Archive for the ‘Healthcare as a Business’ Category

Increasing pharmaceutical market penetration in the developing world through in-house innovation hubs   Leave a comment

Just how many “me too” cholesterol-lowering agents do we really need? (Photo Courtesy: The Daily Mail)

The pharmaceutical industry’s fundamental business model has become increasingly less attractive in the last two decades, and a number of firms and industry experts have advocated large-scale change (e.g., E&Y’s Pharma 3.0 strategy, McKinsey’s pharma manufacturing revolution) in how pharmaceutical companies do business. In particular, GlaxoSmithKline (GSK) has staked much of its future success on pairing its longstanding strengths in traditional pharmaceutical product development with a top-down mandate to grow the size of its customer base in the 50 poorest countries in the world. Currently, these markets have less than 5% market penetration by Western pharmaceutical companies, and GSK views these underserved populations as missed opportunities for sales and revenue growth.

Last summer, three of us from Saïd Business School’s MBA Program, the London-based the International Centre for Social Franchising, and GSK collaborated to identify innovative, replicable models that would improve GSK’s ability to access and serve populations in developing countries. This work was based on an underlying assumption that a host of creative delivery models existed but were difficult to identify and evaluate. Once found and verified, GSK could partner and contribute as an investor, operational and technical expert, and multinational influencer as a means of scaling up and replicating these initiatives across multiple national markets.

The study team used a mixture of high-throughput quantitative methods and visit-based qualitative interviews. The former helped the team to screen a 1200-item aggregated universe of programs and identify common program type and geographic foci of innovation. The team then traveled to these geographic hotbeds, visiting over 50 delivery models and technical experts spread across Kenya and India. The major findings of this study included both overarching themes that were applicable to nearly every program visited (e.g., poorer customers are highly price-sensitive but will pay a premium if they value a product highly relative to other needs) as well as model-specific themes that relate to specific success factors for a given model type (e.g., social marketing programs usually required a local NGO partner with an established source of trust in the community). Some of the original assumptions of the study team were challenged by the findings. For example, the number of financially-sustainable, scalable projects that were worthy of multinational investment or partnership – and did not already have it – was exceedingly small.

Packaged food manufacturers have a longstanding history of rapidly altering prices, products, and brands to suit the needs of consumers best. What features of such everyday innovation would best suit the pharmaceutical industry? (Photo Courtesy: Paul Mullins)

Recommendations were developed with a variety of near-term actionable items (e.g., what to invest in, how to invest) for GSK as well long-term strategic considerations. The most universally relevant of these findings was a need in the pharmaceutical industry to rethink how it develops business strategies for these new, atypical markets. It could be argued the hunt-and-peck strategies that many pharmaceutical companies are using to experiment with new business models are inherently flawed. Instead, our team of MBAs recommended a variation on an approach popularized by many fast-moving consumer good firms (FMCGs; e.g., Procter&Gamble, Unilever). Although models vary, open innovation frameworks or innovation hubs typically create an internal business unit at large multinationals that standardizes how promising new business models are screened, evaluated, tested, and replicated. For example, many of the new products developed today at Procter & Gamble and Mars are rapidly rolled out in this way. These lean workgroups allow otherwise large, complex companies to nimbly experiment with an approach that accepts failure as learning activities and rapidly identifies promising goods or services for corporate scale. Pharmaceutical multinationals looking to expand in the developing world will need to build a similar series of internal systems and processes to remain competitive.

Contributions to the work described here were provided by Andy Thornton (Oxford MBA 2012), David Wong (Oxford MBA 2012), Jackie Horn (ICSF), and Dan Berelowitz (ICSF). Public findings from the completed study can be found here.

Disclosure: The work our team completed for GSK described above was a professional consulting project with financial remuneration conducted in collaboration between Saïd Business School, the ICSF, and GSK.

