Laura Houshmand

The first week of the Clinical Immersion Program in the Department of Plastic and Reconstructive Surgery was full of adaptation, learning, and discovery. This week involved extensive shadowing of our clinical mentors, Dr. Alkureishi and Dr. Purnell, in a variety of clinical settings, including in the OR and outpatient clinics. We observed a large variety of cases and procedures such as cleft lip repairs, reconstruction of pressure ulcers in paraplegic patients, and surgically assisted rapid palatal expansion in patients with hemifacial microsomia. In addition to clinical observation, we actively analyzed workflows and medical devices that either enhanced or hindered surgical efficiency. This week laid the foundation for evaluating how device design can impact surgeon performance, team dynamics, and patient care. Using the AEIOU framework, I examined two contrasting devices observed in the OR.

Good Design: VersaLight – A Handheld Device Combining Surgical Light, Suction, and Irrigation

Maxillofacial surgeries typically involve constrained anatomical environments where access is limited, visibility is poor, and critical structures such as nerves, vessels, and ducts are tightly packed. I found VersaLight to be a particularly valuable device in maxillofacial procedures due to its ability to provide focused illumination, suction, irrigation, and retraction in a single compact device for the tight anatomical spaces of the head and neck.

Activities: VersaLight is a multifunctional handpiece combining four tools into one: illumination, suction, irrigation, and moderate retraction. VersaLight uses patented MicroLens technology to direct cool, focused light, allowing for maximum visualization in small cavities and rapid localization of bleeders. It is designed for dynamic intraoperative use and is especially beneficial in deep or narrow surgical fields where visualization is challenging. VersaLight is used across surgical specialties including: Orthopedics, Gynecology, Urology, Oncology, Oral and Maxillofacial Surgery, and Thoracic Surgery. Surgeons and OR staff have successfully integrated VersaLight in a wide range of procedures, such as hip replacements, knee revisions, hysterectomies, pelvic floor reconstructions, prostatectomies, organ/tissue resections, and maxillofacial reconstructions.

Environment:  The operating room is a high-pressure environment that demands efficiency, sterility, and adaptability. Lighting is often a limiting factor, particularly in deep-cavity procedures. Additionally, surgical fields can become crowded with multiple tools and personnel, creating ergonomic and spatial challenges. VersaLight helps streamline the OR setup by reducing tool redundancy, minimizing handoffs, and improving access and visibility in complex surgical sites. Therefore, its integration into standard OR environments reduces clutter and allows for smoother workflows during surgery.

Interactions: VersaLight supports intuitive, hands-on interaction. Its ergonomic design allows surgeons to maintain control over multiple functionalities with one hand, decreasing the need to pass off tools for suction, lighting, or irrigation. This decreases reliance on circulating staff during critical moments and enhances team coordination. VersaLight also facilitates clear communication as its integrated lighting and suction functions reduce the need for verbal instructions and handoffs, allowing the surgical team to operate with greater fluidity and fewer interruptions.

Objects: VersaLight itself is a compact, lightweight, and durable handpiece. By combining multiple tools, VersaLight reduces the number of objects needed in the surgical field, improving spatial efficiency and lowering the risk of instrument contamination or misplacement.

Users: Surgeons are the primary users of VersaLight. However, surgical assistants, scrub techs, and circulating nurses also interact with the device, whether during setup, tool management, or intraoperative support. Because there is constant pressure to maintain efficiency and sterility in the OR, VersaLight’s ability to consolidate tools into one streamlined device is valuable to the entire surgical team. Furthermore, patients benefit indirectly through shorter operative times, reduced invasiveness, and potentially lower complication rates due to improved visualization and workflow.

By addressing the critical needs of visualization, fluid control, and spatial efficiency in the operating room, VersaLight exemplifies how thoughtful medical device design can directly enhance surgical performance and user satisfaction.

Bad Design: Osteotomy MicroSaw – A Piezoelectric Device with Inefficient Manual Operation

The Osteotomy MicroSaw is a piezoelectric surgical device designed for precise bone cutting, commonly used in oral and maxillofacial procedures. While it incorporates advanced ultrasonic technology to cut bone while preserving soft structures, its poor ergonomic design and reliance on inefficient manual up-and-down motions make it more challenging to use, particularly for trainees operating in confined anatomical spaces. I myself witnessed residents struggle when using this tool in the operating room which supported my assessment of this device.

