The Value of Scientific Publications in Surgical Device Innovation.

BACKGROUND: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature. PURPOSE: We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding. RESEARCH DESIGN: We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results. STUDY SAMPLE AND DATA COLLECTION: We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation. RESULTS: Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely. CONCLUSIONS: Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.

Cutaneous Patches to Monitor Myoelectric Activity of the Gastrointestinal Tract in Postoperative Pediatric Patients.

PURPOSE: Limited means exist to assess gastrointestinal activity in pediatric patients postoperatively. Recently, myoelectric gastrointestinal activity recorded by cutaneous patches has been shown in adult patients to be predictive of clinical return of gastrointestinal function postoperatively. The aim of this case series is to demonstrate the feasibility of this system in pediatric patients and to correlate myoelectric signals with return of bowel function clinically. METHODS: Pediatric patients undergoing abdominal surgery were recruited to have wireless patches placed on the abdomen within two hours postoperatively. Myoelectric data were transmitted wirelessly to a mobile device with a user-interface and forwarded to a cloud server where processing algorithms identified episodes of motor activity, quantified their parameters and nominally assigned them to specific gastrointestinal organs based on their frequencies. RESULTS: Three patients (ages 5 months, 4 year, 16 year) were recruited for this study. Multiple patches were placed on the older subjects, while the youngest had a single patch due to space limitations. Rhythmic signals of the stomach, small intestine, and colon could be identified in all three subjects. Patients showed gradual increase in myoelectric intestinal and colonic activity leading up to the first recorded bowel movement. CONCLUSION: Measuring myoelectric intestinal activity continuously using a wireless patch system is feasible in a wide age range of pediatric patients. The increase in activity over time correlated well with the patients' return of bowel function. More studies are planned to determine if this technology can predict return of bowel function or differentiate between physiologic ileus and pathologic conditions.

A Simplified Method for Three-Dimensional Optical Imaging and Measurement of Patients with Chest Wall Deformities.

BACKGROUND: Pectus excavatum and carinatum are two of the most commonly observed chest wall deformities in pediatrics. The standard diagnostic evaluation for these conditions includes either chest radiograph (CXR) or computed tomography (CT). Our research aims to develop a novel and reliable way of quantifying chest wall deformities in the clinic setting without radiation exposure. METHODS: Using a handheld structured light scanner, we created three-dimensional (3D) models of patients with chest wall deformities through an IRB-approved protocol. Raters from a variety of backgrounds were then asked to take measurements based on the 3D model utilizing commercially available 3D graphical software. The standard deviation of the measurements and intraclass correlation coefficient (ICC) were then calculated to quantify inter-rater reliability. RESULTS: Sixty patients with pectus excavatum (Haller index range 2.0-6.38) and pectus carinatum were enrolled and imaged in our outpatient clinic using a structured light scanner. Five patients were used to verify interuser reliability. The standard deviation of all the measurements was 2.2 mm. The ICC for absolute agreement was 0.99139, with 1.0 being perfect correlation. CONCLUSION: Structured light scanners provide an alternative approach to quantifying chest wall deformities in pediatric patients without radiation exposure. Our method is highly reliable, even among users with minimal image processing or 3D modeling experience. Our protocol can potentially be used to track treatment progress in children with chest wall deformities.

Feasibility and reliability of pancreatic cancer staging using a new confocal non-fluorescent microscopy probe: a double-blind study in rats.

BACKGROUND: Surgical management of pancreatic cancer depends on tumor resectability and staging. Lymph node (LN) metastases represent an important decision-making factor when it comes to surgical treatment. AIMS: To evaluate a new in vivo, endoscopic confocal microscopy (CM) system not requiring fluorescence markers, for detection and staging of pancreatic cancer in rats. METHODS: A confocal system consisting of a confocal scanning laser operating in reflection mode and a dedicated rigid Hopkins rod-lens endoscope were used for in vivo imaging in a rat model of pancreatic ductal adenocarcinoma. A double-blind study compared CM to standard histology in (1) the detection of tumors in rat bearing cancer (n = 11) and controls (n = 6), and (2) in the detection of local nodal involvement at 3 and 6 weeks after tumor induction. RESULTS: CM detected all pancreatic tumors with 100 % sensitivity and specificity and identified 15 metastatic LNs with an average adenocarcinoma nodule diameter of 2.3 mm (range from 1 to 4.2 mm) out of the 66 examined. CM demonstrated a sensitivity of 87.5 % and a specificity of 98 % in LN detection. The Spearman's rank correlation/rho calculator was of 0.87. CM demonstrated a negative predictive value of 96.1 % and a positive predictive value of 93.3 % in the detection of metastatic LNs. CONCLUSIONS: Interpretation of confocal images has a high concurrence rate with histopathology examination for primary tumor and lymphatic involvement detection making it a promising technique for in vivo real-time detection and staging of pancreatic cancer. Larger studies are warranted to confirm these preliminary results.

Original technique to close the transrectal viscerotomy access in a NOTES transrectal and transgastric segmental colectomy.

Segmental colectomy is an ideal procedure for natural orifice transluminal endoscopic surgery (NOTES). Transanal endoscopic approaches have enabled rectosigmoid colectomy through a viscerotomy that is resected with the specimen. To extend NOTES segmental colectomy to the entire colon and beyond, a rectal viscerotomy will have to be safely and effectively closed at the end of the procedure. A new technique for rectal viscerotomy closure using a circular EEA hemorrhoid and prolapse stapler with DST series technology (Covidien) is described.