Aanya Roy

This week marked the beginning of our team’s clinical shadowing experience under the guidance of Dr. Purnell and Dr. Alkurieshi in the Department of Plastics and Reconstructive Surgery at UI Health. As part of the Clinical Immersion Program, I began familiarizing myself with the diverse clinical environments we’ll engage with over the next six weeks, including the operating room, outpatient clinic, and craniofacial center. I aimed to explore the scope of care within the Plastics department, which this week emphasized functional improvements in reconstructive cases. On Tuesday, we observed a range of outpatient cases, including Hidradenitis, post-traumatic healing, keloids, and Mohs surgery follow-ups. We also noted how clinicians considered both localized concerns and broader systemic risks, such as cardiovascular factors and potential pulmonary embolisms, when formulating care plans. On Wednesday, we observed a variety of procedures in the OR, including facial revisions for a patient with Treacher Collins and interdisciplinary procedures with neurosurgery while closing for a spinal fusion. Finally, on Thursday, we were able to observe various clinic cases, including osteoradionecrosis, metopic craniosynostosis, and anaplastology cases using skin grafts.  Our primary objective this week was to assess the intersection of engineering and clinical practice within the field of plastic surgery, with particular attention to the implementation, usability, and effectiveness of medical devices in both surgical and outpatient settings. These findings are listed below.

Good Design: Resin Surgical Models

The 3D printed surgical models are patient-specific, anatomically accurate replicas created from medical imaging data. They enable surgeons to visualize, plan, and execute complex procedures with greater precision, serving as tactile references for implant fitting and real-time decision-making during surgery. Their use improves surgical outcomes by reducing guesswork and enhancing team coordination.

Activity: Surgeons, residents, and medical teams utilized these patient-specific 3D-printed resin models throughout the entire treatment process. In the Craniofacial Center (CFC), they were used to plan reconstructive procedures by studying anatomical variations, testing implant placement, and communicating surgical intent across the care team. Intraoperatively, models were brought directly into the OR (ex. image b) to guide real-time implant modifications when pre-fit malar implants did not conform to the patient’s actual zygomatic anatomy.

Environment: These models are used in multiple clinical environments. They were originally printed in the Craniofacial Center’s printing space, where they serve as a shared physical reference for interdisciplinary teams and are shown to patients and their families to explain procedures and expected outcomes. In the OR, they served as sterile, to-scale visual aids that sit directly beside the surgical field, allowing surgeons to compare implants or anatomy without relying solely on screens or memory.

Interactions: Interactions occurred between providers (surgeons, residents, nurses) and the physical models in both planning and surgical settings. In the clinic, surgeons annotated models while discussing surgical strategy or implant fit. During surgery, the model was positioned within arm’s reach and directly compared to patient anatomy, sometimes marked or used as a shaping guide for adjusting implants, as shown in image a.

Objects: The primary objects are the 3D printed resin models themselves, created from CT or other imaging data, and custom-fabricated in the CFC using high-resolution printers. These include full or partial craniofacial structures (see images a–c), with clear, white, or amber tint to highlight bone density or fit areas. Surgeons also use the models alongside implants, bone drills, and shaping tools. The presence of the model as a static, accurate physical reference helps anchor other tools and decisions in real time, especially when digital imaging lacks depth or scale context. The models are also durable, due to their washing and curing process post-printing. They are often utilized by the surgeons, but are also manipulated by other techs and nurses who are scrubbed in to help improve visualization.

Users: Users include craniofacial and plastic surgeons, surgical residents, nurses, biomedical engineers, and patients. Surgeons use the models to simulate surgical steps, refine implant fit, and make intraoperative adjustments to plans. Residents learn from the models by comparing anatomical variability across cases. Biomedical engineers and medical artists are involved in translating imaging into printable files, ensuring anatomical fidelity. Patients and families also interact with the models in clinic settings to better understand upcoming procedures.