Activities: The Osteotomy MicroSaw is used to perform precise bone cuts during surgeries such as dental extractions, orthognathic procedures, and osteotomies. Piezoelectric surgery is a technique that uses ultrasonic vibrations generated by piezoelectric crystals to cut bone while sparing soft tissues such as nerves, blood vessels, and mucosa. Therefore, piezoelectric surgery is particularly useful in Oral and Maxillofacial surgery, Neurosurgery, ENT and spinal procedures, and Periodontal and implant surgery. While piezosurgery is valued for its ability to selectively cut bone without damaging soft tissue, the Osteotomy MicroSaw undermines this benefit by requiring manual up-and-down hand motions to activate the saw. These motions are awkward and counterintuitive, especially in confined anatomical areas or deep surgical fields. This introduces unnecessary physical strain and leads to slower, less controlled cuts.

Environment: Surgical environments, especially in oral and maxillofacial procedures, demand precise and steady hand control in constrained fields. Instruments must support delicate manipulation, often in awkward angles, and maintain consistent cutting efficiency throughout the procedure. The Osteotomy MicroSaw complicates this by requiring a repetitive manual motion that disrupts smooth workflow and may increase the risk of error, especially in long or complex procedures. In teaching hospitals such as UI Health, it poses an additional challenge for trainees who have not yet developed the muscle memory or grip control needed to compensate for its design flaws.

Interactions: User interaction with the Osteotomy MicroSaw is unintuitive and physically demanding. Instead of allowing continuous, powered cutting via a foot pedal or adaptive tip motion, the device forces users to apply vertical oscillating movements to activate the blade, resulting in inefficient force transfer and inconsistent cuts. This breaks the rhythm of the procedure and makes it difficult for users to maintain precision or depth control. Surgeons may also overcompensate for this inefficiency with excessive pressure, potentially compromising surgical accuracy.

Objects: The device’s physical design lacks ergonomic optimization as its handle does not sufficiently support neutral wrist positioning during manual motion. Moreover, the need for external irrigation without built-in integration can add to the messiness of the operative field, reducing precision and overall usability. While it appears sleek and high-tech, the underlying mechanics fail to support the intuitive use expected of modern surgical tools.

Users: Although experienced surgeons may eventually adapt to the Osteotomy MicroSaw’s flaws, its design is especially problematic for residents and trainees who rely on responsive, intuitive tools to develop their technique. Poor ergonomics and inefficient cutting mechanics hinder learning and increase the likelihood of surgical fatigue and error. For assistants and scrub staff, the device’s design may complicate setup and require additional instruction or intervention when a user struggles mid-procedure. Meanwhile, patients are indirectly affected through prolonged operative times and potentially less precise osteotomies.

Ultimately, the Osteotomy MicroSaw illustrates how even advanced technologies like piezosurgery can be undermined by poor ergonomic and design, resulting in increased surgical risk, procedural inefficiency, and unnecessary cognitive and physical burden on the user.

Our second week of the Clinical Immersion Program was another great week of being immersed in and learning more about plastic and reconstructive surgery. Major focuses for this week included breast reconstruction, flaps, and facial prosthetics. Breast reconstruction plays a vital role in healing as it addresses the physical and psychological trauma caused by mastectomy procedures and helps restore quality of life for patients with breast cancer or other pathological conditions. I learned that it often occurs in a two-stage procedure. In the OR, patients first underwent mastectomy with insertion of a device called a tissue expander that helps to stretch the remaining soft tissue of the breast. These devices are regularly injected with either saline or water to expand the device and remain in the patient for 3 to 7 months before being replaced with a more permanent breast implant. One of the plastic surgeons we followed this week explained that he preferred injecting saline into the tissue expander over air as changes in pressure (such as in airplanes) could cause the device to expand, resulting in patient discomfort and potential risk of rupture.

