University of Pittsburgh’s Swanson School of Engineering and McGowan Institute for Regenerative Medicine at the Forefront of Additively Manufactured Biomedical Device Research


America Makes
, the National Additive Manufacturing Innovation Institute, in its second call for additive manufacturing (AM) applied research and development projects, awarded the University of Pittsburgh’s Swanson School of Engineering and McGowan Institute for Regenerative Medicine funding for additive manufacturing research with focus on biomedical devices for medical applications such as bone plates, tracheal stents and scaffolds. Corporate partners include ExOne, Hoeganaes Corp., and Magnesium Elektron. (For information about the America Makes funding contract, press here.)

Principal investigator is Prashant Kumta, PhD, the Swanson School’s Edward R. Weidlein Chair Professor and co-PI is Howard Kuhn, PhD, adjunct professor of industrial engineering. Patrick Cantini, director of Scientific Collaborations for the University of Pittsburgh Medical Center (UPMC) and director of the McGowan Institute’s Center for Industry Relations is project manager.

We caught up with Dr. Kumta to learn more about the research effort in an exclusive AMazing® Q&A session.

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AMazing®: Dr. Kumta, thank you for your participation. The prospect of additively manufacturing biomedical devices like scaffolds is fascinating and exciting. Is it fair to say the Bioengineering department at the University of Pittsburgh is at the forefront of medical research involving additively manufactured biomedical devices such as bone plates, tracheal stents and scaffolds?

Dr. Kumta: Yes, the Bioengineering department in partnership with the McGowan Institute of Regenerative Medicine, the school of medicine and the school of dental medicine, is clearly at the forefront of research in medical devices. With pioneering research in ceramic materials, injectable ceramic putties, hydrogels, synthetic and natural polymers as well as in the burgeoning field of degradable metals, the Swanson School of Engineering and the bioengineering department have embarked in the arena of additive manufacturing which gives the unique opportunity to customized devices that can be matched to the specific needs and requirements of the patient mimicking and matching the dimensions and specifications of the patient.

This is a major advancement in the additive manufacturing arena which already boasts of layered manufacturing and rapid solid prototyping. However, with recent advances in degradable metals made by my group as part of the National Science Foundation funded Engineering Research Center on Revolutionizing Metallic Biomaterials housed at North Carolina A&T in partnership with University of Pittsburgh and the University of Cincinnati, compounded with the recent award from America Makes, we have the ability now to engineer 3-D constructs from the CT scans of patients generating devices directly to fit the patient needs.

Moreover, the degradable nature of the material will lead to regeneration of the defective tissue thus obviating the need for secondary procedures to remove the implanted material or allowing the material to remain within the body as in the case of currently used inert materials running the risk of infections, hypersensitivity, scar tissues, etc. that can lead to problems in the long run.

AMazing®: As we understand conventional scaffolds for medical use are typically processed using subtractive technologies and produced from an array of materials including synthetic or biologic, and either degradable or nondegradable. What benefits would additively manufactured scaffolds offer over conventional scaffolds?

Dr. Kumta: Additive manufacturing provides tremendous improvement over currently used traditional manufacturing methods which involve subtractive technologies. For one, there is customization to fit the patient needs. As a result, there is considerable less wastage of materials or raw materials. Second, the process being completely automated and digitized with specific controls of various parameters brought about by computerized controls, there is less room for error and more control on reproducibility and moreover resulting in a perfect fit with the various needs of the patient. Third, the sheer variability and advances made by the field in itself and the variety of technologies currently available, it is possible to achieve precision and control of the geometry and configuration. As a result, it can be envisioned that parts will be readily made in every part of the world to completely fit the specific needs of various individuals.

Finally, it is possible with the advances being made in both automation and precision, the designed and additively manufactured components and parts will also end up being economical compared to the traditionally manufactured materials.

Binder-Jetting 3D Printing in collaboration with Ex-One (Video courtesy of University of Pittsburgh)

AMazing®In our research, we discovered an ideal scaffold should be three dimensional, highly porous with a robust interconnected pore network, biocompatible and bioresorbable with a controllable degradation and resorption rate to match the cell/tissue growth, appropriate surface chemistry for cell attachment and growth, and mechanical properties to match the surrounding tissues. And of course, custom designed to meet the anatomical implantation. Based upon your research, is it possible to additively manufacture a scaffold to today’s industry standards? What challenges must be overcome to create an ideal scaffold?