Bad Design: Surgical Table Accessory Rail

The tubing and wires on the OR table are tangled, poorly secured, and extend across the workspace, creating hazards and inefficiencies. Although a metal bar is intended to organize multiple tubes, it fails to manage the volume and complexity of lines effectively. This disorganized setup disrupts the surgical flow, requiring mid-procedure adjustment by the nurse and limiting safe, easy access for the anesthesiologist and others.

Activity: During surgery, clinicians, nurses, and techs are performing time-sensitive and highly coordinated tasks: monitoring vitals, managing airways, adjusting lines, and administering medication. The unorganized tubing creates an obstacle course beneath and around the bed, forcing staff to step around, reach through, or pause to untangle lines mid-procedure.

Environment: This occurs in a high-acuity operating room, where sterility, efficiency, and mobility are essential. The environment is tightly packed with people, carts, monitors, ventilators, and other surgical equipment with already limited floor space.

Interactions: Nurses, anesthesiologists, and surgical staff constantly interact with the tubing, both intentionally and unintentionally. The nurse in this case had to intervene mid-surgery to reposition and organize the lines that had become obstructed. The anesthesiologist, whose station is usually at the head of the bed, struggled to access their monitors and equipment when tubes were not securely routed or began to dangle or twist across critical pathways.

Objects: The primary object in question is the metal bar clamped to the side of the bed, meant to hold and organize tubing. However, it accommodates only a few lines and lacks routing structure or adjustable holders, leading to chaotic overlap of ventilator tubing, suction, monitoring leads, and IV lines.

Users: Users include nurses, anesthesiologists, surgeons, and surgical techs, all of whom are affected by the disorganization. Nurses are tasked with setting up equipment and must troubleshoot issues under pressure. Anesthesiologists depend on clear access to the head of the bed and tubing pathways, while surgeons need unobstructed movement and timely support.

Primary Data: OR Observations

This week was primarily spent in the operating room, observing a wide array of procedures and surgeries, including but not limited to a craniectomy, body contour abdominoplasty and panniculectomy, brachioplasty, mammoplasty, and ectropion revision. A case that was particularly illuminating was a pediatric operation involving wound care for an autoimmune epidermal condition that presents as painful blisters on the skin. An amniotic matrix, a gel layer derived from amniotic fluid, was placed intraoperatively over the blisters and the eyes to enhance skin and tissue integrity.

Secondary Data: Literature Review

One review laid out the wide range of clinical uses for the amniotic membrane (AM), especially in areas including wound healing, eye injuries, and reconstructive surgery. AM is naturally anti-inflammatory, anti-scarring, and carries a lower risk of immune rejection. It’s rich in growth factors like TGF-β, EGF, and HGF, which help speed up epithelial repair and reduce fibrosis¹. In practice, this translates to less pain, faster healing, and fewer infections, which maximizes comfort for the patient and longitudinal healing. It’s also worth noting that AM is ethically sourced – taken from placentas after birth, with no harm to donor or baby – and hasn’t been linked to tumor formation¹. From the patient perspective, the amniotic matrix is an innovative workaround for healing and wound care that engages biointegration and engineering to prioritize chronic, instead of temporary, care.

Further literature investigation centered on how these matrices are engineered. Researchers used a detergent-based process with 0.03% SDS, followed by DNA-cleaving enzymes and peracetic acid sterilization. The result? Over 95% of DNA was removed, but key proteins like collagen, elastin, laminin, and fibronectin were preserved². In fact, elastin content increased from 359.2 to 490.8 µg/mg, and hydroxyproline (a collagen marker) rose from 34.7 to 49.7 µg/mg. Even after treatment, the material stayed mechanically strong and didn’t harm fibroblasts or epithelial cells in vitro². From a viability perspective, the development of the amniotic matrix retains biological structure and functionality.

Together, these studies affirm the amniotic matrix as both clinically powerful and bioengineerable. This raises exciting questions about how scalable and customizable these matrices can become in future surgical applications.