Review Article: Two-Stage Tissue-Expander Breast Reconstruction: A Focus on the Surgical Technique by Bellini et al

In relation to this week’s breast reconstruction cases, I have identified the following peer-reviewed paper by Bellini et al to promote more discussion on the use of tissue expanders in breast reconstruction cases. The objective of this study was to review the surgical technique and rationale behind two‑stage tissue‑expander breast reconstruction following mastectomy. Breast cancer is the most commonly diagnosed malignancy in women, comprising 18% of female cancers. While mastectomies are life-saving procedures, they can also severely disrupt body image and self-esteem making reconstruction essential to recovery. Below are the steps to the two-stage procedure described in this article:

1. During or after mastectomy, a tissue expander is placed in a submuscular or musculofascial pocket matching the contralateral breast.
2. Over weeks to months, the expander is incrementally filled (more commonly with saline but surgeons can also fill the device with air) to stretch the skin and muscle envelope.
3. Once desired volume and skin expansion are achieved, the tissue expander is removed and replaced with a permanent implant.

The authors of this review outlined several advantages to this surgical technique. Tissue expanders enables gradual and controlled expansion of the skin and soft tissues while providing surgeons with flexibility in shaping the breast pocket and adjusting the final size. For many patients, it offers more acceptable aesthetic outcomes and is also suitable for patients with co-morbidities who may not be candidates for longer surgeries. Most importantly, this type of reconstruction reduces psychological distress by helping patients regain a sense of normalcy and femininity. Overall this review concluded that two‑stage tissue‑expander breast reconstruction is a safe, effective, and reliable method with flexible and patient-centered results.

Tissue Expander – Patent number: 11382709

I have also identified the following patent for a novel tissue expander design. As a reminder, the purpose of tissue expanders are to gradually stretch the skin and soft tissues, used commonly for post-mastectomy breast reconstruction.

• Patent Number: 11,382,709
• Issue Date: July 12, 2022
• Filed: Feb 9, 2018
• Issued: July 12, 2022
• Inventors: Gordon L. Kirchhevel and David H. Taffe
• Assignee: Mentor Worldwide LLC

This invention centers around a flexible shell that forms a chamber equipped with two distinct access points: a channel and a port. The key innovation lies in the staged injection approach. A first volume of fluid is rapidly injected into the chamber through the channel to initiate expansion, followed by a second, slower injection through the port at least a week later. This dual-access, dual-timing system allows surgeons to tailor the expansion process more precisely, reducing patient discomfort and tissue trauma while improving aesthetic outcomes. By separating the initial and follow-up expansion phases, the device offers enhanced flexibility and customization in tissue reconstruction which addresses common limitations of traditional single-port expanders.

Desirability

Primary Observation:

Flap reconstruction is a major technique used in plastic surgery to cover complex wounds and restore form after trauma, oncological resection, or congenital defects. It involves transferring tissue (skin, fat, cartilage, bone, and/or muscle) from one part of the body to another with either its own blood supply left intact (known as a pedicled flap) or by microvascular anastomosis (free flap). In the last few weeks, we observed challenges with ensuring adequate blood flow following microvascular anastomosis during flap reconstruction in the OR. Vascular compromise of the flap can lead to ischemia, venous congestion, and ultimately tissue necrosis, resulting in major complications such as total flap loss, partial flap necrosis, infection, donor site morbidity, and the need for revision surgery. Therefore, intraoperative and postoperative monitoring of the flap is essential to ensuring flap survival particularly because the risk for vascular complications is highest within the first 72 hours following flap reconstruction surgery.

Methods used to monitor flap perfusion in the OR included basic clinical assessment of skin color, capillary refill, temperature, and turgor as well as handheld Doppler ultrasound. Of note, handheld Dopplers often lack reliability due to false positives/negatives, ambient noise, and user variability, significantly affecting signal detection. During the procedure, we were unable to hear blood flow to the flap using the Doppler and the surgeons were uncertain whether this was due to the limitations of the Doppler instrument or whether there was vascular compromise to the flap. The team attempted to use 4 different Doppler ultrasound probes before confirming that there was a problem with the anastomosis. This resulted in a significant loss of time and resources and extended the procedure as the surgeons had to reopen the previously closed wound to fix the anastomosis. This experience led us to reflect on whether better methods for the detection of tissue perfusion exist and if current solutions can satisfactorily fulfill this need.

