By Linda DiPersio, MSM, MSHC

In the book “The Innovator’s Prescription: A Disruptive Solution for Health Care,” Clay Christensen, who developed the theory of disruptive innovation, stated, “There are more than 9,000 billing codes for individual procedures and units of care. But there is not a single billing code… for helping patients stay well.” In the pharmaceutical industry, disruptive innovation improves health by generating ideas that create new drugs at the expense of existing ones. It is an alliance between technological advances and new business models that dramatically changes the performance of the industry. The progressive spectrum of disruptive innovation challenges include lessons from the past showing resistance to change, implications surfacing in the present which emerge from cautious analytics and trailblazing dynamics in the future aligned with patient centricity.

Past: Resistance to Change

Despite the remarkably positive success of antiseptic surgery with carbolic acid saving many lives during active combat in late 19th century Europe, Surgeon Dr. Samuel Gross from the United States said, “Little, if any faith, is placed by any enlightened or experienced surgeon on this side of the Atlantic in the so-called carbolic acid treatment of Professor Lister.” The medical community in the United States not only disapproved of the concept of germ theory that promoted the protection of patients against airborne microbes, and any drug associated with it, but also they fully rejected it – instead believing that miasma or bad air caused infection. After 30 years of successful usage in Europe, the jolting factor of antiseptic surgery acceptance in the United States is attributed to the almost assuredly avoidable death of President James Garfield. His non-life threatening gunshot wound from an assassination attempt was cared for by a team of doctors with germ-laden contact, including non-sterilized instruments, which lead to a major infection most likely being the cause of death.

As the above example shows, the advancement of pharmaceutical innovation efforts are most often prevented by established world views, opinions, customs, attitudes, societal values and complex psychological and emotional issues ingrained in the network of relationships that define individuals singly or collectively. In certain situations, innovation challenges are rejected directly because they are seen as threats to the means of support and character of many stakeholders, such as pharmaceutical companies, Federal regulatory institutions and the American Medical Association, that deploy an intangible but forceful influence on decision-making. Resistance to change in pharma emanates from industry incumbents whose jobs rely on sustaining the existing business model and political power. As Upton Sinclair said, “Never expect someone to understand change when their livelihood depends on not understanding it.”

Present: Cautious Analytics

Currently, pharma believes that marginal innovation is actually “safe” disruptive innovation because it is supported by confirmed targets, proven forms of action and/or established drug classes. In reality, it is extremely risky. Marginal pharmaceutical compounds have a high risk of not achieving end results, not being accepted by regulators and/or not performing up to the standards of existing less costly therapeutics and fail commercially. Recent studies with marginal drugs show a 50% failure rate due to a lack of efficacy or safety.

Safer trials, which are designed to add evidence-based support of the versatility of top drugs, take away the amount of funds from innovations and discovering new cures. There are no pre-competitive consortiums to divide the challenges and costs of developing new knowledge about disease causation. Today, innovation is distributed over a group of partners with universities conducting the riskier early translational research and pharma investing in late development with perceived low risk. Beginning as low risk, low returns and low R&D, cautious analytics eventually equate to bad risk with ill-fated consequences.

Future: Multi-Dimensional Patient Centricity

In the future, the drug lifecycle needs to incorporate many facets of patient centricity, including the use of new technologies such as gene- and proteomics, gene therapy, nanotechnology, and Big Data driven predictive analytics. Precision medicine will identify exact patient needs and tailor molecular profiles to create the most beneficial treatment plans for patients on an individual level. New social media tools will allow patients to share information and participate in collaborative discussions with regulators and pharma.

