Successful Implementation of a Medical Device Company’s Regulatory Strategy

Software Risk Management (RM) within Medical Device (MD) companies is a critical area. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators penalise MD manufacturers that do not devote sufficient attention to the areas of hazard analysis and RM throughout the software lifecycle. This paper describes the experience of a MD software development organization when they engaged in a research project to improve their RM practices. We explain how this was achieved through the development of a software process improvement RM model that integrates regulatory MD RM requirements with the goals and practices of the Capability Maturity Model Integration (CMMI). This model is known as the Risk Management Capability Model (RMCM). The authors describe the complete project lifecycle and evaluate the success of the project.

Validation and Verification of WLAN Medical Devices

Regulatory aspects and strategy in medical device and bio materials safety evaluation

The medical device industry is uniquely characterized by both resourceful global companies and innovative catching-up companies. The studies by Chatterji have analyzed how large and established medical device companies could better utilize the ideas from innovative groups such as physicians. While the existing literature on the topic of open innovation is enriched, there are few studies on the partnership between larger global medical device companies and smaller catching-up medical device companies. This study focuses on a structured partnership with global medical device companies. To understand how such a deal could be better arranged, this study adopted the Analytic Hierarchy Process (hereafter, AHP) analysis to derive the success factors of such partnership with a focus on the case of the Korean medical device industry. This survey interviewed 30 experienced professionals who currently work for global medical device companies. The study results found that global medical device companies prefer a licensing deal along with broader territories. In terms of the preferred requirements for a partnership deal, the study revealed that there is strong emphasis on factors such as Quality and Intellectual Property (hereafter, IP) protection. This study has practical managerial implications for catching-up medical device companies which drive an open innovation practice with a view to accelerating their growth trajectory in the global market.

Background Medical devices can seek patent term extensions (PTEs), which extend market exclusivity to compensate for delays related to clinical trials and regulatory review. Pharmaceutical companies commonly use PTEs, but their use by medical device companies has not been clear. Research Design and Methods We examined the use of PTEs by medical device companies between 1984 and 2024 using a database published in the Federal Register and a list published by the Patent and Trademark Office. Results Only 178 medical device submissions were linked to a PTE application. They were mostly concentrated in 116 product codes associated with 15 medical specialties; nearly half were associated with cardiovascular devices. Numbers increased significantly in the past decade. Successful applications restored 987 days on average. Conclusions The patent restoration opportunity appears underutilized. It is unclear whether some companies do not recognize the opportunity it promises, or whether it does not meet their needs. Different business features and marketing strategies in device versus pharmaceutical industries may decrease the usefulness of the PTE program for these types of medical products. However, the finding that a small subset of manufacturers operating in competitive markets adopted patent extension strategies more commonly suggests a significant competitive advantage when competition increases.

The significance of big data is increasingly acknowledged across all sectors, including medicine. Moreover, the trend of data trading is on the rise, particularly in exchanging other data for medical data to rejuvenate the medical industry. This study aimed to discern the facilitating factors of healthcare data trade. We assessed five medical data market platforms on October, 2022, based on three criteria: (a) clarity in articulating the data for sale; (b) transparency in specifying the data costs; and (c) explicit indication that payment grants data access. This helped identify the traded medical data types. Additionally, we anonymously surveyed 43 representatives from medical device companies about their demand for medical data trading, achieving a response rate of 66%. Of the medical data traded on these platforms, 93.34% was structured, while 5.66% was unstructured, indicating an imbalance. Although there was a higher demand for structured medical data, there was also interest in purchasing unstructured medical data. Unstructured big data are crucial for medical device development, fueling the demand for trading such data. Many stakeholders view the data market as essential and are willing to procure medical data. Consequently, medical device companies will need methods to acquire unstructured medical data for developing innovative and enhanced medical devices.

Apart from whether a mark can be protected under the trademark law, there may be government regulations that can restrict or prohibit use of the mark in advertising or labeling any products with the mark. Any medical device company using or selecting a trademark should be aware of the nature and kind of regulations that may be applicable to their product. The rules vary from state to state, and there are different rules that apply to labeling and marketing outside of the United States. Medical device companies need to be aware of what labeling and marketing rules apply to their business in order to avoid potential fines, penalties or litigation.

Though not currently in the scope of the European Union's Restriction on the use of certain Hazardous Substances directive (EU RoHS) , medical devices are addressed by China's Management Methods for Controlling Pollution Caused by Electronic Information Products Regulation (China RoHS) . Medical device companies are now “playing catch-up” when it comes to preparing and showing compliance with RoHS-type legislation. From parts shortages to parts with incorrect finishes, there are many lessons to be learned from other industries when responding to RoHS-type laws. The medical devices industry can use the “lessons learned” by other businesses to competently approach eco-compliance. This paper outlines a strategy for a proactive approach to eco-compliance in the production of medical devices. Without focusing on specific environmental or RoHS-type legislation, it also presents a strategy for compliance information gathering, storage and organization.

