provide a summary table of the MDDI metrics requested above.In addition, you are requested to identify a specific entrepreneurial medical device company relevant to your BME area of emphasis and that is developing a disruptive technology either for profit or nonprofit, i.e., ‘socially entrepreneurial’.

Asindicated in the BME 417 course philosophy and conduct handout and re-iterated in our first, ‘in-house’, group capstone session, in order to realize the full potential ofBME capstone design as a ‘transforming experience’ from BME student to a budding professional biomedical engineer, you are expected to apply your utmost due diligence at all times toward meeting, if not exceeding, the objectives of BME capstone design. Initial steps recommended toward achieving this end goal is to read the required text materials and/or related reading materials called out for in the design tasks (DTs), as well as, reading the DT at hand (DT#2) in its entirety before embarking upon the design task. You areasked to confirm that these steps were taken in yourcompleted DT work product handed in. Note that DT#2 is an independent effort and the author should explicitly indicate that this was the case.If there are any questions regarding this expectation, please direct them directly to BME capstone upper management, i.e


RationaleAs aspiring bioengineering medical device product designers and developers, it is important to continue building upon your newly expanded knowledge base of the global medical device industry that you are beginning to obtain from selected resources utilized in DT#1.At this early stage of identifying BME capstone design projects, it is important to first understand the generic characteristics of successful product development that can then be extrapolated to specific attributes leading to the successful development of medical device products. For the former, you are asked to first read Chapter 1 of Ulrich and Eppinger’s(U&E) text on Product Design and Development. For the latter, this includesbeing well versed in identifying product opportunities and their translation to the various product segments of the Biomedical & Biotechnology Health Care Industries where we will initiate in this design task (DT#2).


In doing so, it should become apparent to you, from the industry metrics and demographicsthat you are asked to assemble, that there existsignificant diversity of expertise and medical device product areas in the Medical Device and Diagnostic Industry (MDDI). As such, this thenoffers significant product development opportunities within the aggregate Medical Device & Diagnostic Industriesin the US and Worldwide. Altogether, this information, if well researched and analyzed, should better assist you in the design of medical device productsstarting with your fledging BME capstone project. For example, such a resource can help you to more efficiently conduct external searches to help you identify product opportunities that can potentially meet unmet needs, as well as, ‘benchmark’ existing medical device products that are designed and manufactured to meet the needs of biomedical/biotechnological health care product market segments, i.e., clinical therapeutics, diagnostics, and related applications, amongst many other beneficial outcomes.  As such, this task can serve you well if it is done with ‘due diligence’. This will, however, require much effort … so please do not delay in getting this tasks started!


DT#2 ChargeIn order to help define this continuously evolving and expandingbioindustry ‘landscape’, your design task at hand is to prepare a technical report that succinctly provides both the breadth and depth, i.e., the ‘big picture’, of the medical device and diagnostic industry (MD&DI), as well as, an objective, fact-finding, assessment of the current state of product development affairs of the MD&DI. Note that the more recent and emerging MD&DI products and associated product segments may be so-called ‘combinations’ of drugs, biologics and devices. These so-called ‘combination products’ clearly fall within the scope of the MD&DI and, thus, under the FDA’s Center for Devices and Radiological Health (CDRH) regulatory purview. Thus, it is important to also include those MD&DI companies that produce combination products, but not biotechnology companies, per se that fall outside of the MD&DI (e.g., biotechnology companies producing genetic engineered foods).


More specifically, you are requested to utilize the appropriate information technology (IT)-based resource information that will help you construct a ‘profile’ of the MD&DI including its health-related Biotechnology Industries in the US and at least one other country in the world. For the US and other countries around the globe, a potentially more efficient way to accomplish this aim is to first construct a comprehensive list of relevant industry metrics that best summarize registered medical device companies. Examples of relevant industry-related metrics that are important to consider (but not limited to) include their size (no. of establishments), location (geographic locations/regional distribution), employment figures (number of people involved, salaries for various levels of BME professionals, e.g., entry level, ‘x’ years of experience, etc), employment trends (current and projected new job areas), medical device product types and market ‘value’ (e.g., value of shipments, distribution of sales, etc), international trade (imports and exports), how they are commercially classified (e.g., NAICS), other pertinent medical device product metrics (trends in marketing, trends in distribution, etc), and any other relevant information that would be useful in creating a comprehensive MD&DI profile. Once your profile is completed, please write a short brief’ on the state of the medical device industry in the US and the world, i.e., current and future economic health, impact on health care and its delivery, e.g., affordable care act, etc, career opportunities, growth in entrepreneurship (for profit and social benefit, i.e., social entrepreneurship), among other factors you deem relevant, Please defer to the file located on the BME 417 Capstone Design I blackboard website under Design Task #2 assignment entitled ‘Industry Resources’. This file contains a number of useful industry references that can assist you in creating the MD&DI profile requested.  Supplementary resources are the following articles: (i) Medical Devices and Disruptive technology: Boston Scientific; (ii) Entrepreneurship by Russell S. Sobel.