If pharma practices the five skills of questioning, observing, networking, experimenting, and associating that are outlined in the book “The Innovator's DNA” authored by Gregersen, Dyer, and Christensen, disruptive innovation will be constructively delivered, empowering patients, and effecting positive change through physicians who will proactively treat and potentially prevent illnesses before they become a major source of concern. Creativity that changes behavior will be framed by:

• Asking controversial questions that confront existing knowledge of the industry;
• Thoroughly examining behaviors to identify new ways of doing things;
• Encountering people with fundamentally dissimilar ideas and perspectives;
• Building interactive experiences that trigger non-traditional responses to discover what insights emerge; and
• Connecting the dots with questions, issues or ideas from unrelated fields.

In summary, the past and present challenges mapped out on the spectrum provide valuable information that will shape future disruptive innovation in a beneficial way. Lessons learned from the past indicate that attitudes impacted the resistance to effective existing pharmaceuticals. Presently, with pharma’s perception of “safe risks,” engaging in cautious analytics eventually results in bad risks. In the future, leading the way with a multi-dimensional, patient-centric approach to the drug pipeline will allow for increased profits and improved health outcomes. As Clayton Christensen said, “Disruptive innovation is a positive force.”

Sources:

Christensen, C., Hatkoff, C. and Kula, I. “Disruptive Innovation Theory Revisited.” Innovation Excellence. (2013)

Coleman, D. “The DNA of Disruptive Innovators: Will Pharma be Disruptors or Disrupted?” Eye for Pharma. (2014)

“Disruptive Innovation and the Future of the Drug Lifecycle.” PhRMA. (2013)

“Growing the Pipeline, Growing the Bottom Line: Shifts in Pharmaceutical R&D Innovation.” KPMG Pharmaceutical R&D Innovation. (2014)

Munos, B. and Chin, W. “How to Revive Breakthrough Innovation in the Pharmaceutical Industry.” Science Translational Medicine. (2011)

“Creativity is thinking up new things. Innovation is doing new things.” – Theodore Levitt, author of Innovation in Marketing

Creative assessment in pharma is the ability to generate and evaluate new, varied, and unique ideas to achieve innovative approaches. Flexibility, originality, fluency, elaboration, and brainstorming are only a few of the factors connected to this tool. It involves finding new ways, making unusual associations, and seeing unexpected solutions. This technique uncovers difficulties, issues, gaps in information, and missing elements followed by formulating hypotheses about characteristics, evaluating, and testing guesses, and then, finally, communicating results. By applying the Innovation Styles Model to pharma, novel methods stimulate curiosity and promote divergences that bring about successful outcomes.

Innovation Styles Model

Visioning, Modifying, Exploring and Experimenting are four distinctive strategies included in the Innovation Styles Model that reveal how to approach new methods, ideas or products in pharma.

1. Visioning forms a mental image of the ideal future. Specifically, original ideas about the future are developed through intuition trailed by facts that are gathered to support those concepts. The long-term outcome is a clear future impression. Visioning endorses innovation by crafting the big picture and presenting certain direction over a length of time. This strategy encourages commitment and provides an impetus for an expansive vision.

2. Modifying refines and optimizes what occurred previously. Priorities for improvement are established through facts and then intuition allows the entire picture to surface. A specific short-term goal is optimized and achieved. Modifying upholds innovation by adding to what predecessors have accomplished without developing anything new. This strategy also motivates a group to concentrate on realistic, short-term success.

3. Exploring discovers new and interesting possibilities. Assumptions are questioned with intuition and new options are discovered. Hypotheses and insights are supported by ascertained facts. Exploring searches for unusual breakthroughs and challenges to uncover sole perspectives. This strategy is enthusiastic and hopeful under vague conditions.

4. Experimenting combines and tests many exclusive groupings. Leverage points are identified with facts and then meaning is realized using intuition. New combinations expose strengths and weaknesses. Experimenting detects ways to overcome barriers, assimilates the ideas of many people, and generates new notions to makes decisions. This strategy tests and formulates new concepts in a detailed manner and provides organized methods to take risks in increments.

