction space and ISS Robodoc, which allows operators to specify a task and the device performs all the actions necessary to complete the task such as drilling a cavity for an implant from CT data, and represents the body interaction space.
Our panelists spoke eloquently both about how they got into the business, for personal and professional reasons, what their companies are doing, as well as the obstacles and opportunities ahead. Below is a summary of advice and comments about the industry overall.
• With the advancement of technologies in software, hardware, mechanical engineering, databases/business intelligence, networks and integration of all, there are many more MedTech opportunities for successful businesses now than ever before.
• With that said, the aging and more affluent global population/potential customer base, and the demand for more versatile, customizable solutions will dramatically increase to serve an ever-growing global market where there are needs for robots to do everything from body interaction to power sourcing to movement detection to patient benefit.
• Entrepreneurs experienced in this area have withstood the financial/economic ebbs and flows of the valley, particularly over the past decade, and seen the rapid rise and fall of technologies-looking-for-a-market. They are best able to see what’s next, based on market needs and customer feedback/demands and are best positioned to leverage existing technologies to serve these needs, many times integrating proven technologies, or applying them in a new way for a new purpose or market.
• Focus more on incremental improvements on proven technologies, for that’s far easily to forecast and plan for than disruptive changes, and you’re far more likely to encounter disruptive changes if you focus on the incremental ones.
In fact, a disruptive change may involve using existing technology in a new way in a new industry rather than inviting a new technology and solution from scratch, which is much less tested, much harder to get adoption and approval and funding and customers.
• Always start with the market need and consider regulatory and reimbursement factors as well as social and cultural issues rather than focus on building the technology and waiting for the patients and doctors to come.
• Design solutions that make therapists more efficient, one that is easy to understand and adopt, one that makes it easier for them to run their clinic as a business.
• Focus on solutions which make sense, and bring patients to caregivers when the need is to specific, too mission-critical. For example, instead of doing remote surgery at a battle site, invest in quickly getting patients to care centers with far more people and resources for customized treatment.
Our panelists agreed that there are tremendous opportunities ahead in this space:
• Integrating software engineering, data analytics, medical device production and pharmaceutical research can help accelerate the development of custom treatments for specific patients and needs. Indeed, it can do much more than that!
• There are huge opportunities in applications of robotics in food production, research (to find a more versatile, nutritious corn for example), distribution, treatment, etc.
• Robotics could enable rapid, customized diagnostics, in the near term in the areas of staph infection,
• Industrial robots did not take off in the US, due more to market/people resistance than technology implementation hurdles. As such, widespread adoption industrial robotics solutions is more prevalent outside the US. If we can change the mindset of the users and adopters, we can welcome and adopt industrial robotics solutions, factory automation at a next level, and once again become more competitive in the manufacturing/operations space. If not, we can design further industrial robot automations for international customers and markets.
• Investigate the convergence of cameras (imaging), networks/mobile, data analytics, etc. as it applies to quickly diagnosing and treating patients in an efficient, customized way.
• Investigate how gaming, sensors and augmentation will intersect with robotics and the opportunities therein.
• See where materials science, medtech, data analytics, and robotics intersect and the implications on how we can better serve our patients.
• To find opportunities to apply robotics, look at what repetitive or dangerous tasks should be done efficiently and precisely and how it can be automated in an efficient (time and money) way to an audience (like patients and doctors) who may not embrace technology. It must be simple to understand and use.
• Each of the robotics categories from body interaction to Power Source to Movement Detection to Patient Benefits may all be applied to how robots can support an aging population to assist movement-impaired patients limited through age-related physical degeneration, diseases or congenital limitations:
o Surgical robots, prosthetics, end-effect robots
o Luggable and fixed robots
o Programmed movement and myoelectric
o vertical wheelchairs, stance control
In the end, complex automation is the key, leveraging technology (software, devices, databases, networks, etc), but it must be integrated into a simple, sustainable solution, easily managed, to serve complex problems for specific users/customers/needs.
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Please join us in thanking our panelists for our final life science forum, on the topic of Robotics in MedTech:
Facilitator Jack Moorman, LeVaunt, LLC
Presenting Entrepreneur Robert Horst, Ph.D., Vice President of R&D & Cofounder, Tibion
Presenting Entrepreneur Mike Ouren, Clinical Development Manager, Restoration Robotics
Presenting Entrepreneur Bruce Richardson, CEO, Accel Biotech
Presenting Entrepreneur Dr. Ramesh C. Trivedi, President, Calbiomed International, Inc.

