Lydia Eisenbeis

As I reflect on my first week of the Clinical Immersion Program shadowing Drs. Purnell and Alkureishi in the clinic and OR, I have come to two early conclusions. The first is that quality (almost always) exceeds quantity. Although both physicians had full schedules and saw countless patients each day, the time they spent with each individual was not quantified by minutes in each clinic room or hours spent scrubbed in to the OR. While these metrics are of course important, especially as physicians aim to maximize the number of patients receiving healthcare, the quality of these interactions was far more critical. I observed Dr. Alkureishi take extra time to investigate the unknown cause of a patient’s chest pain and connect them to a primary care provider. I also witnessed Dr. Purnell exceed his allotted visit time with a patient, helping to answer their questions and ease their anxiety about an upcoming procedure. It quickly became clear that both physicians are on a mission to provide the highest quality of care for their patients, and to teach students and future providers to do the same.

My second conclusion from this first week is that plastic surgery is about far more than aesthetics. It’s meticulous, innovative, and incredibly reliant on tools that shape outcomes, both surgical and patient-centered. This intersection between design and clinical practice was most apparent in the operating room. Here, I witnessed both good, bad, and even hazardous designs that either improved or complicated the surgeons workflow.

Good Design: Ronin Surgical Headlight

Activity:

Many surgeons use a personal surgical headlight to provide focused light in their direct line of sight during surgeries. These headlights can increase the surgeon’s visibility and provide an extra source of light during complex procedures.

Environment:

Most OR’s are equipped with LED overhead lights to help surgeons visualize their surgical field. For more complex procedures, or surgeries done in small/tight spaces like plastic surgery, however, this light is usually insufficient. Surgical headlights therefore allow surgeons to have direct visibility into their surgical field, without having to constantly maneuver an overhead light.

Interactions:

The surgical headlight is primarily used by the surgeon themselves. It has both side and top headband adjusters to help the headlight sit comfortably on the surgeons head with minimal movement. The headlight is turned on before the surgeon scrubs in for the surgery, and remains on throughout the entire procedure. The surgeon may adjust the tilt of the light before the surgery begins to make sure it is in the correct position. If a battery pack needs replacement, a nurse, medical student, resident, or other non-sterile individual in the OR will swap out the dead battery with a new one.

Objects:

The surgical headlight consists of two adjustable headbands to fit the circumference and height of the surgeons head. It also has a high-quality headlight with spot distribution. Finally, the light is powered by a battery pack connected to the surgeons waistband. The battery pack features include audible notifications and visual light indicators of the battery life.

Users:

The primary user of this device is the surgeon; however, secondary users include non-sterile individuals who may adjust the headlight and batteries for the surgeon during an operation. In addition, the patient is indirectly a user of this device as their outcomes are dependent on the surgeon’s visibility of the surgical field.

Bad Design: Wire & Tubing Organization

Activity:

In almost every procedure I witnessed this past week, there were numerous wires, tubes, and cables scattered across the operating room. Although I may not have been able to identify the purpose of each cord, it was evident that they were all critical to keeping the patient stable during surgery. What I couldn’t understand, however, is how no one has designed a better system for keeping OR wires and tubing organized and less hazardous.

Environment:

Operating rooms are becoming increasingly more high-tech as new surgical innovations are introduced. With these advancements however, come more cables and cords. The more machines there are, the more tripping hazards arise.

Interactions:

As a medical student, my sole responsibility in the OR is to avoid anything sterile. “Don’t touch blue!” has become my new slogan. Unfortunately, sterility is only one obstacle we must avoid in the OR. The cords, cables, and wires that scatter the floor make it challenging to find an open place to stand in a packed operating room. In addition, anesthesiologists, nurses, and surgeons have to constantly reposition or step around wires mid-task. Particular activities like patient positioning and equipment adjustments became unnecessarily difficult when wires become twisted. At the start of most surgeries, I watched the nurses tape wires down, drape them over other machines, or kick them out of the surgeons way. While there are some inventions in place, such as tube separators (seen in figure 1), to mitigate this problem, the lack of proper wire and cable organization becomes a constant friction point in the OR.

