Health care is getting miniaturized, highly personalized and is full of uncertainty over who will pay for its ever-increasing costs, experts said at the Plastics in Medical Devices 2011 conference.
The event, held April 11-13 in Huron, brought together more than 200 plastics raw materials suppliers, machinery vendors, molders, toolmakers and others involved in the exploding global medical-device manufacturing industry.
Wynn Bailey, a Chicago-based principal in PricewaterhouseCoopers LLP's pharmaceutical and life-sciences industry group, warned in an April 12 keynote address that the United States risks falling behind as a leader in device research, development, and production as its competitors — especially China, Brazil and India — grow in sophistication.
“The center of gravity in medical-technology innovation remains the United States, but the U.S. is losing ground to other markets, and the U.S. leadership position in medical-device innovation is not guaranteed,” he said.
In addition to foreign competition, U.S. medical-device manufacturers face increased scrutiny from federal regulatory agencies — not to mention the possibility of increased lawsuits over defective devices — as the trend toward home-based health care grows, several presenters agreed.
“When the physicians and nurses are taken out of the equation, and [untrained caregivers are] brought into the equation, this raises a whole other dimension of liability,” Stephen Wilcox, founder of Design Science Consulting Inc. in Philadelphia, said during an April 12 panel discussion.
According to Tom Bonnell, director of industrial and engineering design at Phillips Home Healthcare Solutions, the world is getting older and sicker; by 2050, half of the developed world's population will suffer from at least one chronic illness.
At the same time, most of the population growth that is expected to reach 9 billion by 2050 will occur in developing markets such as China and India, which will be home to a third of the world's patients, Bonnell said.
Matt Beale, president of product-development firm Daedalus Inc. in Pittsburgh, cited the increase in home dialysis as a dramatic example of the demands facing medical systems: This year, 4,200 dialysis clinics are serving 370,000 patients in the U.S. Worldwide, there are about 1.8 million people requiring dialysis; that number is expected to shoot to 5 million by 2040.
Sheer numbers will drive growth in home-dialysis machines and components, he said. “What's exciting about this, besides the cost control, is that the outcomes are anticipated to be significantly better — actually resulting in double the life expectancy due to continuous home dialysis.”
A recurring theme at the conference was that the old-school, one-size-fits-all approach to medical care is rapid vanishing, replaced by a personalized system of medicine that values innovations such as implantable devices and those that can be absorbed over time by the body, as well as home dosing and monitoring devices.
“Real innovation — if it's going to drive economic benefits, if it's going to help companies grow their business — it's got to be pointed at a specific solution that creates value that wasn't there before,” Bailey said.
Ankit Gupta, a manufacturing engineer at Boston Scientific Corp. of Natick, Mass., agreed, as he described how the current medical-device engineering model places new product development at the forefront of research. He spoke of a “sustaining engineer” model, in which the goal for companies is to improve products over a series of years — in terms of patient safety, product quality, regulatory compliance, and business value — rather than looking to shed older product lines, from which value could still be extracted.
“If a product line is strategically and economically not viable to keep in the market, what do you do?” he asked. “If you're selling 1,500 … drainage catheters and you pretty much have one competitor, would you want to let that competitor take over that market, or would you want to invest a little more, make your product better, deliver a better product line and take on the challenges that you get?”
Hanging over the entire conference was the issue of cost — how costs are driving changes in health care, as well as how they affect medical manufacturing.
According to Bailey, the U.S. continues to lead the world in health-related government spending — 19.3 percent of the gross domestic product as of 2006, the last year for which World Health Organization data was available.
“The last time the U.S. spent 20 percent of its GDP on anything was 1944. So that begins to put in some context that what we're spending on health care today is approaching what we spent on the war effort during World War II. [That is] an unsustainable equation,” he said.
According to PwC's survey of the nine medical markets, the U.S. has fallen to second place behind Israel in ease of reimbursement for medical costs, with the United Kingdom coming in third.
The uncertainty over reimbursements amid the ongoing debate over health-care reform in the U.S. is driving cost shifting — away from expensive, invasive surgical procedures and from doctor-administered dosing and monitoring to patient-driven systems, the experts said.
Medical-device product failures due to design error — such as the highly publicized FDA watchdog effort on external infusion pumps — cost the U.S. health-care system $29 billion annually, David Fink, vice president of product development at Ximedica LLC in Providence, R.I., said in an April 13 presentation.
Manufacturers need to bring in “human factors” to produce designs that are user-friendly and as fail-safe possible, he said.
Several speakers blamed the complexity of the Food and Drug Administration approvals process — which they almost universally expect to get tougher — for driving some U.S. manufacturers to debut devices in Europe and elsewhere.
Bailey cited the case of OrthoAccel Technologies Inc., which developed an orthodontic device designed to accelerate tooth realignment only to have its U.S. debut slowed by FDA compliance procedures. The company went ahead and marketed the device in the U.K., Hungary, and Australia, where regulatory environments are friendlier, he said.
According to marketplace watchers, one nontraditional area of opportunity for medical-device makers will be in remote monitoring and mobile devices that enable patients to communicate with doctors via email; doctors to access medical records securely in cyberspace; nurses to remind patients to take their medicines; and for companies across the medical spectrum to communicate through social media.
Bailey pointed out that there are 10,000 apps for Apple's iPhone related to medical matters.