Personalized Medicine

FountainBlue’s November 14 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine, Biomarkers, Invitro Diagnostics: The Science Advances, The Business Opportunities, The Cultural Dilemmas. Below are notes from the conversation.
We were fortunate to have a wide range of perspectives and experiences on our panel, representing decades of expertise in personalized medicine, biopharma, oncology, infectious diseases, internal medicine, proteomics, and optics. They each spoke eloquently about the evolution of the personalized medicine industry and the opportunities and challenges ahead.
Our panelists are quite bullish about the opportunities in personalized medicine, remarking on the great progress made over the last decade or two, leveraging revolutionary technologies, research and other innovations and success stories from companies such as Cepheid, Genomic Health, Roche and Gilead. As we move from the first generation of non-specific diagnosis focused on treating symptoms (all typical of health care today), we gravitate toward solutions which require information correlation, providing organized therapies targeting those who would be most responsive to them, based on detailed analysis and research prior to treatment, known as translational medicine. Examples of such include digital imaging, genetic predisposition testing, and clinical genomics. The longer-term objectives for personalized medicine might include disease prevention and effective chronic disease management, and might leverage molecular medicine, CA diagnostics, pre-symptomatic treatment and lifetime treatment. (Source: Richard Bakalar, MD, IBM Healthcare and Life Sciences, November 3, 2004.)
Based on a Bernard Associates October 2003 report published in PharmExec.com, the opportunities in personalized medicine might include the following:
• Addressing patients with adverse event risk
• Serving treatment non-responders
• Serving treatment low-responders
• Introducing solutions to market with faster approvals
• Recruiting patients with less effective, more expensive drugs to new treatment
• Increasing use of drugs for diagnosed patients not treated
• Expanding treatments to new diseases and subgroups
• Diagnosing earlier and leveraging preventive treatments
• Enhancing patient compliance
• Securing better reimbursements for best-in-class drugs
Our panelists made the following comments and advice:
• Because of the nature of the industry, personalized medicine is not a sprint, it’s a marathon, with opportunities for success for only the most committed and resilient.
• Segmenting the patient base (high/low responders, high/low likelihood of recurrence for example) will provide better treatment for the patients, better data for the practitioners, better results for the payers and insurers alike.
• Making solutions easy for the physicians to use, for patients to take, will increase the overall effectiveness of the treatment.
o Getting quick test results will help doctors more quickly make diagnosis and recommend treatments, and also increase the likelihood that the patients will begin treatment. An example is TB testing which currently may take a week, but may eventually take an hour or two, while the patient is still in the office.
o Educate physicians about how to fold these easy-to-implement solutions into their day-to-day practice cost-effectively, and within reimbursement requirements and regulations.
• Focus on creating actionable testing to striate the patient base and recommend treatments based on patient-specific data.
• Create more cost-effective, more effective alternatives to current traditional treatments to 1) serve a more niche market, or a larger market, 2) save costs for patients and insurers, 3)
• Collaborate with clinicians to create value-based pricing and a more receptive regulatory environment conducive to more effective translational medicine.
• Leverage experts in databases and automated systems who can analyze data and recommend treatments, help research differences and similarities in patient and disease and further the research and effectiveness of personalized medicine overall.
• Research families/chapters of diseases as well as types of patients and their correlations with disease susceptibility, with an eye to prevention and treatment.
• There are huge opportunities around treatment resistance – whether it’s a low-responding patient or a patient which develops resistance to treatment over time.
o If it’s delayed resistance, make sure that lab data is current, rather than that taken at the onset of treatment.
o With that said, the difference between samples taken at the beginning of treatment and after the resistance has developed might give insights about the disease, the treatment and/or the patient and classes of each.
• Combination therapies might address the needs of low/non responders, or those who have developed resistance following initial treatment.
As the industry evolves, here are some critical questions to consider:
• Will patients be willing to pay higher prices for treatments more specific to their profile?
• Will diagnostics become more valued and more expensive as people begin to recognize the importance of detailed patient data prior to treatment?
• Will pharma continue to the most influential stakeholder?
• How can patient groups, advocacy groups, clinical collaboration groups, insurers, pharma and other stakeholders better collaborate?
• Will it be cost-effective enough to provide conclusive data which physicians would embrace?
• Will physicians have the time and inclination to embrace new diagnostics and personalized treatments? What are some practical financial incentives for them to do so?
• Will payers band together to insist on better diagnostics and more specialized treatment options based on more sophisticated diagnostics? How will payers work with insurers and physicians and others to make this so?
• What is the most efficient way to measure and communicate ROI and overall savings for diagnosis and treatments?
• Who will fund entrepreneurial innovations in this area, and if it’s not funded, how will the industry continue to evolve?
• How will global solutions and markets evolve?
Whatever the opportunities and questions ahead, we’re in agreement that personalized medicine is not to be swept aside: it is a business opportunity and there is a real need to deliver optimal treatments for patients, and benefit stakeholders across the value chain.
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We are grateful to our panelists for FountainBlue’s November 14 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine, Biomarkers, Invitro Diagnostics: The Science Advances, The Business Opportunities, The Cultural Dilemmas:
Facilitator Audrey S. Erbes, Ph.D., Principal, Erbes & Associates
Panelist Michael Bates, M.D., Vice President, Oncology Research and Development at Cepheid
Panelist Dean Schorno, Chief Financial Officer, Genomic Health
Presenting Entrepreneur Giacomo Vacca, Ph.D., Founder & CEO, Kinetic River
Please join us in thanking our speakers for taking the time to share their advice and thoughts.