Stroke prevention trials: where is the discussion on costs?   Leave a comment

ClevelandClinicPFO

A patent foramen ovale is a defect in the wall between the two sides of the heart that allows the passage of blood and its contents. This course bypasses the lungs. (Courtesy Cleveland Clinic)

One controversial cause of some strokes is a small hole between the two sides of the heart known as a patent foramen ovale. Although rarely symptomatic for patients, this hole allows blood clots that occur in otherwise healthy individuals to bypass the lungs and lodge in critical arteries that serve the brain. In individuals without this defect, these small blood clots would normally lodge in the small vessels of the lungs and typically never lead to a disease state (see note at end for a more complete explanation). Because of the unresolved structural defect, conventional thinking considers these individuals at increased risk for future strokes that remains even after typical stroke prevention strategies.

Kurt Amplatz is an interventional radiologist who has spent his  career developing a number of devices to repair these patent foramen ovale and other defects using a catheter-based device that closes the hole with a permanent metal disc. The procedure is similar to cardiac catheterization procedures used for patients with coronary artery disease (e.g., heart attacks).

AMPLATZERPFOOccluder

An Amplatzer occluder deployed on the end of a catheter. (Courtesy St. Jude Medical)

Two recent papers(1,2) in the New England Journal of Medicine report findings from long-term studies designed to demonstrate the expected benefit of using these “Amplatzer” devices versus traditional medical therapies (e.,g., aspirin, Coumadin®, Plavix®). The Journal effectively uses these two studies to demonstrate just how fine a line of improvement may be found with use of the devices and ultimately concludes that true believers and skeptics will likely not be swayed from their opinions by the limited findings of both studies.

What I found most interesting about this recent revival of the debate of catheter-based occlusion devices is the near-zero discussion of the cost component of these devices. The Amplatzer occluder used in these studies was not a one-time quick-fix for these patients but was a supplemental therapy that was often used in conjunction with traditional medical therapies. Although exact pricing is not available, the cost of the device alone adds an additional $3,000-5,000 to the cost of the patient’s care and insurance is usually billed an additional $10,000-$25,000 for the procedure.

With the current evidence, these devices add additional costs and procedural risks to a patient’s care without demonstrating definitive benefit. Addressing the escalating cost-problem in U.S. healthcare starts with regulatory authorities scrutinizing care scenarios such as this one to determine if we are getting value for money in procedural medicine.

Note on blood clots: Venous thromboembolisms are a major cause of morbidity and mortality. However, the specific sequence of events that produces small clots that the human body can easily degrade versus those that cause life-threatening events is poorly understood. Although any blood clot seen in the healthcare setting is typically treated as if it were potentially life-threatening, the general thinking is that small blood clots as in the example given above are somewhat routine in the older population and can resolve spontaneously if not symptomatic.

Dermatology’s two-tier patient classification and its implications for effecting change in the medical profession   Leave a comment

A few years ago, the New York Times reported a strange scheduling phenomenon encountered by patients at dermatology clinics in southern California. The article cited a study in the Journal of the American Academy of Dermatology that examined scheduling wait times in a number of American cities. If a patient were looking for a chemical peel or Botox® injection, clinics could routinely schedule the patient for later the same week. In contrast, if a patient had a concerning mole or eczema that had not responded to routine treatment, it would often take a month to get an appointment. Interviews with industry experts at the time suggested that many dermatology practices were effectively running two separate practices split along patients needing medical versus cosmetic dermatological consultations. “Medical dermatology” is a category within the specialty that addresses dermatological disease (e.g., skin cancer, acne, eczema, psoriasis). “Cosmetic dermatology” refers to dermatologic needs to improve one’s appearance but are not the result of any derangement within the body. Common problems in cosmetic dermatology include wrinkle-reduction, altering skin pigmentation, and removing age spots.

An important aspect of this distinction between the two major categories of dermatologic needs is the grossly different financial impact of each. Cosmetic dermatology is almost never reimbursed by medical insurance while medical dermatology is usually required by law to be included in insurance coverage. This difference effectively creates two classes of patients in a typical dermatology practice. The medical dermatology patients pay a nominal co-pay and then a physician could spend weeks trying to capture a relatively small amount of additional revenue from the patient’s insurance company. In contrast, cosmetic dermatology patients are paying in full at the time of their visit at a price that can theoretically be as high as the local market will bear. The New York Times article noted that a dermatologist could double his or her annual income by focusing more of their practice on cosmetic procedures. The reported scheduling behavior suggests that many dermatology practices attempt to capture a greater share of cosmetic dermatology while potentially limiting the volume of medical dermatology because of these financial incentives.

