Biomedical Business &Technology Contributing Writer
NEW ORLEANS — Eerily absent since the last time the American College of Surgeons (ACS; Chicago) met here, just prior to the devastation of Hurricane Katrina, was the cacophony of New Orleans street sounds — curbside jazz musicians, traffic horns and the around-the-clock hustle of crowds.
In sharp contrast to this new and unfamiliar quiet of the New Orleans streets, the Ernest N. Morial conference hall was abuzz at the ACS 93rd annual Clinical Congress in October, surgeons discussing and sharing data concerning new techniques, vendors discussing the benefits of their products, the sounds of innovation in the air.
And amidst this buzz was the considerable babble, again of surgeons presenting their products and their product ideas, for improved patient care, for the first time.
Traditionally, manufacturers seek surgeons' "wants and needs" and then bring in a team of engineers and develop products that meet these surgical requirements and must-haves. Even most start-up companies have been launched by an idea or concept developed by engineers rather than clinicians.
But the 93rd annual ACS clinical congress featured a bumper crop of this oncoming entrepreneur/surgeon breed. Following a pattern perhaps best seen in Israel — which features a much higher than average physician-to-patient ratio and an aggressively entrepreneurial physician culture — many more physicians in the U.S. and around the world are developing products and establishing companies on their own, based on what they see as unmet patient needs.
This was so clearly a new trend — and in medicine perhaps a "microtrend" pushing to become a "macrotrend" — that an entire afternoon symposium was dedicated to the surgeon as an entrepreneur, titled "From Napkin Scribbles to Improvements in Patient Care," moderated by Thomas Fogarty, MD (Portola Valley, California), and Thomas Krummel, MD (Stanford, California) — both "poster physicians" for this new entrepreneurial species, having spawned more than 35 new companies.
No longer napkin-bound
Although there has always been a handful of physicians who have launched and grown device companies, the typical surgeon, for the most part, has left the business of new product development to established manufacturers. "Part of the reason for innovation coming from the surgeons and immediately making its way through corporations was because surgeons were so busy taking care of patients that they became famous for having great ideas still left on napkins," was Krummel's explanation.
Among the distinguished panel members was John Adler, MD, Stanford University (Stanford, California), founder and board member for Accuray (Sunnyvale) whose presentation "Show me the Money: Financial Essentials for a Start-Up" ignited a discussion on the various ways to finance a start-up.
After elucidating several development and financial pathways, Adler said that "when all other options have been used or exhausted, you will need to go to venture capital" and continued with his take on what venture capital partners are looking for (see Table 1).
Accuray has enjoyed strong growth in recent years, via worldwide sales of its CyberKnife (CK) radiosurgery system. The CK system, selling for $2.5 million to $4 million, integrates modern imaging technology, intelligent robotics and high-dose radiation delivery, merged with complex algorithms to precisely target cancerous tumors.
Accuray launched the CK in 2001, and as of June 30 (the end of the company's fiscal year), it had installed a total of 109 units worldwide, about two-thirds in the U.S.
The most common CK uses are for cancers of the brain, spine, lung, liver, prostate and pancreas, their main commonality being the difficulty of removing them with open surgery and their location, which requires highly invasive surgery and the risk of damage to surrounding critical anatomical structures.
Accuray went public in early 2007, with its IPO garnering about $100 million.
Although the journey taking Accuray to a publicly traded company has paid off for Adler, he said that it is not "the financial reward that makes the agony of the journey worthwhile — it is the fact that now 40,000 patients have been able to benefit from a technology that would not have existed."
Preparation H, move over
By far the most exciting example of a totally out-of-the-box, surgeon-powered new company product at thie ACS show was that of transanal haemorrhoidal dearterialization from THD America (THD; Ankeny, Iowa).
Given that about half of the adult U.S. population will develop hemorrhoids at some point in their lives, and that options for treatment are limited (Table 2), once non-surgical treatments have been exhausted, this company's THD device is an ingenious little product positioned to serve hundreds of thousands of untreated patients and perhaps threatening Preparation H.
The word is out among hemorrhoid sufferers that, until now, the only surgical option that offers permanent removal of hemorrhoids is extremely painful, and the pain may last for up to three months following surgery. Hence, patients postpone the procedure as long as they can, allowing the problem to progress so that it frequently results in scar tissue formation, thus limiting their surgical success.
The gold standard therapy in this case, referred to as the Milligan-Morgan procedure, costs little in terms of supplies, but a lot in terms of patient discomfort because it removes tissue that surrounds a highly dense nerve bed.
In recent years, a newer surgical approach called Procedure for Prolapsed Hemorrhoids (PPH) has been utilized that excises tissue that lies away from the nerve bed, reducing much of the patient pain. Unfortunately, long term results showed a higher than ideal (5%) recurrence rate, and there was the occasional, but rare, fatality.
So although the newer PPH procedure captured almost 20% of the number of hemorrhoid patients in the first few years after its introduction, it has since dropped in popularity to just around 10%, leaving, once again, the only proven surgical option a very painful one.
But Morinaga has developed the THD device — and has since retired — used on more than 20,000 patients in Europe for the past five years, a procedure having only a 4% recurrence rate, no stenosis and no serious complications.
Just cleared by the FDA for use in America in January 2007, this non-invasive Doppler-guided device locates and ligates the terminal branches of the arteries feeding the hemorrhoids, leaving sutures in place behind that resolve along with the hemorrhoids that are starved of their blood supply. If prolapsed mucosa is also present, the same ligation procedure can be performed on them at the same time. The procedure takes about 25 minutes and is price competitive to a PPH, which utilizes a surgical stapler.