Dr. Kumta: Despite the advantages outlined above that Additive Manufacturing brings in; the technology still needs much improvement. These include:

  1. Speed of manufacture
  2. Precision at the micron, and sub-micron scale is still needed
  3. Surface finish at the sub-micron and nanoscale
  4. Cost of the instrumentation

Currently, scaffolds can be made of complex geometries without any problem. However, control of the microstructure, micro and macro scale finish and control is still much needed. Ability to control the surface finish to a smooth sub-micron scale finish or create surface unevenness that can range from the nano to sub-micron and micron scale is still much needed. I believe however, with the advances in the science and engineering, it should be possible to achieve this level of precision and perfection.

AMazing®Would you please share with us the different materials being investigated and also potential use of Fe as a scaffold material?

Dr. Kumta: The different materials that are being investigated are several magnesium alloys that can exhibit a range of mechanical strengths, ductility and corrosion rates to match the various defect sites in the body and various requirements for the different tissue types whether, bone, trachea, cardiovascular stents, AV fistula etc. These materials have been tailored by my group and me utilizing theory and experiments to gain control on the structure, mechanical attributes and the corrosion without compromising the cytocompatibility. The other materials are ceramics mostly, calcium phosphates as well as magnesium phosphates, and a range of polymers exhibiting a host of degradation characteristics as well as elastomeric and plastic characteristics.

“Scanning electron microscopy images showing bone cells attached on the surface and infiltrating into the pores of a 3D printed iron-based degradable scaffold construct.” Credits: Da-Tren Chou, Daeho Hong, Abhijit Roy and Prashant N. Kumta

“Scanning electron microscopy images showing bone cells attached on the surface and infiltrating into the pores of a 3D printed iron-based degradable scaffold construct.” Credits: Da-Tren Chou, Daeho Hong, Abhijit Roy and Prashant N. Kumta-University of Pittsburgh

With regards to iron, we have been engaged in designing alloys in such a manner that the corrosion control can be accelerated compared to pure iron. This improvement in corrosion characteristics comes without any loss of mechanical attributes thus making iron a very affordable and an attractive material for a variety of devices. We believe that these alloys will exhibit the same level of biocompatibility and cytocompatibility as magnesium.

AMazing®: With regard to the research project, which AM technologies have been studied? Which AM technologies will be investigated going forward?

Dr. Kumta: We are currently exploring powder based binder jet printing in collaboration with Ex-One our industrial partner for making the 3-D constructs. We hope to explore other laser based as well as electron beam based techniques of 3-D fabrication for both iron and magnesium based alloys. We hope to achieve this in the near future.

AMazing®Finally, how will industry benefit from your research? What do you hope to see?

Dr. Kumta: I foresee significant benefit for industry. This is because manufacturers involved in 3-D printing and additive manufacturing such as SLM solutions, 3-D systems, Ex-One etc. can now soon begin to enter the business of manufacturing medical devices all in one step or utilizing multiple additive manufacturing steps to generate a perfectly functional part or construct. Moreover, I also envision industry taking the fabricated construct in partnership with a clinician demonstrating the feasibility and efficacy of the system in pre-clinical trials, the success of which will lead to an FDA submission with the eventual clearance obtained that will lead to human trials.

The successful combination of pre-clinical and clinical trial success will demonstrate the utility, efficacy, and safety of the system and the technology which will likely lead to FDA approval. This will ultimately result in a product that can be used to treat patients with a variety of disorders and ailments thus improving the quality of life. This is what I am aspiring to achieve and hope to see the technology transition to.

AMazing®: This concludes our interview. Thank you very much Dr. Kumta for your participation. We are very grateful for the opportunity to learn about the exciting biomedical device research, utilizing additive manufacturing, being conducted at the University of Pittsburgh’s Swanson School of Engineering, school of medicine, school of dental medicine and the McGowan Institute for Regenerative Medicine.

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AM_Dr_PrashantAbout Dr. Prashant N. Kumta
Professor Kumta obtained his Bachelor of Technology with Honors in Metallurgical Engineering from the Indian Institute of Technology, Bombay, India in 1984. This was followed by M.S. and Ph.D. degrees in Materials Science and Engineering from the University of Arizona in 1987 and 1990, respectively. He joined the Department of Materials Science and Engineering at Carnegie Mellon University following his graduation in 1990 as an Assistant Professor and was promoted to Full Professor with tenure in 1999. He was instrumental in creating the department of biomedical engineering at Carnegie Mellon in 2004 in which he also held joint faculty appointment. He joined the University of Pittsburgh in 2007.