Please provide a summary table of the MDDI metrics requested above.In addition, you are requested to identify a specific entrepreneurial medical device company relevant to your BME area of emphasis and that is developing a disruptive technology either for profit or nonprofit, i.e., ‘socially entrepreneurial’. Once you have identified a medical device company (hopefully of interest to you) that is related to your area of emphasis and is working on a disruptive technology, you are then requested to create a succinct profile of that company. The company profile should what key enterprise/organizational factors that promotes theirunique innovative and entrepreneurial culture that promotes their development of disruptive technology, as well as, their size, location, product line(s), their relevant bioindustry segment(s), parent organization (if applicable), specific medical device design activities, potential career opportunities in this MDDI/biotechnology segment, and other pertinent information that you deem relevant based upon the results of your broad industry profile. In order to assist you in completing this part of the design task, please refer to the file entitled, ‘How to Research a Company’.  There are also articles published in various trade magazines among other sources, e.g. MMDI, of the top 50 or so Medical Device Companies to Watch’thatcan serve as a good resource that list ‘up and coming’, as well as, very well established and very successful companies of all sizes that represent very diverse health care technologies.


In order to assist you, our longstanding Noble Science and Engineering Librarians Linda Shackle and Sheila Young) along with business librarian colleagues at Hayden Library, have over the years put together a rich compilation of information resources to assist you on researching a specific company, as well as an entire industry, such as, the MDDI. In this regard, Linda and her library colleagues have created an Assignment Help page with a sub-page for ‘BME 417 Researching Company and Industry Profiles’. Here you can follow the link to the ‘Bioengineering LibGuide’ [] that contains number of resources relevant to this design task, including a direct link to a so-called ‘Company and Industry Profiles’ research page.


When you access this site, you will see that it has two flow charts with links to lists of resources used at a specific stage in the research process. In the third box, there is a list of resources by type – these are the same as what is linked in the flow chart but just grouped by type (such as company financial data or industry market studies) rather than order of use. The path is to click on LibGuides from the home page and the search Bioengineering, then the tab “Assignment help” and then BME 417 Company and Industry Profiles.




When you have completed your research and have created your technical report that provides the salient MDDI profile features requested, you are also asked to create a one page summary sheet, e.g., a table that succinctly summarizes the metric requested that should be placed at the front of the report just after your LoT. Please include the effort expended, i.e., how many hours, to complete DT#2.


Note also to use the MLA Format for referencing (see guideline posted on class website). Also, provide a record of your effort expended for this design task. Please refer to the DT#2 assessment criteria provided herein to help guide you to MDDI information pertinent to this design tasks.


In summary, DT#2 is comprised of essentiallythree main subtasks for this assignment, i.e., (a)US MDDI Industry Profile, (b) US MDDI Industry Profile Summary Table, and (c) Specific MDDI Industry Profile.Please provide headers for each of these subtasks.  Then, undereachsection header, delineate the various components that were called out in the DT.


For Subtask (a):US MDDI Industry Profile,

  • Introduction/Background:
  • US MDDI Size:
  • Location/Distribution:
  • Product (types, shipments/distribution):
  • Product Classifications:
    • Include a table with NAICS codes and a separate table forSIC codes (with captions).
  • Employment Data and Trend:
  • Market Values:
  • International Trade:
  • Other Pertinent MDDI Information:
  • Overall MDDI Assessment:
  • Write a well thought out, insightful, summary pageon this, i.e., it should be a well thought out and retrospective reflection of your overall findings.


For Subtask (b):US MDDI Industry Profile Summary Table

Make a table along with a descriptive caption. Then populate this summary table with pertinent findings obtained from your independent research that capture ALL of the key highlights reported on in subtask #1. This table should be a comprehensive but succinct tabular summary of your findings in subtasks (a).


Subtask #3:Specific MDDI Industry Profile

  • Company Identified:
  • Identity Key Factors of Corporate Culture:
  • Company Size and Location:
  • Listed Company’s Disruptive Technology:
  • Product Line(s)/Classification:
  • Product Sales
  • International Trade
  • Employment Data and Trend:
  • Design Activities:
  • Product Sales:
  • International Trade:
  • Other Pertinent Information:


Note, also,that Subtask (a) is for the entire US MDDI Industry. For Subtask (c), pick a specific company. Also, please delineate everything in paragraphs, no lists (unless it is for a table). When it calls out to write aparagraph, write a good sized paragraph. Don’t forget to caption your table. Also please cite allwebsites in MLA format. You should have a very large reference section for this DT. Note how that the format of the DTs directly reflects the assessment format below.


Finally, as discussed in the in-house session, DT#2 and all ensuing DTs require a sustained and concerted effort. So do not wait until the last minute to start DT#2 but start now and get your research done ASAP in within the first week, so that you can create a well thought out report on your independent findings.


Please submit your of BME 417 Design Task #2 technical report work product on the MD&DI that is accompanied by a ‘Letter of Transmittal’ in both (1) electronic form to the BME 417 website in the appropriate location no later than Wednesday, September 6, 2017 by 10:00pm and in (2) hard (paper) copy form that you submit at the beginning of your respective BME 417 Design Session scheduled for Thursday, September 8th in the Design Center Studio (SCOB-340) or prototype lab (SCOB 290).






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