Drug Delivery Innovations

FountainBlue’s October 17 Life Science Entrepreneurs’ Forum was on the topic of Drug Delivery Innovations. Below are notes from the conversation.
We were fortunate to have a range of perspectives on the panel, with a mix of entrepreneurs, researchers, providers, engineers and executives. Everyone’s diverse perspectives, thoughts and experience led to a rich, thought-provoking discussion around drug delivery innovations.
The panel commented on some of the hot areas of innovation in the drug delivery space:
• Delivering drugs to difficulty-to-treat areas, including the eye and the brain
• Consider chronic disease treatments and other illnesses which require frequently injection or medical procedure and the opportunity for delivering regular low-dose medication as an alternate to this more invasive approach.
• Provide less-invasive drug delivery mechanisms for the elderly which are more effectively and more convenient.
• Make implants less invasive, more reversible, easier to use and more effective. Same with inhalable and other methods.
• Consider delivering proteins and peptides in novel ways to address specific patient needs for many potential patients.
• Research existing and expired patent on drugs and consider the opportunities for delivering them in a novel way.
The panel had the following advice for entrepreneurs innovating in this space:
• Visualize and realize success, based on understanding the customer and their needs, and delivering it in a way that is both efficient and effective.
• Always start with the problem, not with the solution looking for the problem. If you start with the problem and work backwards from there, you would be more likely to remain customer-focused, a cornerstone of success for any company, particularly early-stage life science/biopharma companies.
• Consider the end-to-end needs of the solution, from the market, design, delivery and manufacturing/distribution perspectives.
• Be selective about which drug you choose for which drug delivery mechanism, considering factors such as market size, optimal delivery mechanisms (and why), stakeholders currently delivering solution, resistance to use and adoption, addictiveness and side-effects of drugs, and innovative alternative drugs (which may get approval, making your solution moot).
• Partner with large pharma companies, who may have limited budgets for internal R&D, but are chartered with creating new solutions, and finding more solutions for existing drugs. They are now in general interested in renting talent and expertise to solve problems in the market, and generally have a prioritized view of which markets are hottest.
• Partner with research organizations and universities, who may share the R&D costs and burden. There may even be existing solutions you can leverage and integrate into your desired solution. But this is not an easy path, so navigate it gingerly, considering the needs of all throughout the process.
• Focus on creating and leveraging value from the customer perspective, not just creative the latest hot technology.
• Consider leveraging existing delivery mechanisms and existing drugs for new purposes and markets.
• Funding is tight, unless you have a proven solution and are past the R&D phase, so focus on leveraging grants, partnerships, seed funding, etc and live leanly while building momentum.
• Optimize the number of ‘shots on goal’ by being strategic, recruiting the right team, and executing well.
• Select a drug delivery technology that changes the risk-benefit profile for the better.
Although all the panelists commented on the importance of the technology innovations, they were even more vocal about leveraging that technology to best address the needs of the customer, and working with the system and the stakeholders to bring the solution to market. This is a far greater challenge today than in decades past, when there were fewer patents, fewer and less stringent regulatory hurdles, fewer generic options, and larger R&D budgets.
But in the end, despite these challenges, the panel was bullish about the promise of drug delivery innovations, noting that innovations in the new and even established ways drugs are delivered can impact the efficacy and effectiveness of existing drugs and also provide new ways to deliver new and existing drugs, all with an eye to ease of use, needs of the customer, and optimal treatment for the patient.

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Please join us in thanking our speakers for FountainBlue’s October 17 Life Science Entrepreneurs’ Forum was on the topic of Drug Delivery Innovations:
Facilitator Robert Mackey, Biopharma Consultant
Panelist Richard Haiduck, Impel NeuroPharma
Panelist Matthew Hogan, CFO, Durect
Panelist Jeffrey Schuster, Triple Ring Technologies
Panelist Eric Sheu, Ph.D., Chief Scientific Officer for Vanton Research Laboratory, LLC
Presenting Entrepreneur Adam Mendelsohn, CEO, Nanoprecision Medical
Presenting Entrepreneur Harm Tenhoff, Bay Link LLC