Translational Review: Patent Evaluation

UI Health currently uses the Arthrex Amnion Matrix in surgical wound care, reflecting its growing presence in clinical practice. The technology is protected under U.S. Patent US20200217178A1, which outlines a graft made from layers of amniotic tissue, either amnion, chorion, or a combination, processed to preserve its biological activity while enhancing ease of use and sterility in the operating room.

One of the key innovations is the matrix’s ability to retain important structural proteins like collagen, laminin, and fibronectin, along with naturally occurring growth factors such as EGF, TGF-β, and FGF. These elements help drive tissue repair by promoting cell migration, angiogenesis, and inflammation control. Because the matrix is dehydrated and terminally sterilized, it has a long shelf life and can be stored and applied easily during surgery.

The product has a wide range of clinical uses, including treatment for chronic wounds, soft tissue defects, and tendon injuries. Its low immunogenicity reduces the risk of rejection, and it can be used on its own or with stem cells and other biologics. The patent itself is fairly broad, covering various forms, combinations, and preparation methods of amniotic tissue matrices, which helps Arthrex protect a broad scope of applications and formulations. On its website, the matrix is actually heavily marketed for orthopedic procedures, although we observed it in the OR being used in a plastics, skin engineering, and ophthalmology range. It cites over 40 sources, grounding the matrix in both scientific literature and clinical precedent, including prior innovations in extracellular scaffolds and regenerative biomaterials.

References: 

[1] Mamede AC, Carvalho MJ, Abrantes AM, Laranjo M, Maia CJ, Botelho MF. Amniotic membrane: from structure and functions to clinical applications. Cell Tissue Res. 2012 Aug;349(2):447-58. doi: 10.1007/s00441-012-1424-6

[2] Wilshaw SP, Kearney JN, Fisher J, Ingham E. Production of an acellular amniotic membrane matrix for use in tissue engineering. Tissue Eng. 2006 Aug;12(8):2117-29. doi: 10.1089/ten.2006

[3] Arthrex Inc. Amnion-derived therapeutic matrices and methods of preparation. U.S. Patent No. 2020/0217178 A1. Filed Jan. 15, 2020

Desirability

Primary Observation:

During our time in the OR and clinic this week, particularly for post-operative follow-ups, patients often left the hospital with invasive draining tubing and bags that required manual monitoring of fluid output. This was seen primarily for patients with Hidradenitis Suppurativa or patients who had major reconstructive surgery or cranial procedures that required skin flaps from the leg or abdomen. In practice, this created several points of failure: patients occasionally forgot to measure or record accurately, caregivers had difficulty tracking changes over time, and providers lacked timely access to data unless the patient was physically present or remembered to bring documentation.

In addition, patients reported uncertainty about when to drain the bag and how full was “too full,” which sometimes led to discomfort, minor leakage, or unnecessary worry. For providers, reviewing output trends required combing through inconsistent tracking or relying on patient self-reporting, which introduces the possibility of human error and general inaccuracy with measurement. Moreover, fluid analysis in the drainage bag, especially in low-resource areas, is limited to patient follow-ups in the clinic with the provider.

The process as it stands is low-tech, imprecise, and puts the burden of both measurement and reporting on the patient or their caregivers, often at a time when they’re already managing pain, medications, and mobility restrictions.

AEIOU Breakdown:

• Activities: Patients manually monitor and record drainage output using visual estimation of the volume on existing drainage bags and paper logs.
• Environments: Most tracking occurs at home post-operatively, where clinical supervision is limited and inconsistencies are common.
• Interactions: Patients and providers rely on verbal reports or handwritten logs at follow-up appointments due to difficulty in ploading paper logs onto MyChart (especially for older patients).
• Objects: Drainage bags used are typically standalone devices with printed volume markers and no digital connectivity.
• Users: Post-op patients, caregivers, and healthcare providers all depend on accurate, timely drainage data for recovery management.

