© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.

Columns and Departments

VIEW FROM THE TOP

Anatomist Executive Talks Device Development Tell us how you first connected with AAMI and why.

A mutual consultant that has worked with AAMI and AAA made the initial introduction because she saw an opportunity for our organizations to discuss ways to possibly collaborate to the benefit of both our memberships. AAA’s executive director, Shawn Boynes, met with Mary Logan and Steve Campbell to learn more about our associations’ initiatives. As a result of that meeting, I was invited to share my thoughts in this article. It is an honor to share my insights with AAMI’s membership. You are heavily involved in the Dallas Fort Worth

commercialize said devices, sensors, and doohickeys. Our group meets two to three times a year, and we rotate our meetings through all the academic institutions in the North Texas region (at least five universities and four health-related institutions). We have a core of about 30 regulars, but we have at least 60 people at every meeting, and many people return when we rotate through their institution a second or third time. The purpose is to get the clinicians and engineers to understand each other better, and hopefully the right combination of needs and inventions lead to new collaborations and translational ventures.

Bioengineering Interest Group (BIG). Can you tell

What is the goal going forward with BIG?

us a little bit about that group and its purpose?

I would love to see this as a national model for engineering associations and biological associations to hold joint meetings in a regional format. This is why as president of the American Association of Anatomists I have been attending the annual meetings of a variety of bioengineering societies, and addressing their executives in an attempt to foster these kinds of joint meetings.

This group brings together clinicians, biologists (anatomists), engineers, and the business community in a forum where the clinicians talk about unmet needs and their “if only I had….[a new device, sensor, doohickey]” moments with patients. The engineers talk about their newly developed devices, sensors, and doohickeys, and the business community talks about how to

When research and development (R&D) related to healthcare technology management or clinical engineering requires an understanding of human anatomy to adapt the technology for appropriate conformation, comfort, or safety, anatomists can serve as a resource and as collaborators.

Lynne A. Opperman, PhD, FAAA, is president of the American Association of Anatomists and a professor of biomedical sciences and director of technology development at Texas A&M University Baylor College of Dentistry. She focuses on preclinical translational research related to bone development and growth, and bone response to trauma, surgery and dental materials, such as implants. She co-owns a small business (Craniotech ACR Devices, LLC) and has been awarded several STTR and SBIR grants to build and test device prototypes.

Biomedical Instrumentation & Technology March/April 2015

125

© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.

Columns and Departments

Do you have examples of how engineers and anatomists can interface for the benefit of both groups?

One example from BIG is a manufacturing engineer and a materials engineer from an undergraduate university heard a dentist talking about the problem of breakages in removable dentures. They have formed a group that are brainstorming methods of manufacturing dentures out of “smart materials” using methods and materials to make dentures break less often, but also to make them cheaper to replace if they do break. Should anatomy be a formal part of education of someone in healthcare technology management? If so, why?

If someone is going into healthcare management because they are interested in making devices and technologies that directly interface with the human body safer and more effective, then absolutely they would benefit from taking courses in anatomy/ anatomical sciences. Can you describe the role that healthcare technology management or clinical engineering departments can play when it comes to anatomists and the American Association of Anatomists (AAA)? How can these two groups work together?

When research and development (R&D) related to healthcare technology management or clinical engineering requires an understanding of human anatomy to adapt to the technology for appropriate conformation, comfort, or safety, anatomists can serve as a resource and as collaborators. The engineers also can educate anatomists on what kinds of

Small businesses often do not have experience with preclinical research, and do not understand how to design good, wellcontrolled experiments that will produce significant publishable data. I spend a lot of time with them discussing ways to design experiments that are scientifically excellent, commercially relevant, and focused on small, significant questions.

126

Biomedical Instrumentation & Technology March/April 2015

R&D issues and opportunities exist to build these collaborations. Often our anatomists have a tremendous amount of knowledge and experience teaching the anatomy, but they do not have insights or experience developing research projects. What about healthcare technology and devices? How are they used in your research?