Emerging Trends in Medical Devices

FountainBlue’s September 19 Life Science Entrepreneurs’ Forum was on the topic of Emerging Trends in Medical Devices: Mobile Health, Personalized Medicine and Consumerization. Below are notes from the conversation.
Our panelists concurred that it’s an exciting time to innovate in the medical device space, because of the advancements in technology, rising consumerization and expansion into global markets, and the growing receptiveness of an industry which has historically been slow-moving.
Technology Advancements Enabling Innovation
They remarked on some trends in the medical device space and their implications for the industry. The overarching themes is the advancement of technology and the transference of technology solutions from traditionally other sectors and impacting the medical device industry.
1. There was much discussion around the miniaturization trend, where products which were the size refrigerators are reduced to the size of a microwave, products the size of a microwave reduced to the size of a hand-held, and products formerly the size of a hand-held are getting really small, even nano size. The implication is that products will be manufactured, tested and delivered more efficiently and more cost-effectively.
2. Sensor technologies are being applied to implantables, therapeutic, diagnostic, and other devices.
3. Database solutions are enabling business analytics solutions which address challenges ranging from IT in healthcare to patient diagnostics to personalized medicine.
4. Cloud storage is an enabling technology for business analytics and other database solutions, making it more cost-effective to manage huge volumes of moving data, and empowering fact-based decision-making which impact patients, providers, care-givers, insurers, etc.
5. Advancements in wireless and mobile devices and software are enabling novel diagnostic, monitoring, enabling and other solutions for patients and their caregivers.
6. Technology advancements in biochemical discovery and genetic markers are enabling additional opportunities for medical devices around diagnostics, monitoring, and other areas.
Consumerization and Expansion in Global Markets
Baby boomers in the US will increasingly demand more consumer solutions to better monitor, enable, and support their personal health and well-being, especially given the rising cost of healthcare, the increased needs of an aging population, and the growing range of options available. This techno-philic demographic group will also be receptive to technology-enabled solutions which would deliver the information they seek in a timely manner.
Emerging countries such as Asia, India and Brazil will have an ever-growing, more financially independent middle class with a similar desire to take more control and responsibility for their own health.
Growing Receptiveness and Collaboration Based on Technology Advancements and Market Trends
With technology advancements and rising global demand, our panelists are hopeful that the industry will see more collaboration and cross-pollination between pharma, medical device and medical imaging companies, leveraging software and technology plus more opportunities for getting solutions developed, tested and into the hands of eager users.

With these overarching trends, our panelists had words of wisdom and caution for those innovating in this space:
• Minimize technology development and regulatory and market adoption risks by being strategic and proactive, so think carefully through your regulatory needs and work early and well with the right regulatory bodies and people to help ensure the approval of your product and think strategically about your customer and your markets.
• Whatever your solution, deliver higher-level care at lower cost.
• Sometimes miniaturization may compromise quality. Sometimes that’s OK, sometimes that’s not, depending on the needs of the customer.
• Innovation is coming from small companies, and small companies with partnerships with larger corporations may get the market, funding, research and other support they need to continue innovating.
• When consider FDA approval, note that the FDA standards require both safety and efficacy, whereas just safety is required in other regulatory bodies. Remember that the FDA approval team itself encourages your communication and wants to get your products approved, but may be locked into a process which makes it difficult.
• We will come to a crossroads and have to decide do we pay more or get less? We can’t have both or it will squeeze innovation.

Specific opportunities around medical devices include:
• Leveraging medical devices as a diagnostic, tracking or monitoring or communicating tool, whether it’s related to mobile solutions or web or other platforms (e.g. beimmunized.com)
• Monitoring devices that look and act like medical devices but don’t call themselves that and avoid FDA approval needs;
• Gamafication leveraging mobile phones and tablets to monitor, manage, communicate, train, connect, etc.
• Health self-management tools and resources leveraging databases and clouds and even social media;
• Outsourcing of innovation for specific problems

The bottom line that there is a wealth of opportunities ahead and the industry itself is rapidly evolving and growing, and it will look much different in many ways, in the next quarter, in the next year, in the next three-five years.
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We would like to thank and acknowledge our speakers for FountainBlue’s September 19 Life Science Entrepreneurs’ Forum on the topic of Emerging Trends in Medical Devices: Mobile Health, Personalized Medicine and Consumerization:
Facilitator Gil Peterson, VP of Sales, Triple Ring Technologies
Panelist Geetha Rao, PhD, Springborne Life Sciences, CEO and Founder, MyMedFax; Vice President of Strategy and Risk Management, Triple Ring Technologies
Panelist Frank Ingle, CEO and CTO, Instruments for Science and Medicine
Presenting Entrepreneur Bronislava Belenkaya, President and Founder, 3S Corporation
Presenting Entrepreneur Jay Miller, former President and CEO, Zonare Medical Systems & Vital Images, Inc.