Secondary Observation:

In a study published in 2017, the authors prospectively compared visible light spectroscopy (VLS) to traditional handheld Doppler monitoring in postoperative free tissue transfer patients¹. They found that VLS provided continuous, objective data on tissue oxygenation and perfusion, enabling earlier and more reliable detection of vascular compromise. In contrast, handheld Doppler offered intermittent and subjective information that could miss early signs of flap distress. The study concluded that VLS is a superior adjunct tool for free flap monitoring, offering improved sensitivity and reduced reliance on manual checks.

Needs Statement:

Surgeons performing flap reconstruction surgery do not have a reliable modality to monitor flap perfusion intra and postoperatively, highlighting the need for early detection of vascular compromise to improve flap survival, reduce operative time, and enhance patient outcomes.

Feasibility

IP Landscape – Patents

1. Devices and methods for measuring vascular deficiency using Doppler ultrasound detection (Patent number: US11266373B2)
2. System and method for hyperspectral imaging (Patent number: US8891087B2)
3. Method and system for monitoring oxygenation levels of compartments and tissue (Patent number: US9314165B2)
4. Method and system for providing versatile Near-Infrared Spectrometry (NIRS) sensors (Patent: US20220192501A1)

Commercial Solutions

While there are a variety of commercial solutions available to monitor flap perfusion, I have listed below two of the most widely used monitoring techniques for microsurgical free flap reconstruction.

1. Cook-Swartz Doppler – This is an implantable Doppler that provides continuous, real-time monitoring of blood flow. The device itself involves a 20 MHz crystal attached to a cuff, which allows for easy attachment and safe, continuous monitoring of microvascular anastomoses. Although it requires intra-operative placement on a blood vessel, it has high sensitivity for detecting vascular compromise and provides early warnings to alert surgeons before clinical signs of flap distress appear. It is highly reliable but can nonetheless have false positives due to probe displacement or malfunction.
2. SPY Elite Fluorescence Imaging – This system enables surgeons to visualize microvascular blood flow and perfusion in tissue by providing real-time, high-resolution perfusion mapping of the entire flap intraoperatively and postoperatively. Additionally, this technique involves no ionizing radiation and utilizes a fluorescence imaging agent known as indocyanine green (ICG) that has a very short half-life, allowing surgeons to repeat intraoperative perfusion assessment numerous times throughout the procedure. The visual and objective nature of this system can aid in flap design and intra-operative decision-making. However, this system is not continuous as it requires repeated ICG injections and is expensive equipment.

Overall, implantable Dopplers and ICG angiography are considered the most effective modern gold standards for assessing flap perfusion and high-volume centers often use both in combination. While clinical judgment remains essential, it should be supplemented with reliable and objective tools such as the Cook-Swartz Doppler or SPY Elite System. Other methods that have been gaining popularity include NIRS, laser doppler flowmetry, and tissue oximetry.

Viability

Market Assessment

The global perfusion systems market size was valued at $1.2 billion in 2024 and is estimated to reach $1.62 billion by 2033². While there exists relatively cheaper options for flap perfusion monitoring: $200 (handheld Doppler), $500 (Cook-Swartz Doppler), $1,450 (SPY Elite System), methods such as NIRS can range in price from $15,000 to $100,000, with the higher-end models being more expensive.

Total Addressable Market = total # of units used/year * device cost

~20,000 flap reconstruction procedures performed annually

Cheaper flap monitoring methods: $700*20,000 = $14 million

Expensive flap monitoring methods: $50,000*20,000 = $1 billion

References

[1] Mericli AF, Wren J, Garvey PB, Liu J, Butler CE, Selber JC. A Prospective Clinical Trial Comparing Visible Light Spectroscopy to Handheld Doppler for Postoperative Free Tissue Transfer Monitoring. Plast Reconstr Surg. 2017 Sep;140(3):604-613. doi: 10.1097/PRS.0000000000003600. PMID: 28582335.

[2] Perfusion Systems Market: Global Perfusion Systems Market Size, Share, Trends & Growth Analysis Report – Segmented By Component, Type, Technique & Region – Industry Forecast (2025 to 2033). Market Data Forecase. ID: 3409. Last updated May 2025.