A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

Round 1

Reviewer 1 Report

The structure of the manuscript is well-organized, and the study appears to be sound. As stated, the major issue of combining various tools and practices with Lean is that it increases complexity in terms of process management. I would like to see authors' ideas to improve this complexity. In addition, it would be clearer if authors added explanations of how the deployment of Lean using VSM affects and overcomes regulatory issues in medical device development processes in Section 4. Mistakes in numbering on headers and pages, unseen Figure 1 in statements, and missing spaces between words are minor issues.

Author Response

Thank you for your feedback, we have attached a response. 

Olivia

 

Author Response File: Author Response.docx

Reviewer 2 Report

Dear authors, thank you for having a chance to read your work. The paper topic is interesting due to area of medical markets. However, actually is not in final form for publishing. My recommendations:

 

Type of the paper

--  Type of the paper is set as “article”. However in abstract authors highlights review goals and results. “The purpose of this study is to review Lean tool application …”. This sentence could be confusing for readers. The paper is research article or review? (in methodology is used “systematic approach review” method.

·   --       So, according to the text, it looks like that authors wrote review paper using systematic review methodology.

 

Introduction

· --         Small and Medium Enterprises(SMEs) - LINE13 on PAGE3 – separate (SMEs), comma is missing

·  --        I recommend include which lean tools are mostly used in medical area (it could be in last paragraph on page 3 or in first paragraph on page 4)

 

Literature review

·  --        “2.1 The Regulatory Landscape and its effect on NPI” (PAGE5) and “2.1 Current Medical device NPI Approaches” (PAGE7). Both headers have same numbering.

·   --       This section deals with the general theoretical background of the topic under study. However, I think that it does not need to be so long (only main points and terms definitions are important for paper). It would help if it focused more on other "literature review" articles on the topic (or related topics - e.g. review of lean, review of product development methods, review of medical area improvement methods etc.).

 

Methodology

·  --        Header „3.0 Methodology” should be only “3. Methodology”

·   --       The methodology could be enlarged, see PRISMA methodology for systematic review. Some point from PRISMA checklist are missing (analysis, evaluation phase etc.), including “PRISMA checklist” as a whole. Add it to the attachment.

·    --      PRISMA flow chart could be better than flow chart in Figure 5 where are missing numbers of selected and eliminated papers.

 

Results

·    --      Header “4.0 Results from the Literature Research” should be only “4. Results ….”

·     --     If was “systematic review methodology” used then should be results in line with this method. Which papers were in final selection of systematic review? How were these papers analysed (keywords, abstracts and their frequencies in tables, what were theirs aims or methods used etc.; what have these papers common. What these articles imply?)? If you used systematic review methodology then I recommend study more review papers methodology.

·    --      Limitations are missing. I think that main limitation of this study and paper is wrong use of systematic review methodology.

 

Conclusion

·    --      This part should connect introduction (research questions) and results. The conclusion should be based more on the findings and analysis.

 

·   --       RQ2 is related to comparison of lean NPI in medical area with other industries. This question is defined in introduction and answered in conclusion. What is missing, however, is a link between the conclusions and the results section. (or it is based on review part 2?). Research questions should be linked to results, not preliminary review.

 

 

To sum up, the paper is not well prepared. The article should be rewritten into a form corresponding to a systematic review paper. The conclusions would then correspond better with the results based on the analysis of the selected publications.

 

 

 

Comments for author File: Comments.pdf

Author Response

Thak you for your feedback. We have uploaded a response. 

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

The authors have made some changes to the article, but the following things should still be done:

·        Results - The authors state that they used 135 articles in the main body of the article. I recommend starting the Results section with a description of these 135 articles. That is, indicate what keywords, goals or other characteristics were similar. What I'm missing here is an analysis of these 135 articles, under which journals, what topics are central, what methods were used, which authors, what is the citation rate of these articles. At least some of that information should have been included in the first part of the results. This will make it clear that the authors really used these 135 articles to produce the results.

·        In the conclusion section, I would recommend adding a paragraph describing the latest trends in lean manufacturing in healthcare. For example, how COVID-19 has affected supply chains and what impact it has had on the just in time method. Similarly, how have trends in Industry 4.0 (3D printers), for example, affected lean manufacturing.

The paper needs now minor revision related to two changes – in results and conclusion part.

Author Response

Dear reviewer,

 

we have attached our responses.

Best wishes

Anna

Author Response File: Author Response.pdf