Commercialization Of Medical Devices Research Articles

Ala®sil chemical characterization and toxicity evaluation: an example of the need for the Medical Device Regulation 2017/745.

Introduction: Ala®sil infusion was on the market for clinical use under the Medical Devices Directive (MDD) 93/42/EEC as an irrigating solution based on polydimethylsiloxane (PDMS). The product was withdrawn in 2016, and to the best of our knowledge, it did not cause any health damage. Methods: A bibliographic review and experimental analysis were conducted to evaluate whether this CE-marked product could have been used in patients under the current Medical Device Regulation (MDR) 2017/745. Analytical results from gas chromatography-mass spectrometry (GC-MS) and matrixassisted laser desorption ionization (MALDI) were performed. Citotoxicity studies were also carried out. Results: Only one study related to Ala®sil clinical use was found, describing a pilot series of five patients. The authors rated the product as not helpful in three out of the five cases for internal searching of retinal breaks and in four out of the five cases for drainage of subretinal fluid. No other scientific papers or documentation was found regarding Ala®sil's safety. Nevertheless, the product was introduced in the market after achieving the CE marking. GC-MS and MALDI showed that the polymer has a low molecular weight of 1,000g/mol. Several linear and cyclic low-molecular-weight components (LMWCs) were identified as impurities ranging from L3 to D8, with a molecular weight below 600g/mol. The Ala®sil sample was found to be cytotoxic after 24h of cell culture but non-cytotoxic after 72h, probably due to the cellular regeneration capacity of an immortalized cell line. Tissular cytotoxicity revealed an increased apoptosis rate but without morphological modifications. Discussion: Although Ala®sil cannot be classified as cytotoxic, this substance appears to increase retinal cell death processes. This study supports the notion that the MDDwas not functioning adequately to ensure the safety of medical devices. However, the current MDR 2017/745 imposes stricter standards to prevent the commercialization of medical devices without high-quality preclinical and clinical information, as well as precise clinical verification for their use, information not available for Ala®sil infusion.

How to Support the Development and Commercialization of Medical Devices -based on my academic research experience-

How to Support the Development and Commercialization of Medical Devices -based on my academic research experience-

A multi-institutional partnership catalyzing the commercialization of medical devices and biotechnology products.

The commercialization of medical devices and biotechnology products is characterized by high failure rates and long development lead times particularly among start-up enterprises. To increase the success rate of these high-risk ventures, the University of Massachusetts Lowell (UML) and University of Massachusetts Medical School (UMMS) partnered to create key academic support centers with programs to accelerate entrepreneurship and innovation in this industry. In 2008, UML and UMMS founded the Massachusetts Medical Device Development Center (M2D2), which is a business and technology incubator that provides business planning, product prototyping, laboratory services, access to clinical testing, and ecosystem networking to medical device and biotech start-up firms. M2D2 has three physical locations that encompass approximately 40,000 square feet. Recently, M2D2 leveraged these resources to expand into new areas such as health security, point of care technologies for heart, lung, blood, and sleep disorders, and rapid diagnostics to detect SARS-CoV-2. Since its inception, M2D2 has vetted approximately 260 medical device and biotech start-up companies for inclusion in its programs and provided active support to more than 80 firms. This manuscript describes how two UMass campuses leveraged institutional, state, and Federal resources to create a thriving entrepreneurial environment for medical device and biotech companies.

Use of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices

In addition to extensive preclinical testing, commercialization of medical devices in the United States under some circumstances may be supported with clinical data derived from single arm studies where the clinical endpoint is compared with a performance goal (PG). Since the performance is expected to be different between two clinically defined mutually exclusive patient subpopulations, the use of weighted PG is often adopted. In this article, we discuss the limitations of the current practice where weights need to be prespecified and fixed, and we propose an alternative approach that relaxes the fixed weight requirements.

The Social Implementation Process of Medical Innovation: Preventing Commercialization of Medical Devices from Ending as Pie in the Sky

The Social Implementation Process of Medical Innovation: Preventing Commercialization of Medical Devices from Ending as Pie in the Sky

Strategies for Development and Commercialization of Medical Devices: Taking Artificial Trachea as an Example

Strategies for Development and Commercialization of Medical Devices: Taking Artificial Trachea as an Example

A atuação do laboratório de Engenharia Biomecânica (LEBm/HU-UFSC) na avaliação pré-clínica de tecnologias de implantes cirúrgicos no âmbito do complexo industrial da saúde

http://dx.doi.org/10.5007/1807-0221.2017v14n25p211O Laboratório de Engenharia Biomecânica (LEBm/ HU-UFSC) é um centro de ensino, pesquisa e desenvolvimento tecnológico na área da saúde com foco no projeto e na avaliação pré-clínica da segurança e eficácia de implantes cirúrgicos. A referida avaliação requer a definição de métricas clinicamente relevantes que permitam quantificar os riscos associados ao uso da tecnologia. No Brasil, a permissão para a comercialização de produtos médicos é fornecida pela Agência Nacional de Vigilância Sanitária (ANVISA) após a demonstração de que o produto é livre de riscos não aceitáveis. Portanto, a superação das barreiras técnicas para a comercialização dos produtos desenvolvidos no Brasil é de suma importância para a indústria nacional e pode impactar positivamente na balança comercial do setor odonto-médico-hospitalar. No presente artigo, é descrita a atuação extensionista do LEBm do Hospital Universitário da UFSC no desenvolvimento da área de dispositivos médicos e na capacitação de recursos humanos para a avaliação pré-clínica de tecnologias de implantes cirúrgicos fabricados no Brasil.

