Medical Products Industry Research Articles

A maturity assessment methodology for ISO 13485 implementation in the medical devices industry

PurposeThis study aims to develop a novel diagnostic methodology for implementing ISO13485:2016 and test its applicability to improve quality management systems (QMS) in the medical devices industry context.Design/methodology/approachFirst, a literature review on the topic was conducted. Second, insights gained from the literature and expert interviews were employed to develop the new maturity assessment methodology. Subsequently, the methodology was tested on a medical device manufacturer. Next, based on the evaluation of the intervention, actions were recommended to improve the QMS.FindingsResearch findings have developed a maturity assessment methodology comprising 52 certifiable requirements structured into four macro-requirements derived from ISO 13485:2016. Findings show that the methodology is valuable for aiding QMS implementation, and the diagnosed maturity levels corresponded with the company’s empirical perceptions of the requirement’s maturity.Practical implicationsEmpirical evidence validates the significance and practical utility of the proposed methodology, as evidenced by the company’s attainment of FDA (US Food and Drug Administration) approval after the intervention. Findings suggest that the methodology could be replicated within the medical products industry or adapted to assess other QMS, leveraging the organizational alignment with the international regulations of the sector and the ISO 9000 requirements.Originality/valueThe developed methodology fills existing gaps in both literature and practice within the medical devices industry, providing a valuable contribution by addressing the limited research on diagnostic methodologies designed for ISO 13485:2016 implementation. The article assists medical device enterprises in addressing QMS maturity levels as a metric for evaluating QMS requirements, which is an underexplored avenue in existing QMS evaluation approaches.

Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry

BackgroundMedical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage a challenging patchwork of regulatory activities. A standalone regulatory agreement could clarify the relationships and responsibilities between companies working jointly on a single regulated product. This study explored the need for and current use of standalone regulatory agreements.MethodsA survey instrument was developed using an implementation framework and disseminated to mid- to senior-level employees and consultants for sponsor and vendor companies in the medical products sector.ResultsOf 294 respondents, about half, primarily from companies with more than 200 employees, were familiar with standalone regulatory agreements, and half of this subgroup had moved forward to implement them. Such agreements were considered beneficial to clarify regulatory roles and responsibilities, standardize regulatory expectations between the companies, and stimulate earlier discussion about joint regulatory strategies. However, the development of regulatory agreements appears challenged by the fact that such agreements are not required by regulatory agencies overseeing medical products and have no standardized templates, agency or industry guidance. Respondents whose organizations do not now use regulatory agreements either had not considered or did not see a need for a standalone agreement.ConclusionsStandalone regulatory agreements are becoming more common but are not yet implemented fully by most companies. Their usefulness and content appeared to depend upon the type of partner, the complexity of the relationship and the availability of internal expertise and support.

Digital marketing strategies for medical products: A theoretical and practical review

Digital marketing has emerged as a crucial component in the promotion and dissemination of medical products. This theoretical and practical review delves into the strategies essential for navigating this dynamic landscape effectively. The paper begins with an exploration of the target audience, emphasizing the importance of understanding the needs and behaviors of healthcare professionals, patients, and caregivers. Subsequently, it discusses various digital marketing tactics, including content marketing, search engine optimization (SEO), social media marketing, email marketing, and influencer marketing, elucidating their roles in engaging and educating the target audience. Moreover, the review emphasizes the significance of data analytics and optimization for continuous improvement, while also highlighting the necessity of regulatory compliance and ethical considerations. Drawing upon case studies and practical examples, the paper provides insights into successful digital marketing campaigns within the medical products industry, offering valuable lessons and best practices. Ultimately, this review aims to equip stakeholders with the knowledge and strategies needed to harness the full potential of digital marketing in promoting medical products while adhering to regulatory standards and ethical principles.