Software Meets Healthcare

FountainBlue’s August 8 Life Science Entrepreneurs’ Forum was on the topic of Software Meets Healthcare. Below are notes from the conversation.

Our panelists shared many different ways of implementing software meets healthcare solutions: from pharmacy prescription management to simulations and training, from development tools to mobile monitors and sensors. Regardless of the application, the focus is on serving the customer, by improving efficiency through software automation, by training and learning new behaviors in a safe environment, by reducing development time, by better monitoring behaviors and symptoms, or by providing more accurate, personalized and timely products and services.
Software meets healthcare offers huge opportunities, but there are also many barriers to entry. Solutions must serve a market and customer need, and meet policy, reimbursement and regulatory requirements which are ever-changing. Some of the advances in the technology world, including business analytics, cloud computing and mobile applications, are being leveraged in the software-meets-healthcare space, in the areas of sensors and monitoring, personal genomics, electronic medical records, and other areas. Indeed, we
are moving to a world of intelligent agents, which would assume a more active monitoring role than a typical nurse or doctor, in a much more cost-effective, automated and efficient way. This becomes so much more important as demand increases for a variety of reasons, including the aging of the population in general, the increasing health care costs, and the ever-increasing demand for real-time, inexpensive solutions from patients, hospitals, care-givers, providers and insurers alike.
Below are some examples of upcoming opportunities in the software-meets-healthcare space:

– Intelligent agents will help monitor, track, report on and inform
others regarding basic indicators from glucose to heart rate to ocular pressure. There is an opportunity for automating hardware and software agents and generating actionable reports to people who would pay for it, and making it easy to spread the word through social media.
– Training and education which would help people make positive
lifestyle changes and creating tightly-knit, easily-expandable communities can not only help raise the overall health and quality of life for all in the community, but also create revenues for those managing and creating those communities.
– Adopting software and database solutions into the healthcare spaces offers opportunities in electronic medical records, diagnostics, genomics, and many other areas which require rapid processing of huge amounts of data, and generating reports that inform, educate, and facilitate decision-making.
– There is a drive from the patient side and the provider side for
patients to assume more responsibility for their care, and training and education, automation and monitoring solutions which are easy to manage and easy to use for laypeople will be in high demand.
– Solutions which inform the patient and their select network will
empower and inform, and ultimately help patients live more independently for longer period of time, which is less expensive and more satisfying for all.
– Mobile devices and solutions will be in high demand, if they are
readily available and easy to use. But to ensure ready adoption, make it easy for customers to leverage social media to spread the word and IT departments to approve and support them.

Below is advice or entrepreneurs innovating in this space:
– Develop a solution which your target customer can easily navigate and utilize with minimal training. Take into account, for example, the dexterity, visual acuity, flexibility, etc. of your customers, particularly if they may be limited by physical ailments/diseases, aging, etc.
– Consider the security and data integrity standards for the industry overall.
– Protect patient-sensitive information as people are as sensitive and protective of that as they are of their personal financial information, where there are high standardized requirements for security.
– Serve an existing and passionate market, don’t just create a
technology looking for a problem.
– For many reasons, the adoption rate is much slower in the
software-meet-healthcare space. Invest time in building relationships with hospitals, insurers, providers, etc.
– Build your credibility by having a great solution for a ready, proven market, having an experienced team, developing a scalable solution, and delivering based on milestones.
– Consider who will ultimately pay for the solution, which may not be the end patient, and build a business case on why it is in the best interest of the payor to do so.

The bottom line is that there are huge opportunities for those who are persistent, work with all the key stakeholders and deliver solutions to an eager customer base willing to pay for it.
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FountainBlue would like to thank and acknowledge our panelists for our August 8 Life Science Entrepreneurs’ Forum, on the topic of Software Meets Healthcare:

Facilitator Dipankar Ganguly, CEO, BioTelligent
Panelist Ted Driscoll, Technology Partner, Claremont Creek, Member, Life Science Angels and Founding Director, Sand Hill Angels
Panelist John Sotir, Senior Manager, Medical & Test Group, Altera
Presenting Entrepreneur Rohan Coelho, CEO, Rexanto
Presenting Entrepreneur Parvati Dev, PhD, FACMI, President, Innovation in Learning Inc., Distinguished Visiting Scholar, Media-X, Stanford University, Former Director, SUMMIT Lab, Stanford University School of Medicine
Presenting Entrepreneur Marco Smit, President, Health 2.0 Advisors

Please join us in thanking our sponsors at KPMG for sponsoring this event and this series. Thank you also to our speakers for taking the time to share their advice and thoughts.