While the reader’s knee-jerk reaction may be that government regulation be used to “force” dermatologists to more equitably accept both types of patients, I would suggest that the current situation highlights an opportune moment for professional activism of a kind rarely seen in medicine. The ultimate obstacle to scheduling a medical dermatology appointment is a limited supply of appointment slots in certain localities. Ironically, this long-time shortage of medical dermatology care notwithstanding, clinical training in dermatology is one of the most competitive specialties in medicine within which to receive a training position. In theory, if enough dermatologists were trained and sent to practice in an area this shortage would solve itself. However, increasing the number of dermatologists being trained would likely create a disproportionate amount of cosmetic dermatology practices. This disproportionate desire from graduates to practice cosmetic dermatology limits the profession’s desire to expand the number of trainees each year. One potential solution is for a formal distinction in training to be made from cosmetic and medical dermatology. Doing so would not be easy and would likely require a combined effort from accreditation bodies to require the trainees in dermatology only be trained in either subspecialty, and it would also require cooperative state medical boards to prohibit one group practicing the other’s trade. Given the different financial incentives of each subspecialty, a likely result of such a change would be that cosmetic dermatology would continue to be the highly-competitive, highly-compensated field that dermatology largely resembles today while medical dermatology would be a more academically-focused, less competitive, moderately-compensated field that it should be.

The real take away from this discussion is not determining whether the greater dermatology community ever makes such a radical step to fix a distorting externality of the profession. The ultimate point here is that the medical profession, its accrediting bodies, and training institutions ultimately have many of the tools to improve healthcare delivery and training in the U.S. today. Historically, our profession has been relatively passive which encourages external actors (e.g., governments, industry) to shape how we provide care to patients. While engaging outside influencers is important, medical providers are often best suited to recognize and adapt to problems that arise in the practice of medicine. It is up to medical providers then to embrace their role as change-makers.

End-of-life care and the need for professional activism   2 comments

This post is proceeded by a short case vignette to help frame the discussion that follows.

An 85 year-old man is brought to the hospital with a fever and found to have pneumonia. The man had been diagnosed about six months ago with an incurable form of leukemia, a cancer of the bone marrow. Because of his age and medical history, his pneumonia quickly leads to respiratory failure and he is admitted to an ICU for mechanical ventilation and other critical life-sustaining measures. Over the next few weeks, the patient’s overall condition failed to improve and he suffered a number of further physiologic insults. He became anemic and was transfused two units of blood. The patient then got a bladder infection that resulted in sepsis which caused the patient to cardiac arrest before being successfully resuscitated. After all of these events and the patient’s stable but poor condition, the medical team faced a difficult situation where the patient was too sick to be transferred to a long-term acute care facility but also had little chance of significant improvement. Given the current findings and poor prognosis, the medical team asked the family to reconsider the patient’s status as a “full code,” requiring all life-sustaining measures in the event of further cardiac or respiratory failure. The family felt very strongly that “ALL” medical efforts should be afforded to the patient and refused the medical team’s request. An ethics consultation was called by the primary team.

It is estimated that better management – meaning less aggressive – of patients’ care in the last six months of their life could save $700 billion of U.S. healthcare spending, one-third of the total annual spending on healthcare. Currently, the irreconcilable differences around end-of-life decision-making problems outlined above are handled by hospitals with the use of “ethics consultations.” An ethics consultation typically triggers a review of a patient’s case by a member of the hospital’s ethics committee who has been trained to use the four principles of medical ethics to reframe a particular ethical problem and provide a recommendation for moving forward. For example, in the case above an ethics committee member would highlight the balance that must be struck between the patient’s (and family’s) autonomy to make their own medical decisions versus the continued use of limited healthcare resources on a patient who will never be independently functional and suffering a series of interventions that are likely only prolonging the patient’s guaranteed death from his cancer. The intended purpose of such an exercise is that reframing the discussion in a more analytical manner may help the family or the medical team better understand the other side and highlight a potential resolution.

