Development Of Medical Products Research Articles

Development of orphan medical products

Development of orphan medical products

Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule.

While the development of medical products and approval by the U.S. Food and Drug Administration (FDA) is well known, the development of countermeasures against exposure to toxic levels of radiation, chemicals, and infectious agents requires special consideration, and there has been, to date, little experience in working with the FDA to obtain approval of these products. The FDA has published a regulation entitled "Approval of Biological Products when Human Efficacy Studies are not Ethical or Feasible." This regulation, known simply as the "Animal Rule," was designed to permit approval or licensing of drugs and biologics when efficacy studies in humans are not ethical or feasible. To date, 12 products have been approved under the Animal Rule. It is highly recommended that sponsors of products that are to be developed under the Animal Rule meet with the FDA and other government entities early in the development process to ensure that the efficacy and safety studies that are planned will meet the FDA's requirements for approval of the product.

Improving Regulatory Education: Can We Reconcile Employers' Expectations With Academic Offerings?

The growing belief that an effective regulatory function is vital to the successful development of medical products has spurred initiatives in regulatory education. To help prepare highly skilled professionals, some academic institutions have begun to incorporate new competencies into their curricula and to offer innovative programs in the field of regulatory studies. This study is the first national survey aimed at identifying the degree of adoption of an educational model based on well-defined professional competencies for graduate programs in regulatory studies. Respondents disclosed the challenges faced by faculty in implementing such a model. The study revealed the relevancy of this type of model and that a competency-based approach is largely perceived as a prerequisite for aligning a program's mission and vision with the skills that graduates need in the job market. Survey results show a strong general agreement regarding the suitability of a competency-based education model for regulatory studies. The challenges in implementing such a model, as described by survey participants, are significant but can be addressed. The barriers to implementation of regulatory curricula based on a competency-based education model should be better understood so that academic programs can educate highly skilled regulatory professionals. Such a workforce could best contribute to the delivery of high-quality, safe, and effective medical products.

Bioceramics and Biocomposites from Marine Sources

Advanced technologies and biocomplexity offer new dimensions for the development of novel medical products obtained from marine resources. Because several biomaterials can be derived from synthetic or natural sources, this area offers a very large variety of natural species that may be used for biomedical applications, including tissue engineering, drug delivery and surgery. The marine environment is a natural collector of porous materials the porosity of which varies from submicron to millimeter. The production of hydroxyapatite from synthetic chemicals can sometimes lead to a costly work and sea creatures may represent an alternative way to produce very fine and even nano-structured biomaterials. Rapana venosa is, in this sense, a study marine organism because its shell is made of aragonite that can be converted into bioceramic powder, which can subsequently be used for biomedical applications. The indirect use of marine organisms was tackled according to different routes: synthetic precursor casts using biomorphic moulds, chemical conversion of the inorganic marine matrix into a biomorphic substitute, and self-assembly of nanoparticles via chemical and molecular interactions. The chemical conversion is the most developed practice to obtain biomaterials for bone regeneration. It can be realized by hydrothermal synthesis or hydrothermal hot pressing. Both methods suppose a pre-treatment to remove the organic matrix of the skeleton. Hydrothermal synthesis involves heating the marine skeletons under alkaline conditions at a specific temperature pressure in either a reaction vessel or an autoclave. The temperature and pressure have an important significance concerning material structure properties of final product in terms of degree of crystallinity, grain size, and specific surface area. The temperature has an importance on the crystallite size (50-150 nm), and in general, the optimal temperature ranges between 200-250°C. Hydrothermal hot pressing is the process used in the fabrication of some commercial bone substitutes from coral sources and involves the solidification of synthetic hydroxyapatite powder. Some experimental results related to the processing of Rapana venosa snail shell in order to obtain hydroxyapatite for medical applications are presented at the end. In conclusion, preliminary results obtained by us show that this snail shell appears to be suitable to be used as raw material for obtaining hydroxyapatite.

Special Aspects of the Development of Health Information Systems as One of the Areas of Expertise of University Students Majoring in Professional Instrument Engineering

The article describes distinguishing features of development and production economics of health information systems. Characteristics of medicine as a subject area from the point of view of developers are presented. Basics of medical informatics and the special aspects of development of medical products are proposed to be one of the areas of expertise of university students majoring in professional instrument engineering.

