Access

With the ability to enhance quality of care and productivity, innovative medical technologies can be a significant part of the solution to chronic disease. However, global access to our therapies remains a challenge. Only a fraction of individuals who could benefit from our products receive them. A variety of factors, from inadequate medical infrastructure to cost, contribute to the problem. Medtronic is actively pursuing strategies that improve patient access in both advanced and developing countries.

During the fourth quarter of fiscal year 2010, we conducted a 60-day Greater Access Platform review of all our existing efforts to increase access to our therapies. More than 60 initiatives were included, spanning our business units, geographies and functions. An internal team evaluated each initiative based on its ability to create both business and social impact. The results will guide our next steps as we work to bring our therapies to more patients, especially those at the lower levels of the economic pyramid.

As we move forward, we will also pursue collaborative models that engage several stakeholders, from our businesses and employees to healthcare professionals, patient advocacy groups, and policy makers, to tackle specific issues, such as eliminating disparities in U.S. healthcare or increasing awareness, availability and affordability of cardiac therapies in India. (See case studies below.)

And we continue to address access through the following channels:

Global Regulatory Approval and Reimbursement

We’ve identified opportunities to support government and healthcare systems in building regulatory, reimbursement, and health technology assessment policy frameworks.

Systematic regulatory approval and post-market surveillance are pivotal to ensure that patients get access to safe, effective, and high quality medical technologies. In key markets around the world, Medtronic is working with multilateral bodies at international and national levels to shape regulatory policies and support regulatory capacity-building. 

For example, we bring experienced practitioners from other geographies to provide training on regulatory systems – including lessons learned from other countries – and engage with policymakers on the critical differences between medical devices and pharmaceuticals. We also have leadership roles in regional and international regulatory forums that promote internationally harmonized regulatory processes and practices to further reduce barriers to patient access.

In addition, we work to expand the approved intended uses and indicated patient populations for approved devices. For example, Medtronic supported studies conducted by the National Institutes of Health designed to expand the population and conditions for which implanted cardioverter defibrillator (ICD) therapy is recommended and we are now seeking to expand the approved uses of our deep brain stimulation therapy beyond Parkinson's disease, essential tremor, and obsessive-compulsive disorder (humanitarian use) to include epilepsy.

Reimbursement is another critical factor in patients getting access to the right therapies at the right time. To this end, Medtronic hosts events with payers (government funds, private health insurance and HMOs) to support policies that fund therapies for patients who cannot otherwise afford them.

Humanitarian Use: As part of our Mission, Medtronic also pursues regulatory approvals for Humanitarian Use Devices for rare diseases or conditions. Six of the 50 U.S. Food and Drug Administration-approved Humanitarian Device Exemptions (HDE) are Medtronic products. Therapies approved by the U.S. FDA under HDE have demonstrated safety and probable benefit in treating conditions that occur in fewer than 4,000 patients per year.  These HDE therapies for rare diseases have low commercial value due to the small market size. Our development efforts provide access to these therapies, which allow physicians to treat patients with serious unmet medical needs.

Market Acceleration through Education

Training healthcare professionals on the safe and effective use of our products is essential to expanding the availability of life-enhancing therapies. Medtronic has 22 education centers in 16 countries, including India, Japan, the Netherlands, Switzerland, and the United States. These centers feature classrooms, hands-on training areas, high fidelity simulation, and technical facilities and host product training sessions, medical and scientific seminars and professionally accredited workshops.

Through Medtronic Foundation MedLink, Patient Link and HeartRescue grants, we invested nearly $30 million to educate healthcare professionals in countries that lack critical infrastructure, to support leading patient advocacy groups in Canada, Europe,  Japan, the United States, and selected developing countries that promote in awareness and prevention, and to improve survival rates from the leading cause of death in the United States -- sudden cardiac arrest. 

Medical professionals also use Medtronic Connect, an award-winning web resource, to meet their educational needs online. The site displays personalized content to 29,000 physicians and nurses and 6,000 Medtronic employees from 135 countries based on their specialty, areas of interest, geography, and language.

Product Donations

In fiscal year 2010, Medtronic increased product donations by 165 percent from $6.7 million in fiscal year 2009 to $18 million.The Medtronic Foundation played an instrumental role accelerating donations by connecting our businesses with nonprofits looking for products to fulfill unmet needs in communities around the world. For example, Medtronic donated pacemakers for patients in South America suffering from Chagas disease and nearly $900,000 worth of Medtronic CardioVascular and Spine devices for victims of the earthquake in Haiti.