What’s New? Looking for Innovation in Medical Device Industry

question-marksWe recently completed the yearly pilgrimage to AORN EXPO held in Denver. The weather was fantastic, the venue perfect thanks to AORN planning and the participants were engaged. The meeting had all the elements for success except that I didn’t see much innovation as I traversed the aisles of exhibits.

Where were all of the new product ideas, new knowledge, and new directions? Certainly, the Exhibit Hall, long the font of newness in years past, offered little except for teddy bears and other giveaways. Aside from vendors hawking their new data retrieval and analysis software, clinical advances that directly affected the perioperative teams or their patients were hard to find.

This paucity of new products reflected the suppression of innovation in American medicine, primarily through government policies that have delayed the rewards from investment in the medical device industry. Yes, dollars still flow to Silicon Valley information technology start-ups but what about device start-ups that focus on improving patient care in the operating room and their subsequent outcomes? All we see is continued emphasis on data and what to do with it!

As I walked about the Hall, I was looking for disruptive ideas that flowed like water in the 70’s-90’s and allowed the medical device industry to grow. Please permit my personal reverie but at my surgical meetings, I heard about coronary artery bypass from Dr. Rene Favarolo and new orthopedic instrumentation that allowed advances in spine surgery. Lasers provided reversal of death sentences by being used for tumor vaporization while laparoscopic instruments and methods allowed for gallbladder removal and repair of hernias. MIS was born and patients, health and insurance systems were mightily benefitted. Clinical care was improving through the development of new surgical devices, methods and companies like Ethicon, U.S. Surgical, Sharplan and Olympus were created and prospered.

How much of that did you see at this year’s meeting? At Nascent Surgical, tucked into our 10’ x 10’ booth, we tried to make our contribution by introducing a prototype outer surgical drape that incorporated our proprietary smoke capture technology. It garnered both interest and some degree of excitement but its clinical availability must await significant testing. Although our miniSquair product is currently available, its wider acceptance is still captive to initial surgeon resistance to change which is a problem common to the industry. We believe that dissemination of new data that supports prioritization of smoke evacuation is the essential step to gaining their approval. Unfortunately, when doctors ask for the data related to the effect(s) of surgical plume on perioperative personnel or patients, we come up short because no such data exist, at least I have been unable to find any. However, I have been able to find lots of data related to the systemic illnesses resulting from chronic inhalation to nanoparticles in smoke but these studies are in the environmental and occupational health journals but none in the surgical/clinical journals. Amazing!

Education is the key to answer, “What advantage does smoke capture have for the surgeon?” Our research, which will appear in a future issue of AORN Journal tries to answer that question by pointing out the potential of effective, documented smoke capture on clinical bacterial issues. A previous article (AORN J., February, 2014) pointed out the relationship between chronic smoke inhalation and serious systemic illnesses. NIOSH and OSHA have already told us of the potential carcinogenic and mutagenic properties of gases within surgical plume and have provided guidelines for its removal.

Nonetheless, it is the dissemination of yet more cogent reasons for smoke removal that is needed to gain surgeons support and more aggressive advocacy that will create the needed hospital-wide smoke evacuation policies. Nascent Surgical is asking the questions and seeking the answers that will make such advocacy more effective. I ask that you help us help you through your suggestions for further action.

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