Advances in Biomaterials and Medical Devices

Experts will present some recent advances in biomaterials and medical devices and discuss challenges and opportunities ahead of us.

Chair

K. Krishnamurthy, vice provost for research, Missouri University of Science and Technology

Speakers

Sonny Bal, associate professor of orthopaedic surgery, University of Missouri-Columbia

Orthopaedic disorders of the major joints, specifically, osteoarthritis of the hip and knee joints have an enormous economic and functional impact on our society, affecting millions of patients every day. In the late 1960s and early 1970s, replacement of diseased joints with metal and plastic components was developed as a salvage technique for elderly, and relatively sedentary patients.  Now, with an aging and active population that expects to maintain function and mobility, the demand for major joint reconstruction is increasing worldwide.  Younger, heavier, and active patients place greater demands on biomaterials and implants. Our collaborative team is focused on developing new biomaterials that can meet the challenge of skeletal repair, and joint replacement, and on exploring tissue-engineered cartilage as a possible biological replacement of diseased and arthritic joints. An interdisciplinary team approach to these goals has resulted in peer-reviewed publications, graduate student education opportunities, and extramural funding. Going forward, a major goal is to leverage our resources to create products that can be positioned profitably in the commercially-attractive orthopaedic device market.

David B. Henthorn, chemical and biological engineering department, Missouri University of Science and Technology

Devices and Materials in the Continuous Monitoring of Metabolites: The importance and need for continuous monitoring of metabolites cannot be overemphasized. Most recent developments for in vivo monitoring devices have focused on miniaturization and the exploratory use of new functional materials. As most biosensors tend to drift and degrade over time, the development of a simple, dependable, on-demand, in situ (and possibly in vivo) self-calibration/self-diagnosis technique is a key obstacle for convenient, continuous monitoring with minimum intervention. The availability of this "weak link" would greatly improve the reliability and convenience of continuous monitoring technology. Work at Missouri S&T addresses these issues and provides solutions toward reliable and continuous monitoring of metabolites (glucose, lactate, etc.) with minimal human attendance using either optical or electrochemical detection methods.

Reza Derakhshani, computer science and electrical engineering department, University of Missouri-Kansas City

Modern Tools for Noninvasive Analysis of Brainwaves: Applications in Assistive Technologies and Medical Diagnostics: Digital signal processing is arguably one of the most important segments of any modern medical equipment. Recent advances in intelligence signal processing have married machine learning methods to traditional signal analysis and classification practices. In this talk, I will review state of the art brainwave analysis methods and our related advances in quantitative electroencephalogram (qEEG) analysis for brain computer interfaces (thought translation devices), as well as cerebral ischemia localization (e.g. for clamp monitoring during inetroperative carotid endarterectomy). The presentation will conclude with a discussion on corresponding R&D trends, especially near infrared spectroscopy (NIRS) as a new complementary modality to EEG for portable and affordable monitoring of brain functions.

Yinfa Ma, Curators' Teaching Professor of chemistry, Missouri University of Science and Technology

Early Cancer Screening with Pteridines as Biomarkers: Early detection and treatment of cancers continue to be the best line of defense to prevent fatalities as a result of developing cancer. Several tests have been developed, such as mammograms for breast cancer and colonoscopies for colon cancer, but most of these tests are invasive, uncomfortable and are not always able to detect cancer earlier enough to provide a winning scenario for patients. Some cancers are still very difficult to diagnose in the early stage, such as ovarian cancer, colorectal cancer, and some liver cancers. In our study, we have developed a P-scan instrument to successfully identify and quantify six pteridines in urine samples. The data demonstrated a great correlation between pteridine levels and cancer development. The detailed experimental conditions will be presented at the life science summit. After analysis of over 60 urine samples from cancer patients, we also discovered that two chemical components exist only in the urine of cancer patients but are not present in individuals who do not have cancers. We are now in the stage to identify and quantify these two peaks. Once these two components are identified, they can be used as a “yes” or “no” marker for cancer development since they are not present in normal human urines. In addition, this technique can be used to detect cancer in very early stage (before stage 1) due to its high sensitivity.

Cydney Boler, special counsel, Foulston Siefkin LLP

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. In recent months the FDA and the courts have provided an array of changes to the landscape of medical device regulation. The medical profession and consumer groups have become increasingly critical of the FDA’s process for approval of medical devices including studies published in the Journal of the American Medical Association and the American Journal of Therapeutics. However, as critics increase concern over safety, the ability of device manufacturers and emerging technology companies to put new products onto the market has never been easier. The Supreme Court’s decision in Riegel v. Medtronic, 2008, held that the Medical Device Amendments to the FDCA preempt many tort claims against manufacturers of PMA-approved devices. The broad reading of this case leaves individuals injured in product liability cases few options for redress against medical device manufacturers who have sought and won FDA approval for their devices. In addition to this broad protection for manufacturers, the FDA has allowed broader statistical efficacy interpretations providing published guidance on Bayesian Statistics in Medical Device Clinical Trials. As a manufacturer or start up, knowing who to contact in the FDA and knowing the advantages can put you ahead of your competition. This presentation will introduce you to the basics of the FDA and CDRH as well as recent, emerging trends coming out of the FDA that could impact you and your business.

Mohamed N. Rahaman, professor of materials science and engineering
director, Center for Bone and Tissue Repair and Regeneration, Missouri University of Science and Technology

Biomaterials Research and Development at Missouri S&T: Biomaterials are critically important to future developments in the life sciences. They provide a backbone for biomedical research in academia and industry, and are a key component of reconstructive medical and dental research as well as patient and animal care. The worldwide demand for biomaterials for use as biological substitutes to restore and improve tissue function, currently estimated at $40 billion, is expected to grow substantially (10–20 percent per year) with future advances and an aging population. A major area of emphasis for future biomedical research is the development of new, more advanced biomaterials to replace hard and soft tissues, lost because of age-related attrition or degeneration, disease, or trauma. Although existing biomaterials and reconstructive procedures have improved the quality of life for many patients, the clinical performance and longevity of prosthetic replacements is considerably lower than that of the original tissue. The promising field of tissue engineering has the potential for overcoming many of the limitations of existing materials and procedures. The success of tissue engineering will, to a large extent, depend on biomaterials and the understanding of their biological interactions with molecules, cells, tissues, and organs. This presentation will provide an overview of the biomaterials research and development efforts in the Center for Bone and Tissue Repair and Regeneration (CBTRR) at Missouri S&T. Areas such as bioactive glass for hard (bone) and soft tissue repair, hydroxyapatite and bioactive glass microspheres for drug delivery, orthopaedic biomaterials, and advanced techniques for fabricating biomaterials with the requisite anatomical shape and structure, will be covered. Ongoing research collaborations in biomaterials and tissue engineering with the University of Missouri campuses at Kansas City and Columbia will be described. Potential economic and health benefits that could result from expansion of these collaborative research efforts among the University of Missouri campuses will be discussed.