How country of origin, perceived quality, and trust influence intention to purchase sars covid medications

To maintain business survival and continuous research and development in the medical product industry, investigating the factors that influence the public's intention to buy Sars Covid medications is a primary mission for all the related medical institutions. This research aimed to examine how product attributes (country of origin and perceived quality) influence user attitude (consumer trust) and user decision-making (the intention to buy medications). Researchers collected data from 800 Thai people who were previously infected with COVID-19 using a convenience and snowball sampling method. Data were analyzed using a path analysis technique. Results indicate that consumer trust was influenced by country of origin and perceived quality. Furthermore, the intention to buy Sars Covid medications was influenced by trust and perceived quality, but not country of origin. Finally, consumer trust mediated an association between country of origin and intention to buy the medications. These results provide supportive evidence to the proposed theoretical model which underlines the relationships between product attributes, user attitudes, and user purchase decisions on Sar Covid medications. Particularly, this research contributes to the understanding of how country of origin and perceived medication quality influence patient trust which paves the way for their decision to purchase the medications for their future consumption. Thus, recommendations have been provided to all related medical institutions to consider labeling the country of origin on the medication packages, promoting medication quality to the patients, and enhancing patient trust. Therefore, these can positively lead to high purchase decisions among the patients.

Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership

This cross-sectional study examines the ties between pharmaceutical and medical device industries and the executive leadership of the 50 highest-revenue US-based patient advocacy organizations.

Influence of the Process Parameters on the Properties of Cu-Cu Ultrasonic Welds

Ultrasonic welding (USW) is a solid-state welding process based on the application of high frequency vibration energy to the workpiece to produce the internal friction between the faying surface and the local heat generation required to promote the joining. The short welding time and the low heat input, the absence of fumes, sparks or flames, and the automation capacity make it particularly interesting for several fields, such as electrical/electronic, automotive, aerospace, appliance, and medical products industries. The main problems that those industries have to face are related to the poor weld quality due the improper selection of weld parameters. In the present work, 0.3 mm thick copper sheets were joined by USW varying the welding time, pressure, and vibration amplitude. The influence of the process variables on the characteristics of the joints and weld strength is investigated by using the analysis of variance. The results of the present work indicate that welding time is the main factor affecting the energy absorbed during the welding, followed by the pressure and amplitude. The shear strength, on the other hand, resulted mostly influenced by the amplitude, while the other parameters have a limited effect. Regardless the welding configuration adopted, most welds registered a failure load higher than the base material pointing out the feasibility of the USW process to join copper sheets.

Health Care Equity and Justice Scorecard To Increase Diversity in Clinical Trial Recruitment and Retention.

Health Care Equity and Justice Scorecard To Increase Diversity in Clinical Trial Recruitment and Retention.

Discourse Analysis of Marketing of Medical Skincare Products in Health-Related We Media

More and more marketing methods that borrow health knowledge popularization to marketing are used in the medical skincare products industry. Based on the discourse analysis method proposed by Fairclough, this paper explores the establishment of situational dialogue in the marketing of skincare products in health-related We Media. Besides, it subverts the original cognition and explains the three discourse strategies in a simple way to reflect the “scene-based” consumption situation. In addition to analyzing the “story-based” communication strategy of advertising content, this paper also plumbs the marketing logic that appeals to “sensibility” and “rationality” in vision as well as the unity of advertising discourse order and knowledge science discourse order. Consumers, producers, and knowledge owners struggle for discourse, a social power.

Realizing supply chain agility under time pressure: Ad hoc supply chains during the COVID‐19 pandemic

When the COVID‐19 pandemic began in 2020, the medical product industry faced an unusual demand shock for personal protective equipment (PPE), including face masks, face shields, disinfectants, and gowns. Companies from various industries responded to the urgent need for these potentially life‐saving products by adopting ad hoc supply chains in an exceptionally short time: They found new suppliers, developed the products, ramped‐up production, and distributed to new customers within weeks or even days. We define these supply chains as ad hoc supply chains that are built for a specific need, an immediate need, and a time‐limited need. By leveraging a unique sampling, we examined how companies realize supply chain agility when building ad hoc supply chains. We develop an emergent theoretical model that proposes dynamic capabilities to enable companies building ad hoc supply chains in response to a specific need, moderated by an entrepreneurial orientation allowing firms to leverage dynamic capabilities at short notice and a temporary orientation that increases a company's focus on exploiting the short‐term opportunity of ad hoc supply chains.

Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions.

