Fifty Years of Innovation in Plastic Surgery

© 2016 The Korean Society of Plastic and Reconstructive Surgeons.Background Innovation has molded the current landscape of plastic surgery. However, documentation of this process only exists scattered throughout the literature as individual articles. The few attempts made to profile innovation in plastic surgery have been narrative, and therefore qualitative and inherently biased. Through the implementation of a novel innovation metric, this work aims to identify and characterise the most prevalent innovations in plastic surgery over the last 50 years. Methods Patents and publications related to plastic surgery (1960 to 2010) were retrieved from patent and MEDLINE databases, respectively. The most active patent codes were identified and grouped into technology areas, which were subsequently plotted graphically against publication data. Expert-derived technologies outside of the top performing patents areas were additionally explored. Results Between 1960 and 2010, 4,651 patents and 43,118 publications related to plastic surgery were identified. The most active patent codes were grouped under reconstructive prostheses, implants, instruments, non-invasive techniques, and tissue engineering. Of these areas and other expert-derived technologies, those currently undergoing growth include surgical instruments, implants, non-invasive practices, transplantation and breast surgery. Innovations related to microvascular surgery, liposuction, tissue engineering, lasers and prostheses have all plateaued. Conclusions The application of a novel metric for evaluating innovation quantitatively outlines the natural history of technologies fundamental to the evolution of plastic surgery. Analysis of current innovation trends provides some insight into which technology domains are the most active

REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY

Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature. Data sources PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. Eligibility criteria for study selection Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.” Main outcome measures Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. Results 5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be “substantially equivalent” to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. Conclusions We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study

Quantifying innovation in surgery

Objectives: The objectives of this study were to assess the applicability of patents and publications as metrics of surgical technology and innovation; evaluate the historical relationship between patents and publications; develop a methodology that can be used to determine the rate of innovation growth in any given health care technology. Background: The study of health care innovation represents an emerging academic field, yet it is limited by a lack of valid scientific methods for quantitative analysis. This article explores and cross-validates 2 innovation metrics using surgical technology as an exemplar. Methods: Electronic patenting databases and the MEDLINE database were searched between 1980 and 2010 for “surgeon” OR “surgical” OR “surgery.” Resulting patent codes were grouped into technology clusters. Growth curves were plotted for these technology clusters to establish the rate and characteristics of growth. Results: The initial search retrieved 52,046 patents and 1,801,075 publications. The top performing technology cluster of the last 30 years was minimally invasive surgery. Robotic surgery, surgical staplers, and image guidance were the most emergent technology clusters. When examining the growth curves for these clusters they were found to follow an S-shaped pattern of growth, with the emergent technologies lying on the exponential phases of their respective growth curves. In addition, publication and patent counts were closely correlated in areas of technology expansion. Conclusions: This article demonstrates the utility of publically available patent and publication data to quantify innovations within surgical technology and proposes a novel methodology for assessing and forecasting areas of technological innovation

Tax vs. Debt Management Under Entitlement Spending: a Multicountry Study

In this paper we study the taxes vs. debt choice for public funding when spending is in large part predictable due to entitlement programs, but the necessary fiscal corrections may not be instantly and indefinitely elastic as usually assumed. We study fiscal behavior in a large sample of countries to determine what fiscal regimes have been used in practice, and what they reveal about the trade-off between raising taxes vs. issuing debt. Unsurprisingly, we find that fiscal discipline and the aims of fiscal rules have varied over the past 50 years. Discipline has generally weakened and there has been a greater tendency to use debt. But governments are no less forward looking than they were. Perhaps more surprising, the high debt countries were more disciplined than low debt economies\u2014but with worse outcomes because of their poor starting positions and more persistent public spending. The low debt countries have exploited their stronger initial position to allow less discipline; a \u201cresting on one\u2019s laurels\u201d approach

Making the leap: the translation of innovative surgical devices from the laboratory to the operating room

MINI-ABSTRACT: A decade from publication, approximately one in ten surgical devices described in the literature made the leap from the laboratory to a first-in-human study. Clinical involvement was a significant predictor of translation; devices developed with clinical collaboration were over six times more likely to be translated than those without. STRUCTURED ABSTRACT: OBJECTIVE: To determine the rate and extent of translation of innovative surgical devices from the laboratory to first-in-human studies, and to evaluate the factors influencing such translation. SUMMARY BACKGROUND DATA: Innovative surgical devices have preceded many of the major advances in surgical practice. However, the process by which devices arising from academia find their way to translation remains poorly understood. METHODS: All biomedical engineering journals, and the five basic science journals with the highest impact factor, were searched between January 1993 and January 2000 using the Boolean search term “surgery OR surgeon OR surgical”. Articles were included if they described the development of a new device and a surgical application was described. A recursive search of all citations to the article was performed using the Web of Science (Thompson-Reuters, New York, USA) to identify any associated first-in-human studies published by January 2015. Kaplan-Meier curves were constructed for the time first-in-human studies. Factors influencing translation were evaluated using Log Rank and Cox proportional hazards models. RESULTS: 8,297 articles were screened, and 205 publications describing unique devices identified. The probability of a first-in-human at 10 years was 9.8%. Clinical involvement was a significant predictor of a first-in-human study (p = 0.02); devices developed with early clinical collaboration were over six times more likely to be translated than those without (RR 6.5 [95% CI 0.9 - 48]). CONCLUSIONS: These findings support initiatives to increase clinical translation through improved interactions between basic, translational, and clinical researchers