A Project Course Sequence in Innovation and Commercialization of Medical Devices.

There exists a need for educational processes in which students gain experience with design and commercialization of medical devices. This manuscript describes the implementation of, and assessment results from, the first year offering of a project course sequence in Master of Engineering (MEng) in Design and Commercialization at our institution. The three-semester course sequence focused on developing and applying hands-on skills that contribute to product development to address medical device needs found within our university hospital and local community. The first semester integrated computer-aided drawing (CAD) as preparation for manufacturing of device-related components (hand machining, computer numeric control (CNC), three-dimensional (3D) printing, and plastics molding), followed by an introduction to microcontrollers (MCUs) and printed circuit boards (PCBs) for associated electronics and control systems. In the second semester, the students applied these skills on a unified project, working together to construct and test multiple weighing scales for wheelchair users. In the final semester, the students applied industrial design concepts to four distinct device designs, including user and context reassessment, human factors (functional and aesthetic) design refinement, and advanced visualization for commercialization. The assessment results are described, along with lessons learned and plans for enhancement of the course sequence.

Management of Risks and Benefits for Medical Devices

Medical device safety is of paramount importance. Application of the international standard ISO 14971 is mandatory for obtaining approval for commercialization of medical devices. One of the requirements of ISO 14971 is demonstration that the residual risk of the medical device is outweighed by the benefits that it offers to the patients. This poses a difficult challenge for the medical device manufacturers, as risk and benefit are not easily comparable. This comparison must be done on each hazard and also on the overall system. Some of the challenges that device manufacturers face are: How do you determine the overall residual risk of the system? And, if you do determine the overall residual risk, how do you know if it is acceptable? How do you compare the residual risk against the benefit of the device? For example, if the benefit is improved quality of life, but at a 0.1 percent increased risk of death, which is greater — the benefit or the risk? This paper offers techniques and methodologies to provide objective evidence that the device design has met the risk benefit requirements of ISO 14971.

Medical technology development and globalization: the role of the medical device industry

Modern medical technology aligns with medical device advancement, and new medical devices create the need for new procedure techniques. Unmet needs that physicians experience in clinical practice suggest solutions to problems; to solve these, collaboration between medical device manufacturers and physicians becomes a starting point for new medical device development. Commercialization of medical devices is greatly impacted by the product regulatory approval system, health technology assessment, and reimbursement system. Speed to market plays a far greater role in the medical device market than in the pharmaceutical market. Considering the current trend of evidence-based medicine and value-based pricing, efforts to generate clinical evidence should be strengthened even further while a greater focus should be placed on efforts to introduce global multicenter pre-market clinical trials in the Republic of Korea through strong collaboration with global companies. Since the strength and quality of clinical evidence is comparatively low in medical device studies, this could affect the decision making process and raise the issue of uncertainty. To overcome this issue, a risk-sharing system in the medical device field and ‘coverage with evidence development’ should be introduced; by doing so, evidence generation opportunities can be created without burying innovative technology and solving the issue of uncertain decisions. In addition, reimbursement coverage to support the costs of clinical studies needs to be established for early evidence generation, as seen in other countries.

2011 Sino-American Symposium on Clinical and Translational Medicine

Prefaces: The second annual Sino-American Symposium on Clinical and Translational Medicine was held on 24 June 2011 in Shanghai, China. It provided a forum for scientists, physicians, and officers from China and the United States to come together to discuss important issues and challenges in making quality health care accessible to all peoples. As the Chinese Minister of Health, Dr. Zhu Chen, puts it: "The per capita expenditure on health in China is much less than that in the United States, and the two nations' health care systems are quite different. However, both countries face the same challenge: To meet the growing health needs and expectations of their citizens, while facing an increasingly restrictive financing environment. We think that translational medicine is one of the best solutions to tackle this challenge." This booklet, produced as a special sponsored supplement to Science , collects in one volume several reports from the symposium covering a broad range of topics from pure scientific research to decision-making and policy, and accounts of the successful implementation of translational strategies and the commercialization of medical devices. It also provides a foundation for the future cooperation between China and the United States, as well as the rest of the world, on which to build a strong strategy for applying the tenants of translational medicine to the benefit of all human kind.

The Alpha Stem Cell Clinic: A Model for Evaluating and Delivering Stem Cell-Based Therapies

Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies.