Medical Device Development Process Research Articles

User involvement in the design and development of medical devices in epilepsy: A systematic review.

This systematic review aims to describe the involvement of persons with epilepsy (PWE), healthcare professionals (HP) and caregivers (CG) in the design and development of medical devices is epilepsy. A systematic review was conducted, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included peer-reviewed research focusing on medical devices for epilepsy management, involving users (PWE, CG, and HP) during the MDD process. Searches were performed on PubMed, Web of Science, and Scopus, and a total of 55 relevant articles were identified and reviewed. From 1999 to 2023, there was a gradual increase in the number of publications related to user involvement in epilepsy medical device development (MDD), highlighting the growing interest in this field. The medical devices involved in these studies encompassed a range of seizure detection tools, healthcare information systems, vagus nerve stimulation (VNS) and electroencephalogram (EEG) technologies reflecting the emphasis on seizure detection, prediction, and prevention. PWE and CG were the primary users involved, underscoring the importance of their perspectives. Surveys, usability testing, interviews, and focus groups were the methods used for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception. User involvement in the MDD process for epilepsy management is an emerging area of interest holding a significant promise for improving device quality and patient outcomes. This review highlights the need for broader and more effective user involvement, as it currently lags in the development of commercially available medical devices for epilepsy management. Future research should explore the benefits and barriers of user involvement to enhance medical device technologies for epilepsy. This review covers studies that have involved users in the development process of medical devices for epilepsy. The studies reported here have focused on getting input from people with epilepsy, their caregivers, and healthcare providers. These devices include tools for detecting seizures, stimulating nerves, and tracking brain activity. Most user feedback was gathered through surveys, usability tests, interviews, and focus groups. Users were involved in nearly every stage of device development except production. The review highlights that involving users can improve device quality and patient outcomes, but more effective involvement is needed in commercial device development. Future research should focus on the benefits and challenges of user involvement.

Methods for Medical Device Design, Regulatory Compliance and Risk Management

Despite the evolution of design controls and compliance as critical elements in the medical device development process, as stipulated by both domestic and international regulations and standards, a comprehensive model describing the comprehensive approach to medical device design is needed. This gap exists because design controls and regulatory compliance have become integral to the medical device design process, mandated by regulations and standards at both national and international levels. The medical device sector prioritizes design controls and compliance with regulatory requirements in isolation. On the other hand, the integration of design controls and compliance, such as those associated with projects involving complex medical device designs, have not been considered nearly enough. This review focuses on the integration of design controls and compliance in the medical device sector. Initially, the definition of a medical device and the different phases of medical device development are introduced. Afterwards, medical device development using the basic safety and essential performance concepts outlined in the IEC 60601-1 standard is discussed. The role of risk management practices about medical devices is also elaborated upon.

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF

BackgroundMedical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context.MethodsWe developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting.FindingsThe TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023).ConclusionsThese 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Improved screening of retinopathy of prematurity (ROP): development of a target product profile (TPP) for resource-limited settings

BackgroundAs more preterm infants survive, complications of preterm birth, including retinopathy of prematurity (ROP), become more prevalent. ROP rates and blindness from ROP are higher in low-income and middle-income countries,...

Best Practices for Use-Related Risk Analysis Through Collaboration of Human Factors and Clinical

Integrating the human factors engineering (HFE) process, and its user-centered approach, into the medical device and combination Product and Development Process (PDP), has been an ongoing challenge for its respective industries and Human Factors (HF) practitioners within it for decades. Yet, despite continuous process adaptation and evolution of the HFE process, as well as the introduction of standards and health authority guidelines, the early integration of a risk-based and user-centered approach within the development and design process remains an ongoing practical challenge occupying the minds of most. With the introduction of the European MDR 2017/745 in 2017, an additional emphasis was put on the importance of use-related risk identification, assessment, and data based evaluation within the clinical evaluation process, and with such introduces clinical teams to (new) ‘use-related risk challenges’ as well. This paper provides a framework for early integration of an iterative use-related risk analysis approach, addressing common practical challenges, and providing best practices for such. Furthermore, it highlights how applying a collaborative approach between HF and clinical efforts would permit for collection of more robust use-related data sets, thus potentially optimizing use-related risk, residual risk, and risk-benefit analyses and their processes.