<p>El propósito de este artículo es dar prioridad a Gestión de Calidad Total (GCT) prácticas y examinar su importancia relativa en la implementación de GCT en pequeñas y medianas empresas (PYME) de la industria de dispositivos médicos, utilizando el método de Analytical Hierarchy Process (AHP). Modelación matemática fue el método de investigación adoptado. La elección de AHP también se basó en la necesidad de adquirir conocimientos de diferentes empresas. Algunas implicaciones se pueden destacar. Dos factores estratégicos (Sistema de Gestión de Calidad y Planificación de la Calidad) y un factor táctico (Gestión de procesos) están fuertemente correlacionados y indicados por los expertos como tener la mayor importancia. Por último, el método AHP desarrollado en el presente estudio ha demostrado ser útil para dar prioridad a las prácticas relativas a la aplicación de la GCT en las empresas de dispositivos médicos. Los resultados pueden ser información útil para los administradores de dispositivos médicos que trabajan en las principales prácticas con el fin de mejorar el rendimiento de la GCT.</p>

To improve successful development and clinical use of medical technologies, it is suggested that manufacturers should start collecting evidence on devices effectiveness and efficiency early in their development. The aim of this study was to explore whether and how Dutch manufacturers perform an early assessment of medical devices through semi-structured interviews with key-informants from medical device companies. The primary focus was to identify why, how and to what degree these informants were engaged in early assessment activities to analyse the clinical context, the market, potential stakeholders, and the financial and health economic impact of their medical device. 37 interviews were performed with key-informants of 36 companies. The majority (N=19) of the companies are using internal resources and external consultants to perform early assessment activities. Typically, the assessment activities starts at the idea generation stage, and lasts until the post-marketing surveillance. The least developed areas of the assessment are health economic evaluation from the society perspective and formal stakeholders’ analysis. Many methods seem to be in use to assess medical devices, however, there is no clear understanding of how they should be used, what evidence manufacturers could gather with their use, and how they influence the decision-making process within the companies.

Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association

With the optimization of China’s healthcare policy, the rise of the aging population, the increasing health awareness of society, and the impact of the global epidemic, China’s medical device industry has become a key market for investors. However, compared with the mature and well-funded medical device companies in overseas developed countries, China’s local medical device companies have apparent disadvantages and jumping battles. Yuyue Medical Co., Ltd. is a prominent player in the medical device industry in China, having sustained a significant profit margin over an extended period. Its profitability has changed over the post-epidemic period, in any case. Given Yuyue Medical Co., Ltd.’s exceptional standing in the medical equipment sector, an analysis of the company as an industry investment case makes sense. Based on Yuyue Medical Co., Ltd. as the industry investment benchmark, the study analyses the industry’s competitive development situation, financial performance, and impact on the external environment by adopting Porter’s Five Forces, ratio analysis, and PESTEL. The study found that China’s medical device industry has growth potential due to the low bargaining power of customers and suppliers, high technological barriers, and low threat of substitution by new entrants. Yuyue Medical Co., Ltd. has healthy financial performance and several advantages from the external environment, so Yuyue Medical Co., Ltd. is worthy of investment.

Spinal implants constitute the fastest growing segment of the orthopaedic medical device industry. The area has until the last five to ten years been vastly under‐studied for the proportion of patients who are afflicted with diseases and injuries to the spine. Consequently, new spine medical devices and medical device companies are emerging every day with new and better treatment strategies for prevalent spine disorders. This chapter will explore the physiological conditions and disease states that require treatment and then demonstrate some treatment strategies that are being used today. The devices in this text are not comprehensive but do allow an understanding of the state‐of‐the art in medical treatment of spinal disorders.

Lean Six Sigma (LSS) is a common methodology adopted by organizations to improve operational and financial performance by removing waste and reducing variation. While literature agrees LSS is beneficial, it is unclear whether the initial improved performance is sustained over time. Research has identified several critical success (CSFs) and failure (CFF’s) factors which determine the effectiveness of LSS implementation along with its sustainability. Integral in sustaining the initial positive impact is recognizing these success factors during LSS implementation in conjunction with identifying and preventing critical failure factors.This study aims to investigate whether the implementation of LSS has sustained a positive impact on the operational and financial performance of a Medical Device Company based in the West of Ireland. Using a mixed method approach; a case-study within one Medical Device organization was conducted. Key performance indicators (KPI’s) such as defects and non-conformances were analyzed and trended. Additionally, survey data of critical success and failure factors in the areas of management, training, and culture was collated. The quantity of unit rejects, which ultimately leads to increased costs was used as the financial indicator in this study. The influence of Quality 4.0 and the global pandemic were also considered. A comparison was then made with two other similar sized companies in the region using semi- structured interviews.Results indicated LSS has a sustained positive impact on the organization’s operational and financial performance. Findings suggest Quality 4.0 was a significant contributing factor for sustaining this positive performance. The pandemic was shown to magnify the failure factors albeit offset somewhat by Quality 4.0. The comparison with the other two medical device organizations suggested that LSS alone could not sustain a positive impact highlighting the need to conduct further research into self-sustaining LSS methodologies along with the value to consider the new ‘LSS 4.0’ approach.KeywordsLSS implementationLSS sustainabilityCritical success factorsCritical failure factorsMedical device

This study examines payments from medical device and pharmaceutical companies compiled in the Open Payments Database to physician-authors of the Congress of Neurological Surgery’s clinical practice guidelines.