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)
mproving 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.
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.
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.
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.
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.
Relative advantage. Gather an understanding of the ROI and cost mindset of the patient, medical staff, and decision makers.
Health beliefs are predisposing characteristics that are not easily changed.
Developing Specific Targeted Strategies
Narrow Impact: Fee-for-Value
Broad Impact: Patient & Lifestyle Autonomy
The experience of encountering advertising tailored to one’s behaviors or interests on the internet has become ubiquitous in a very short time. We’ve all had that experience – shopping for a particular shoe on Zappos or gadget on Amazon, not buying it, then having an ad for that shoe or that gadget magically appear in a whole variety of other websites during the course of our browsing over a period of days or even weeks. Or, perhaps, buying that shoe or gadget, and then encountering ads for similar shoes or gadgets, or shoe/gadget accessories.
As Executive Vice President, Angela Tenuta leads client services for 
Shannon Gallagher serves as Vice President, Analytics Services at Crossix Solutions, where she leads the ongoing expansion of Crossix services and capabilities at the intersection of pharmaceutical and consumer healthcare. A veteran consultant in market research and data analytics for the pharmaceutical, healthcare and CPG sectors, Shannon is passionate about Crossix’s unique position to harness Big Data to empower better communication to the patient as a consumer. Prior to joining Crossix, Shannon spent 10 years working at Nielsen in Innovation Analytics, consulting on new product development for Rx and OTC/CPG manufacturers. Connect with her on