My non-smoker mother died of lung cancer with no family history of the disease.
Her death ten years ago was a decisive moment in my life. My life’s work has been in medical devices, where I’ve always been proud of being part of the best health care system in the world. After having to navigate for my mother through the eyes of a family member, it changed the course of my life. Once her journey ended, my own life pivoted.
It is no small task deciding which technology to invest your future in, then determining which opportunity will yield the desired outcome. I spent a year using my entire network of contacts and those of my partner to locate the right opportunity.
After a hunt for new technology, I chose to fight cancer. As is so often the case in a new venture, along the way I met individuals who would be “collected” to join the fight.
A New Diagnostic Modality: Opto-Acoustics
The world of breast imaging has not had a totally new modality for over 10 years.
I had found that new way to diagnose cancer in a technology called opto-acoustics. When I first saw opto-acoustics at work, it offered promise but with great compromise. It was like any idea that was not fully grown up – it was in its awkward stage – clumsy, overpowering in size and it needed lots of nurturing.
Opto-acoustic imaging technology combines optics and acoustics to improve the accuracy of the cancer diagnosis without the use of radiation – no x-rays. The process starts by illuminating the breast with laser light of specific wavelengths. Tumors absorb the light, which is converted into acoustic energy and forms a real-time image.
At the beginning, there were only a small handful of scientists and engineers, like the nucleus of a family, who knew how to coax it along – I needed to expand the family of people to help it mature and change. Once we built our team of experts bringing in talent in optics, acoustics, and lasers, we began to test the technology and see where we could modify the design. Initially, like the history of many technologies, we filled a room with equipment. This magnitude was needed since the equipment used was housed essentially in storage closets allowing the engineers access to make quick modifications.
Refining the Design – Listen to the Users
For anyone who walked in the room, the combination of storage cabinets and the radiologist adjusting everything under a table covered by a sheet that was covering the patient, there appeared to be a séance going on. The table required the patient to climb several stairs and was placed in a prone, facedown position, with her breast placed in a hole in the table. Next, the large probe was adjusted around her breast and the radiologist would turn on the computer. The lasers, which were also very large, needed to be warmed up at least one hour prior to any procedure. The arm providing the light from the lasers was an articulated arm and it required a service “tune up” after each use.
We gave her a name – Imagio®. Many a day at the beginning, would I dream that Imagio would be streamlined into a piece of equipment that would reflect what I believed to be her magnificence.
Focus groups came next, to confirm many of our suspicions and to tell us about design concerns which we had not even considered. As a dedicated device for opto-acoustics, like other functional technologies, we thought Imagio would require her own dedicated room. When interviewing the physicians that would someday become the users, we learned they did not want another device with a separate space requirement. They also informed us that a table with a maximum weight limit of 350 pounds might not serve the needs of all the future patients. In addition, the ability to place those same patients in a prone position and climb stairs was beyond the capabilities of many of the potential candidates that would someday benefit from this technology. Further, the desire of most, following the current trends, was to fuse our technology with another modality, such as PET, MRI or ultrasound. In the end, all stakeholders concurred that if we really wanted to make a difference, opto-acoustics should be fused with ultrasound; the thought being, it would be readily available worldwide and could even be transported into remote villages. These focus groups were mind blowing, transformational, and changed the course of our development path. Having seen other entrepreneurs time and again fall into the trap of inventing a new device in a vacuum, then attempt to introduce it to the end user without acceptance, I knew we had to listen to the suggestions made.
Get Her In Shape
Prior to any fusion of another modality, such as ultrasound, to our opto-acoustics, we needed to design special electronics. Opto-acoustics must have a strong signal to noise ratio of the sound coming back from the lesion to create the image, and it must also have a very high signal to noise ratio from the electronics. This initial component was one of the first commercial designs toward our future efforts in the electronic facet of the product. It was a very exciting moment.
The next big step was locating a transparent manufacturer of ultrasound that would be the caliber of quality we sought to align our technology with during this development pathway. Once we identified the company, we purchased a unit and began using it alongside our opto-acoustic technology, overlaying opto-acoustic images with the ultrasound images. For the nontechnocrat, this means using software to show these two types of images overlayed to appear as a single image. This began to offer what I termed the “GPS” aspect to potential users, as they could use the familiar technology – ultrasound – to guide them to the suspicious mass and then use our technology to learn more from the functional aspect. During this period of development, we brought the height of the table down so the patient could simply sit on the bed before and during the procedure eliminating the need to climb any stairs. We also, after many iterations, could now use a very large probe we designed to scan the patient without the need of having to place her in the facedown prone position – reducing the risk of breathing complications and table breakage due to weight. We got fancy and offered several monitoring screens for the physician or technologist to see the images while scanning and afterwards.
Next, as other technology capabilities were evolving, we were able to capitalize on them and initiated our efforts with fiber-optics to replace the articulated arm, in order to deliver our laser light to the patients. With all of this capability now captured into a single cart-based unit, we realized her mobility needed to be validated. So, many of the team members, including myself, tested her mobility. I usually wear heels to work, so to move a device of Imagio’s size would prove her mobility. Initially weighing in at 750 pounds, we knew a diet was in her future.
With the initiation of the fusion of two modalities came the need to turn our attention to yet another important design element, the probe. In traversing new territory and remembering that this is an entirely new modality, we moved ahead with such decisions as the number of transducers (the transducers convert quantities of pressure or brightness into an electrical signal, or vice versa), to be used. We also needed to determine the ideal shape of the probe for opto-acoustics.
Since our first application is for breast diagnosis, it was only fair to perform a study to determine if the probe shape should be arched, as is the curvature of a breast or flat as are many probes used in imaging. With much effort and hours invested, we determined the optimal shape of the probe.
Once all of this was implemented, it was like we were unleashed and we started using focus groups to understand how the users would like to have the cart-based product designed for comfort and user ease. This was and is a slow process, due to the ability to translate users’ “likes” into engineering design and sometimes due to technology “lags” that simply do not allow us to move in certain directions.
Getting to Commercialization
Now that we are in our clinical trial we have long since locked down the device to maintain the quality and consistency needed to move toward commercialization. We have learned much from the use at our clinical sites and are now incorporating valuable changes that will add to the robustness and reliability for user satisfaction. We have also conducted usability studies and have taken much away from them to complete the aesthetic aspects of our product.
They say that beauty is in the eye of the beholder, and if that is true, Imagio® certainly is the prettiest device I have ever seen! (Imagio’s diet has been successfully implemented bringing her well within the weight limit for her frame size).
I read a quote from William Bernbach that I like very much: “An idea can turn to dust or magic, depending on the talent that rubs up against it.” My team is the “talent” and we are working to make our technology the “magic” that I sought 10 years ago to help others.
It has been a long time since we started, but I feel that the idea will truly be realized as “magic” for us and I believe, for the benefit of the world.
Janet Campbell is the CEO of San Antonio-based Seno Medical Instruments.
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