However, the major limitation of the ethics consultation is that its recommendations are not legally binding and therefore truly irreconcilable differences can rarely be solved by the process. When some form of cooperative agreement cannot be reached, the ethics committee has no power to enforce a recommendation on either party. Published reviews of the history of end-of-life care and medical ethics have highlighted the limited legal protection for either hospitals or patients with end-of-life care as a major hindrance to the available options for resolving these differences of opinion. Without strict legal guidance, hospitals have been forced to utilize a quasi-legal “fair process” system when faced with patients and decision-making surrogates who insist on continued care that has become medically futile. Fair process for withdrawal of care involves an onerous series of consultative steps that requires a medical team to explore alternative care options that include cross-specialty consults, an ethics consultation, an attempt to transfer to another hospital service, and an attempt to transfer to another hospital before being able to cease futile medical interventions. It is important to note that these safeguards are necessary, but only because the government has failed to legislate a more streamlined process of ceasing futile care efforts.

While it is probably unsurprising that legislators have been wary to pick up such a hot-button political issue – particularly after the pillorying of “death panels” during recent healthcare debates – my greatest disappointment lies in lack of professional association’s attempts to fill the void. Although recommendations from professional groups like the Society of Critical Care Medicine or the American College of Physicians may not carry legal weight, such professional association guidelines are regularly used in medical malpractice cases to demonstrate whether a physician’s actions were considered “standard of care.” The issuing of such guidelines by professional organizations would provide the kind of backstop needed for physicians to more comfortably navigate ethical dilemmas like the one presented above. To date, the only national physician’s organization that has provided public recommendations  for withdrawal of care is the American Society of Nephrology with a particular focus on withdrawal of dialysis for kidney failure. In the present political climate, further efforts to manage end-of-life care will need more physician and patient groups to publicly take a stand on what qualifies as appropriate care. Without such courageous steps, end-of-life care will become a further emotionally destructive and financially untenable part of our healthcare system.

Disclosure: I have no conflicts of interests with regard to end-of-life care and medically futile interventions.

When “go-local” doesn’t work: sanitary napkins in sub-Saharan Africa   Leave a comment

7 years ago, an enterprising Harvard student, Elizabeth Scharpf, began a project to produce sanitary napkins using local workers and local materials in sub-Saharan Africa. Although difficult to quantify, the amassed evidence has suggested that many women in developing countries– particularly school-age girls — are routinely sequestered and miss multiple days of school each month because of the lack of hygiene products to use during menstruation. This issue has been long ignored largely because of the associated stigma around a woman’s menstrual cycle in conservative societies and the lack of health officials familiar with women’s needs. Sustainable Health Enterprises (SHE), the company founded by Sharpf, was an attempt to a) address the needs of rural women through a locally available commercial product AND b) provide a self-sufficient business model to entrepreneurial women in these countries.

The basic model has been to first find local entrepreneurs interested in starting a local sanitary napkin production operation. The raw materials for these sanitary napkins are then sourced locally using banana tree fiber, a waste product of banana harvesting, as a substitute super-absorbent material. The cost savings on materials and production help reduce the cost per pad from US$0.11 to US$0.07.Local women are then trained to produce these with small table-top workshops that can be used in their private homes. These are then collected by the local entrepreneur and sold in markets or with door-to-door sales models.

SHE Pad Prototype

First-generation SHE Pad. Not exactly what Rwanda’s women were looking for. (Courtesy Ecouterre)

SHE’s success to date has been mixed. Between 2009 and 2011, Scarpf used funding from Echoing Green and Harvard Business School to setup the first franchise model of banana fiber-based sanitary napkin production and distribution in Rwanda. However, using the available public information on SHE’s website and blog, the latest updates dated August 3, 2012 suggest that company is just now completing its supply chain and brand strategy. The largest hurdle seems to have been that the uniqe selling point SHE pads offer — their attractive lower price — are exactly why consumer demand from Rwandan women has not been strong. In a critical oversight, Rwandan women who cannot afford imported pads would rather use their existing coping mechanisms in a pad-less world than use SHE’s product. Although SHE is actively working through these issues and is currently completing a redesign, SHE has yet to prove its model for a new sanitary napkin for the low-income communities.

