In Medtech, Too Much Data Isn’t a Good Thing

A fundamental lesson one learns in business management programs is that perfect knowledge is unattainable and that almost always, the cost of obtaining knowledge to make decisions starts to become too high once one reaches the 70% level. These lessons need to be remembered as the medical device or indeed any industry interacts with regulatory organizations.

That perfect knowledge cannot be obtained is substantiated by the fact that every advance in knowledge raises new possibilities and therefore new questions. The costs of answering these questions becomes prohibitive and can hinder decision-making.

Research scientists and physicians should be the ones making decisions about the safety and efficacy of medical devices. Scientists are trained to obtain as much knowledge and as much experimental data as possible and generally do not have to assess costs and timeliness of decision making as key concerns. Business leaders, however, are often required to make decisions within a rather short time frame so as to take advantage of opportunities. This shortness can be caused by many factors. Most often it arises from the need to manage efficiently capital and investments Sometimes it is necessary because of the threat of competitive technologies. Occasionally it is dictated by the vagaries in the prices of raw materials or by such factors as expiring tax credit allowances. For most medical businesses, the earlier the decision making, the greater amount of time a company can take advantage of its patents and other intellectual property before these become part of the public domain.

Regulatory agencies by nature are cautious. Very often, its safe and uncontroversial response is “Please provide more data.” From the perspective of these agencies, concerns and implications that have been overlooked by businesses filing petitions for device registration must be evaluated as to potential benefit and harm. This further research however can result in increased costs and longer delays in marketing.

But regulatory agencies can and should work to be more efficient. For example, pathogen-killing chemicals and devices often have to go through three different groups within the EPA. Regulatory agencies, despite the best of intentions, occasionally make counterproductive decisions and issue poorly thought out policies. Such missteps often have to be taken up with the White House Office of Management and Budget, which, with its subsidiary agencies the Office of Information and Regulatory Affairs and Office of Science and Technology Policy, maintains oversight over cabinet agency decisions.

Instead of having the medical device or other concerned industries be adversaries of regulatory agencies, they should act as partners as much as possible in making sure that devices are safe and effective. Agencies must also realize that decisions on a petition must be made within a reasonable time period, perhaps within three to six months, unless by mutual agreement specific concerns warrant more study.

Agencies have a legitimate concern that they don’t have the necessary personnel required to handle the many registration requests that come their way. However, measures such as user fees have been levied to speed the process. Regulatory agencies, as well as businesses, must accept the limitations of knowledge acquisition, and be prepared to cooperate under such constraints. Delays in the introduction of useful innovative products could also have harmful consequences.

Jeffrey R. Ellis, Ph.D., MBA has more than 30 years of experience in the design and manufacturing of medical devices and has written many technical articles. His previous research in medical devices includes developing materials for IV-fluid administration systems and evaluating compatibility of materials with medical formulations and sterilization procedures. His most recent work in medical device research is in evaluating the need for antimicrobial technologies to prevent hospital acquired infections. He has recently been very active in evaluating regulatory impositions and policies and determining whether such impositions are justified and helping clients develop strategies for getting such impositions rescinded.