Secondary Observation:

Despite being a routine part of post-operative care, traditional surgical drainage systems place a significant burden on both patients and providers to ensure accurate monitoring and timely intervention. If the patient takes the drain home post-op, they would be expected to keep track of the consistency, color, and smell of the fluid, as well as record volume of the drains. If there is more than one drain, these volumes must be recorded separately [1]. This process relies on patient adherence, which may not be as feasible across underserved patient populations or patient populations without efficient/consistent correspondence with their provider. This system is also vulnerable to inaccuracy during home recovery or between clinical visits. For Jackson-Pratt drains and Hemovac drains, as well as other wound draining systems, recording of volume and appearance of fluid is crucial to understanding when the drains need to be removed, if there is an underlying infection, and if there are post-op complications to be concerned about [2]. Errors in recording fluid quality and volume can prolong healing and lead to lacking consistency in treatment.

A quality improvement study conducted in a plastic surgery department highlighted major documentation gaps in inpatient drain management, revealing that baseline compliance with eight essential monitoring criteria – including 24-hour output, drain type, fluid description, and timing – was only 20% prior to intervention This inconsistency was attributed in part to a lack of uniform systems, unclear documentation spaces, and the shift toward algorithmic charting systems that often omit fields for drain output. Even after introducing a standardized chart, full compliance with key monitoring criteria plateaued below 80%, with critical data like post-op fluid volume and recovery documentation still frequently missed [3]. These issues persist in inpatient facilities and are likely visible in outpatient healing.

Needs Statement: Post-operative patients with surgical drains that require fluid volume and quality rechecking need a way to accurately and consistently track drain output and draining fluid properties between clinical visits to prevent inaccuracies in measurement, decrease infection risk, and support timely provider intervention.

Feasibility

Intellectual Property Landscape

• CN111388775A: Anti-infection drainage bag with retractable mounting and positioning features
• US20050137539A1: Closed wound drainage system with suction, porous pouch, and optional antibacterial beads
• US20200306423: Wound monitoring system with sensors for color and flow rate, wireless transmission, and EHR updates
• US10441690B2: Drainage container with infection detector (e.g., leukocyte esterase indicator), volume indicators, and rotatable mounting
• CN211356993U: Drainage bag with hard inserts for accurate volume measurement and liquid level alarms

While existing wound drainage technologies offer various features like infection control, fluid monitoring, and digital data integration, there remains a critical need for a reliable way to accurately and consistently track surgical drain output between clinical visits. Current solutions often rely on complex or costly systems that may not be practical in all settings. Improved monitoring of drain volume and fluid quality is essential to reduce measurement inaccuracies, lower infection risks, and enable timely clinical interventions for post-operative patients.

Commercial Solutions

• Hemovac® Autotransfusion System (Zimmer Biomet): Offers gentle suction and a closed system to minimize exposure. It includes graduated markings for manual volume tracking but lacks digital automation.
• Drainobag® 600 (B. Braun): A high-vacuum drainage system with a built-in scale for visual volume estimation. No digital recording or infection detection.
• TRU-CLOSE® Suction Drainage System (Uresil): Uses bellows for suction and includes hydrophobic filter vents. It has a write-on area for manual volume tracking but no smart features.
• Eakin Wound Pouches (ConvaTec): Offers flexible wound drainage with access windows and remote drainage attachments. Some models allow visual assessment of fluid but not automated analysis5.

These commercial products highlight a consistent pattern: while they address basic volume monitoring and patient safety through features like suction control, built-in scales, and visual assessment tools, they generally fall short in offering comprehensive, integrated solutions. Most rely on manual tracking methods, which are prone to user error, inconsistent documentation, and limited clinical utility outside the immediate care setting.

Critically, these systems do not include built-in mechanisms for detecting early signs of infection, such as changes in fluid volume color, clarity, or biomarkers: factors that are vital for timely clinical intervention. Additionally, the lack of digital connectivity means there is no automatic way to transfer patient drainage data into electronic health records. This creates a disconnect between at-home or bedside monitoring and provider oversight, potentially delaying the recognition of complications.