The Patient Revolution

FountainBlue’s July 18 Life Science Entrepreneurs’ Forum was on the topic of the Patient Revolution. Below are notes from the conversation.
With the aging of the baby boomer generation, and the resultant huge volume of older, more affluent, more empowered consumers, there have been increasing demands for delivering life science solutions, from diagnostics to personalized medicines, from devices to nutragenics. Our panelists agreed that the challenge and the opportunity is to cost-effectively and efficiently create personalized, patient-specific data, services and products which would serve the breadth and depth customers from individual patients to physicians, hospitals and clinics, from payors to small providers to insurers. Indeed, the key is to leverage technology in a way which automates the production and distribution of information and services while minimizing risk and maximizing impact and quality treatment for the patient, benefiting everyone throughout the value chain.
Baby boomers have created a population spike which, like a snake who has swallowed a mouse, has impacted markets and industries throughout their life cycle, from infant to toddler, from teenager to young adult to middle age. As boomers are techno-philic, affluent, health-conscious and influential, their voices have been heard and have impacted market development and direction. So as they age, infirmities and elected treatments of an aging patient, from obesity to diabetes to sleep apnea, from baldness to arthritis, from sports injury treatment to knee replacement, will quickly rise in demand.
So the opportunities are there, but there are also challenges in meeting the opportunity, including reimbursement policies (particularly with Medicare changes), regulatory approval (particularly in the US where the FDA is becoming both more stringent and more unpredictable), as well as the ‘normal’ challenges of the life science industry overall: the longer development cycle, the greater need for capital, the greater risks involved, etc.
Those who will be able to meet those challenges will be more creative in bringing their products to market. Our panelists’ suggestions on how to do so are listed below:
• Put your products in the hands of the patient through channels such as your local drugstore (like Walgreens) or market (like Costco).
• Where possible, avoid the need for FDA approval or seek approval in countries outside the US before bringing it to market in the US.
• Serve a market need and target customers who are willing to pay for it, even if it has to come from their own pockets. Leveraging personal health care savings accounts (an increasingly popular strategy for patients) might help.
• Angels are syndicating and supporting early stage companies with a promising business model and plan and proven technology. Build relationships with angels who might be great mentors and potential funders.
• Help our policy-makers make decisions which would reward physicians to do the right thing for their patients, reward patients for making effective health decisions.
• Leverage social media and the web to grow your customer base, build your brand, create new channels, etc.
Our panelists commented on some hot opportunities for better serving the empowered patient.
• Help providers such as clinics and hospitals better, more efficiently treat and serve their patients leveraging IT offerings from databases to cloud to business analytics.
• The days of the blockbuster drugs are past, so whether you are in pharma or devices or biomed or mHealth, create personalized solutions which serve all stakeholders more cost-effectively.
• Baby boomers have historically adopted wellness and nutragenics solutions throughout their lifetime, and as they age, their preferences and needs will change. Anticipating and addressing this need will help forward-thinking companies succeed.
• Baby boomers love their independence, so products, services, solutions which help them remain independent as they age-in-place will likely be popular.
• Services and solutions which would help baby boomers make good health decisions for diet and exercise, and those that help patients understand their risks and genetic make-up will continue to grow.
The bottom line is that all stakeholders, from patients to providers to clinics, hospitals and insurers and policy-makers, need to forge a convergence between the world of technology, with its access to databases, business analytics, dynamic solutions, etc and the world of patient care, with its combination of pharma, device, medical record and health management solutions. The trick is t do this in a way which helps all parties make the best health decision *and* the most cost-effective solution for all parties, and collaborating to make it work.
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We would like to thank and acknowledge our panelists for FountainBlue’s July 18 Life Science Entrepreneurs’ Forum, on the topic of the Patient Revolution:
Facilitator William Wright, VP Operations/ Business Development, Bay Area, at California MedTech LLC
Panelist Richard Ayllon, Director, Global Business Development, Ventus Medical
Panelist Don Ross, Healthtech Capital
Presenting Entrepreneur Ash Damle, Founder and CEO, Medgle
Presenting Entrepreneur Howard Edelman, President & CEO, VitalWear
Presenting Entrepreneur Oostur Raza, President & CEO, OmegaGenesis

Please join us in thanking our sponsors at KPMG for their ongoing support of the series.

Trends in Medical Imaging

FountainBlue’s Life Science Entrepreneurs’ Forum on the topic of Trends and Opportunities for Medical Imaging. Below are notes from the conversation.

