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Undergoing any medical procedure – especially one involving surgery or implantation of a medical device – can be a worrisome and stressful experience for patients. That is why it is so important for patients to have a frank and honest discussion with their physicians before deciding on any medical intervention.

Medical technology manufacturers and FDA share a common goal: To ensure patients have timely, access safe and effective medical devices and diagnostics. To achieve that shared goal, manufacturers and FDA must have clear, well-understood regulatory requirements and open lines of communication.

The U.S. Food and Drug Administration (FDA) is one of the country’s most critical health agencies. With jurisdiction over everything from foods, dietary supplements and bottled water, to prescription drugs, cosmetics and tobacco (not to mention medical devices and diagnostics), FDA is responsible for products that impact every American on a daily basis.  

But while these products are vastly different from one another, as Dr. Susan Alpert stresses, FDA’s mission remains the same:  To protect and promote the public health.

Dr. Susan Alpert, MD, is one of the nation’s foremost experts on medical technology regulation. As a physician, former director of FDA’s Office of Device Evaluation, and former industry executive, Susan understands the medtech innovation ecosystem from all angles. Her unique perspective and decades of experience make her the ideal person to explain the complexities of medical technology development and regulation and the need to ensure that any requirements promote both patient safety and innovation.

When Ed Covert stopped by the nurse’s station at work, he was hoping to get some extra-strength cold medication or a decongestant. Little did Ed know, his cold-like symptoms pointed to a much scarier reality: Ed had already suffered two massive heart attacks, and he was heading for a third.