Imagine a woman with spine problems who needs an artificial-disk implant. The implant happens to be made by a company within a short drive of her home. So it’s readily available to her, right? 

Wrong.

In fact because this particular device is unavailable to anyone in the United States, the woman has to travel from her home near the manufacturer to Europe in order to have access to this life-saving technology. And scenarios such as this one are actually happening more than many people realize.

It’s true that medical technology in the United States enables people today to live longer, healthier, more productive and independent lives. In fact, medtech has helped lower mortality rates for heart attacks by 50% over the last two decades, by 30% for strokes, and by 20% for breast cancer. And increased understanding of human biology has the potential to produce even greater gains.

Yet, America’s medical manufacturing success story now faces challenges like never before. A slower and less predictable regulatory approval process, outdated reimbursement formulas, and a misguided tax policy are stifling the industry’s next wave of innovation. If we don’t address these challenges with a comprehensive policy agenda, the US will step down or off the podium of worldwide leaders.  

Right now nearly half of the healthcare technology purchased around the world comes from the United States. Domestically, the industry is directly responsible for more than 400,000 jobs and two million overall. Further, these jobs have average salaries of more than $58,000 a year, about 40% higher than average wages. These jobs are in cities such as Boston, Minneapolis-St. Paul and Los Angeles, as well as smaller towns such as Kalamazoo, MI and Spencer, IN.

However, recent research illustrates the danger of our eroding leadership, just as countries like China, India, and Brazil are gearing up to develop home grown medtech industries or lure foreign investment. A PricewaterhouseCoopers (PwC) study ranked the US system seventh out of nine in the efficiency and predictability of the FDA regulatory process. Another study from the Boston Consulting Group showed that European patients have access to medical technologies for months or even years before American patients, with no discernible difference in patient safety. Not only does the American economy suffer, American patients do, too.

What will be the effects if these trends continue? Medical technology companies will put their research and development, clinical trials and manufacturing investments in Europe, where their products come to market first. Then companies will likely turn their attention to commercializing their products in emerging markets like China, India, and Brazil. Only then will they decide to take the risks inherent in the US system. Patients will wait longer and jobs will move elsewhere.

Only a comprehensive policy prescription can change this future and solve America’s innovation crisis, which is why AdvaMed and its members propose the following six-point “competitiveness agenda:”

• The Administration and Congress must make innovation in the life sciences a national priority, so good policy throughout the government can sustain a true innovation ecosystem. To help spearhead that effort, an Office of Medical Innovation Policy should reside in the White House.
• The FDA review process must be reformed, to reduce total review times and make the approval process as smooth as our European counterparts.
• A vigorous trade policy must support export growth and provide a level playing field for US-based manufacturing.
• We must implement strategic tax policies that lower the corporate tax rate and strengthen the R&D tax credit. A tax system that penalizes jobs made in America is something we can no longer afford in this globalized world.
• Payment policies of Medicare, Medicaid, and private insurers must support medical innovation and not penalize early adopters of new treatments and cures. 
• The American research and development infrastructure must be sustained and improved—from NIH to NSF to our nation’s great public and private research universities. We should place special emphasis on creating research structures that support R&D with an aim toward getting discoveries into the marketplace.

The right public policies can help the US maintain its innovation leadership. If we take the right steps, physicians, inventors, and companies can help bring about the next generation of life-changing, life-saving medical technology. If we take those steps, we’ll also fuel economic growth and create more good-paying jobs in communities across the country. And that’s healthy for everyone.