Partial Gland Ablation for Prostate Cancer: Report of a Food and Drug Administration, American Urological Association, and Society of Urologic Oncology Public Workshop

To summarize the discussion that took place at a public workshop, co-sponsored by the U.S. Food and Drug Administration, the American Urological Association, and Society of Urologic Oncology reviewing the current state of the art for partial gland ablation (PGA) for the management of patients with prostate cancer. The purpose of this workshop was to discuss potential indications, current available evidence, and designs for future trials to provide the evidence needed by patients and providers to decide how and when to use PGA. A workshop evaluating PGA for prostate cancer was held in New Orleans, Louisiana, in May 2015. Invited experts representing all stakeholders and attendees discussed the regulatory development of medical products, technology available, potential indications, and designs of trials to evaluate this modality of therapy. The panel presented the current information on the technologies available to perform PGA, the potential indications, and results of prior consensus conferences. Use of magnetic resonance imaging for patient selection, guide therapy, and follow-up was discussed. Designs of trials to assess PGA outcomes were discussed. The general consensus was that currently available technologies are capable of selective ablation with reasonable accuracy, but that criteria for patient selection remain debatable, and long-term cancer control remains to be established in properly designed and well-performed prospective clinical trials. Concerns include the potential for excessive, unnecessary use in patients with low-risk cancer and, conversely, that current diagnostic techniques may underestimate the extent and aggressiveness of some cancers, leading to inadequate treatment.

Data sharing for public health research: A qualitative study of industry and academia.

Data sharing is a key biomedical research theme for the 21st century. Biomedical data sharing is the exchange of data among (non)affiliated parties under mutually agreeable terms to promote scientific advancement and the development of safe and effective medical products. Wide sharing of research data is important for scientific discovery, medical product development, and public health. Data sharing enables improvements in development of medical products, more attention to rare diseases, and cost-efficiencies in biomedical research. We interviewed 11 participants about their attitudes and beliefs about data sharing. Using a qualitative, thematic analysis approach, our analysis revealed a number of themes including: experiences, approaches, perceived challenges, and opportunities for sharing data.

How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs: Some Illustrative Examples

Since 2008, the Critical Path Initiative has supported FDA's program of intramural research projects in regulatory science, with the goal of improving translation of advances in emerging sciences to the development of safe and effective medical products. Since 2011, the research of FDA's Center for Drug Evaluation and Research (CDER), including the work supported by the Critical Path Initiative, has been guided by the regulatory science needs identified in the CDER science and research needs report. In this review, the authors highlight a few of CDER'S Critical Path Initiative research projects, each addressing a different regulatory science need, to illustrate the diversity of regulatory science at CDER. They also describe elements common to these research projects, including broad collaboration with external partners, an increasing dependence on large data sets and computational models, and requirements for resources or perspectives specific to FDA.

Polymeric materials in treatment of wounds

This article deals with recent trends in the development of medical products for covering wounds of different etiologies (polymeric film, foams, hydrogels and hydrocolloids), which have been proven to have a notable therapeutic effect.

Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan.

The Japanese regulatory framework for pharmaceuticals and medical devices has recently been reexamined and the revised Pharmaceutical Affairs Law, which has been renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, was developed in 2013 and implemented in November 2014. In the revised Act, regenerative medical products are newly categorized and independent from conventional pharmaceuticals and medical devices. This enables these products to be reviewed more appropriately and allows for conditional/time-limited marketing authorization. Following the implementation of the new Act, the Good, Gene Cell and Tissue Manufacturing Practice was established to address the different requirements and concepts for appropriate research and development of regenerative medical products. Based on these changes to the regulatory framework for regenerative medical products in Japan, this article aims to examine how this framework could be utilized as an appropriate system to develop innovative regenerative medicine.