Viability

Market Analysis:

The global wound drainage bag market was valued at approximately $1.5 billion in 2024 and is projected to grow to $2.8 billion by 2033, reflecting a compound annual growth rate (CAGR) of 7.5% between 2026 and 2033 as proper wound drainage can significantly reduce post-op complications and reduce patient and provider costs [4]. This growth is fueled by rising surgical volumes, increasing attention to post-operative infection monitoring, and the emergence of IoT-enabled healthcare solutions. Existing commercial drainage solutions range widely in price and functionality. Passive systems like the TRU-CLOSE® Suction Drainage System (Uresil) retail between $69 and $104 per unit, while premium high-vacuum kits such as the Drainobag® 600 (B. Braun) cost $340 to $360. The Hemovac® Autotransfusion System (Zimmer Biomet), offering gentle suction, is priced between $610 and $980 per 400 mL unit, with smaller silicone configurations reaching $1,760. Eakin Wound Pouches (ConvaTec) span $225 to $395 per box, depending on size and drainage features. Despite this variety, none of these products offer the combination of automated volume sensing, infection detection, and EHR integration.

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

Upper bound estimate: 10-15% of major surgeries utilize post-operative wound drainage  [5]

Targetable procedures: 45 million surgeries per year: 45*0.125 = 5.6 million cases a year

Applicable procedures: 60% of 5.6 million surgeries = 3.36 million cases a year

TAM: 3.36 million cases/year×$550 = $1.85 billion/year

Note: doesn’t include non-major surgeries that utilize wound drain systems or higher-cost advanced wound drain systems

References:

[1] 1. Doyle G, McCutcheon J (2015) Clinical procedures for safer patient care. BCcampus, Victoria, B.C

[2] 1. (2025) Surgical drain: Types, care, Complications, Removal & Healing. In: Cleveland Clinic. https://my.clevelandclinic.org/health/drugs/15199-surgical-drains. Accessed 30 Jul 2025

[3] Lyons N, Heron P, Bethune R. Improving the recording of surgical drain output. BMJ Qual Improv Rep. 2015 Sep 4;4(1):u209264.w3964. doi: 10.1136/bmjquality.u209264.w3964

[4] 1. (2025) Wound Drainage Bag Market Insights. In: Global Wound Drainage Bag Market Size By Product Type (Active Drainage Bags, Passive Drainage Bags), By Material Type ( Polyvinyl Chloride (PVC) Polyethylene (PE)), By End-User ( Hospitals, Ambulatory Surgical Centers), By Application (Post-Surgical Wound Management, Trauma Care), By Distribution Channel (Online Pharmacies, Retail Pharmacies), By Geographic Scope And Forecast. https://www.verifiedmarketreports.com/product/wound-drainage-bag-market/. Accessed 30 Jul 2025

[5] Centers for Disease Control and Prevention (U.S.). Surgical Site Infection Event (SSI). Atlanta (GA): National Healthcare Safety Network; 2025. Available from: https://www.cdc.gov/nhsn

Upon reflecting on the needs statement drafted in week 3, some minor tweaks were in order. The prior needs statement is as follows:

Post-operative patients with surgical drains that require fluid volume and quality rechecking need a way to accurately and consistently track drain output and draining fluid properties between clinical visits to prevent inaccuracies in measurement, decrease infection risk, and support timely provider intervention.

However, after revision and peer review, a new needs statement was developed:

Post-operative patients recovering with surgical wound drainage need an intuitive, reliable way to automatically monitor drainage volume and fluid characteristics between clinical visits to prevent inaccuracies in measurement, decrease infection risk, and enable timely, data-driven provider intervention.

The indicated changes to the needs statement were founded in not only peer review suggestions, but also primary and secondary research falling into the categories of the IDEO model (desirability, feasibility, and viability) while focusing on the populations, outcomes, and opportunities that are featured throughout the needs statement.

