Dr. Beth Ann Fiedler,

           I am interested in collaborating with you, contributing development of the medical device regulatory book. Strategic partnerships among bioengineers, collaborating developers/engineers, entire spectrum of healthcare providers, FDA, public transparency, CMS, and government at the federal, state, and local level could make widespread adoption of new and existing revolutionary inventions and innovations designed a reality. My vision as an aspiring biomedical engineer, is to foster global intersect-oral cross-disciplinary collaborations focusing on breakthrough fundamental research, discoveries, and applications that integrate computer science, biology, and engineering that are cost-effective and eco-friendly. Through punctilious illuminating academic instruction, experimental research, discussion of parameters such as sensitivity, specificity, reproducibility, robustness, and inherent limitations with prestigious faculty, students, and additional collaborators we can research, design, and monitoring engineer innovations and inventions which will one day seem impossible to live without. Engineering smaller medical devices, which combine the use of materials with quantum properties, artificial intelligence, robotics, sensors, and wireless technologies. Curing and or preventing once burdensome diseases, improving life expectancy and quality of life, in addition to boosting productivity and economic growth. As computer scientist Alan Kay, president of the Viewpoints Research Institute once said, “The best way to predict the future is to invent it,” and that’s precisely what engineering, medicine, you and I are going to do. On March 31, 2015 the FCC and FDA are hosted a public workshop entitled, "Promoting Medical Technology Innovation - The Role of Wireless Test Beds," (which I attended), addressing the "hospital in the home," concept which continues to catalyze medical technology innovation, & critical components which must be addressed (need for wireless coexistence) in order to facilitate and maximize the development, device efficacy, strategies to consider resulting in widespread adoption and use, and. The CPIM (Critical Path Innovation Meeting) is a means by which the Center for Drug Evaluation and Research (CDER or we) and investigators from industry, academia, patient advocacy groups, and government can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. CDER will identify some of the larger gaps in existing knowledge that requesters might consider addressing in the course of their work . The guidance and administrative procedures for a Critical Path Innovation Meeting (CPIM), including how to request such a meeting and other similar comprehensive strategic insightful avenues which I have un-paralleled access to will instrumentally influence the successful development of your medical device. In addition to this workshop, I have, and continue to enroll, participate, and engage with ONC, HHS, FDA, Major Corporations, Manufacturers, Developers, Physicians, etc. Leveraging the perpetual rapid growth of my global network, my past and current research, I am certain that I will fulfill the answers to the questions which you have now, and may have in the future. Feel free to invite me to connect on linkedin ----> Lars Lafferty (My Email: [email protected]). I would be thrilled to discuss with you in further detail at your earliest convenience. I look forward to hearing from you, hope that you are having a wonderful evening.

Sincerely,

Lars Lafferty

I am interested in knowing more, such as when would a manuscript be needed, the scope you envision me writing, if funding is available to support writing, etc.

Lars and Brian: In terms of general information, the book deal is already contracted and I am looking for support on six sections with specific subsections that have already been vetted and approved. However, there is some wiggle room for items of interest that can be addressed under the general topics that I have put forth. The final contract signature is pending some corrections to lead members information.  Myself, Dr. Yadin David, and Dustin Telford are designated author and co-authors.  I did not receive any funds for this project and therefore, would not be able to offer any monetary compensation.  Additionally, the designated author and co-authors will only receive compensation based on annual sales.  So, you should not expect any compensation other than co-authorship of a sub-section in which I believe your particular expertise may be best utilized.  Currently, I have a schedule in place for each of the six primary sections. The final product is due February 1, 2016 and should be published within 6 months of final submission/edits/approvals. I have also obtained Larry Fenningkoh for the forward.  Each of these individuals that I have named have a particular expertise in relation to Biomedical Engineering, Technology, Maintenance, and Regulatory Compliance both nationally and internationally. Brian, I am of course aware of your work but would like to see what you have been up to since we worked together in 2011.   Can you and Lars please send me a current copy of your CV?  At that point, I will be better able to direct specific material in your direction should there be a mutual fit.  If you are selected as a contributor, it would also be necessary to complete some paperwork with the publisher.   The primary document is a Contributor's agreement from the publisher. You will be asked to provide your full name,  telephone numbers, mailing addresses, including postal zip codes, and electronic mail addresses. It is also important that you list your affiliations.  Since you both currently represent a University, please have an authorization from it indicating that you are allowed to use the affiliation for the purposes of this book. This document

can be an email requesting the authorization. However, you should print it and

ask an authorized, legal representative to sign the document and forward it

to me via my Data 2 Policy address which I will post separately.  That email must also indicate that the university acknowledges that they are not entitled to compensation/royalties from the publication of my book. This document is for my files so that there are no misunderstandings regarding compensation.   If you are still interested, please send your CV to [email protected].  

PS

Lars: based on what you have written, I feel that you may fit in the future trends of healthcare but might also have some input into other earlier sections.

Brian: Our prior work on medical simulation and regulatory standards may have some application but we are generally focusing on systemic medical devices such as robotics and drug administration. Off the cuff, integration is a big deal and may be an area of interest.  

Update: there is a small contingency for Lead Author's on subsections for a Contributor Honoraria as well as a free copy of the book.  

Beth Ann,

I don't think my work is going to align well with your book as I am off onto some new endeavors in healthcare.  I wish you and your team the best in putting together this book.

@ Dr. Goldiez. Understood...good luck to you, as well. 

@ Dr. Goldiez.  Any new developments on the research from 2011?  Developing Data Exchange Protocol Standards for Healthcare Simulators?  

May I make a small comment about the intellectual property rights associated with a written script. These rights are usually protected through copyright and publishers would want ownership of those transferred to them prior to publication, as it is with journal publications, I assume.

Although there is kudos associated with publications, I doubt if a book can carry more kudos than a publication in a journal with a high impact factor. Therefore, in case of a book, if there is new knowledge contained within the script, then how is the author compensated for it. It is all fine to say publisher will pay some percentage from the sales, when they happen, but all that depends on their market penetration and strategy, advertising, etc.

I found it interesting to read your method of seeking collaborators for a book. I hope there will be new knowledge and/ or methodology in the contents.

with best wishes