Creating systems that work

Sengstack PP, Boicey C (2015) Mastering Informatics: A Healthcare Handbook for Success. Sigma Theta Tau, Indianapolis IN. INFORMATION TECHNOLOGY is becoming so pervasive in health care it is almost impossible to find a care setting void of some type of electronic clinical system. Evaluating and managing these electronic tools require an understanding of patient care delivery and technology. They also require the knowledge to design systems with which nurses interact on a daily basis and the skills to evaluate care delivery effectiveness. Nurse informaticists are perfectly positioned to meet these requirements. The American Nursing Association recognised nursing informatics as a specialty in 1992. Some say, though, that the first nurse informaticist was Florence Nightingale back in the 1850s, when she compiled and processed data to advocate for appropriate nursing and medical protocols and to improve sanitation in military hospitals during the Crimean War. Fast forward to the 1960s, when the electronic medical record made its debut and continued to evolve as adoption increased over several decades. The Health Information Technology for Economic and Clinical Health Act, signed in 2009 as part of the American Recovery and Reinvestment Act, drove even higher levels of adoption. As of June 2014, three quarters of the nation’s eligible professionals, equivalent to more than 403,000 people, and more than nine out of ten eligible hospitals, equivalent to more than 4,500 organisations, had received incentive payments (Office of the National Coordinator for Health Information Technology 2014). Add to this the increasing use of mobile technologies, the expansion of telehealth, the proliferation of health-related apps, the demand for patient-engagement tools and the drive toward interoperability of patient data, and the need for nursing informatics expertise becomes imperative. Devices developed without the expertise of someone with clinical informatics skills typically result in end-user frustration and systems that do not support clinical workflows. Workforce survey results from the Healthcare Information and Management Systems Society (HIMSS) confirm that nurse informaticists play a crucial role in the development, implementation and optimisation of clinical applications including nursing clinical documentation, computerised practitioner-order entries and electronic health records (HIMSS 2014a). Other survey results show that four out of five healthcare organisations had plans to hire additional IT staff this year, with almost all vendors indicating similar plans. They also show, however, that more than one in three respondents working for a healthcare provider are scaling back or putting IT projects on hold because they cannot be fully staffed (HIMMS 2014b). Delaying IT projects to improve the support of clinician workflow and reduce system inefficiencies ultimately affect patient care. The bottom line is that nurse informaticists are needed more than ever. It is also important to engage nurses in the design, development, purchase, implementation and evaluation of medical and health devices and IT products (Institute of Medicine 2010). The education and training required to serve in the role of a nurse informaticist is not taught at the baccalaureate, or bachelor’s degree, level, nor is it learned on the job alone. Expertise requires graduate education in the field of informatics. There are universities around the world that offer nursing informatics education at master’s level and above and it is here that nurse informaticists and nursing informatics leaders are prepared. While nurses at baccalaureate level with no formal informatics training can assume informatics positions in some organisations, they will not have studied the science formally and developed the focused competencies that graduate informatics education provides. Additionally, nurses serving in informatics roles should obtain their board certification in nursing informatics offered by the American Nurses Credentialing Center. A career in nursing informatics will drive clinical transformation and care delivery. Clinicians and patients count on technology that works for them, not the other way around, so nurses must be there when decisions are made. If you’ve been thinking about a career focus, consider informatics. Our patients and fellow nurses need you.

Pharmaceutical Industries Expectation for the Revision of the Pharmaceutical Affairs Law to be enforced in November 2014 –From the Viewpoint of Development of Medical Products–

Pharmaceutical Industries Expectation for the Revision of the Pharmaceutical Affairs Law to be enforced in November 2014 –From the Viewpoint of Development of Medical Products–

2015 and Beyond.

Risk of New Antidiabetic Therapies for Type 2 Diabetes’’ by Geiger et al 4 continues to demonstrate the importance of precompetitive partnering. This study examined the cardiotoxicity of drugs used to treat type 2 diabetes. Teasing out disease effects, drug effects, endpoints, and unwanted side effects is critical to the development, approval, and clinical use of medicines. We have seen the complexity of all this, demanding transparent, collaborative, and rigorous biomedical and statistical scientific approaches. Looking to the future of translational biomedical science, we will have several forward-looking papers later this year that challenge current assumptions and discuss the enormous potential that scientific advances have and will continue to provide. We anticipate an exciting year for TIRS, publishing papers that facilitate important conversations around the development of safe and effective medical products as well as increasing coordination with the Global Forum and with DIA activities to deliver to you a continuum of knowledge as we work together to foster health and well-being worldwide. —Stephen P. Spielberg, MD, PhD Editor-in-Chief, DIA Publications

Urotechnology: a new interdisciplinary platform for promoting and managing of technical innovations in urology

The innovative power in medical engineering and technology development requires a close cooperation between universities and non-university research institutions and a collaboration with industrial partners. German knowledge in the fields of video and micro-optics, microsystem technology and of informational technology and software applications seem to be highly competitive at international level. Germany's previous leadership in the development of technical equipment will be challenged by today's requirements and difficulties in medical engineering. Research and expenses demands for the development of novel medical instruments, products and applications will increase continuously. Transparency and coordinated collaboration between universities and industrial partners will contribute to a substantial improvement in surgical therapy. Medical technology of the future, including urotechnology, requires professional structures and coordination and will have to be based on evidence.

Whence a Journal….