In the last decade there has been a significant increase in the literature discussing the use of benefit-risk methods in medical product (including devices) development. Government agencies, medical product industry groups, academia, and collaborative consortia have extensively discussed the advantages of structured benefit-risk assessments. However, the abundance of information has not resulted in a consistent way to utilize these findings in medical product development. Guidelines and papers on methods, even though well structured, have not led to a firm consensus on a clear and consistent approach. This paper summarizes the global landscape of benefit-risk considerations for product- or program-level decisions from available literature and regulatory guidance, providing the perspectives of three stakeholder groups-regulators, collaborative groups and consortia, and patients. The paper identifies key themes, potential impact on benefit-risk assessments, and significant future trends.

New Study Shows Complex Financial Ties Between the Medical Product Industry and the Health Care Ecosystem

New Study Shows Complex Financial Ties Between the Medical Product Industry and the Health Care Ecosystem

Managing conflicts of interest in healthcare: the new frontier

Our research team spent countless hours examining over 500 original research reports to identify, characterise, and map all documented ties between the medical products industry and the individuals, institutions, and...

Mapping conflict of interests: scoping review

ObjectiveTo identify all known ties between the medical product industry and the healthcare ecosystem.DesignScoping review.MethodsFrom initial literature searches and expert input, a map was created to show the network of...

Realizing Hyperagility under Time Pressure: Ad Hoc Supply Chains in the COVID-19 Pandemic

Early in the COVID-19 pandemic in 2020, the medical product industry faced an unprecedented demand shock for personal protective equipment (PPE) such as face masks, face shields, disinfectants, and gowns. In response, many companies from different industries built ad hoc supply chains for these potentially life-saving products. When building ad hoc supply chains, companies showed supply chain hyperagility that allowed them to respond at an extreme speed. In this paper we investigate how companies realize supply chain hyperagility in the context of ad hoc supply chains built in the COVID-19 pandemic. Following a grounded theory-building approach, we conducted and analyzed 52 interviews with representatives of 37 German companies to develop a theoretical model that explains the relationships of four constructs to supply chain hyperagility: Internal and external (dynamic) capabilities have a direct effect on supply chain hyperagility and are moderated by an entrepreneurial and a temporary orientation. Our theoretical model contributes to the literature stream of supply chain agility by developing a new agility construct that addresses the extreme condition of time pressure. Supply chain managers will be able to develop their capabilities for future external shocks such as natural disasters and economic crises in line with our theoretical model.

MELHORIA DE EFICIÊNCIA PRODUTIVA DE UMA LINHA DE PRODUÇÃO: UM ESTUDO DE CASO EM UMA INDÚSTRIA DE PRODUTOS MÉDICOS

A competitividade nos diversos segmentos industriais tem estimulado as organizações a desenvolverem formas de tornar suas operações e processos produtivos cada vez mais eficientes e com maior produtividade. Com isso as empresas buscam características que permitam ter bons resultados em relação à concorrência. Assim, este estudo apresenta conceitos acerca da aplicação de ferramentas, adequação de layout e técnicas para resolução de problemas, melhorando a eficiência produtiva em uma linha de produção, garantindo o aumento da qualidade e produção pelo índice de produtividade e redução de desperdícios, em uma indústria de produtos médicos. O método para a aplicação das ferramentas de melhoria de processo foi dividido em etapas, iniciando com definição de uma estrutura conceitual teórica, seguido pelo planejamento de caso, teste piloto, coleta de dados, análise de dados e geração de relatórios. Por fim, dos principais resultados obtidos com estas alterações, pode-se destacar a redução de tempo do processo em aproximadamente 17%, a melhoria de alocação de recursos e o aumento de produtividade em aproximadamente 20%. O balanceamento de linha proporcionou também a redução da ociosidade dos funcionários, devido a distribuição de atividades de trabalho, sem acúmulo de estoques intermediários e com menos colaboradores por célula, além de reduzir as paradas não planejadas. Assim, o trabalho contribui para a geração de resultados positivos ao processo, permitindo ganhos de produtividade e redução de custos com a melhoria dos indicadores, permitindo a potencialização dos resultados com a continuidade da aplicação das ferramentas.

Rapid Prototyping : An Effective Tool for Manufacturing of Intricate Geometries of Automotive Components : A Case Study

Tooling is one of the most important elements in the manufacturing process. To achieve the high quality requirements, moulds are traditionally made by CNC-machining, electro-discharge machining or conventional technologies. The term Rapid Prototyping (RP) refers to a group of technologies that can automatically construct physical model from Computer Aided Design data. Rapid Prototyping allows them to be made quicker and less expensively. The Rapid Prototyping techniques involves basic five step process like, Create a 3D CAD model of the required design, Convert the CAD model to STL format, Slice the STL file, Construct the model Layer by Layer and finally Clean and finish the model. Rapid Prototyping is widely used in fabrication of intricate parts of automotive, aerospace, medical and consumer products industries. Also especially moulds are made from RP model from Rapid Tooling. In this paper, a case study of manufacturing of engine head is taken. In contrast to construction of models by machining, based on the removal of material until the required form is achieved, RP model is made by adding material layer by layer until the whole part will be completed.

試行錯誤におけるテクノロジーの活用：医療・医薬産業における事例

試行錯誤におけるテクノロジーの活用：医療・医薬産業における事例

β-type Ti Alloys for Biomedical Applications

In the world market, medical products emerge as a sector that directly concerns people’s life quality and related activities. The medical product industry continues to grow rapidly in the world, especially in developed countries in line with the advances in technology, along with the elderly population and welfare level. In this context, biomedical implants constitute an important branch of the medical product industry. Among the materials preferred for implant production, the metallic biomaterials are very popular due to their superior mechanical properties. Ti and Ti alloys, among the metallic biomaterials, draw more attention considerably compared to stainless steel and Co-Cr alloys due to their characteristic features such as high specific strength and superior corrosion resistance, low density and low modulus of elasticity. Although the elastic modulus of titanium and its alloys is low compared to the other metallic biomaterials, it remains higher than bone. β-type Ti alloys have been developed to prevent the stress shielding effect caused by the elastic modulus mismatch and sterilization of the biomaterials used in the body from toxic alloy elements. In this article, the effect of the use of β-type Ti alloys, which are extremely prospective materials and open to development, in the body on host organisms, and the efficiency of the developed alloys have been investigated.

Role of DNA Repair and Protective Components in Bacillus subtilis Spore Resistance to Inactivation by 400-nm-Wavelength Blue Light.

The high intrinsic decontamination resistance of Firmicutes spores is important medically (disease) and commercially (food spoilage). Effective methods of spore eradication would be of considerable interest in the health care and medical product industries, particularly if the decontamination method effectively killed spores while remaining benign to both humans and sensitive equipment. Intense blue light at a ∼400 nm wavelength is one such treatment that has drawn significant interest. This work has determined the resistance of spores to blue light in an extensive panel of Bacillus subtilis strains, including wild-type strains and mutants that (i) lack protective components such as the spore coat and its pigment(s) or the DNA protective α/β-type small, acid-soluble spore proteins (SASP); (ii) have an elevated spore core water content; or (iii) lack enzymes involved in DNA repair, including those for homologous recombination and nonhomologous end joining (HR and NHEJ), apurinic/apyrimidinic endonucleases, nucleotide and base excision repair (NER and BER), translesion synthesis (TLS) by Y-family DNA polymerases, and spore photoproduct (SP) removal by SP lyase (SPL). The most important factors in spore blue light resistance were determined to be spore coats/pigmentation, α/β-type SASP, NER, BER, TLS, and SP repair. A major conclusion from this work is that blue light kills spores by DNA damage, and the results in this work indicate at least some of the specific DNA damage. It appears that high-intensity blue light could be a significant addition to the agents used to kill bacterial spores in applied settings.IMPORTANCE Effective methods of spore inactivation would be of considerable interest in the health care and medical products industries, particularly if the decontamination method effectively killed spores while remaining benign to both humans and sensitive equipment. Intense blue light radiation is one such treatment that has drawn significant interest. In this work, all known spore-protective features, as well as universal and spore-specific DNA repair mechanisms, were tested in a systematic fashion for their contribution to the resistance of spores to blue light radiation.

Transparency at the U.S. Food and Drug Administration

Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.