{"id":463,"date":"2019-11-08T10:15:58","date_gmt":"2019-11-08T10:15:58","guid":{"rendered":"http:\/\/guires.uk\/newsroom\/?p=463"},"modified":"2019-11-11T12:37:31","modified_gmt":"2019-11-11T12:37:31","slug":"healthcare","status":"publish","type":"post","link":"https:\/\/guires.uk\/newsroom\/case-studies\/healthcare\/","title":{"rendered":"Healthcare"},"content":{"rendered":"\n

TTK Healthcare is focused on bringing a high level of precision into their orthopedic manufacturing process. The Ortho Division is engaged in the manufacture of quality orthopaedic implants and instruments under the brand name “Altius”. TTK Healthcare Ltd acquired the orthopaedic business of M\/s. Invicta Meditek Ltd. in July 2009 to consolidate their medical devices business. <\/p>\n\n\n\n

The Challenges<\/h3>\n\n\n\n

In order to comply with the European\nUnion Medical Device Directives \u2013 90\/385\/EEC Active Implantable Medical\nDirectives (AIMD), 93\/42\/EEC Medical Device Directive (MDD) and 98\/79\/EC In\nVitro Diagnostic Device Directive (IVDD), its mandatory that manufacturers\nshould conduct post-market surveillance (PMS). PMS is a collection of processes\nand activities that are used to monitor the performance of a medical device\nthat accurately characterize the real-world device behaviour and clinical\noutcome. The flow of information into risk management comes from a wide variety\nof activities and one such is the clinical data obtained from post-marketing\nsurveillance. PMS study methodology should adhere to relevant guidelines and\nstandards and described in a Clinical Investigation Plan (CIP) that include a\ndescription of the rationale, objectives, endpoints, statistical methods, and\nclinical processes. A statistical analysis plan (SAP) offers a detailed\ndescription of the methods required and it should be performed in accordance\nwith the SAP by experts experienced in medical device. <\/p>\n\n\n\n

The Company has approached us to provide statistical Analysis Plan and the report for the Post market surveillance study. The objective is to track the feedback from end users (patients and surgeons) about our product to strive and make a continuous improvement in the safety, performance and efficacy aspects. The information filled out in pen\/pencil is the feedback and typed out content in the sheet from the sales invoice information. The feedback was measured in qualitative scale (ex: good, very good, excellent, fair, poor) and the Knee score measures feedback quantitatively. Data discrepancy was challenging as the practice of scoring using knee score by the surgeons\/patients is not a prevalent practice in this geography and is just an upcoming process, that was not mandatory. So, the surgeons who are acquainted with this methodology has provided this information and others are blanks. Missing data and outliers were one of the challenging when preparing SAP and reports. <\/p>\n\n\n\n

Our Strategy<\/h3>\n\n\n\n

Guires Partnered with TTK for Statistical Analysis plan (SAP) and report preparation. Since the basis for SAP is the PMCF Strategy plan (PM surveillance programs) we have edited an existing PMCF to match with statistical analysis plan. That includes research questions, objectives, endpoint, study population (inclusion & Exclusion criteria), methods (with rationale of chosen study design, [not focused on selection of sites and investigators], duration of patient follow-up, data to be collected, (including questionnaire design for few of our clients), statistical analysis, a method of quality control of data a plan for conduct and an analysis of the data. Here, the objectives, efficacy end points and the hypotheses, study methods and rationale, study methods, will be set based on the outcome obtained from the draft data analysis.<\/p>\n\n\n\n

Outcomes and Impact<\/h3>\n\n\n\n

The Basic data management activities were carried out such as coding and decoding, outliers, missing data etc. Data were categorized based on factors like (i)patient’s age, (ii)gender, (iii) type of diagnosis, (iv) type of deformity, (v) product sizes, (vi) complications (if any), all of which needs to be correlated to the feedback that is being provided by the hospitals\/ surgeons and this was achieved via a valid hypothesis framing and testing. An in-depth analysis of data was conducted and presented in the form of a Statistical report. A clinical inference in the form of a Clinical Study Report (CSR) was prepared as to the findings based on the mutual understanding. All adverse events were carefully recorded and notified (see Regulation 16(10) of the Medical Devices Regulations 2002 (SI 2002 No 618) [1] and Annex X of the Medical Devices Directive 93\/42 EEC). We have adhered to EN ISO 14155: 2011 for the design, conduct, recording and reporting of clinical investigations. We also adherence to statistical principles for clinical trials (International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH] E9)4 state that \u201cthe principal features of the eventual statistical analysis of the data should be described in the statistical section of the protocol.\u201d <\/p>\n\n\n\n

Lessons Learned <\/h3>\n\n\n\n