The ability to improve, restore and enhance patients’ lives is a privilege that is founded in public trust. The medical device industry’s ability to bring products and therapies to patients who need them requires the trust of many different groups: patients, physicians, hospitals, payers, other healthcare institutions, regulators, policy makers and even the media.
At Medtronic we have been talking a lot lately about that fundamental trust, about whether it has eroded and if so why, what it means for us as a company and for our industry, and how we can help foster positive change.
As I reflected on various compliance challenges when asked to author this piece, several conventional challenges come to mind: how to use risk assessment to shape an ethics and compliance program to really address a company’s greatest risks, how to build processes and systems to meet and anticipate rapidly changing state and federal reporting requirements, how to structure an effective international organization, how to determine what standards to follow in countries where law and industry standards are undeveloped.
Reflecting on the issue of how we can sustain and rebuild public trust in industry, though, led me down a different path, to focus on a compliance challenge that is much more basic: how to manage collaboration with physicians and other healthcare professionals in a way that will address conflict of interest concerns while allowing the type of physician-industry collaboration that is so necessary to preserve innovation and to bring life-saving and life-enhancing products to patients who need them.
Educating the broader community about the unique role that physicians play in developing medical devices is a priority for us. Device development and commercialization relies heavily on a close collaboration with physicians.
One of the most important challenges faced by the device industry right now is preserving legitimate collaboration with physicians. The importance of this collaboration is well recognized. “Substantive, appropriate, and well-managed interactions between industry and academic medicine are vital to public health. For example, the medical device industry depends on physicians and biomedical scientists to help define needs, inform product design, and test and improve devices. Both the interests and responsibilities of each party require that the relationship be maintained in a way that is principled and upholds the public trust.”1 Without close industry physician partnership, many medical marvels that society takes for granted–the pacemaker, the implantable defibrillator and the mechanical heart valve, to name but a few–may not have been developed.
We at Medtronic characterize this innovation model as “bedside to bench to bedside.” This model both starts and ends with the physician, in an ongoing and iterative cycle that fuels rapid and essential product and procedure innovation. In this model, a physician is often the inventor who sees the “flash of light” of a new idea during an interaction with a patient. The physician provides vital clinical insight regarding the suitability of new technology to actual patients. The physician suggests improvements to existing products and to products under development. The physician devises surgical techniques necessary for safe device implantation, conducts clinical trials to support regulatory submissions, assesses long-term performance, and, often greatly under-appreciated, they teach their colleagues how to correctly utilize technological innovations for the benefit of indicated patients.2
Of course, collaboration between doctors and industry must be carefully managed, as it presents the potential for competing interests, both real and perceived. These perceived conflicts can negatively impact patient and stakeholder trust in clinicians, products, companies – and the entire industry. At Medtronic, our goal is to minimize this potential for conflict so patients can trust that treatment decisions are motivated by what is best for their health. We do this by fostering a culture of ethics and transparency, and continuously reviewing our practices and evolving them as necessary to maximize trust and preserve innovation. Historically, Medtronic, like other device companies, relied on the adherence to industry codes as the way to demonstrate the appropriateness of industry physician relationships. More recently, Medtronic has focused on the importance of transparency. Despite these efforts, however, skepticism about physician-industry relationships has increased and public trust has eroded.
As I mentioned at the beginning of this piece, Medtronic has spent considerable time recently strategizing about how to approach this challenge. Specifically, we have revisited our basic principles to ensure that we are clear internally and externally about what is important and why. We have reviewed our internal standards and controls, restating some and focusing on how others might be bolstered to drive greater confidence in those relationships. Finally, we have committed to a renewed public conversation in this area.
There are two fundamental principles that are designed to preserve physician collaboration for the benefit of patients while minimizing actual or perceived conflicts of interest. First is a focus on the relationship between a patient and his or her physician, and to always protect the integrity of that relationship. Second is a commitment to transparency around physician-industry collaboration, including transparency around policies and around payments, coupled with a commitment to appropriate disclosure of physician relationships. We want these principles to become part of the public conversation, and believe that a focus on these principles will help rebuild public trust around physician-industry collaboration.
While principles are the first step toward the type of culture change that will ultimately impact public opinion and increase trust, principles must be coupled with action steps. At Medtronic, we are in the midst of reassessing our already robust standards around physician collaboration to make sure that our practices meet the current challenges as effectively as possible. We have renewed and restated our commitment to several key approaches to physician industry collaboration, focusing on the following:
Collaborate when needed: We engage physician partners only for specific projects that match an identified business need in the areas of research and development/product development, clinical research, Advisory Services, and training and education.
Compensate fairly: We are committed to fair and appropriate compensation of physicians. We all recognize that what physicians provide during the collaborative process is unique. They make skilled contributions that can only come as a result of their hands-on practice of medicine. There should not be any controversy around the fact that this type of genuine contribution deserves fair compensation.
Be transparent in policies and payments: To provide patients and physicians with adequate information to make informed decisions, to maintain trust, and to minimize actual and perceived conflicts, we are committed to transparent and appropriate disclosure of our policies and processes with respect to physician relationships, and also to transparency and appropriate disclosure regarding payments to physicians.
Continuously improve business practices: The continuous improvement of ethical business practices regarding physician collaboration is as important to our Corporate Mission and Values as all other business-critical functions and product innovations.
Facilitate industry dialogue on best practices: Effectively managing conflicts of interest in healthcare demands a collective dialogue among all stakeholders, aimed at further evolving best practices to preserve collaboration.
In conclusion, Medtronic hopes to raise the level of conversation and to work together with all stakeholders to agree on how to manage collaboration with physicians and other healthcare professionals in a way that will address conflict of interest concerns while allowing the type of physician-industry collaboration that is so necessary to preserve innovation and to bring life-saving and life-enhancing products to patients who need them. Education and conversation in this area can only serve to positively impact overall public trust in the healthcare arena
1 Association of American Medical Colleges. Industry Funding of Medical Education: Report of an AAMC Task Force. Washington D.C.: AAMC; June 2008. Available at: https://services.aamc.org/Publications/index.cfm?fuseaction=Product.displayForm&prd_id=232&prv_id=281 Accessed February 12, 2010.
2 The device industry relies heavily on practicing physicians to train other physicians on the safe and effective use of our products. We have strict standards and policies around this training to ensure it is balanced and ‘on label’. Absent this training, many patients may not have the access to these therapies or may be provided these therapies by under-trained and/or inexperienced physicians. It is totally in patients’, physicians’ and industries’ best interests to ensure these forms of legitimate collaboration is preserved.