Another of the device's dramatic benefits is that it is so easy to learn that general surgeons without colorectal training will be able to use it. By comparison, other hemorrhoid procedures are technically challenging and so require specialized training.
Piero Nastro, MD, of Whipps Cross University Hospital (London), presented "Prospective Trial of Staples Hemorrhoidopexy vs. Transanal Hemorrhoidal Dearterialization" and compared THD and PPH procedures following 52 patients (about half in each arm) at eight months after surgery.
He found similar effectiveness and post-operative pain in the two groups; but a significant reduction in complications and much earlier return to work following the THD procedure.
The real beauty of the device, according to Nastro, is the no-fault ability to move to a do-over. "No harm has been done. If for any reason the patient is not satisfied, he can go on to have a surgical procedure."
Another representative of the surgeon-turned-entrepreneur phenomenon is Kambiz Dowlatshahi, MD, of Rush University Medical Center (Chicago), who felt that there was a better way to perform lumpectomies for discreet breast cancer.
In a post-graduate skills course, "Advanced Technology in Image-Guided Diagnosis and Treatment of the Breast," sponsored by the Committee on Emerging Surgical Technology, Dowlatshahi presented three case studies of image-guided in situ ablation of breast cancer using an interstitial laser treatment that he has developed.
Currently, small breast cancers are usually removed by excising the lump. Dowlatshahi's new technique leaves the lump in the breast but kills off all the cancer cells using a laser and leaving no scar. The technique is non-invasive, and offers improved cosmesis. The procedure was FDA- cleared in May 2007 for benign breast tumors.
Dowlat continues his research in this area on cancer patients and has formed NovianHealth (Chicago), a company focused on bring this less disfiguring approach to women for treatment of discreet image-detected breast cancers.
Pulsed plasma energy
Yet another new surgeon-founded company — not with FDA clearance yet — is Peak Surgical (Palo Alto, California), co-founded by Mark Blumenkranz, MD, professor and chairman of the Department of Ophthalmology at Stanford University. Peak has developed a novel radio frequency (RF) tissue dissection instrumentation that uses pulsed plasma energy to create surgical incisions more precisely and without thermal injury, thus promoting improved wound healing.
In the presentation, "Comparative Healing of Surgical Incisions Created by a Standard Bovie, PEAK PlasmaBlade and Standard Scalpel Blade," Shang Loh, MD, Stanford University School of Medicine, studied full thickness incisions made by each of the three instruments and compared each wound in regard to bleeding, scarring, healing and inflammatory response.
At six weeks, results showed minimal scarring of the PEAK and standard scalpel incisions compared with significant scarring of the traditional electrosurgery incisions.
There was no significant difference in tissue injury between the PEAK and scalpel incisions, and both were significantly better than the traditional electrosurgery incision at one week. This demonstrated "that pulsed plasma RF energy is clearly a superior method for efficient tissue dissection with superior hemostasis and minimal thermal damage," according to Loh.
Why do they do it?
"Why do surgeons develop products?" Rodney Perkins, MD, of Stanford, California, asked attendees at the session.
A panel member and founder of several household-named companies, including Novacept (Marlborough, Massachusetts), Collagen (Palo Alto, California) and Resound (Bloomington, Minnesota), Perkins answered that there are many reasons.
But he said that the one "that resonates loudest is that by creating a new product one can leverage the amount of good done for patients." Surgeons, in their practices, are able to treat only so many patients, he said, "but if they develop a device that can reach other patients, then they have helped 10-fold the amount of patients that they could have helped themselves."
Target: massive bleeding
Representing the way in which surgeons work together to solve key problems was a study reported at the conference offering data on new ways of treating the No. 1 cause of death from trauma — massive bleeding. Investigators from MassachusettsGeneral Hospital (Boston) are deeply cooling the entire body to prolong the time to correct bleeding problems before the brain dies.
In their study, the surgical researchers found that profound hypothermia effectively treated shock that could not be reversed by standard cardiopulmonary resuscitation
Hasan Alam, MD, associate professor of surgery at Harvard Medical School (Boston) and a trauma surgeon at Massachusetts General Hospital, presented the data and said,"We're using this strategy in a situation where the alternative is almost certain death.
"We're not talking about a scenario where you might decrease the mortality from 10% down to 5%. We're talking about a highly lethal model, so we need to do something that is fairly dramatic and outside the box."
In reporting on the Massachusetts General Hospital study, Alam said that more patients under the age of 34 die of traumatic injuries than of all other diseases combined, and it is the No. 1 reason why these patients die is massive bleeding.
"If you look at autopsy data, most patients have bleeding problems that were fixable. We weren't able to fix them because once patients lose enough blood, they go into cardiac arrest, and the brain dies in about four to five minutes. We simply don't have enough time to get to the bleeding source and control it," Alam said.
Profound cooling of the body decreases the metabolic rate of the brain so it slows down but does not completely stop. So instead of consuming huge amounts of oxygen, the brain can be kept alive with only small amounts of oxygen delivery.
According to Alam, once the brain is cooled down to about 10 degrees C, it can stay alive for about two hours, giving surgeons enough time to fix underlying bleeding problems.
Alam and his associates have been testing hypothermia as a treatment for massive blood loss for about five years. They said that in that time they determined the optimal rate of cooling and rewarming, the desired depth and duration of cooling, and other practical aspects of the technique through a series of studies.
"The goal of this study was to take the technique into a realistic scenario," Alam said. In the past, we found that the technique worked in models that had no confounding variable other than an injury to a blood vessel, which is easy enough to fix. Once you get to it, you sew it up and you control the bleeding.
"But what if you have an injury to the abdomen and there is spillage of stool in the abdomen or an injury to the liver or the spleen that continues to spill blood? This study looked at a realistic lifelike trauma scenario."