Photograph of the south side of the White House. The flag on the pole on the roof of the White House is at half-staff. A fountain is active in front of the white house, there are leaves on the surrounding trees, and a row of red tulips runs in front of the bushes framing the fountain.

Export control regulations undergoing reform

A map of the world in which each country is represented by its flag. The outlines of each country are drawn on the map, with the flag being modified to fit within those borders.
As the numbers of international students and visitors at U.S. institutions grow, export control regulations will be of increasing concern for higher education officials.

The framework of export control regulations (ECR) in the United States is an immensely complex structure with historical underpinnings that date to the Cold War era. Much of the statutory authority for today’s laws dates back to the 1970s, yielding regulations that were designed to mitigate threats that have evolved greatly over the subsequent decades. The essential purpose of export controls remains the same, that being to require governmental authorization to export certain information and items to foreign entities, but the patchwork of existing regulations challenges even the most seasoned export control administrator due to the multiplicity of agencies and overlapping, highly technical nature of the regulations.

All Presidential administrations since Kennedy have undertaken various efforts at restructuring export controls to improve and enhance national security and foreign policy objectives. President Obama’s announcement in 2009 of a broad inter-agency review of export regulations was welcomed by industry. In remarks to the Department of Commerce Annual Export Controls Update Conference in 2010, the President said, “We need fundamental reform in all four areas of our current system, in what we control, how we control it, how we enforce those controls, and how we manage our controls.” The timing, though, invited speculation that perhaps a shift toward deregulation was afoot, in light of the administration’s work on the National Export Initiative (NEI). The NEI was indeed focused on economic growth, embodying the President’s stated goal of doubling exports between 2010 and the beginning of 2015. The Administration’s current export control reform initiatives were not developed as a component of the NEI and are expected to enhance and support current national security and foreign policy objectives with respect to items on the International Traffic in Arms Regulations (ITAR) munitions list and the Department of Commerce’s Commerce Control List (CCL).

In spite of the recent rise in enforcement actions against higher education institutions (HEIs) for violations of export control laws, there persists a misconception among many in the HEI community that export regulations do not apply to post-graduate educational institutions. While this deficit in awareness has not been a primary driver, or even a key factor, in the move toward recent reform initiatives, the impact on HEIs from the changes that have been proposed for implementation is expected to be mixed. These effects derive from the fact that HEIs collectively are an important locus of activities that reflect global-scale societal changes which are reshaping the risk landscape for militarily critical technology. University research and education is a fundamental driver of the rapidly increasing pace of technological development worldwide, channeling information into ever more freely-flowing conduits of knowledge exchange to a world population that is more connected and mobile than ever. These trends are well-represented on the campuses of many U.S. HEIs, with the Brookings Institution reporting that the number of foreign students on F-1 visas in U.S. colleges and universities grew almost five-fold between 2001 and 2012. Foreign students and visitors on campus, coupled with the long-standing ethos of openness in academia, present risk for HEI’s in certain circumstances related to “deemed exports.”

While the prevalence of export controlled research activities at universities remains relatively low, the risks and deficits in the intersection of these societal changes with export laws was laid bare in a 2007 report by the Department of Commerce’s Deemed Export Advisory Committee. These findings, together with the broader critique assembled by the National Research Council of the National Academies in their 2009 report “Beyond ‘Fortress America’: National Security Controls on Science and Technology in a Globalized World,” are generally acknowledged to have played a role in motivating the President’s strategy for export control reform. Succinctly summarizing the President’s strategy in remarks at the Business Executives for National Security Conference in 2010, Defense Secretary Robert Gates called for “higher walls . . . placed around fewer, more critical items” to address an existing regulatory framework that is excessively complicated and fragmented, with too much emphasis on lower risk items due to the way those items are classified, listed, and controlled.

The long-term blueprint for the President’s export control reform plan involves three overarching changes. The first change involves the creation of a single list of controlled items, merging the ITAR-based U.S. Munitions List (USML) and the Commerce Department’s CCL, while in the interim transferring thousands of items from the USML to the CCL under a new export control classification number, known as the 600 Series. The second major reform will result in a single licensing entity having jurisdiction over military and dual-use items, with the intent of producing more consistent and higher quality licensing decisions. A Single IT System to integrate these changes is proposed as an additional major reform. Finally, a single enforcement agency is proposed to streamline and harmonize coordination with existing intelligence infrastructure to produce more robust investigation and prosecution with fewer jurisdictional uncertainties.

Update on the Reform Process

In April 2013, the Departments of Commerce and State issued the first set of a number of anticipated final rules that will begin the process of implementing the first phase of the reforms laid out by the President and the Secretary of Defense. Additional rules were issued in October 2013, and January 2014, resulting in the transfer of thousands of ITAR controlled items (primarily parts and components) to the jurisdiction of the Export Administration Regulations administered by the Department of Commerce through the CCL. All of these items will now be classified under a new Export Control Classification Number (ECCN) structure designated as the 600 Series, with a smaller set of items now classified within 9×515 (satellites, spacecraft and components).

These new ECCNs remain restrictive, but pose new challenges for the university export compliance administrator in that they don’t follow the prior standard for dual-use technology established by the “use technology” definition. The technology controls applicable to these new categories may require more careful analysis of licensing requirements and more diligence in avoiding deemed export risk when items from these categories are involved in campus research activities. In addition to reclassification for items, changes have been made to reduce the vagaries and confusion of jurisdiction and classification by moving away from the old “design intent” standard to a new approach of specific enumeration of performance characteristics or other specifications for the highest levels of controls. When this level of specificity is not possible within the USML or CCL, a new definition for “specially designed” will be applicable. Both approaches are intended to apply more objective criteria to the classification process by moving away from the subjective standard of “design intent” that industry felt was the source of variability, uncertainty and risk in the commodity classification process. The newly classified 600 series items will also benefit from more flexibility in the tailoring of controls under the CCL regulations, affording many items the benefit of much more limited control based on item sensitivity, country of destination and end use/user, in contrast to ITAR’s “one size fits all” broad-based controls, which offer very few country-based exemptions. This, coupled with a new Strategic Trade Authorization exception, will benefit commercial exporters of controlled items, but is not expected to offset the increased burden of compliance review that the new rules will require for 600 Series and 9×515 items.

The Bureau of Industry and Security within the Department of Commerce maintains an ECR dashboard that periodically updates progress on the various elements of the President’s ECR priorities. The most recent update available indicates that final rules have been set for a number of categories, and implementations . However, it may be some time before definitions related to public domain and fundamental research, which are important to HEIs, are finalized and the Single IT System is fully implemented.

Written by Reid Smith, Director of Technology Transfer & Business Partnerships, Miami University.

Photo of White House by Black and White on en.wikipedia (public domain) via Wikimedia Commons.  Map and flag image by Merasoe via Wikimedia Commons, used under Creative Commons license.

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3D printing is a promising new dimension in medicine

Two women in white lab coats are focused on and touching a piece of machinery on a tabletop. The machine is made primarily of white plastic, but also has some metal parts, and it has some cables extending out from it. The woman in the left of the frame has long, dark blonde hair. She is seated and wears glasses. The other woman stands to the first woman's left. She also wears glasses and has short, dark hair.
Master’s student Martha Fitzgerald (left) and Dr. Jessica Sparks, associate professor in chemical, paper, and biomedical engineering, conduct research to create lifelike tissues with a 3-D printer.

Painful pressure ulcers often afflict the elderly and people with limited mobility. Better known as bedsores, these ulcers sometimes lead to life-threatening complications and can be costly to treat.

“They’re something that all long-term care facilities want to prevent in any way that they can,” says Jessica Sparks, an associate professor in the department of chemical, paper, and biomedical engineering at Miami University.

Sparks is collaborating with Miami nursing faculty Deborah Beyer and Brenda Barnes ’82 on a proposal to develop pressure ulcer models that are realistic in color and shape.

Their proposal involves additive manufacturing (AM) technology. AM — often referred to as 3-D printing — uses three-dimensional design data to deposit successive layers of metal, plastic, or other material until a three-dimensional solid item is complete.

“We’re going to use the models to train the frontline staff, who would be the most likely to see a very early-stage pressure ulcer developing on a patient,” Sparks says.

Those staff members could then call in a wound care specialist to administer treatment before the condition progresses.

“Using 3-D printing in the field of medical simulation for training has lots of potential,” Sparks says. “Those two things should go together.”

Sparks, Beyer, and Barnes plan to request funding for their project from the Ohio Board of Regents’ Workforce Development and Equipment Facility program within the next two years. They are encouraged that recent conversations with a large regional hospital and wound care specialists at the Veterans Affairs health system have generated enthusiasm for this work.

“Their response makes it clear there’s good potential demand for what we’re trying to create,” Sparks says. “I’m confident we’ll have a good test platform for this technology.”

As valuable as models like this are for training, Sparks thinks they’re just beginning to tap into AM technology. With pressure ulcers, she explains, patient-specific anatomy is less important.

The same is not true for other clinical applications, such as a tumor with a specific geometry. In those situations, surgeons need to be able to practice with 3-D models that resemble the real tumor as much as possible, Sparks says.

Commercially available AM equipment can use anatomical data from a CT scan or an MRI to print the type of patient-specific training models Sparks envisions for surgeons. But, these models lack tissue-like mechanical properties.

“Some 3-D printers can print in flexible materials,” Sparks says, “but those materials don’t do a great job of mimicking biological tissue.”

Sparks wants to change that. Aided by a research incentive grant from Miami’s Office for the Advancement of Research & Scholarship, she and her biomedical engineering colleagues Jason Berberich and Justin Saul are developing new 3-D printing platforms. They use materials that look and feel more like human skin, muscle, blood vessels, and other soft tissue.

The research incentive grant also supports the work of research assistant and master’s student Martha Fitzgerald ’13, who plans to write her thesis on the techniques she has helped develop.

Together with Sparks and Berberich, Fitzgerald has written an oral presentation that she will deliver at the Biomedical Engineering Society national conference in October, an “excellent opportunity for Martha,” Sparks says.

Other students have benefited from work in Sparks’ lab as well. Last year, Sparks, Berberich, and Saul supervised two teams of senior biomedical and chemical engineering majors whose yearlong, self-directed capstone projects focused on the new 3-D printing platforms in development.

One of the two teams won a prestigious Undergraduate Research Award, which provides financial support for the university’s most promising faculty-mentored research by students. Sparks and Berberich plan to mentor two more teams this year.

“By involving students in research — where there is no recipe or cookbook that tells you, ‘If you follow all these steps, you will get the exact answer you’re expecting’ — I help student engineers develop not only technical skills, but also the problem-solving skills they’ll need to meet the growing demand for AM in the economy,” Sparks says.

Her commitment to mentoring may mean that her contributions to the field of AM will extend well beyond her own discoveries and innovations to influence those of future generations of engineers.

Written by Heather Beattey Johnston, Associate Director & Information Coordinator, Office for the Advancement of Research & Scholarship, Miami University.

Image of hand holding hydrogel by Heather Beattey Johnston, OARS. Image of Fitzgerald and Sparks by Jeff Sabo, Miami University.

This post originally appeared as an article in The Miamian, the magazine of Miami University’s alumni association.  It is re-used here with permission.

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Inventor plays larger role in tech transfer at institutions with smaller offices

 

A woman and a man sit at a table in an office. Between them on the table are parts of their invention -- two opaque white cups, an opaque grey cup with small holes on its surface, an opaque white screw-on lid, and a royal blue screw-on lid. File cabinets with various brightly colored toys are in the background.
Inventors like associate professor of speech pathology and audiology, Dr. Donna Scarborough (left), and associate professor of mechanical and manufacturing engineering, Dr. Michael Bailey-Van Kuren (right), play a critical role in the technology transfer process at Miami University.

A common misconception about the inventive process is the idea that great inventions with strong commercial value are almost always the result of a flash of brilliance, sparked by the combination of intuition and creativity. The invention, in this idealized scenario, is essentially complete and ready for a patent attorney simply to translate it into the stylized format of the patent application and submit to the U.S. Patent and Trademark Office (USPTO) for examination. The reality, of course, is that successful inventions owe as much to longer term planning and strategy — together with commensurate investment of resources — as to serendipity or chance. This is even more true in the academic research environment, where constrained resources and competing priorities make research programs and investments that are purely commercialization-oriented much more uncommon than in the business world.

In the university research environment, the first step in the inventive process — conception — often takes place quite some time before the development of a prototype or other constructive reduction to practice occurs. Generally, the process of invention development in academia is a more linear or serial process where funding and time are allocated according to the “next best step” rather than to a comprehensive development plan where many paths run in parallel toward a quicker commercialization outcome. In light of recent changes in U.S. patent law, this approach creates timing issues that bear on how early in the process the inventor should engage with their patent management office.  However, in most cases the right time to submit an invention disclosure form is between three and six months prior to making a public disclosure of information or results that would create a patent bar. Once the Office of Technology Transfer & Business Partnerships (TT&BP) receives this report of an invention, it is reviewed for completeness and assigned a case number. Following that, an initial meeting will be scheduled with the inventor(s) to discuss the technology. The most important role of the inventor in this step is to provide as much information as possible about the commercial potential for the invention and the elements of the technology that are novel.

Although copyright/software is an important component of many university innovation portfolios, patented technologies remain the primary revenue source for protectable innovations in academia. For that reason, the assessment process for new invention disclosures focuses on two equally weighted elements: commercial potential and patentability. The inventor can play a substantial role in helping to gauge these two aspects. First, in the area of patentability, many larger technology transfer offices have a broader range of subject matter expertise among the licensing staff, and in some cases have revenue volume that will support the use of external search consultants for prior art or formal patentability opinions. Smaller offices, like Miami’s, depend on the inventor to help provide subject matter expertise and to review and provide feedback on prior art found during literature and patent searches.

