Formal technology assessment is here to stay - medical technology

Early this year, I took part in an unusual conclave at one of the largest medical centers in the nation. It was the monthly gathering of the first formal technology assessment committee in the long history of this prestigious institution. The medical center is a part of a small but growing cadre of institutions across the country that are committing resources to the development of formalized, standardized and practical criteria and methods for assessing new technologies.

The important thing for medical products suppliers to recognize is that formal technology assessment committees are not one of healthcare's fleeting fads that will disappear. Rather, they are the early adopters of techniques that all providers will soon use to evaluate and select tomorrow's devices and drugs. And the success or failure of your products will depend on the decisions that they make.

The committee at the medical center is a high-level, decision-making group whose permanent members include vice presidents of administration and operations; the general counsel; directors of medicine, surgery and reimbursement; and professors of clinical investigation, nursing and public health.

They are very dedicated, very serious and very cognizant of the critical need for more effective delivery of the health services at much lower cost, because they believe that the survival of the U.S. healthcare system as we know it today is at stake.

Why is a new, systematized approach to technology assessment a significant tool for health professionals? Stanley Reiser, M.D., Ph.D., editor of the International Journal of Technology Assessment in Health Care, summed it up when he said:

"Pressure and challenges make essential a systematic method to sort out and weigh the many factors that influence the choice, adoption and use of healthcare technology. These challenges cannot be addressed by only the safety and efficacy standards of the FDA. Such standards do not address the multiple influences on providers that greatly affect the adoption and use--or rejection and decline--of a given technology. While safety and efficacy are important, suppliers often do not appreciate the many other pressures on providers from patients, the law, reimbursement agencies, ethical conflicts, peer-review systems, competition and the search for status among providers--all of which determine the success or failure of a technology in being adopted. Accordingly, suppliers and developers of technologies face difficulties if they can't speak the language of assessment and provide answers to assessment questions."

I thought I could speak the language of assessment and provide answers to assessment questions, especially with more than 20 years involvement (both as a supplier and consultant) in the evaluation of technologies relative to new product development. However, a couple of hours with the committee revealed that health providers will now be asking different and more penetrating questions. We'd better have the right answers.

Historically, new medical product development has been devoted to meeting the customers' demands for technical performance, safety and efficacy. The need for more substantive proof of usefulness in these areas will be stronger than ever but a whole new set of parameters has been added. Some of the key considerations are:

* Cost benefit/cost effectiveness

Analysis of the intended benefits and effects, the unintended consequences, the alternative technologies that could produce the same result, and the net cost of achieving a desired net health effect.

* Legal implications

Risk of perceived or real exposure to liability and litigation, based on product claims, performance, safety, use and ultimate effect.

* Ethical/social implications

Ability to provide the most benefits to the largest number of people in an equitable fashion, while at the same time respecting the choices, preferences and values of patients and professionals.

* Operational impact

Improving current methods of productivity; replacing people or other products; requiring minimal support and compatibility with other services.

* Strategic issues

Meeting the needs of the providers' communities and potential markets; enhancing patient referrals and medical staff affiliation; conforming to resource availability; and projecting desirable image.

To deal with the tougher questions and requirements you'll face in the future, it's vital to know what the new environment is all about and where you can get help. Here are three valuable sources of information and contracts.

First, order a copy of the Medical Technology Assessment Directory from the National Academy Press in Washington, D.C., at (202) 334-3313. It has hundreds of organizations, programs publications and data bases that you can access. At $250 a copy, it's only for those who are serious.

Second, find an independent, unbiased organization that has the technical capability to help you test and evaluate new technologies relative to safety and performance. A good choice would be CITECH, an affiliate of ECRI, both in Plymouth Meeting, Pa. CAll them at (215) 825-6700.

Third, join the organization I belong to, the Interntional Society of Technology Assessment in Health Care. It's composed of over 500 academic, clinical, governmental, industry and research professionals from all over the world who have a common interest: advancing the science of the medical technology assessment. Call me for details at (708) 459-9189.

In the '90s and beyond, technology assessment is product planning insurance because tomorrow's healthcare markets will not buy, nor will insurers reimburse, products that are called "new" because of gimmicks or marginal changes.

Technology assessment is not an expense, but rather an investment in more viable products.

Ted R. Tyson is president of Tyson Consulting Group, Buffalo Grove, Ill., a market and product development consulting firm (708) 459-9189.

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