29 Jul Clinical Product Trial- a Vendor’s Perspective

I’ve recently been involved in a number of clinical trials of our “miniSquair® surgical smoke and bioaerosol capture device. It is a component of a smoke evacuation “system” which consists of the smoke capture device (the ESU “pencil” or the miniSquair®), a length of flexible tubing, an ULPA filter and a smoke evacuator (“LEV” or “local exhaust ventilator”). Our company only sells the capture device which connects with an ULPA filter via a 1 ½” corrugated tube.

Although I recognize that a clinical trial is a necessary step toward product acceptance, I have started to question the real purpose of the “trial” which requires on-site training and free product samples which can be a significant up-front investment.

After one to two weeks of training, usually with a predominantly positive response from clinicians, I get a pat on the head and am told to expect a purchase order after another committee meeting. Hallelujah! After one to two months, a minimal purchase order comes and then I request to spend additional time with staff to increase use and confidence with our product…but the requested invitation to return doesn’t come. Huh? Everything went well so why not keep the momentum going?

Any of a number of reasons come to mind:

1. Your visit was only to allow management to be thorough.
2. Future orders will be limited because your product was to allow compliance from a few recalcitrant physicians who have refused to use the ESU “pencil.”

Our response:  “But our product has been documented to have a much higher smoke capture efficiency that can best remove nanoparticles which will protect your operative teams from the ill health effects of chronic inhalation of the nanoparticles in the smoke. Our product has been documented to capture almost all airborne and most droplet transmitted bioaerosols that are responsible for wound contamination and post-operative infection.”

Silence!

Alternatively, no purchase order arrives, nor does an e-mail explaining why the product was rejected for use despite favorable clinical reviews. This part hurts! The trial was just for show so the hospital could check the box labeled, “We looked at all alternatives” but without a serious consideration given to purchase. Why? Because they already knew that they needed to work with a major distributor with whom they had extensive contracts but needed to show their clinicians what the market offered. I rarely see this with small to medium-sized hospitals but do with large multihospital health systems. And you want to know why start-up and development stage medical device companies find it increasingly difficult to prosper? Look to the health system-major distributor contractual relationships for the answer.

Nevertheless, if you need a superior alternative product to the ESU “pencil” because physicians refuse to use it despite your mandated smoke evacuation policy, give us a call and we will be happy to help you increase your compliance statistics and work to establish a smoke-free operating room. We can be reached at 952-345-1112 or contact me directly at lschultz@nascentsurgical.com

Leonard Schultz, M.D.

Chief Manager

Nascent Surgical, LLC