  Citation: Trubetskaya, A.; Manto, D.; McDermott, O. A Review of Lean Adoption in the Irish MedTech Industry. Processes 2022, 10, 391. https://doi.org/10.3390/pr10020391 Academic Editor: Pietro Bartocci Received: 1 February 2022 Accepted: 14 February 2022 Published: 17 February 2022 Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affil- iations. Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/). processes Review A Review of Lean Adoption in the Irish MedTech Industry Anna Trubetskaya 1, * , Declan Manto 1 and Olivia McDermott 2, * 1 Department of Engineering, University of Limerick, Castletroy, V94 T9PX Limerick, Ireland; declanmanto316@yahoo.co.uk 2 College of Science & Engineering, National University of Ireland Galway, H91 TK33 Galway, Ireland * Correspondence: anna.trubetskaya@ul.ie (A.T.); olivia.mcdermott@nuigalway.ie (O.M.) Abstract: There have been many literature reviews carried out on Lean implementation in larger organisations with specific focus on the automobile industry. Lean implementation in the medical device industry has not been extensively investigated. Thus, this research endeavored to analyse the benefits of Lean, tools utilised and challenges and results of Lean implementation in Medtech companies. This article aims to bridge a gap in the literature by reviewing the literature that discusses Lean implementation in MedTech companies in Ireland with a perspective of identifying the benefits and challenges faced. The quantitative methodology allows us to review the comprehensive numbers and data which were collected from 20 Enterprise Ireland MedTech case studies. There are very few published case studies in the literature on Lean due to the highly regulated nature of MedTech sector and the vast array of medical devices, which are often under privacy and confidentiality constraints. The results showed that integration of Lean has brought benefits to companies by increasing productivity and product quality, optimised cost, and time. An inclusive discussion of Lean tools for Lean implementation within MedTech was established and suggestions for future research orientations are thus provided. Keywords: Lean; medical device industry; Ireland; supply chain management 1. Introduction Various industries have seen, over recent decades, massive improvements to manufac- turing processes due to the application of the Lean methodologies [1]. Heavily regulated industries such as medical technology (MedTech) and Pharmaceutical Manufacturing have been slow to adopt and implement Lean strategies [2]. In the medical device and phar- maceutical industries, which are highly regulated to assure patient and customer safety, continuous improvement programs can face many challenges [3]. Due to the regulated nature of the industries, medical device manufacturing focuses on quality, and for good reason, though this means little time is left to remove the sources of waste. It is critically important to have all released products be 100% compliant with all specifications and understand all factors which have a strong impact on the improvement of Lean strategies in MedTech to remain a competitive industry [4]. Ireland has gained tremendously from this high-growth industry and currently em- ploys over 40,000 people within this sector [5]. Ireland has been identified as a desirable location for MedTech companies as 9 of the world’s top 10 MedTech companies have located their manufacturing facilities here [6]. Ireland is seen as a high-cost manufacturing location mainly driven by high cost of labour, property, transportation, and utilities [7]. Despite all of this, Ireland is globally recognised as being competitive in a range of sectors including food, medical devices, pharma/biopharma, ICT, engineering, and green technologies [8]. Due to the thriving success of the MedTech industry, organisations in Ireland are increasingly transitioning to the adoption and deployment of Lean methodologies with the objective of driving new and innovative technology, delivering on new product development, and looking to improve operational efficiency and product quality [9]. The MedTech companies Processes 2022, 10, 391. https://doi.org/10.3390/pr10020391 https://www.mdpi.com/journal/processes