Objects:

Most of the wires and cables in question include monitoring wires, suction tubing, cautery pen cords, and IV lines. While all of these wires are necessary to the success of a surgery, and likely designed well in isolation, collectively they create chaos. The absence of routing systems for all of these wires means that tripping hazards and tangled messes often ensue. Improvising with tape and velcro is therefore commonplace.

Users:

The main users impacted by this poor design are nurses, surgical techs, anesthesiologist, and surgeons (not to mention the medical students just trying to stay out of the way). Patients are also impacted by poor wire management. While they may not be moving around during surgery, the hazards introduced by loose cables and wires can increase safety risks and even affect sterility.

Primary Data Focus:

This week’s time was spent hopping between ORs, watching mastectomies, cleft palate reconstructions, and a rare craniectomy. While observing a breast implant reconstruction on a patient who underwent a prior mastectomy, I noticed the surgeons using a fancy new tool: an Illuminated Surgical Retractor. This device incorporated the design of a typical retractor with a thermally-cooled light to increase intracavity illumination. After further investigation, the device was a Stryker Invuity Retractor, equipped with a proprietary solid-core optical grade polymer to protect tissues from thermal damage. The device was used to gain visualization to the breast cavity, allowing the surgeons to excise necrotic tissue and make space for a new implant. The light itself was connected to an external power source via a cable that fed through the retractor, as seen in panel B. Interestingly, the device came in two separate sizes, which had to be swapped out during the case to allow for correct use.

Secondary Literature Review:

Overall review of secondary literature indicates the importance of appropriate illumination in the operating room. One paper written by J. Curlin and C. Herman in 2020 highlights the four current methods of illumination used in the surgical field: surgical lighting systems, lighted retractors, headlights, and operating microscopes¹. The authors go on to describe how each of these methods address different illumination needs, including intensity and control. They then explain that lighted surgical retractors, like the Stryker Invuity, are relatively new innovations that provide “in-field focused illumination targeted to the surgical site”. Although there are many pros to these devices, the authors also describe many of the cons, including the high degree of contamination and sterilization, which can lead to high rates of infection. They highlight multiple retrospective studies which found that up to 29.5% of reusable devices tested positive for pathogens following sterilization². While this reusable device may improve visualization and illumination of the surgical field, these results indicate a potential pitfall of this innovation.

Patent Review: 

While I could not find the exact patent for the Stryker Invuity using the proprietary polymer, I did find an almost identical product with patent US9867602B2, shown in panel C. This patent details the design of a self-illuminated surgical retractor. The claims describe an integrated light source which improves visibility during procedures without needing external lighting attachments. Interestingly, this patent is described as being “compatible with existing retractors,” meaning it can be adapted to different sizes and types widely across surgical specialties. The invention appears to be part of a family of OBP medical patents focused on illuminated surgical tools and builds on earlier designs focused on retractors with integrated lighting. It is later cited by additional patents including speculums and suction devices.

Works Cited:

[1] Curlin J, Herman CK. Current State of Surgical Lighting. Surg J (N Y). 2020;6(2):e87-e97. doi:10.1055/s-0040-1710529

[2] Health C for D and R. About Manufacturer and User Facility Device Experience (MAUDE) Database. FDA. Published online June 6, 2024. Accessed July 13, 2025. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/about-manufacturer-and-user-facility-device-experience-maude-database

[3] Obp Medical Corporation. Illuminated surgical retractor. U.S. Patent No. 9,867,602 B2. Filed Feb. 5, 2015; issued Jan. 16, 2018.

Desirability

Primary Observation:

Fat grafting is a multi-stage process that requires harvesting fat from a patient (oftentimes from the abdomen or thigh), removing excess liquid (via absorption with a gelatin sponge or centrifugation) as seen in image B, emulsifying it through a nano-filter (shown in image A), and then re-injecting the fat back into the patient. The process is time-consuming and requires the involvement of multiple users in the OR, including the surgeon or resident, a scrub nurse, and the patient. There are a lot of hand-offs between users during this process, increasing the risk of error and decreasing overall efficiency.

