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

@Hamid.  COLLABORATORS This site promotes collaborations!  This was one method that I used for seeking collaborators.  I am leading two others and we bring various connections to the table.  But as is the case with any research, there is always a need for fundamental research, photography, graphics, etc.  There are also contacts on this system who I have worked with in the past and follow me.  Also, these individuals may have access to the exact software that I need so I would prefer to ask them to contribute to showcase their work versus the cost of investing in software that I may only minimally use.  Also, being led by a PhD on a project is extremely valuable for graduate/undergraduate students to get their feet wet in real research methodologies.  COMPENSATION  There are a variety of methods of compensation that are dependent on whether you are an editor of the book or an author.  Authors are generally entitled to a higher percentage of sales compared to editors.  But in the case of those editing, there is also some direct compensation for the senior author of individual items which varies by publication house.  COPYRIGHT In regards to what seems to be your main question: copyright, when I sign an agreement to a publishing house, I make sure that my intellectual property rights are maintained.  Hence, I can extract any portion of documents that I have written and publish them separately without penalty because, after all, I am the author. Of course, I would disclose the source which would lead to publicity for the book/document.   Further, book sales may present opportunities to present the information at conferences for further compensation.  Since I would be the subject matter expert on the new material, it would be difficult for another person to gain any notoriety if (s)he simply just verbalized my work.  Any conference that would allow that would be a major thumbs down.  If a major publisher/journal took my work and held onto it (kept it from being published) for the sole purpose of selling contents, their dirty deeds would surface.  Eventually, that information would become apparent and that hypothetical publishing company/journal or unethical individual would lose academic credibility.   When I write, I keep all of my revisions electronically on my system and on a backup.  If there is any question as to how a topic or new information was formed, I can direct the person to that information without blinking an eye.  If I see pieces of my work surfacing or find that others are being paid, then that will eventually surface and I would sue for damages.  STORY This reminds me of a man who said that he came up with the THERBLIGs. THERBLIGs were essentially elements of motion studies done by the Gilbreths in the early years of US automation/healthcare procedures.  Knowing that men were not always ethical, Frank Gilbreth and his wife Lilian came up with the acronym which was basically the reverse of their last name.The man could not explain why he had used this acronym and was duly humiliated in court.  The Gilbreths happily maintained their claim to their original work and the person  making the false claim was booted out of the courtroom.  This took some time, but time always allows the truth to come out.  If you want more definite information on copyright laws regarding publications, I would advise that you speak to an Intellectual Property attorney.   But I agree, there are times when others benefit from this work without compensating/acknowledging the originator. If you know how to stop that, please advise.  Also, you may be interested in knowing that one of their daughters Ernestine Gilbreth Carey  (1948) wrote the book "Cheaper by the Dozen"  The Gilbreths had a large family.  A mid-20th century movie was made as well as a more recent one.  Fun stuff....