Regulation of medical diagnostics and medical devices in the East African community partner states.

BACKGROUND: Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC). METHODS: Data was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States. RESULTS: Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices. CONCLUSIONS: Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation

Improving access to new diagnostics through harmonised regulation: priorities for action.

A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient or overzealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, as well as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable

A Tissue Engineering product development pathway

Tissue engineering is a field of inquiry and research that uses engineering techniques and principles of biological sciences to develop functional substitutes for reconstruction of damaged organs. Commercial translation of tissue engineering products is currently in progress all over the world. Many companies are moving their interest towards this market segment that grows by 6% per year. Aim of this thesis is to probe the possibility of developing tissue engineering products in the most cost-effective way, minimizing the industrial risk and developing a specific fund raising model. Tissue engineering is based on three main features: cells, scaffolds and bioreactors. Cells are seeded on a scaffold and cultured in a bioreactor in order to obtain a tissue engineering product. Nevertheless, developing cell carrying products is hampered by certification claims ("advanced therapies" certification rules) that unbearably increase R&D and certification costs and can be faced by either big companies or start-ups of big companies and spin-offs of complex aggregates of research centers involved in advanced cell research. On the other hand, scaffolds (certification class IIb) and bioreactors for tissue engineering (certification class I) can be developed with a lower economic effort, being the competition based on innovation, since their market is in the "growth phase" for scaffolds and in the "introduction phase" for bioreactors in the Levitt's product life cycle theory. Purpose of this thesis is to basically study scaffold and bioreactor features, then to preliminarily design some models of bioreactors and, eventually, to set a business model, based on private and public fund raising, aimed to the development of scaffolds for dental implantology and of bioreactors for cardiovascular and bone tissue engineering. Finally, a business plan of a company being spin-off of Politecnico di Torino and industrial start-up has been elaborate

Electronic Health Records and Cloud based Generic Medical Equipment Interface

Now-a-days Health Care industry is well equipped with Medical Equipments to provide accurate and timely reports of investigation and examination results. Medical Equipments available in market are made for specific tests suited for a particular laboratory leading to a wide variety of devices. The result viewing experience on console of these devices is not only cumborsome for medical staff but inefficient. Therefore, Medical Equipment Interfaces act as backbone of any Hospital Management Information System assisting in better management and delivery of test results. It also acts as a mode to collect data for further research and analysis. These equipments communicate via a fixed data format but compatibility among these formats is a major issue being faced in modern and legacy medical equipments. In this paper, we present a case study of designing and implementing a cloud based Generic Medical Equipment Interface(GMEI) along with the state of the art in such systems. This solution removes the burden of reentry of patient details into the Electronic Health Record(EHR) and thrives for accelerating EMR initiative in the countryComment: National Conference on Medical Informatics 2014 (AIIMS, New Delhi

Best Practices Associated with Medical Device Regulatory Strategy Success: A Case Study

In the evolving medical device industry, understanding how to achieve effective regulatory strategies is crucial. This study explored the foundations of regulatory strategy success in the United States, using qualitative insights from regulatory affairs professionals and industry investors. It identified operational, leadership, product design, and external factors essential for developing and implementing successful regulatory strategies. Key findings highlighted the importance of financial planning, agile regualtory process management, strategic knowledge integration, and proactive engagement with regulatory authorities. The study also pointed to the role of business ecosystems in supporting regulatory outcomes, suggesting a strategic planning approach that aligns product design with quality and business goals. This research contributed to the academic and practical discussion on regulatory strategy in the medical device sector, providing insights for stakeholders from entrepreneurs to investors. It shed light on the complexity of regulatory pathways in the United States and its influence on market access, encouraging further research on the impact of technological advancements and global regulatory changes on strategy effectiveness

Applications of Automated Identification Technology in EHR/EMR

Although both the electronic health record (EHR) and the electronic medical record (EMR) store an individuals computerized health information and the terminologies are often used interchangeably, there are some differences between them. Three primary approaches in Automated Identification Technology (AIT) are barcoding, radio frequency identification (RFID), and biometrics. In this paper, technology intelligence, progress, limitations, and challenges of EHR/EMR are introduced. The applications and challenges of barcoding, RFID, and biometrics in EHR/EMR are presented respectively