Paulina Sequeda Malave

My first week in the Clinical Immersion Program was intense, and even though I expected it to be comprehensive, it was way more dynamic than I expected. The first day consisted of a plastic surgery clinic, where we were introduced to many conditions, including hidradenitis, keloid scars, pressure ulcers, skin injuries, and lesions; along with their treatment options, minor procedures, and reconstructive techniques. This was incredibly useful as I spent most of the following days inside an operating room observing the treatment of many of these conditions. Plastic surgeons treat a wide variety of conditions, and in just two days, I observed a mastectomy, implant replacement, liposuction, SARPE, pressure ulcer debridement, hidradenitis excision, and several reconstructive procedures. Some procedures were complex and lengthy, while others were quick and straightforward. It was impressive that some were performed simultaneously, adding to an already dynamic environment.

This week, our main tasks were to observe, interview, and document in order to identify unmet needs, using the IDEO model for innovation, focusing on desirability, as well as the AEIOU framework to structure our observations. With that in mind, I paid close attention to the design of tools and devices used in the clinical environment. I looked for signs like wear patterns, user discomfort, adaptations, repetitive tasks, and barriers, trying to spot unmet needs. This was a challenging process, as it involved determining whether the issues I witnessed were one-time situations or recurring problems rooted in design; however, this analysis was fundamental to understanding when innovation is necessary.  In this way, I selected one example of a good and a bad design, as described below:

Good Design: Stryker Cautery Tool 

Activities: This tool is used by surgeons and residents to cut and coagulate tissue, and to control bleeding. It is utilized during various surgical procedures, including mastectomy, SARPE, and pressure ulcer debridement.

Environment: This device is used across multiple operating rooms and procedures, with different setups and patient positioning. It is connected to a standing smoke evacuation unit next to the OR table.

Interactions: The surgeon controls the device using a push-button switch on the handle. Scrub techs also interact with it by passing it between the surgical team and changing tips as requested.

Objects: The cautery unit includes the handpiece, resembling a pencil, as well as a variety of interchangeable tips, and it is connected to a smoke evacuation unit.

Users: Surgeons and residents are the primary users; however, nurses and techs also handle the bovie while assisting during procedures.

Bad Design: Foot Pedal for MicroAire PAL LipoTower

Activities: During the liposuction procedure, the surgeon uses a MicroAire PAL system cannula to remove fat, which was activated and deactivated via a foot switch.

Environment: The MicroAire PAL system is used in fat removal procedures, which are performed in an operating room. The MicroAire PAL system is placed in a surgical cart next to the operating table.

Interactions: The foot switch can be repositioned, and it is sometimes challenging to find. It was not positioned on the same side as the lead surgeon, forcing the resident to press the pedal while the surgeon operated the cannula, which created workflow interruptions. Additionally, the pedal mechanism had to be pressed once to start and again to stop, with no clear feedback, which led to confusion on whether the device was actively running.

Objects: The foot switch was small, easy to overlook or misplace under drapes or among other cables. The MicroAire PAL system included the liposuction pump, cannulas, tubing, and fat processing filtering unit, which was placed in a surgical cart.

Users: The plastic surgeon was the primary user of the cannula but couldn’t directly control the power due to the placement of the foot pedal. The resident had to activate and deactivate the cannula.

References:

[1] SafeOR, “SafeAir Pencil,” [Online]. Available: https://www.safeor.com/products/smokeevacuation

[2] MicroAire, LIT-ASP-1021 Rev C, 2016. [Online]. Available: https://www.microaire.com/wp-content/uploads/2016/11/LIT-ASP-1021-Rev-C.pdf

Plastic surgery is a remarkably diverse medical field, encompassing procedures across all parts of the body. This week, I had the chance to visit the Craniofacial Center, a specialized facility where they treat a wide range of congenital and acquired conditions, such as Apert syndrome, bite problems, Crouzon syndrome, and other craniofacial anomalies. I had the opportunity to learn about the conditions and the available treatment options. Additionally, patients who need prosthetic ears, noses, and eyes also receive care at this center. This comprehensive approach is made possible by an interdisciplinary team that includes surgeons, orthodontists, anaplastologists, and other specialists; highlighting how essential collaboration is in this field. While observing the different specialties at work, I found craniofacial prosthetics to be a fascinating synthesis of art, creativity, and engineering. Designing and fabricating these prostheses involves multiple steps, which can vary widely depending on the patient and clinical equipment available. From selecting the most appropriate retention mechanism, to performing surgery if needed to place implants, to constructing and color-matching the prosthesis; with each step tailored to the patient’s needs.

