After the Smoke Clears: Analyzing the 2008 Elections and Their Impact on Medical Innovation: Charlie Cook, publisher of the Cook Political Report, says that the priorities for healthcare are different than a year ago. “Healthcare is a huge part of the economy. We need changes, but how do we do that in the midst of a recession?” One thing that he says is important to remember is that the Democrats’ gains were not so big that the Republicans can be ignored. Any healthcare plan will need a broad base of support and a solution that is far beyond the base of the party, notes Cook. Chris Jennings, president of Jennings Policy Strategies, adds, “You can’t deal with the issues in this country without dealing with healthcare. He says that polls show that healthcare is a leading issue for Americans—above gas costs and job loss. He says that cost will be the driver in healthcare reform: cost to families, cost to business, cost to government (i.e, CMS), and cost to the nation. And the biggest drivers of these costs, he says, are chronic illnesses that should be managed better. There will be major reform, he says. His advice to stakeholders: Focus on strategy to ensure that you are well represented. Tim Ring, CEO of C. R. Bard, noted that for device makers, the view depends on who takes the reins at FDA. Most device manufacturers, he says, believe that enforcement will increase. He also notes that the pay-for-performance model will present new opportunities. Going forward, he says, it will be imperative for device makers to demonstrate an economic benefit to new technology. It is imperative to have data that show that a device will save money.
Forecasting the 111th Congress: Will Healthcare Innovation and Access Be Capitol Hill Priorities? The answer is a resounding, “yes,” says Ron Wyden (D—OR). The real issue, he says, is how much, how soon, and how many pieces of legislation. “We cannot get the economy back on track unless we fix healthcare,” he says. There are three reasons to be optimistic that something will be done. One is that there is proposed legislation that is cosponsored and bipartisan. Second, Congress’s budget office has analyzed the proposal and has determined that it would be “budget neutral” in two years and then would drive costs downward in the third year. Finally, he says, there seems to be an ideological truce on the issue of healthcare. How will it play out? Wyden says that change will start with expanded coverage for children. He also says, there will be a “down payment” on broad healthcare reform. After that, he says, the debate will be about whether change should be incremental (e.g., electronic health records), or bold, which he advocates. A bold plan, he says, changes the incentives that drive behavior. Wyden foresees a system that covers everybody, but isn’t one-size-fits-all. Everyone, though, will have a “floor” from which they can buy more if they want. This approach would change the health insurance model, and it would mean that every family could have basic care.
The Innovation Opportunity: Innovation will drive growth, but reimbursement could limit potential. That was the prediction of Karen Licitra, company group chairman for Ethicon Endo-Surgery. The focus of the conference was on the urological/gynecological market, and so she discussed the dynamics of this market and the future for technology. Innovations will include the increased use of robotics for laparoscopy and the increased use of lasers for treatments. In particular, she says, ablation procedures will be a driving force in improving treatment of uterine disease. Pelvic organ prolapse, for example, is an underpenetrated market with much potential. For technology, we will see a shift from inpatient to outpatient treatments, she says. The future will require manufacturers to develop devices that enable less-invasive procedures. Such advances will be driven by nanotechnology and imaging. She says devices will be held to higher standards than ever. But, she says, the trends are here. Consumers and changing lifestyles are driving the need for more cost-effective solutions. She points to developments such as NOTES (natural orifice transluminal endoscopic surgery) as the next evolution in minimally invasive surgery. Robotics, she says, will be a market-driven demand that will allow physicians more control. From an industry perspective, she says, new technologies must prove that they are superior to existing treatment in terms of efficiency and cost. Funding and reimbursement must be addressed. “The market opportunity is there for the taking,” she says. Products for office-based settings and procedures developed to treat the aging population are among those that she says will enable device makers to capitalize on this new market and changing paradigm. “To be a leader in this market, innovation must be addressed from the patient perspective. We are moving in the right direction.”
Top 10 Medical Innovations: Cleveland Clinic physicians presented their selections for the 10 new technologies that will affect clinical practice in the future.
1. Use of circulating tumor cell technology. This will be used to measure circulating tumor cells as a predictor of success of chemotherapy. The technology allows patients to monitor their progress at any point along their treatment course and guide the doctor in adjusting therapy as needed.
2. Warm organ perfusion device. This device preserves organs for transplantation. The doctors called this a “game-changing” innovation because it can keep a heart beating form as long as 12 hours in the device, greatly expanding the current four-hour transplant window.
3. Diaphragm pacing system. Use of this phrenic nerve stimulator enables paralyzed patients to breathe without the assistance of a mechanical ventilator. When electrodes are stimulated by current, the diaphragm contracts and air is sucked into the lungs. When not stimulated, the diaphragm relaxes and air moves out of the lungs.
4. Multispectral imaging systems. Improvements in multispectral image analysis enable assessment of multiple protein pathway configurations in a single sample or cell. Researchers can stain up to four proteins using different colors and look at tissue samples with 10–30 different wavelengths, allowing for accumulation of more information than is currently available.
5. Percutaneous mitral valve regurgitation repair. With an innovative clip, the heart is fixed nonsurgically from the inside out. A catheter is guided through the femoral vein in the groin, up to the heart’s mitral valves. The device could change the way doctor’s approach patients with mitral valve regurgitation.
6. New strategies for creating vaccines for avian flu. Use of new strategies, including genetically engineered virus-like particles will be the basis of new vaccines.
7. LESS and NOTES applications. Laparoendoscopic single-site surgery (LESS) and natural orifice transluminal endoscopic surgery) are touted as procedures that mean less pain and minimal scarring.
8. Integration of diffusion tensor imaging (tractography). Integration of tractography with surgical navigation of the brain can minimize damage to fiber tracts during brain surgery. Doctors can look at the specific pathway that connects brain regions responsible for understanding speech with the brain region responsible for producing speech. Knowing the exact position of this pathway would allow a surgeon to avoid injuring it during surgery.
9. Doppler-guided uterine artery occlusion. This procedure offers an alternative to hysterectomy, surgical removal of uterine fibroids, and uterine fibroid embolization. The simple mechanical compression is temporary. During a time the clamp is in place, the fibroids are starved of oxygen and nutrients and start to die. After six hours, the clamp is removed, restoring blood flow to the uterus.
10. Private sector national health information exchange. Use of a common standard among participants would enable access through the Internet, regardless of provider source. Such a system would put the consumer in control of what information is gathered and stored in a central repository and would put them in control of who they choose to share it with.
Medical Innovation in a Time of Economic Stress: Be Ready for a New, More Selective Era for Investment
Reflections on the Direction of Healthcare Innovation During the Next Four Years: 2009 will be the biggest year any of us has ever seen in the transfer of healthcare, says former HHS secretary Tommy Thompson. He notes that healthcare spending is currently 16% of the GDP. Currently at $2.4 trillion, he says it will rise to $4.6 trillion very soon. “This rate cannot be sustained. Unless we hold down costs, we can no longer compete internationally,” Thompson says. Thompson suggests that it is time for Congress to mandate coverage for all children. He says Congress will certainly mandate some type of coverage in the coming year. “I believe that 2009 will be the year that we completely transform the healthcare system as we know it.”