A particular concerning trend is that efforts to provide locally-produced sanitary napkins have been increasing even though the existing businesses have yet to identify a succcessful business model. At the the University of Oxford’s 2012 TATA Ideal Idol business plan competition in March, one of the finalist was BaNaPads, a similar sanitary napkin effort being attempted in Uganda. No evidence suggests that these me-too ventures are finding solutions to the problems that racked earlier efforts. Although there is a certain attraction to local production and women’s empowerment through independent income generation, the social entrepreneurship and global health communities should be self-critical to such unproven models.

While the work of the organizations above is commendable, none of these efforts have seem to realistically questioned if multinational corporations are already providing female hygiene products in the most financially sustainable way. Patricia O’Hayer, Unilever’s Vice-President for Communications and CSR, challenged the development community in a recent Oxford-based debate to avoid automatically assuming that there was something intrinsically better about local production versus global mass production when it came to making consumer healthcare products. Procter & Gamble and Unilever may be unapologetically “big business,” but their ability to reach economic scale and provide a safe, reliable product may be unmatched in this product category. Entrepreneurial efforts such as these must be compared to existing ways of doing business if they are meant to contribute to societal value creation.

Disclosure: In early 2012, I informally worked with a team from  Procter & Gamble on shared interests to bring health-related retail products to rural communities in rural Kenya. There was no material remuneration from this engagement.

Is Kenya’s healthcare sector ready for a take-off?   2 comments

Last month had me traveling around the world courtesy of Saïd Business School’s capstone Strategic Consulting Project and our multinational corporate partner who is currently looking to become more invovled in healthcare innovation in developing countries. I just finished my second short stint in Nairobi, and I am thoroughly impressed by a number of developments in Kenya. The current macroenvironment for healthcare in Kenya combined with individuals’ entrepreneurial efforts has produced palpable excitement in the sector that may well signal a new dawn for healthcare in the country. Most interesting, the opportunities for Kenyan private sector healthcare may be the best they have ever been.

One of the most important macroenvironment trends is the improving political stability since the post-election ethnic conflict of  2007-2008. Since then, a new constitution has been ratified and the upcoming elections will be preceded by a number of bureaucratic improvements that will streamline the alignment of commercial ventures with committed policy-making. This political normalization has also allowed for an increasing amount of “business as usual” from the administrative arm of the government including more direct financial management of HIV/AIDS spending and a new eHealth strategic plan. Although the next round of elections scheduled for 2013 may well herald a new wave of vote-rigging and subsequent violence, the two rival political parties from the last election have learned to work together through power-sharing and the knowledgeable city-dwellwers I have spoken to in Nairobi seem optimistic.

mPESA Transaction

Many groups are trying to repeat mPESA’s success in mobile money payments by coming up with similar mobile-related leapfrog applications for healthcare. (Courtesy of OpenIDEO)

Another trend occurring in Kenya is the overwhelming success of modern mobile telecom infrastructure. Nearly every business venture I met with in Kenya includes in its business model a component related to mobile technology. Mobile technology in developing countries has been shown to be a major catalyst for healthcare development but where Kenya stands out is in its mobile phone penetration. Over 70% of Kenyans own and use a mobile phone and nearly a 1/4 of the country’s GDP is transacted through Safaricom’s mPESA mobile payment service (see more).