Desirability

Time spent observing in post-operative clinical settings continued to indicate pain points, with patients leaving surgeries with wound drains that are manual and low-tech. While this initially had seemed like a foolproof solution to personally track fluid output in the drains and relay information to the provider, it became clear that patients with these wound drains often had to guess how full the draining bags were due to being unable to see the numbers clearly, and eyeball changes in fluid color or texture. Providers were left interpreting second-hand information, like verbal reports and paper logs. At best, they were uncoordinated and were structured differently based on each patient. At worst, they were completed incorrectly, if at all. It also meant that communication about the wound draining was minimal until the appointment. Finally, it was also interesting to note that many patients were unsure as to what the draining volume meant in terms of their post-operative healing. While many patients came to the clinic hoping to have their drains removed, they were often unaware of the volume required for removal. As a result, they were left disappointed when their request was denied due to the high volume.

In terms of the modified needs statement, these observations about the desirability of proper wound drainage tracking and monitoring showed me that the population had to encompass all post-operative patients using a surgical drain, as clarifying that this was also for patients who had to track the fluid was redundant. Furthermore, the new needs statement also must clarify that a new device to solve the aforementioned issues must be intuitive, to ensure user-friendliness that the manual draining systems don’t have, and reliable, to bridge gaps in communication that currently exist between provider and patient.

Feasibility

As we revisit the IP landscape from week 3, several key advancements are evident, including infection sensors, digital tracking prototypes, and leak detection systems. However, there aren’t existing wound draining bags that pull it all together into a streamlined, user-friendly system. The commercial space is saturated with passive bags that prioritize suction, not smart tracking. While Hemovac and Drainobag offer effective suction and volume estimation, they stop short of integrating with EHRs or automating infection alerts. This gap opens a promising door for innovation: a compact, digitally enabled wound drain system that can detect infection cues, track volume with precision, and share real-time data with providers, without overwhelming the patient.

In terms of feasibility, this would be made possible with a few key points. First, the wound draining bag would have to be made of a material that would be able to host these volume-tracking and infection-noting sensors, while also minimizing bulkiness. The priority would be the automatic monitoring to reduce provider and patient confusion/error, which was also added to the modified needs statement!

Viability

The growing demand for smarter post-operative care creates a clear and timely opportunity to improve wound drainage systems. The global wound drainage bag market was valued at approximately $1.5 billion in 2024, and is projected to grow to $2.8 billion by 2033, driven by the rise in surgical procedures, increasing focus on infection prevention, and the broader push toward IoT-integrated healthcare tools. Yet, despite the widespread need for wound drains, few, if any, existing solutions offer the kind of automated, connected, and clinically actionable monitoring experience providers and patients need.

This is where viability intersects most strongly with the “data-driven provider intervention” aspect of the revised needs statement. A digital wound drain system that collects and shares drainage data through automated sensing and wireless transmission would not only improve measurement accuracy, but also allow providers to spot complications before the patient returns for their follow-up. It could reduce the burden of charting, eliminate delays in drain removal decisions, and flag early indicators of infection, a key driver of readmission and post-op complications.

Furthermore, given that digital health technologies are increasingly covered by payers and incentivized by hospital systems looking to reduce readmissions, a smart, integrated drainage solution stands to be both clinically valuable and economically justifiable. Providers benefit from cleaner documentation and proactive care. Patients benefit from greater clarity, safety, and recovery support. And the market benefits from a high-growth niche with a clearly unmet need.

With these newfound perspectives in the IDEO model, cleaved from surgeon insight, peer review, literature research, and observations in the clinic, the newfound needs statement can be reflected upon:

Post-operative patients recovering with surgical wound drainage need an intuitive, reliable way to automatically monitor drainage volume and fluid characteristics between clinical visits to prevent inaccuracies in measurement, decrease infection risk, and enable timely, data-driven provider intervention.

Needs Statement:

Post-operative patients recovering with surgical wound drainage need an intuitive, reliable way to automatically monitor drainage volume and fluid characteristics between clinical visits to prevent inaccuracies in measurement, decrease infection risk, and enable timely, data-driven provider intervention.