A review by Cobein et al. focuses on retention systems for extraoral maxillofacial prosthetics, with particular emphasis on osseointegrated (implant-retained) systems. The authors analyze several clinical and technical parameters, including mean patient age, etiology, prosthesis type, implant placement region, choice of retention system by anatomical location, number of implants used, implant diameter and length, history of radiotherapy, placement in irradiated tissue before or after treatment, and implant loss rates. These help understand how clinicians select specific retention systems based on each patient. One main finding was that bar-clip systems were most used for ear and nose prosthetics, while magnets were preferred for eye prosthetics. Additionally, the paper compares osseointegrated and non-osseointegrated systems. While osseointegrated solutions involve higher costs, require surgical procedures, and pose a risk of infection, they offer significant advantages, from better stability, to enhanced quality of life [1].

To dive deeper into these retention systems, I reviewed the US Patent 12,137,326 B2, which describes a magnetic retention system designed for medical implants. This device features two magnet-containing components, one implantable and one external, that generate a “group magnetic field” to hold prosthetic devices in place [2]. The patent encompasses a range of configurations that can be customized depending on anatomical location, the type of prosthesis, and the patient’s needs. In this way, this attachment mechanism can be applied to several facial structures; including orbital, auricular, and nasal prosthetics, as we learned at the craniofacial center.

In this way, the choice of a retention system is a multifaceted process that involves careful consideration of the patient’s anatomy, clinical history, and the technical constraints of each case, as well as long-term functionality and daily comfort. It is an intentional and impactful design process that goes beyond restoring appearance, it is about supporting and improving the patient’s quality of life.

References:

[1] Cobein, M. V., Coto, N. P., Crivello Jr, O., Lemos, J. B. D., Vieira, L. M., Pimentel, M. L., Byrne, H. J., & Dias, R. B. (2017). Retention systems for extraoral maxillofacial prosthetic implants: a critical review. British Journal of Oral and Maxillofacial Surgery, 55(8), 763–769. doi:10.1016/j.bjoms.2017.04.012

[2] Inventors (2003). US 12,137,326 B2 – Retention magnet system for medical device (filed 2003; issued Nov 5, 2024). U.S. Patent and Trademark Office.

To identify unmet needs in the plastic and reconstructive surgery department, this week’s focus centered on evaluating the desirability, feasibility, and viability of current clinical methods. Through both primary observations and secondary research, I began to explore potential opportunities based on real patient experiences. In this way, an area that stood out during clinical shadowing was pressure ulcers. I witnessed multiple cases firsthand, including during outpatient visits and operating room debridement procedures. According to Moore, Zena, et al.: “A pressure ulcer (PU) is a localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure, or pressure in combination with shear” [1]. Following the AEIOU framework:

• A (Activities): A paraplegic patient undergoing a debridement procedure and requiring transport and repositioning.
• E (Environments): The Outpatient Care Center and Operating Room.
• I (Interactions): Coordination among the surgeon, residents, nurses, and wound care specialists.
• O (Objects): Surgical tools used in the procedure (cauterizing tool, retractors, irrigation systems), and an air-fluidized bed used for transport.
• U (Users): Patients with advanced pressure ulcers, wound care physicians, OR staff, and transport teams.

Pressure ulcers are considerably prevalent in patients with limited mobility, due to prolonged pressure on bony areas, which limits blood flow and leads to tissue oxygen deprivation [1]. These injuries are not only common but also largely preventable, which makes them a particularly compelling area of interest. Additionally, the risk is considerably high in patients such as those with spinal cord injuries, ranging from 25% to 66%, with the sacral (43%), ischial (15%), and heel (19%) regions being the most affected [1]. Even more concerning is their tendency to recur, often leading to repeated hospital visits, prolonged healing times, and a significantly reduced quality of life.

Currently, several methods are used to prevent pressure ulcers, including multi-layer underpads [2] and air-fluidized beds [3]. However, based on clinic observations and patient feedback, air-fluidized beds, despite their effectiveness, are not well tolerated. Patients often report that they are too hot and noisy, disrupting sleep and overall comfort.

Several factors should be considered when investigating the current market: “In the United States, an estimated $11 billion dollars is spent on pressure ulcers yearly, with $500 to $70,000 being spent on a single wound” [1]. Regarding preventive strategies, the cost is $11.66 per resident in nursing homes per week, on average [4]. Finally, the overall affected population is between 1.3 to 3 million patients in the U.S. alone [2].

In this way, primary observations, secondary research, and market assessment lead to the following needs statement:

“Patients with limited mobility are at risk of developing pressure ulcers due to prolonged bed rest, infrequent repositioning, and inadequate pressure redistribution, creating a need to reduce incidence and improve healing outcomes.”