Professor Kumta is the author and co-author of more than 225 refereed journal publications and has given more than 400 conference presentations with more than 100 invited presentations. He was also the recipient of the Research Initiation Award from the National Science Foundation in 1993 and has been continuously listed in Who’s Who in Science and Engineering, Who’s Who in America, Who’s Who in the World and Who’s Who in American Education since 1999.

He was the founding organizer of the first symposium on “Electrochemically Active Materials for Energy Storage and Devices” for the Annual Meeting of the American Ceramic Society held in Indianapolis in 1995, and has been actively involved in its organization and execution to date. He is currently the Editor-in-Chief of Materials Science and Engineering, B, Solid-State Materials for Advanced Technology, an International Journal by Elsevier Publications. He is also the Fellow of the American Ceramic Society and a Fellow of the American Institute for Medical and Biological Engineers.

Prashant N. Kumta, PhD
Edward R. Weidlein Chair Professor
849 Benedum Hall
Swanson School of Engineering and School of Dental Medicine,
Department of BioEngineering, Chemical and Petroleum Engineering,
Mechanical Engineering and Materials Science, Department of Oral Biology
University of Pittsburgh

Team Members
Graduate Students pursuing PhD:
Da-Tren Chou
Daeho Hong

Senior post-doctoral associate:
Dr. Abhijit Roy

About America Makes
America Makes is the National Additive Manufacturing Innovation Institute. As the national accelerator for additive manufacturing (AM) and 3D printing (3DP), America Makes is the nation’s leading and collaborative partner in AM and 3DP technology research, discovery, creation, and innovation. Structured as a public-private partnership with member organizations from industry, academia, government, non-government agencies, and workforce and economic development resources, we are working together to innovate and accelerate AM and 3DP to increase our nation’s global manufacturing competitiveness. Based in Youngstown, Ohio, America Makes is the pilot institute for up to 45 manufacturing innovation institutes and is driven by the National Center for Defense Manufacturing and Machining (NCDMM). For more information about America Makes, visit http://americamakes.us.

About NCDMM
NCDMM delivers optimized manufacturing solutions that enhance the quality, affordability, maintainability, and rapid deployment of existing and yet-to-be developed defense systems. This is accomplished through collaboration with government, industry, and academic organizations to promote the implementation of best practices to key stakeholders through the development and delivery of disciplined training, advanced technologies, and methodologies. NCDMM also manages the national accelerator for additive manufacturing (AM) and 3DP printing (3DP), America Makes – the National Additive Manufacturing Innovation Institute. For additional information, visit the NCDMM at www.ncdmm.org.

About the McGowan Institute for Regenerative Medicine
The McGowan Institute serves as a single base of operations for the university’s leadingscientists and clinical faculty working in the areas of tissue engineering, cellular therapies, and artificial and biohybrid organ devices.

The Institute’s mission includes the development of innovative clinical protocols as well as the pursuit of rapid commercial transfer of its technologies related to regenerative medicine. Also critical to the mission is the education and training of the next generation of scientists, clinicians and engineers who will be carrying the field forward toward the ultimate goal of patient benefit.

About the Swanson School of Engineering

The University of Pittsburgh’s Swanson School of Engineering is one of the oldest engineering programs in the United States and is consistently ranked among the top 25 public engineering programs nationally.

The Swanson School has excelled in basic and applied research during the past decade and is on the forefront of 21st century technology including sustainability, energy systems, bioengineering, micro- and nanosystems, computational modeling, and advanced materials development. Approximately 120 faculty members serve more than 2,600 undergraduate and graduate students and Ph.D. candidates in six departments, including Bioengineering, Chemical and Petroleum Engineering, Civil and Environmental Engineering, Electrical Engineering, Industrial Engineering, Mechanical Engineering, and Materials Science.

Contact
Paul A. Kovach

Director of Marketing and Communications Swanson School of Engineering University of Pittsburgh
3700 O’Hara St Benedum Hall Suite 104E
Pittsburgh, PA  15261 USA
Phone: 412-624-0265
Fax: 412-624-1010
Cell: 412-427-9422
pkovach@pitt.edu

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