Our panelists represented the full range of medical imaging innovations, from PET/CT to MR/monoclonal tags to radiation therapy. They also commented on the importance of making cost-effective, easy-to-use solutions that generate quick, easy-to-interpret results, and adding clear value to doctors, patients and providers up-front. Policies and regulations and openness of the medical community will impact whether these solutions get into the hands of physicians who would use them. In fact, sometimes, it’s more about incentives and ease-of-use than it is about how sophisticated the technology is.
Below is advice proposed by our panelists for entrepreneurs innovating in this space:
• Adapt a medical device solution for ultrasound rather than MR or CT where possible as it is cheap and readily assessable and much less expensive.
• Consider hybrid solutions which leverage existing and proven technologies and approaches, applied to different patients, locations, conditions, etc.
• Build more reliable hardware and software for existing solutions and markets.
• The market will continue to be driven by reimbursements and policies, so entrepreneurs need to be aware of what these are and how they would impact their business.
• Consider launching outside the US in Europe or Asia for example, as it is less expensive, less time-consuming to do so.
• Solve the problem at hand, rather than filtering the problems you can solve by current financial resources.
• Get your products into the hands of the doctor, and don’t overly-prescribed how the doctor should leverage your solution. He or she would best determine how the solution would be helpful to her or his patients. And if you listen to this feedback and shift your messaging and strategy, you may find yourself targeting a slightly different and more tangible and immediate market.
• Offer solutions which doctors would appreciate – see it from their point of view.
Below are some of the opportunities they see in this space:
• Hybrid approaches leveraging different technologies, approaches and modalities.
• Genome-focused imaging.
• Localized imaging.
• Miniaturization, which will help drive down costs.
• Apply medical imaging to regenerative medicine or cancer solutions.
• There is an upcoming trend toward lowering and limiting radiation exposure, especially for children. What are the opportunities to provide similar information with the dangers of xrays?
• There is another movement to limit stents, and to ensure that those inserted are done right the first time. What are the medical imaging opportunities to support this trend?
The bottom line is that no matter what type of medical imaging solution you offer, make sure that you provide physicians with diagnostic confidence so that they feel *better* using your solution as additional data points, as additional background information as they treat their patients, while limiting their risk and exposure.

FountainBlue’s Life Science Entrepreneurs’ Forum was on the topic of Trends and Opportunities for Medical Imaging and featured:
Facilitator Dennis F. Falkenstein, President and CEO, iOnTrends LLC
Panelist Tom Thomas, Director of Imaging Systems R&D, Boston Scientific
Panelist Brian Wilfley, Ph.D., Director, Chief Scientist, Triple Ring Technologies
Presenting Entrepreneur Caleb Bell, PhD, CEO, Bell Biosystems
Presenting Entrepreneur Kendall R. Waters, PhD, Manager, Intellectual Property and Technology Development, Silicon Valley Medical Instruments, Inc.
Please join us in thanking our panelists as well as our hosts at UCSC Extension and our sponsors KPMG for sponsoring this event and for their ongoing support of the series.

Life Science Leaders: From Strategy to Execution

FountainBlue’s June 15 Life Science Entrepreneurs’ Forum was on the topic of Life Science Leaders: From Strategy to Execution and featured:
• Facilitator Dick Haiduck, Partner to the CEO, Haiduck Consulting
• Panelist Rich Ferrari, Partner, De Novo Ventures
• Panelist Stevan Jovanovich, PhD., CEO, Microchip Biotech
• Panelist Yvonne Linney, VP, Strategy, Marketing and Business Development, Life Sciences Solutions Unit, Agilent
• Panelist Glen Sato, Partner, Cooley Godward Kronish, LLP
• Panelist Charles Versaggi, CEO, OsteoCorp

Below are notes from the conversation.
The panel agreed that an organization’s strategy must focus on the needs of the customer and be more market driven than technology driven. In other words, from its inception, and throughout a company’s life span, the focus should be on understanding and delivering the clinical value of the solution on the specific target market that they are serving, thereby focusing on delivering the company’s unfair advantage. This necessitates an alignment between the goals of the management team, the organization, and all its staff and partners to plan for, communicate and execute on delivering that value, and remaining fluid on HOW the organization will continue to serve its customers. Therefore, there must be utter clarity on who the target customers are, what value is provided through which project, and how the experienced team will execute to milestones based on this clarity of vision, communicated well.

The current economic conditions amplify the importance of both thinking and acting strategically. With resources so tight, it is even more important to ensure that the strategy is customer focused, targeting a specific unmet need and that execution is measurable and milestone driven, with the necessary adjustments in both strategy and execution along the way. There is an overwhelming emphasis on doing more with less, stretching precious dollars to meet milestones, and focusing on providing the core value to customers, making every decision, every action, count.

During these challenging times, when considering a company’s strategy, think about which elements of strategy you’re considering – from business to financial to clinical to positioning – as well as the timing for the strategy and how it is integrated with other strategies. Successful entrepreneurs ensure an alignment between overall company goals and implementing strategies to achieve those goals, even if it means changing the overall corporate objectives along the way. The most experienced entrepreneurs see strategy as a process, not a destination, and are adept at proactively managing the direction of the company, erring on the side of action/decisiveness, and hiring a management team with a similar mindset.