Practical Applications of Creative Assessment in Pharma

Strategic Planning

Improving core competencies, emphasizing cost control, focusing on comparative effectiveness, and elevating market access are part of a new strategic planning process. Payers, such as private insurance plans, pharmacy benefits managers, governments, and employers, have moved to the forefront of the pharma industry. They now strongly desire information about drug safety and efficacy to compare drug cost effectiveness to alternative treatments. In the past, determining how much payers would pay for drugs was a major challenge for marketers. However, most recently economically justifying and identifying the intrinsic value of a certain drug is a more important challenge.

R&D and New Products

Creative ways are now engaged to capture treatment benefit through subjective research. These practices demonstrate full product value to patients, regulators, and payers. Patients visually express disease experience with mood boards using a collage of images and/or text that represents their emotions and thoughts with drawings or online platforms such as Pinterest. People receiving medical care also utilize body mapping to indicate the location on their body where they experience signs of disease and pain. Patients tell their story in video diaries, often times using smart phones to point out their disease experience in real time. In prior years, face-to-face interviews and focus groups were sufficient, and drug developers relied on merely clinical outcomes. Nevertheless, currently patients recognize the significance of comprehending and collecting subjective research about patient attitudes, preferences, and experiences.

Work Process Improvement

Six Sigma and Lean Manufacturing allow pharma to predict and eradicate errors which boost operational efficiency and increase the chance of quality products and compliance, as opposed to relying on end-process testing. These techniques also optimize resources, control inventory, reduce waste and errors, improve customer service and change the market entirely. They identify and remove the causes of defects while minimizing variability in manufacturing and business methods. These tools employ empirical, statistical methods so that a certain group of people materialize as experts in these methods and become an integral part of the infrastructure of the organization. Presently, profits are declining due to greater competition emanating from generic brands and an increase in errors within the manufacturing process. On the other hand, Six Sigma and Lean Manufacturing offer the possibility of saving pharma an estimated $90 billion dollars internationally.

In conclusion, creativity develops fresh ideas, methods or products while innovation puts them into action. Combining creativity and innovation builds an assessment technique that effects positive and profitable change when the Innovation Styles Model is applied to the pharma industry. The practical application of the four unique strategies of the model (Visioning, Modifying, Exploring, and Experimenting) to the strategic planning process, R&D and new products, and work process improvement creates a departure that broadens the reach of pharma and acts as a trajectory to advance the industry worldwide.

References:

• “How Does Creative Thought Differ from Critical Thought? Macquarie University. (2008)
• McClearn, C. and Croisier, T. “Big Pharma’s Market Access Mission.” Deloitte University Press. (2013)

• Meysner, S., Kitchen, H. and Humphrey, L. “Why Creative Research Methods are Essential in Pharmaceutical Outcomes Research.” Abacus International. Decision Resource Group. (2013)
• “Six Sigma and Its Use in Pharmaceuticals.” Six Sigma Online. Aveta Business Institute. (2014)
• “Understanding and Applying Innovation Styles^(R) for Insight, Versatility and Impact.” Global Creativity Corp. (2007)

During his January 2015 State of the Union Address, President Barack Obama introduced the Precision Medicine Initiative as an effort that “will bring us closer to curing diseases like cancer and diabetes – and give all of us access to the personalized information we need to keep ourselves and our families healthier.” The question is how we will achieve this goal. The answer is through Point of Care (POC) ranging from POC testing to POC prescribing. Relying on prompt diffusion of innovation with this initiative will create maximum results and minimum waste in practicing health care.

Precision Medicine

The National Research Council describes Precision Medicine (PM) as adapting medical treatment to the specific characteristics of each patient. It arranges individuals into subpopulations that differ in their likelihood to contract any particular disease. PM is the advanced and detailed understanding of the root causes of a disease and how best to respond with proper treatment taking into consideration genetic changes and ultimate cures.