I am reading a book on 16th-century Italian medicine. There were no journals then; there were books, and scholarship was defined as knowledge of texts. Competence in Latin and Greek, and a comprehensive knowledge of Hippocrates and Galen were the coin of the realm. (For clinical renown, excellence was defined by the number of cures accomplished by the practitioner, mostly self-defined). Little had changed in 1500 years; publications rehashed Galen, perhaps with some new insights, none driven by what we consider ‘‘the scientific method.’’ The anatomic explorations of Vesalius were new; it would be hundreds of years more before the germ theory and Pasteur and Koch, the rise of experimental medicine and Claude Bernard, of chemistry/pharmacology and of Paul Ehrlich. It is sobering to realize that essentially all we do in the discovery and development of medical products is a product of the past 50 years. President Roosevelt died of conditions easily treated by what we consider ‘‘old’’ generic drugs. President Kennedy’s son died as a premature neonate. He would have greater than a 95% chance of survival today. So, what is journal? Journals have been filled with articles that might help authors achieve academic promotions and grants. They hopefully act as a way of stimulating new experimentation, better understanding of human biology in health and disease (or whatever field they focus upon). Disciplinary journals are crucial to continuing education and assurance of high standards of practice within that discipline. However, at a time of an explosion of new information and of the need for interdisciplinary collaboration to drive discovery, development, regulation, and use of new novel therapeutics, a journal such as ours needs to be more than that. DIA membership (and those libraries, consortia, and academics who find TIRS valuable and who are not DIA members) represents a huge diversity of backgrounds, interests, and work environments. They include basic scientists, clinical trialists, statisticians, regulatory experts, and medical writers. They may work in large or small pharma, in CROs, in consulting companies, in academia, and/or in government. They may well move from one arena to another. At a recent retreat at which we began defining the future of

Academic medical product development: an emerging alliance of technology transfer organizations and the CTSA.

To bring the benefits of science more quickly to patient care, the NIH National Center Advancing Translational Sciences (NCATS) supports programs that enhance the development, testing, and implementation of new medical products and procedures. The NCATS clinical and translational science award (CTSA) program is central to that mission; creating an academic home for clinical and translational science and supporting those involved in the discovery and development of new health-related inventions. The technology transfer Offices (TTO) of CTSA-funded universities can be important partners in the development process; facilitating the transfer of medical research to the commercial sector for further development and ultimately, distribution to patients. The Aggregating Intellectual Property (IP) Working Group (AWG) of the CTSA public private partnerships key function committee (PPP-KFC) developed a survey to explore how CTSA-funded institutions currently interface with their respective TTOs to support medical product development. The results suggest a range of relationships across institutions; approximately half have formal collaborative programs, but only a few have well-connected programs. Models of collaborations are described and provided as examples of successful CTSA/TTO partnerships that have increased the value of health-related inventions as measured by follow-on funding and industry involvement; either as a consulting partner or licensee.

The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views.

Survey methods were used to explore the expectations and recommendations of senior business development professionals with respect to the roles, activities, and interactions with US universities in the development of new medical products. This target group was chosen because it was judged to be most likely to interact with university faculty and technology transfer services and seek and acquire university assets. The survey instrument was first reviewed by a focus group of individuals with experience both in technology transfer and in academic or industry policy, then distributed to a selected subset of 80 business development professionals, of whom 72 responded. Serious concerns were expressed over the current mechanisms for technology transfer and university support of commercialization. When asked if they believed that there is a need for a change in the way that universities interact with industry in the US, 86% of the respondents replied that they either strongly agreed or agreed that there was, indeed, a need for change. Among several areas that might be improved, the availability of proof-of-concept facilities and funds for early-stage feasibility studies were most often identified as important.

Developing microphysiological systems for use as regulatory tools--challenges and opportunities.

In the last few years, scientists have made important progress in developing systems using human cells to test the effects of drugs and other substances. These systems have the potential to improve toxicity testing beyond currently available tools. The innovative new tools, which are known as microsystems, microphysiological systems, or organs on a chip, can aid in the development of medical products so that toxicity may be identified earlier in product development. This may lower costs and speed new treatments to patients. Experts believe that these systems may eventually enable scientists to test more environmental compounds more efficiently.

Recent Statistical Contributions to Medical Device Development.

Clinical trials in the development of new medical device products are in many ways analogous to clinical trials in the development of new drug or biologic products. However, the differences are important and not always intuitive to a statistician with only experience supporting development of drug and biologic products. In this paper we discuss some of the interesting differences with focus on the statistical innovation that is coming out of the medical device area. We discuss examples of the differences in clinical trial design and effects of these differences on clinical development programs.