Confronting Medical Device Challenges: How to Maximize Your Firm's Probability of Success

Published: August 5, 2011
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Confronting Medical Device Challenges: How to Maximize Your Firm's Probability of Success

By: Robert G. Launsby

A number of innovative new medical products have been recently developed that have a dramatic impact on our quality of life. One example is a nebulizer that utilizes vibrating mesh technology. A nebulizer is a medical product that has been used as a way of transforming respiratory medication from liquid form into vapor form so that it can be breathed in through the lungs. The Vibrating Mesh Technology creates a nebulizer that is highly portable and can actually fit inside the patient’s pocket. Those that are suffering from health conditions like asthma and COPD find great comfort in such a device to help them relieve their symptoms and live a more normal life. 

Another example of advances in medical products involves hip replacement technology. My neighbor Doug recently had hip replacement surgery as an outpatient! He was doing great in a matter of weeks. An even more recent innovative medical product was developed by a company called Accuray. Accuray has a device that can annihilate cancerous cells without surgery. It is particularly helpful in cases of brain, prostrate and lung cancer. Another company, Ablation Frontiers (recently acquired by Medtronic), is marketing a device in Europe (attempting to get FDA approval in USA) for people with a heart condition called atrial fibrillation. Those fortunate to benefit from these procedures can now go back to living more normal lives. 

Developing these innovative medical devices also includes risks. When there are problems in the field, it can lead to catastrophy. One recent example involves infusion pumps used in the medical device industry. These devices can deliver up to three different medications to a patient intravenously. Unfortunately, a number of companies have experienced problems with these devices in the last decade. One of the most infamous cases involves an infusion pump marketed by Baxter. In 2010, the FDA asked Baxter to pull all of their units of a particular model from the market place. FDA required Baxter to destroy many thousands of units due to the risk of having them in the field. According to a FDA News Release on May 3, 2010, over 500 deaths have been attributed to malfunctions in this device. Several problems were identified. One involved an interaction between the batteries and the controlling software. It seems that if the batteries died the software allowed for a “free flow” of medications to the patient. In August of 2010 Johnson and Johnson issued a global recall of two hip aid systems after more people than expected suffered pain which required additional surgery. According to Johnson and Johnson, 1 in 8 patients who received the ASR total hip replacement needed a second surgery to fix issues.
 
How can a medical device company enhance their probability of success in the market place and minimize these risks? What can management do to assure products being produced are timely, low-cost, reliable, FDA compliant, customer delighting, and hit their market window? In order to assure business success, medical device companies have some special challenges. Keys ones are as follows:
 
  1. Organizational segmentation
  2. Massive sourcing from low cost suppliers
  3. Organizational dysfunction
  4. Understanding of true customer needs
  5. Plan for success

 —Robert G. Launsby


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