Based on questions from the audience on how to best focus on select projects when resources on tight, the panel recommended that entrepreneurs periodically evaluate individual projects to ensure that they are delivering anticipated value, both in terms of meeting the needs of customers and in financial returns, using the anticipated amount of financial and staff resources. The panel even went so far as to encourage a culture where everyone is rewarded both for originating projects, AND for disproving projects, so that resources may be allocated to other more promising projects. Making these types of business decisions objectively based on fact, rather than on popularity, emotions and opinions, will help organizations develop a more resilient, practical strategy that meets the needs of its customers.

In conclusion, the panel noted that start-ups are prized for their innovation and their nimbleness, and in these economic conditions, the stakes are higher, and so are the opportunities for those proven entrepreneurs who can survive the storm, executing on milestones for a vibrant, flexible strategy that serves customers well and brings rich financial returns.

Life Science Follow Up Notes

FountainBlue’s February 23 Life Science Entrepreneurs’ Forum was on the topic of Personalized Medicine: The Breakthroughs, the Opportunities, and the Challenges, featuring:

• Facilitator Steven Cui, Of Counsel, Jones Day

• Panelist Bonnie Anderson, CEO, Veracyte, Inc.

• Panelist Deborah Kilpatrick, Vice President, Market Development, CardioDx, Inc.

• Panelist Geetha Rao, Springborne and Molecular Image

• Panelist Mike Richey, Chief Business Officer, Tethys Bioscience

• Panelist David Rollo, President, Cell Point LLC

Below are notes from the conversation:

With advancements in technology and science, we have not only a greater understanding of people and their various diseases, but we are also better understanding the human genome, and are making progress in creating personalized medicines to customize treatment and even preventive care for people. The panel highlighted the Promise of Personalized Medicine:

• Here’s one way of thinking of molecular medicine. It is comprised of molecular diagnostics – identifying biomarkers for diseases, molecular imaging – targeting location and extent of a disease, molecular therapy – targeting treatment for the diseased cells/areas. Investing in personalized medicine will help providers better diagnose, identify and treat patients more effectively and with less expense.

• Personalized medicine helps people understand their genome and what they are pre-disposed to, based on genetics or environment. Knowing this information will help patients, providers and payers alike better understand, diagnose and treat health challenges, even in the early stages.

• Personalized medicine has the potential to positively impact the regulatory, clinical trials, reimbursement and other challenges which have historically been barriers to delivering medication to patients.

• Personalized medicine has the ability to identify a wider range of solutions for a larger percentage of the affected population. In general, broadly prescribed drugs tend to work effectively on a subset of patients, which could be as low as 15% for some treatments and possibly as high as 80 or 90% for others. The benefit of personalized approaches is to better ensure that patients gets the drug “matched” to their subtype, which saves the costs of unsuccessful treatments followed by later rounds and supports an improved quality of life for the patients. This is overall a more cost effective approach than is used today. This would impact payers, physicians, providers, patients and investors alike, creating a tremendous business opportunity while also better serving everyone. Indeed, there is a lot of interest from patients, physicians, providers, payers and investors alike. But there are also challenges in proving the efficacy of personalized medicine.

• This economic downturn makes it challenging for the funding of even the most promising technologies. Be conservative about cash management, keep developing a business worthy of funding (people, products, market, risk management), build relationships with key stakeholders, and manage your fundraising needs to fit the times.

• If stakeholders move from a philosophy of treating the symptoms to understanding pre-dispositions to disease and providing targeted treatments early on, it may increase the effectiveness of the treatment while lowering the risks and the costs.

• We must prove through clinical trials that personalized medicine can safely and effectively live up to that potential of providing customized medical solutions to patients while still supporting solid business practices and satisfying all stakeholders.

• We must enlist the support of providers and educate them on developing use cases and advocating for the adoption of personalized medical options.

• We must work with the FDA to create new standards for clinical trial approval which are more appropriate for personalized medicine solutions. Current standards are more effective for pharma and device solutions, so while we’re advocating for a new standard, we must find a way to work within the current standards.

• There are political and societal barriers we must overcome in order to develop critical mass for the adoption of personalized medicine. This takes time and must be done through passionate education and advocacy from engaged stakeholders.

• Later, we must empower patients to take charge of their own health.

Your comments are welcome. We look forward to connecting with you soon.

Linda

Linda Holroyd

CEO, FountainBlue

E-Mail: Linda.Holroyd@FountainBlue.biz

The notes above are copyrighted by FountainBlue in 2006-09 and all rights are reserved. You have our permission to forward the notes on to others, provided that they are INTACT, and provided there is proper acknowledgement for our speakers and to FountainBlue.