References:

[1] Z. Moore et al., “A systematic review of movement monitoring devices to aid the prediction of pressure ulcers in at‐risk adults,” Int. Wound J., vol. 20, no. 2, pp. 579–608, 2023, doi: 10.1111/iwj.13902.

[2] D. W. Clark and D. B. Lunsford, “Method and apparatus for detecting imminent pressure ulcer formation,” U.S. Patent 8,011,041 B2, Aug. 30, 2011. [Online]. Available: https://patents.google.com/patent/US8011041B2/en

[3] Hillrom, “Envella® Air Fluidized Therapy Bed,” [Online]. Available: https://www.hillrom.com/en/products/envella-air-fluidized-therapy-bed/?utm_source=chatgpt.com

[4] UpToDate, “Prevention of pressure-induced skin and soft tissue injury.” [Online]. Available: https://www.uptodate.com/

Continuing the research on pressure ulcers, and from the feedback received during the peer reviewing session, I updated the proposed needs statement and refined the Desirability, Feasibility, and Viability components of the IDEO framework.

To support my findings with secondary research, I found data showing that the prevalence of pressure ulcers varies significantly by healthcare setting. Incidence rates range from 0.4% to 38% in acute care, 2.2% to 23.9% in long-term care, and 0% to 17% in home care settings. In the U.S. alone, approximately 2.5 million cases are treated annually in acute care facilities. This highlights the widespread nature of the issue and the substantial burden on healthcare systems [1].

Additionally, it is important to note the risk factors contributing to pressure ulcer development, such as immobility, difficulty repositioning, stroke history, fecal incontinence, low body weight, impaired nutrition, and early signs like non-blanchable erythema [1]. These findings reinforce the necessity for strategies to reduce pressure ulcers in high-risk patients [1].

One point raised during the peer review session was the presence of other commercial solutions for pressure ulcer prevention and treatment. After conducting additional research, I identified several existing products, including pressure-reducing and dynamic support surfaces [1], foam dressings, repositioning aids, and fluidized heel boots [2]. I also found more innovative technologies, such as smart air mattresses, wearable sensors, and pressure mapping systems [3].

Finally, in terms of viability, further research supported previous findings as treating pressure ulcers imposes a heavy financial burden: “…costs associated with care of pressure ulcers were the third highest after those for cancer and cardiovascular diseases” [1]. Estimating the Total Addressable Market (TAM) remains challenging, but looking at the cost difference between prevention and treatment helps understand the potential market. Preventative strategies in nursing homes cost about $11.66 per resident per week [4]; however, this does not include higher-cost strategies like air fluidized beds, which would substantially increase the TAM. In this way, preventing pressure ulcers costs significantly less than treating advanced cases, often requiring longer hospital stays, specialized wound care, and trained healthcare professionals [3].

Revisiting the IDEO framework and feedback from the peer review led me to refine my needs statement:

“Individuals with restricted mobility face a high risk of pressure ulcers due to prolonged immobility and insufficient pressure redistribution, underscoring the need for solutions that enhance prevention and accelerate recovery.”

References:

[1] M. Reddy, S. S. Gill, and P. A. Rochon, “Preventing pressure ulcers: A systematic review,” JAMA, vol. 296, no. 8, pp. 974–984, 2006, doi: 10.1001/jama.296.8.974.

[2] Mölnlycke Health Care, “Prevention of pressure ulcers,” Molnlycke.us. [Online]. Available: https://www.molnlycke.us/products-solutions/prevention-of-pressure-ulcers/. [Accessed: Jul. 26, 2025].

[3] F. Jan, S. Adan, A. Al Safadi, R. Nawaz, and S. Saeed, “Pressure ulcer detection and wound classification using computer vision and artificial intelligence: Past, present and future,” Smart Health, vol. 10, 2024. [Online]. Available: https://www.sciencedirect.com/science/article/pii/S2950307824000262. [Accessed: Jul. 26, 2025].

[4] A. R. Schwartz, “Prevention of pressure-induced skin and soft tissue injury,” UpToDate, Wolters Kluwer. [Online]. Available: https://www.uptodate.com/contents/prevention-of-pressure-induced-skin -and-soft-tissue-injury. [Accessed: Jul. 26, 2025].

This week, I created a storyboard capturing the journey of a patient with pressure ulcers, based on firsthand observations in both the clinic and operating room. It highlights key steps in their care, recurring pain points like delayed healing and recurrence, and decision-making moments for both patients and care teams. The storyboard also includes relevant billing codes tied to procedures and equipment, offering insight into the financial layer of wound care.