All of these trends have directly stoked the entrepreneurial efforts of many Kenyans. Zoe Alexander Ltd is a new technology start-up who is leveraging automated telephone systems (“robo-dialing”) and Kenya’s high mobile penetration to deliver personalized audio messages to pregnant mothers that time appropriate antenatal visits and warn mothers’ of “red flag” warning signs during pregnancy. Zoe Alexander and others have also focused on bypassing the existing healthcare infrastructure because of the its overly bureaucratic nature in Kenya. Another example is Changamka Microhealth’s use of health savings accounts to incentivize individuals to save rather than trying to expand the relatively small population footprint of the country’s national social insurance plan. The latter’s bureaucracy was unable to design a means of participating in the plan for individuals that did not work for major Kenyan corporations.

While such initiatives will not radically change the health and wellbeing of the average Kenyan overnight, these efforts should be complimented for their inventiveness and aspirations for self-sufficiency. Through my travels last month, I have heard far too many stories of companies seeking overly traditional approaches to reaching low- and middle-income healthcare consumers. Marketing techniques designed for industrialized countries will not work elsewhere unless modified to local conditions. Home-grown, for-profit healthcare in Kenya may be the first sign of lessons learned.

Disclosure: I, nor my summer employer, have any financial positions in the companies listed here. However, my trip to Kenya was funded as part of business development field research for a multinational corporation.

Micronutrient powders as a sustainable solution for child malnutrition   5 comments

The World Health Organization rates malnutrition as the foremost threat to global public health. Each year, over six million children die of starvation, and more than one billion people suffer from vitamin and mineral deficiencies requiring medical attention. Media coverage of malnutrition tends to highlight starvation, but micronutrients (e.g., Vitamins A through E, iron, and zinc) are equally important for child wellbeing. Substantial medical evidence suggests “micronutrient malnutrition” in the first two years of life has a lasting impact via physical and cognitive impairment.

A “Sprinkles”-branded Single-use MNP Sachet

Micronutrient food fortification — adding micronutrients to a person’s everyday food — is one of the most cost-effective public health interventions available today. Unfortunately, most children suffering from micronutrient deficiencies live in rural, subsistence economies that are not easily reached by traditional industrial food fortification (e.g., iodized salt, fortified flour). As opposed to manufacturers adding micronutrients through industrial food processing, at-home fortification with individuals adding their own micronutrients have also been successful.  Studies by the U.S. Centers for Disease Control and Prevention(CDC) in rural Kenya demonstrated that at-home food fortification – using micronutrient  powders (MNPs) (see photo at right) – was effective in substantially reducing rates of micronutrient malnutrition in these communities. Most interesting, these MNPs were provided using a market-based model where mothers were paid a  near-market retail price for the product from door-to-door sales agents. Despite this proven demand, there is currently no on-going supply of MNPs in most countries of the world because of limited coordination between commercial distributors and public health advocates.

A community education tool for teaching mother’s how to use MNPs safely and effectively. (Courtesy CDC)

In January 2012, the Global Alliance for Improved Nutrition (GAIN), industry partners, MBA colleagues of mine, and I met in Nairobi to discuss how to introduce micronutrient home food fortification products to Kenya through a market-based mechanism. The consensus reached was that although support from health authorities existed, the collaborative nature of public health interventions in under-resourced areas would required a very unique business model for market-based MNPs to succeed.

Our team of MBA students helped craft a business plan for GAIN and its private partners that demonstrated the economic feasibility of a public-private partnership model that could provide micronutrient powders across Kenya through a market-based, financially self-sustaining process. Armed with the proper cash flow models, marketing plan, and risk analysis, GAIN’s Kenya Fortified program is currently in the process of securing start-up financing and locating Kenyan commercial operators with the appropriate logistical capabilities for distribution and sales (see video below). Delivery of the first locally-branded micronutrient powders to Kenyan communities is expected in early 2013 (with future production scaled to up to 300 million sachets per year).

Even more exciting than this particular project’s success is the potential for future efforts to deliver similar programs around the world. The basis of the solution above was taking existing opportunities and capabilities and reshaping them to fit a unique market macroenvironment (i.e., rural Kenya).  This project demonstrates that although such radical rethinking of business models may be difficult, successful new methods of achieving healthcare goals often lie at the other end of the process.

Disclosure: I have received no monetary or in-kind compensation from my work with GAIN or in promotion of MNPs more generally.