Secondary Observation: 

One study from 2023 compared a new automatic fat grafting system, Adipure, to four existing techniques. The Adipure device is an automated single-use filtration system that washes and filters fat simultaneously via automated centrifugation. The results of this study found that Adipure was superior to classical techniques and devices in both efficiency and oil quantity, indicating a possible solution to the otherwise time consuming and tedious processes currently used today¹.

Feasibility

Patents:

US8858518B2: A canister and method of filtering autologous fat that allows for manual agitation of lipoaspirate and liquid removal (shown in image C).

WO2022087700A1: Fat-separation equipment with an internally coupled sieve-filter built into a negative-pressure liposuction line.

Commercial Solutions:

While there are many commercial solutions, and numerous companies producing automated fat grafting systems, I have identified two below that were analyzed in a 2020 study. This study found that while the AuraGen poloxamer system had a greater adipose volume fraction than the Revolve system, both were preferred over standard methods².

1.AuraGen 123 Suction Lipoplasty System: A novel poloxamer wash, absorber, and mesh filtration system (image D).

2.Revolve Advanced Adipose System: A ringer’s lactate wash with decanter and mesh filtration (Image E).

Viability

Market Analysis:

There are numerous companies and devices with both manual and automated fat grafting and filtration systems, including Allergan Aesthetics, Human Med AG, Genesis Biosystems, and Plus Therapeutics. Each device ranges between several hundred dollars and several thousand dollars. The global autologous fat grafting market size was valued at 1.42 billion USD in 2024³.

Total Addressable Market (TAM) = # units/year x product cost

>500,000 facial fat grafting procedures performed annually⁴

Disposable Products: ~$950 * 500,000 = $475 M

Reusable Devies: ~$3,000 * 500,000 = $1.5 B

Works Cited:

[1] Nelissen X, Licciardi S, Nizet C, Delay E, Roche R. Comparative Analysis of a New Automatic System and Four Existing Techniques for Autologous Fat Grafting. Plastic and Reconstructive Surgery – Global Open. 2023;11(10):e5349. doi:10.1097/GOX.0000000000005349

[2] An Y, Panayi AC, Mi B, Fu S, Orgill DP. Comparative Analysis of Two Automated Fat-processing Systems. Plast Reconstr Surg Glob Open. 2020;8(1):e2587. doi:10.1097/GOX.0000000000002587

[3] Research S. Autologous Fat Grafting Market Size, Top Share And Regional Analysis by 2033. Accessed July 20, 2025. https://straitsresearch.com/report/autologous-fat-grafting-market

[4] Schiraldi L, Sapino G, Meuli J, et al. Facial Fat Grafting (FFG): Worth the Risk? A Systematic Review of Complications and Critical Appraisal. J Clin Med. 2022;11(16):4708. doi:10.3390/jcm11164708

Prior Need Statement:

Plastic surgeons need a more efficient method for autologous fat grafting that reduces the number of manual steps involved in harvesting, emulsifying, and purifying fat while preserving the viability and integrity of adipose tissue.

Following my observations and needs statement from last week, I approached this week with a fine tooth comb, hoping to conduct more interviews and dive deeper into the surgeon decision making process. Having previously observed a need for a more efficient fat grafting system, one question still remained. Why are surgeons undergoing these laborious and time-consuming procedures if there are faster, more efficient technologies on the market? Is it because patient outcomes are better? Is it purely surgeon preference? These are the questions I went into the week with, and the answers I received were quite interesting.