I have worked with many small businesses dealing with all aspects of medical device/ materials development. One small business specialized in reducing oxidation in fuel cells by anodizing those titanium-lined cells with phosphate. Serendipity put them in touch with me to explore the possibility of this anodizing process improving integration of titanium implant into bone in dental surgery, since phosphate is required for bone formation. We generated several federal Small Business Innovation Research (SBIR) grants and found that the phosphating worked at least as well as currently available (and expensive) surface treatments like sandblasting and acid etching. The SBIR track record attracted another small business run by a chemical engineering PhD who specializes in developing new hydraulic materials for use in endodontic root canal treatments. We are currently working on our third National Institutes of Health (NIH) grant doing preclinical testing, and are expecting to ultimately conduct clinical studies testing efficacy of the materials. One of the small business CEOs referred a fellow CEO to me regarding the testing of a new root-form implant her company had developed. We have completed the preclinical studies, and are currently working with an outside consultant and the FDA to conduct the clinical testing of this novel new implant system that is now available for use in Europe (based on our studies), but needs a clinical study before being available for sale in the United States. Can you offer advice from your experience working with small businesses?

Small businesses often do not have experience with preclinical research, and do not understand how to design good,

© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.

Columns and Departments

well-controlled experiments that will produce Given AAA’s connection with AAMI, can you significant publishable data. I spend a lot of talk about how medical industries should time with them discussing ways to design support each other? experiments that are scientifically excellent, I believe we could commercially relevant, cross-pollinate with small and focused on small, The purpose is to get the mini-symposia and significant questions. regional meetings so that Being able to ask a single clinicians and engineers we get the engineers and question also allows one to understand each other the clinicians/anatomists to keep costs controlled, better, and hopefully the in the same room to especially when one first right combination of needs generate research ideas starts working with the and collaboration. Many company. Most small and inventions lead to times we do not know businesses I have worked new collaborations and what is missing from our with will come back to me translational ventures. R&D because we do not for further experiments know what kind of and advice after getting a expertise is “out there.” good publication out of initial projects. The most difficult thing is making them understand that a negative What thing would you want medical device result is not the end of the world—that, in fact, manufacturers to know when they are a modification of a device/material and a designing and developing new devices? repeat of experiments might produce an That every human body is different, both excellent product, at the same time developing genetically and anatomically. Tolerances a track record of product development. tested on dummies and cadavers can be inaccurate and not produce practical data in a What do you see as the single biggest real-life settings. Getting help understanding challenge in healthcare technology? the anatomy/biology from an association full of experts in the field should guarantee Certainly the issue of cybersecurity is huge, finding the perfect fit of personalities that especially after the Anthem data breach lead to innovative new research ideas. disaster. Very large databases are also becoming problematic. A bigger problem for us from the clinician/ anatomy perspective is Imagine that for one day you have the power the regulatory landscape for getting new to single-handedly change one thing about materials, devices, and drugs to patients in a the delivery of healthcare in this country. What safe, cheap, and timely manner. would that be? How do you think that challenge should be addressed?

I believe that all associations that deal with the same regulatory landscape can work together to pool resources so that there is not a duplication of services, and so that research collaborations can be developed to shorten the learning curve, reduce costs, and increase efficiency in navigating the regulatory world.

That all healthcare providers would have to provide UP FRONT a transparent list of the cost of each procedure being recommended for a patient, and that these costs did NOT vary based on a patient’s insurance status. It drives me crazy that healthcare providers can list anything they want, and that there can be 10-fold differences in the cost of procedures from one hospital to another. n

Biomedical Instrumentation & Technology March/April 2015

127

© Copyright AAMI 2015. Single user license only. Copying, networking, and distribution prohibited.

IT Collection This new collection is your one-stop resource for 80001 and Medical Device Data System (MDDS) guidance.

American National Technical Standard American Information Report National Standard ANSI/AAMI/ IEC 80001-1: 2010 ANSI/AAMI/ Application of risk ANSI/AAMI IEC TIR80001management for IT Networks SW87:2012 incorporating medical 2-1:2012 devices—Part 1: Roles, Application of risk Application of quality responsibilities and activities for IT-networks management system management incorporating medicalconcepts to medical device devices — Part 2-1: Step by data systems step risk management of medical IT-networks; Practical applications and examples

Searchable and easy to use, it includes:  11 standards (80001-1, 80001 TIRs, 14971, TIR24971, TIR80002-1, TIR32, 62304, & SW87)  Getting Started with IEC 80001 manual  2 webinars on 80001  3 webinars on MDDS  23 peer-reviewed articles

Order Code: ITCOL-CD List Price: $480 AAMI Member Price: $268

To order, call 1-877-249-8226 or visit http://my.aami.org

Anatomist executive talks device development.

Anatomist executive talks device development. - PDF Download Free
2MB Sizes 1 Downloads 11 Views