Let There Be Light

Doug Rimer, VP of engineering, Invuity, took time to answer a few questions about the company, the technology, and the products.
 

Q: When was Invuity founded and by whom?

Kenneth Trauner, an orthopedic surgeon, and Alex Vayser, an optical engineer, founded Invuity in 2004.

Q: What was their initial goal?

The goal was to improve visualization in minimally invasive surgeries. The company determined the best way to do that was to integrate illumination into surgical devices
 

The Eigr Illuminated Breast Retractor System, with Invuity’s proprietary Eigr technology, provides optimal visualization and retraction during less invasive breast procedures such as mastectomy, lumpectomy, sentinel node surgery and breast reconstruction.

Q: What are the products produced by Invuity?

Invuity produces devices, which combine illumination and optimized access for oncology, spinal, and orthopedic procedures.

In November, Invuity introduced a new line of surgical devices that provide surgeons enhanced visibility during spinal surgeries. The spinal instruments line features the Eigr Saber, a single-use, low profile, ergonomic, hand-held illumination device with integrated suction. The Eigr Saber has uses for spinal and orthopedic procedures – such as cervical and lumbar cases, hip arthroplasty, bone tumor resection, and foot and ankle fusions.

For spinal procedures, surgeons have a critical need for improved visualization, which enables easy identification of anatomical structures. Spine and orthopedic surgeons say that Eigr (pronounced eye-gr) technology improves their ability to perform surgery by reducing glare, shadows, heat, and physical strain caused by traditional surgical lighting equipment such as headlights or overhead lighting.

The debut of Invuity’s illuminated breast retractor system was at the American College of Surgeons’ 97th Annual Clinical Congress in San Francisco, CA. Operating in the breast provides unique challenges for specialists, especially in less invasive surgeries. As breast cancer surgery incisions become smaller, Invuity’s illuminated breast retractor system helps surgeons to better visualize delicate structures. Surgeons can use the Invuity breast retractor system – whether they are working on a lumpectomy or a mastectomy – to enhance visualization and bring illumination inside the incision. The ability to see is critical, particularly in skin and nipple-sparing mastectomies.

Invuity’s team works with surgeons to determine which surgical procedures can best benefit from improved visualization. For example, Invuity consulted with surgeons to design the illuminated breast retractor product line so that they would be conducive to the needs of each specialty in breast cancer surgery. Surgeons can use Invuity’s Eigr breast retractor system with great success no matter what procedure they are performing.

Q: What was the first product developed by Invuity?

Our first product was an optical waveguide integrated into a spinal retractor system.
 

The Eigr Illuminated Breast Retractor System is useful in a diverse array of other surgical procedures. In addition, its proprietary waveguide helps anatomy appear brighter, sharper, and with startling clarity; is able to evenly illuminate deep cavities, small openings, and under flaps; and the cool light eliminates the possibility of overheating in the surgical environment.

Q: Where is the design of products done?

Design of our products is by our in-house engineers, after consultation with surgeons and other healthcare professionals.

Q: When designing the products, which software systems/CAD systems are used?

We normally use SolidWorks for mechanical design.

Q: Now, about manufacturing, does Invuity utilize contract manufacturers for production of the product lines or does Invuity have their own in-house manufacturing capabilities?

We outsource our molding and machining, and we have an in-house assembly/cleanroom. In 2012, Invuity is expanding its 7,000ft2 San Francisco, CA facilities by about 50%.

Q: Regarding contract manufacturing, why did you choose to work with a contract manufacturer? What benefits do you see from this choice?

For our waveguides are precision optical components., the mold fabrication and molding processes are highly specialized to maintain sub-micron order tolerances. Measurement of features this size requires sophisticated metrology techniques such as white light interferometry. The combination of fabrication machinery and measurement capability represents a significant capital investment. Fabrication of retractors requires 5-axis milling, or direct metal laser sintering processes. Choosing of our suppliers is with all these requirements in mind.
 

Q: What other areas of production are handled in-house, where you do not utilize contract manufacturers?

Assembly and packaging is handled in-house.

Q: Regarding in-house production, what benefits do you find with keeping it in house?

The advantages of in-house manufacturing are multi-fold. First is the ability to be flexible to fluctuations in demand. Second, is the ability to more rapidly iterate design revisions based on customer feedback; this is a key benefit associated with Class 1 products. Perhaps most importantly, we are able to maintain direct control of product quality; when operating on a patient’s spinal cord or performing reconstructive surgery for a breast cancer patient, our surgeons expect the highest quality and this is our ultimate goal.
 

Eigr technology provides surgeons with the most sophisticated illumination solution to date. This proprietary technology, in conjunction with optimally designed instrumentation, provides unparalleled synergy of access and visualization.

Q: The latest product from Invuity is the illuminated surgical system for breast procedures utilizing Eigr technology and illuminated surgical devices for spinal procedures utilizing Eigr technology. Can you please tell our subscribers why these areas are perfect for this technology?

These surgical procedures are moving toward less invasive, smaller incisions, which reduce recovery time and minimize scarring. The quality and quantity of illumination that enables visualization through a small incision presents a significant challenge that is optimally addressed with Eigr technology.

Eigr utilizes unique optical structures to control light output to a targeted operative space. By directing light from multiple angles and efficiently managing light across a broad output surface, Eigr virtually eliminates shadows, back reflection, glare, and thermal effects such as overheating.

Q: What precisely goes into the systems for this illumination?

Included in the system are an optimized retractor, an optical waveguide, and a cable.

Q: What exactly is Eigr and how does it work with these systems?

Eigr technology directs and shapes light into a pattern on a target that allows the surgeon to visualize the tissue with great clarity and contrast. The retractors were designed with extensive clinical feedback to maximize integration of optics and ergonomics with optimal clinical effectiveness. Eigr technology provides bright, uniform, and low temperature illumination directly to the surgical field. This enables surgeons to quickly and easily perform procedures with less invasive, smaller incisions.

Q: Do you have any closing thoughts/comments to benefit our subscribers?

Invuity is committed to continuing to develop state-of-the-art photonics solutions for less invasive surgical procedures. We are rapidly developing and commercializing new products based on market demand.

Invuity
San Francisco, CA
invuity.com