Assessing the current state of quality improvement training in urology in the UK: Findings from the General Medical Council 2018 trainee survey

Objective: The General Medical Council (GMC) of the UK has identified the need to support doctors through education in safety and quality improvement (QI) methods. This study reports findings from the GMC annual survey of 2018 from urology trainees regarding the state of QI training and their training needs. Material and methods: We designed a set of four questions to assess how QI methods are being taught nationally, and inserted them in the 2018 annual GMC trainee survey for urology. This is a cross-sectional study assessing the current state of QI training and mentoring received by trainees, and their self-assessed ability and confidence in completing a QI project as part of training requirements. Data were statistically analysed in Stata 15 stratified by Local Education Training Boards (LETBs)/Deanery and by specialty trainee level (ST3–7). Results: In total, 270 responses were received from urology trainees. Data showed significant variation across the country. Responses from ST3–7 trainees ranged from 5–20% on completing more than three QI projects, while 7–58% replied that they had done none. Across all ST grades, 40% of trainees stated they had not undertaken QI, whereas 0–27% reported they had not received any mentoring on QI to date. There was significant variation across training regions too: 11–74% of trainees answered that they have received training in QI methods, and 58–100% responded that they were confident in undertaking QI projects. Across all LETBs, 1–3% responded that they uploaded projects on national websites for dissemination; finally, a range of 0–18% stated they had completed more than three projects. Conclusion: This is the first national snapshot of QI training for the entire urology specialty in the UK. The study demonstrates wide variation in QI training and activity undertaken by trainees, and shows a lack of systematic implementation of QI education across training regions

IDEAL-D Framework for Device Innovation: A Consensus Statement on the Preclinical Stage

OBJECTIVE: To extend the IDEAL Framework for device innovation, IDEAL-D, to include the preclinical stage of development (Stage 0). BACKGROUND: In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety. METHODS: Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL Framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects and minimisation of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted. RESULTS: In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness prior to progression to clinical studies (Stage 1). CONCLUSIONS: The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice

Global trends in paediatric robot-assisted urological surgery: a bibliometric and Progressive Scholarly Acceptance analysis

The inaugural robot-assisted urological procedure in a child was performed in 2002. This study aims to catalogue the impact of this technology by utilizing bibliographic data as a surrogate measure for global diffusion activity and to appraise the quality of evidence in this field. A systematic literature search was performed to retrieve all reported cases of paediatric robot-assisted urological surgery published between 2003 and 2016. The status of scientific community acceptance was determined using a newly developed analysis model named progressive scholarly acceptance. A total of 151 publications were identified that reported 3688 procedures in 3372 patients. The most reported procedures were pyeloplasty (n = 1923) and ureteral reimplantation (n = 1120). There were 16 countries and 48 institutions represented in the literature. On average, the total case volume reported in the literature more than doubled each year (mean value increase 236.6% per annum). The level of evidence for original studies remains limited to case reports, case series and retrospective comparative studies. Progressive Scholarly Acceptance charts indicate that robot-assisted techniques for pyeloplasty or ureteral reimplantation are yet to be accepted by the scientific community. Global adoption trends for robotic surgery in paediatric urology have been progressive but remain low volume. Pyeloplasty and ureteral reimplantation are dominant applications. Robot-assisted techniques for these procedures are not supported by high quality evidence at present. Next-generation robots are forecast to be smaller, cheaper, more advanced and customized for paediatric patients. Ongoing critical evaluation must occur simultaneously with expected technology evolution

Regulatory approval of new medical devices: cross sectional study

OBJECTIVE:  To investigate the regulatory approval of new medical devices. DESIGN:  Cross sectional study of new medical devices reported in the biomedical literature. DATA SOURCES:  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. ELIGIBILITY CRITERIA FOR STUDY SELECTION:  Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article." MAIN OUTCOME MEASURES:  Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device. RESULTS:  5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published. CONCLUSIONS:  We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study