NEWS TRENDS

According to the American Heart Association, coronary heart disease claimed more than 450,000 lives in 2004. Additionally, the American Lung Association reports that the expected five-year survival rate of people diagnosed with lung cancer is 15.5%. These illnesses are not diagnosed early enough to be treated properly, and there are not yet good ways of screening patients to identify potential problems.

This is where the diagnostics industry can help—if it can adapt properly. That may mean changing device development practices, said an industry expert.

“One way to approach development now is to look at specific disease groups,” said Peter Kingma, vice president and division manager of molecular imaging at Siemens Medical Solutions USA Inc. (Malvern, PA).

Today's healthcare industry focuses on treating illnesses. But that is no longer enough. As a result, the healthcare paradigm is beginning to change, according to Kingma. He spoke at a Frost & Sullivan conference in San Francisco in March.

“Where we ultimately want to be is on the preventive side of healthcare, not the corrective side,” Kingma said.

He credits advances in knowledge-driven information technology (IT), such as healthcare management systems, as leading this trend. “Such systems can improve and increase transparencies in hospitals,” Kingma said. Moreover, the forces behind these advances have the power to change when and how healthcare is delivered, he stated.

But what are the implications of these changes for device companies? It is essential for companies to understand the market they're designing products for, Kingma said. If a company sees an opportunity and understands that it may have to change to keep up with the market, it will have a better chance of being successful.

He pointed to Siemens as an example. The company has made several acquisitions to address this trend. The molecular imaging division, he said, represents the company's first foray into combining molecular imaging with in vitro studies. In addition, Siemens's IVD labs are beginning to model immunodiagnostics and genetics.

However, Kingma stressed, it's not just large companies that will have to change. The lessons that Siemens has learned can be applied across the industry. Product development is one area in which every company can make changes, he said. “Many companies try, and fail, to make what I call the perfect product. They design a product and then look for someone who needs it,” he explained.

In fact, what companies need to do is establish a formal innovation cycle. An idea for a product must be stimulated by a clear clinical need. Once the idea is formulated, it should be formally presented to management. If the idea is accepted, it can then go through a customer group review process. “The customers in these groups should include current customers as well as users of competitors' products,” Kingma added.

After receiving feedback from customer groups, a product concept can be implemented and product development can proceed. However, he cautioned, it's critical to have physical collaboration with potential customers throughout the process to continue the feedback loop.

He noted that it can be difficult to find good collaborators. “They must exhibit technical and clinical competence, obviously,” Kingma said. “But they must also be flexible and tolerant of downtime” as changes and problems arise in the development process.

For example, he said, he believes molecular medicine will get the healthcare industry to a point where it can provide diagnostic information on the potential for Alzheimer's disease. Positron emission tomography (PET) and magnetic resonance imaging (MRI) hybrids have already been developed. These hybrids can produce simultaneous imaging of localized foci, without anatomical error.

If biomarkers are developed that can measure specific metabolic activity, a PET-MRI hybrid could use the biomarkers to support a definitive test for Alzheimer's. And, added Kingma, if the onset of Alzheimer's in every patient could be delayed for five years, the United States could reportedly save $50 billion per year, according to statistics from the Alliance for Aging Research.

The long-term goal, Kingma said, is to achieve true patient-centered biodesign. He envisions that eventually healthcare providers will have products that can customize biomarkers based on data gathered from the patient in the room. These products would lead the way to personalized and specific tests and, eventually, personalized treatment. For example, he said, imagine developing biospecific biomarkers that are attracted to only one cell type. When administered, they would deliver treatment only to those cells. “It's product design at the highest level,” he said.

This vision will not be easy to achieve. Large and small companies alike face challenges, he predicted.

Small companies that have niche techniques and niche expertise may struggle to be heard. However, large companies have large weaknesses, Kingma said. They will need to focus on becoming well-rounded, and this will present an opportunity for small companies to find a forum for their specialties.

Also, talk about preventive products and therapies often brings up concerns about whether healthcare providers would use the results to exclude patients. Kingma predicted a potential for abuses in that area, noting that a political resolution will have to be reached.

However, he added, achieving patient-centered biodesign is “more than just a commercial opportunity. [The ability to treat widespread diseases] touches all of us in some way.”

If the industry and its consumers feel strongly that this is the future of medicine and make their voices heard, it will make a difference, he said. “If as a legacy to our children we leave management of wellness rather than management of disease, we will have come far.”

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