Statistics from the USPTO show that about half of all applications will eventually issue as patents, with the caveat that many go through substantial changes in the scope of patent claim coverage during examination. In this respect, the odds are favorable, but the expense associated with applications that do not result in patents represents a significant risk for the technology transfer office with a limited patent budget. The criteria for patentability require inventions to be novel, non-obvious, useful, and enabled. The inventor can provide much needed guidance on how likely the invention is to survive the examination process of evaluating these factors, and thus how risky the patent investment may be relative to other cases. Most offices make positive filing decisions on one-half to two-thirds of their disclosure volume. Differentiating among different technologies and their prospects is challenging in the best of circumstances. The ability of the inventor to provide candid, timely responses to prior art queries is a valuable contribution to the assessment process.

The commercial potential for an invention is not entirely distinct from the patentability aspect because statutory monopoly plays a role in the development of capital- and time-intensive innovations such as pharmaceuticals or medical devices. Other factors, though, are important as well, and the inventor is often in a position to provide valuable advice on the state of the product market that the new innovation would enter if successful. In some cases, new innovations truly create new markets, but many successful academic innovations find their way into more mature markets where existing products present substantial barriers to market penetration in the absence of distinct differentiators that are valued by the end user. An understanding of the advantages that the innovation might achieve are important, as are other factors such as:

  • state of maturity or stage of development of the invention,
  • need for access to background intellectual property,
  • market size, and
  • recent trends in the market that might lend attractiveness to the innovation’s potential.

Here the role of the inventor can be significant as well, but there is less of an expectation that their subject matter expertise extends deeply into the commercial realm. When it does, though, the input from the inventor can be crucial to affording TT&BP the best prospects for making high- quality investments in patents that can benefit society in the future.

Written by Reid Smith, Director of Technology Transfer & Business Partnerships, Office for the Advancement of Research & Scholarship, Miami University.

Featured image (left) by Veronica Aguilar via Flickr, used under Creative Commons license. Image above by Miami University Photo Services.

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Service learning project seeks to diversify computing

A man wearing a purple plaid shirt and a grey suit jacket stands at the front of a computer lab/classroom. Seats in the room are filled by students.
Dr. Bo Brinkman, associate professor of computer science and software engineering, leads the NSF-funded Electronics and Computing Service Scholars program, which seeks to increase the participation of women and minorities in engineering and computing.

There’s no question that women are much better represented in STEM fields than they were in the 1970s. For instance, Census Bureau data show that 47% of all mathematics workers today are women, up from 15% in 1970.

But while upwards of 40% of today’s life/physical science and social science jobs are also held by women, only 13% of engineering jobs are, and just 27% of computing jobs. In fact the rate of women’s representation in computing has actually declined since 1990.

Dr. Bo Brinkman, an associate professor in Miami University’s Department of Computer Science and Software Engineering, lays some of the blame for this underrepresentation on the culture within the technology industry, which he describes as “toxic.”

“The stereotype of the geeky guy sitting alone in his basement coding all night is self-reinforcing,” he says. “That becomes the standard of performance.”

Brinkman points out that that kind of solitary pursuit of an individual goal is in contrast to collaborative pursuit of a communal goal, which is what characterizes predominately female “helping” professions, like teaching, social work, and nursing.

“Women and minorities tend to have more communal goals than white men,” Brinkman says, citing the results of research conducted by Miami psychology professor Dr. Amanda Diekman. “If we want to attract more women to computing, then we need to do more to welcome people who want to work with others and in the service of others.”

To that end, Brinkman – in collaboration with Diekman, electrical and computer engineering faculty professor Donald Ucci and assistant professor Peter Jamieson, and computer science and software engineering professor James Kiper – is implementing a service learning program that lets engineering and computer science students apply what they’ve learned in the classroom to help solve real problems in the local community.

As we continue to integrate computing devices and the Internet into our lives in ways we may not even always be conscious of, Brinkman says there’s enormous potential to solve big and small problems. “In that way,” he says, “computing really is a helping profession. This service learning program is designed to make that idea explicit, in order to attract women and others who want to serve their communities.”

Supported by nearly $621,000 from the National Science Foundation (NSF), the program will include an Electronics and Computing Service Scholars living learning community (LLC) and will provide financial support for student-led service projects and for student travel to professional conferences. Applications are currently being accepted for the first cohort of Service Scholars, who will be enrolled in the fall of 2015.

Written by Heather Beattey Johnston, Associate Director & Information Coordinator, Office for the Advancement of Research & Scholarship, Miami University.

Featured photo (left) by viZZZual.com via Flickr, used under Creative Commons license. Photo of Bo Brinkman by Miami University Photo Services.