Monitoring sitting posture: a low-cost wearable device using alarm and vibration method

Back pain problems are frequently caused by incorrect sitting posture, excessive sitting time, and a lack of awareness of body posture care. When the COVID-19 pandemic spread around the world, it impacted the national education system because the learning process had to be implemented online. Back pain is becoming more common among patients, ranging from office workers to students. While there are products on the market that can assist humans in correcting their body posture, the majority of them are under-promoted or priced too high to be affordable. As a result, the purpose of this research is to develop a body posture detector that will assist humans in becoming aware of their body posture errors and correcting their position while sitting. When this product detects incorrect sitting posture, it will vibrate and sound an alarm. This human body posture detector is being developed in accordance with the Medical Device Development Process model, which consists of five phases: (1) identifying problems, (2) researching and collecting information, (3) generating various solutions, (4) analysing and selecting the best solution, and (5) testing and evaluation. The findings indicate that the developed product can function properly. Furthermore, three experts agreed that this product can assist consumers in recognising and correcting errors in their body posture while sitting. However, in terms of design, this product has room for improvement in order to improve its quality. Overall, the designed product is capable of performing successfully and achieving the intended goals.

PMDedu: Assessing the educational needs of startups and academic investigators focused on pediatric medical device development.

The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regulatory requirements, product development, research, and marketing strategies. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) conducted an educational needs assessment to understand knowledge gaps and inform our educational strategy. We surveyed a total of 49 medical device startups and 52 academic investigators. Electronic surveys were developed for each group on Qualtrics and focused on manufacturing, regulatory, research, commercialization, and funding. Descriptive statistics were used. A larger proportion of academic investigator respondents had a clinical background compared to the startup respondents (45% vs. 22%). The biggest barriers for academic investigators were understanding regulatory and safety requirements testing (52%) and finding and obtaining non-dilutive funding was the most difficult (54%). Among startups, understanding clinical research methods and requirements was the biggest barrier (79%). Startup companies and academic investigators have similar, but not identical, educational needs to better understand the PMD development process. Investigators need more support in identifying funding sources, while startup companies identified an increased need for education on research regulatory topics. These findings can help guide curriculum development as well as opportunities for partnerships between academia and startups.

Strategies for Medical Device Development: User and Stakeholder Perceptions.

Medical device development involves user safety, and it is governed by specific regulations. The failure of medical device developers to consider the influence of users, the environment, and related organizations on product development during the design and development process can result in added risks to the use of medical technologies. Although many studies have examined the medical device development process, there has been no systematic and comprehensive assessment of the key factors affecting medical device development. This research synthesized the value of medical device industry stakeholders' experiences through a literature review and interviews with industry experts. Then, it establishes an FIA-NRM model to identify the key factors affecting medical device development and suggests appropriate pathways for improvement. Results indicate that the development of medical devices should begin with stabilizing organizational characteristics, followed by strengthening technical capability and use environment, and finally, consideration should be given to the user action of medical devices. The results provide medical device developers with optimal development pathways and resource allocation recommendations to support developers in developing medical device development strategies as well as ensuring the safety and effectiveness of the products for end users.

The Importance of Design in the Development of a Portable and Modular Iot-Based Detection Device for Clinical Applications

The integration of human factors engineering methods within the medical device design and development process has been highlighted by international standards organizations. Such methods are contributing to the development of safer medical devices, more suitable to users’ needs. Errors during device operation might hamper effective patient diagnosis and treatment, or eventually lead to injury or death. Thus, the designing process of a medical device is indeed crucial to user experience and safety operation. This paper presents a human-centred design analysis of a novel IoT-based screening prototype (iLoF) based on Artificial Intelligence algorithms built-in in a patented-photonics system developed by a deep tech startup. The influence of the design process during the development of the prototype was addressed, based on a human-centred design methodology and considering the device’s application environment. iLoF’s prototype on-field applicability was evaluated considering a single case-study carried out at one of the main hospitals in Portugal through interviews to ten healthcare professionals with high experience in laboratorial testing. A benchmark assessment and a comparison matrix along with the market products are also presented to fully understand the technology state and to find new solutions that can influence iLoF’s product development.

472 Indiana CTSI Think Tank Program

OBJECTIVES/GOALS: The Think Tanks’ aim to assist faculty innovators along the path from discovery to commercialization; serving as a one-stop-shop where investigators can access advice, pilot funds, and direction toward other available resources within the Indiana CTSI. METHODS/STUDY POPULATION: Faculty receive guidance from a pool of advisors in the drug and device industry, as well as their respective university commercialization offices; who serve as an essential resource for a wide range of scientific, technical, clinical, business, and regulatory questions. Investigators submit a simple intake form to connect with a project facilitator for detailed guidance prior to formal meetings. Projects are guided from start to finish with robust tracking and milestone-based funding to help generate data for Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Project tracking is conducted using REDCap, which is used for all investigator submissions, with internal processes also tracked in REDCap. RESULTS/ANTICIPATED RESULTS: From Feb-Aug 2021; the Think Tanks provided feedback to 15 drug projects and 6 medical device projects. This included 12 from Indiana University; 4 from Purdue University; and 5 from the University of Notre Dame. Interestingly; drug innovations were submitted primarily by tenure track faculty (100%) with a history of NIH/NSF funding (50%); while device innovations were submitted primarily by clinical faculty without a history of NIH/NSF funding (66%). Based on first-round feedback, a total of approximately $3;400 in pilot funds were provided. Efforts are underway to obtain survey-based feedback from all applicants to date; which will be used to inform future program modifications. DISCUSSION/SIGNIFICANCE: The budding “Think Tank” program provides faculty with a broad perspective of the entire drug and medical device development process, helping investigators understand the critical interplay development stages. Future work seeks to enhance faculty engagement in, and understanding of the commercialization process across Indiana CTSI institutions.

Multi-Criteria Decision Making for Medical Device Development

The development of a new product is a complicated multi-stakeholder process with a significant risk of failure. This is particularly true in the medical device sector, where there are strict therapeutic, psychological, and normative constraints. This article presents a multi-criteria decision making process called “Define, Prioritize, Measure, and Aggregate” (DPMA). DPMA is designed to help engineering managers in decision making during the development process of new medical devices. The model is based on two sets of criteria linked to business and customer satisfaction. These criteria are weighted using the analytic hierarchy process (AHP) and group decision making (GDM) process. The performance of a medical device is measured according to each criterion. Furthermore, the final score of GO/NO GO alternatives are calculated with the simple additive weighting (SAW) method. A case study for the development of a new kind of femoral implant is presented to demonstrate the implementation of the DPMA process. This study shows that the application of the DPMA process during the design of a 3D printed femoral prosthesis provided engineering managers the key elements and green light to go ahead with the development of this medical device.

Optimizing the innovation and development process of medical devices - a study based on angiographic equipment

Cardiovascular diseases are the leading cause of death. The gold standard for their diagnosis and treatment are angiographic procedures, which require specialized equipment. The speed of their continued development is important as better technology enables progress in clinical outcomes. This article proposes a new process model for the innovation and development and shows how to optimize it such that it takes minimal time. The conducted literature research identifies this closed loop process model as being unique in comparison to the well-established models proposed by Brockhoff, Cooper, Crawford, Durfee, Ebert, Eppinger, Hughes, Pleschak, Thom, Ulrich, Vahs and Witt. During a long-term observation of the innovation and development process of angiographic systems 672 data sets on 302 topics were collected over 47 months to validate this process model. The data collected is equivalent to efforts worth 30 man-years. This input was used to calculate key process parameters, analyse key process roles, evaluate the use of problem-solving methods and identify key technologies. We recommend to apply a continuous loop process in the context of innovation and development of medical devices. In the analysed datasets a potential of an up to 20% shorter process time was identified. Our results can be used for an Activity Based Costing Approach or be applied to bring new or upgraded angiography systems faster to market benefitting patient outcome due to improved diagnosis and treatment. According to the best knowledge of the authors no comparable data collection relating to angiography systems has been performed and presented anywhere else yet.

Estimation Methods for Viscosity, Flow Rate and Pressure from Pump-Motor Assembly Parameters.

Blood pumps have found applications in heart support devices, oxygenators, and dialysis systems, among others. Often, there is no room for sensors, or the sensors are simply unreliable when long-term operation is required. However, control systems rely on those hard-to-measure parameters, such as blood flow rate and pressure difference, thus their estimation takes a central role in the development process of such medical devices. The viscosity of the blood not only influences the estimation of those parameters but is often a parameter that is of great interest to both doctors and engineers. In this work, estimation methods for blood flow rate, pressure difference, and viscosity are presented using Gaussian process regression models. Different water–glycerol mixtures were used to model blood. Data was collected from a custom-built blood pump, designed for intracorporeal oxygenators in an in vitro test circuit. The estimation was performed from motor current and motor speed measurements and its accuracy was measured for: blood flow rate r2 = 0.98, root mean squared error (RMSE) = 46 mL.min−1; pressure difference r2 = 0.98, RMSE = 8.7 mmHg; and viscosity r2 = 0.98, RMSE = 0.049 mPa.s. The results suggest that the presented methods can be used to accurately predict blood flow rate, pressure, and viscosity online.