POC Testing

The innovation of portable diagnostic and monitoring devices for POC testing depends on moving towards predictive, personalized, and preventive medicine while simultaneously moving forward with remedy medicine for existing diseases. POC testing allows pharmaceutical companies to develop more effective drugs geared to personalized needs. This synergy is influenced by the following factors:

• Speed. Not only does testing produce instantaneous results, it also eliminates the need for laboratory bound samples requiring a wait time.
• Portability. The size, portability, and battery power of POC testing devices allows them to be used in different environments including within the community or in a large hospital.
• Convenience. Clinicians spend less time preparing paperwork for laboratory testing.
• Reduced workload. Non-laboratory staff conducts testing instead of overworked trained clinicians whose time can be leveraged to achieve more medical advancements.
• Connectivity. Errors are reduced by using USB and wireless connections not mandating manual transcription while central database input allows for data mining and research.
• Sample quality. Time does not interfere with quality due to the lack of transport to the central laboratory.
• Analytic viability. Integrity is maintained with analysis performed within a short time of sample being withdrawn.

POC Prescribing

Preventive and therapeutic interventions, such as physicians dispensing prescription medications during medical visits, benefit patients without high cost or side effects. Health care professionals have the ability to prescribe the right drug for the right patient at the right time at the right place. Patient savings are realized in terms of time, energy, convenience, and money. Also, better health outcomes are achieved with patient adherence because the early stage obstacle of compliance is removed – the patient taking the time to process the prescription through mail order or at a pharmacy. Furthermore, assigning clinicians the power of POC prescribing confronts the dilemma of health disparities.

Diffusion of Innovation: Dynamics and Strategies for Success

Comprehending how to improve the pace of disseminating the concepts of this new Precision Medicine Initiative is of paramount importance to its success. Rapid diffusion of innovation is accomplished through the following guidelines and action plans.

1. Relative advantage. Gather an understanding of the ROI and cost mindset of the patient, medical staff, and decision makers.
2. Trial ability. Engage ways to divide the process for tangible benefits.
3. Observability. Choose viral marketing to uncover the invisible.
4. Communication channels. Select mass media to inform and interpersonal methods to persuade while identifying the connectors and the correct target audience.
5. Homophilous groups. Look for other homophilous groups outside of physicians, nurses, health strategic planners, and patient advocacy groups.
6. Pace of innovation/reinvention. Situate listening standards for early warning about issues and monitor practices for potentially dangerous mishaps.
7. Norms, roles, and social networks. Concentrate on target groups and expose chances to leverage existing social networks or create new ones.
8. Opinion leaders. Identify opinion leaders and look for principals who have a broad range of information and a reputation for being most knowledgeable and respected.
9. Compatibility. Become aligned with current behavior and values and mimic everyday universal functions.
10. Infrastructure. Grasp current and future regulatory constraints.

In conclusion, the way to achieve the goal of the Precision Medicine Initiative recently launched by President Obama is utilizing two Point of Care methods which change the way medicine is practiced and health care is delivered. POC testing and POC prescribing promotes the health care climate shift toward prevention, early diagnosis, management of multiple chronic conditions, and eventual cure of existing diseases while increasing patient health engagement by encouraging patients to take a more active role in their health. Health care is more personalized through customization of interventions to individual patients based on the way information is processed. Specific transmittal dynamics accomplish the diffusion of innovation without delay and catapult the overall efficiency of medical practice.

References:

Berry, P. “Drug Dispensing at the Point of Care Benefits Patients.” Northwind Pharmaceuticals. (2015)
Cain, M. and Mittman, R. “Diffusion of Innovation in Health Care.” Institute for the Future and California HealthCare Foundation. (2002)
Moreno, C. “What Precision Medicine Is and How It Might Save Your Life Someday.” Reuters. (2015)
“Point of Care Diagnostic Testing.” National Institutes of Health. (2013)
Wickham, M., McComas, D. and Wickham, C. “Point of Care in Clinical Trials.” PharmaPhorum. (2010)