Desirability

Primary Observations: 

As was previously observed, fat grafting is a multi-stage process that requires harvesting fat from a patient, removing excess liquid, emulsifying it through a nano-filter, and then re-injecting the fat back into the patient. The process is quite time-consuming, requires a lot of hand-offs, and has many steps where error can be introduced. Following these initial observations, we interviewed Dr. Grevious and Dr. Purnell, two plastic surgeons at UIC on their preferences for using this technique. Interestingly, preference had nothing to do with their responses. They recognized the lack of efficiency in the process, and described familiarity with many of the commercial solutions on the market, such as the Revolve Advanced Adipose System. When probed further on why these new solutions are not being used in the OR, the answer was simple. Group Purchasing Organizations (GPO’s) dictate what medical supplies and equipment a hospital uses. Unfortunately for UI Health, these fancy, efficient, but more expensive technologies are not and likely will never be contracted at the hospital. While the current system may be cumbersome, surgeons are limited to this technique due to financial constraints.

Secondary Observations: 

Diving deeper into the cost of fat grafting solutions, I found a study conducted in 2016 that compared centrifugation of fat (or the standard, more time-consuming method) to an autologous fat processing system using the Revolve device¹. In agreement with other studies, the autologous fat processing system resulted in an increased volume of fat harvesting with decreased time to completion (figure D)¹. There were also fewer cysts and nodules post-operatively in the patients who underwent a fat grafting procedure with Revolve vs standard techniques. What was really interesting about this study however, was the cost analysis. Given the increased efficiency and decreased patient risk with the automated Revolve system, the authors calculated a $2,870 average saving per patient when compared to standard techniques. This study highlights not only the increased efficiency and positive patient outcomes of automated autologous fat grafting technologies, but the cost-savings that may counteract the higher market price.

Feasibility

As was described in last weeks blog, there are a handful of patents for fat grafting systems that simplify the complicated steps down to one device. These patents and a more detailed description of the Revolve commercial solution is listed below:

Patents:

US8858518B2: A canister and method of filtering autologous fat that allows for manual agitation of lipoaspirate and liquid removal.

WO2022087700A1: Fat-separation equipment with an internally coupled sieve-filter built into a negative-pressure liposuction line.

Commercial Solutions:

The Revolve Advanced Adipose System is the “only all-in-one fat processing device that harvests, filters, actively washes, and removes strands”². As described on the company website, the device contains a mesh filter to strain and concentrate the lipoaspirate (figure A), a propeller for active washing (figure B), and a syringe extraction to maximize efficiency (figure C). Potential adverse effects are listed as: fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.

Upon further investigation, a few adverse events have been reported for the Revolve device. One specific adverse event, MDR 21245784, identified inflammation and post-operative wound infection following the use of the Revolve device in 3/10 patient cases³.

Viability

Market Analysis:

The global autologous fat grafting market size was valued at 1.42B USD in 2024³. My previous TAM analysis indicated a $1.5B market (calculated using ~500,000 facial fat grafting procedures annually and the $3,000 cost of reusable devices like Revolve).

Despite this market size, hospitals like UI Health, may be limited to the fat grafting technology available to them due to GPO’s. Although this market is large and fairly profitable, the question still remains on if these technology solutions will be adopted by larger, community-based hospital systems. If an argument for cost savings via time efficiency and decreased patient risk can be made, hospitals may be more likely to adopt these tech solutions over the standard techniques.

Works Cited:

[1] Gabriel A, Maxwell GP, Griffin L, Champaneria MC, Parekh M, Macarios D. A Comparison of Two Fat Grafting Methods on Operating Room Efficiency and Costs. Aesthet Surg J. 2017;37(2):161-168. doi:10.1093/asj/sjw169

[2] REVOLVE System User Manual, 2017.

[3] MAUDE Adverse Event Report: LIFECELL 1 PACK REVOLVE FAT PROCESSING SYSTEM; SUCTION LIPOPLASTY SYSTEM. Accessed July 27, 2025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21245784&pc=QKL

The autologous fat grafting process involves multiple steps and stages, numerous hand-offs between personnel, and a lot of opportunity for pain points, errors, and increased patient risk. These steps and stages are illustrated above in Figure 1, highlighting the need for a more streamlined, efficient workflow.