Medical device development, from technical design to integrated product development

The development process of medical devices (MDs) implies the integration of knowledge and skills from the fields of medicine and engineering. Such an integration is difficult because of lack of communication, mismatch of priorities and work-style differences among those fields. Besides, MD development has particularities that make the product development process (PDP) even more complex such as high level of regulations, concurrent technologies application as well as different end users requirements. In addition, these MDs are classified according to the level of risk they offer to users – low, medium and high – what makes their development project very complex in practice depending on the risk associated. For the specific case of SMEs in the broad mechanical and electronic area that develop physical MD with low and medium-risk levels, PDP models in place have proved to be not well fit to the reality they face. This research objective is to synthesise a PDP model for SMEs in the specific medical sector, by incorporating the best practices of the engineering area and particularities of the medical area. The methodology used was an extensive bibliographic analysis and field research conducted towards SMEs in the MD industry.

Integrated SEM-FTOPSIS framework for modeling and prioritization of risk sources in medical device development process

PurposeThe purpose of this paper is to outline and prioritizes risk sources in medical device development (MDD) process using an integrated “structural equation modeling” (SEM) and fuzzy “technique for order performance by similarity to ideal solution (TOPSIS)” framework.Design/methodology/approachRisk sources which deter MDD process are explored through literature review. Initial structural model is proposed, factor loadings are determined by exploratory factor analysis and model fit is established by confirmatory factor analysis. Further, the sources are ranked using FTOPSIS, and sensitivity analysis is carried to check robustness of results.FindingsThe sources of risks have catastrophic effect on MDD process. The initial SEM model developed based on survey of experts is found reliable and valid which breaks up the risk sources into three categories – internal sources of risks, user-related sources of risks and third-party-related sources of risks. The risk sources are ranked and prioritized based on perspective of experts from the categories using FTOPSIS; unmet user needs/requirements is found as the most important source of risk. Results of sensitivity analysis confirm that the factors are relatively less sensitive to criteria weights confirming reliability of initial solution.Research limitations/implicationsThe proposed methodology combines qualitative and quantative approaches, making it little complex and lengthy, but results in dual confirmation.Practical implicationsThe outcomes of this research will be of prime use for MDD industries to mitigate risk sources. It will help to increase the success rate of MDD.Originality/valueIntegrated SEM-FTOPSIS provides a unique and effective structural modeling-based decision support tool. The framework can be effectively utilized in other domains, and failure events of medical devices can be potentially controlled by applying risk mitigation measures.

Human factors in the design of medical devices – Approaches to meeting international standards in the European Union and USA

This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.

Commercial viability of medical devices using Headroom and return on investment calculation

The market success of a medical product depends on its commercial viability, yet this may be hard to predict during the development process of medical devices. This paper aims to determine if applying the Headroom method combined with return on investment (ROI) analysis allows for estimation of the potential commercial viability of one therapeutic and five diagnostic devices. The devices were targeted at different disease areas. Information regarding the maximum additional health benefit that could be obtained with the new device, the estimated production price and expected sales volume was gathered from literature and expert opinions. A willingness-to-pay threshold for one additional Quality-Adjusted Life Years of €30,000 was assumed for Headroom calculation. The analysis showed that the device with the highest estimated headroom per unit was RAPAI: a computed tomography photo-acoustic instrument for imaging inter-phalangeal joints (€1,645,120), followed by CBPM: continuous blood pressure measurement device (€922,440), Home Brain Monitoring (HBM) device (€750,000), a portable point-of-care (POC-CKD) device (€36,250), and the IHP: injectable healing plasters (€22,100). The devices with the highest estimated ROI were RAPAI (€14,951,200), and POC-CKD (€14,100,000), followed by HBM (€9,450,000), CBPM (€8,624,400), and IHP (€7,050,000). Overall, RAPAI is expected to have the highest potential commercial viability and HBM and IHP the lowest. The presented combined method is feasible, useful, and informative to help assess the potential commercial viability of medical devices under development. It might be an answer to the growing need of performing value-based pricing of devices replacing currently dominating cost-plus pricing approach.

Interpretive structural modelling of risk sources in medical device development process

Development of new devices is known to bring substantial amount of revenues to medical device manufacturing companies, but is often a risky endeavour. The risks are stemmed from number of sources which have catastrophic effects on medical device development (MDD) process. This paper explores risk sources in MDD process. A model of interaction among these sources is developed based on contextual mutual relationships among them. The risk sources which can jeopardize the MDD processes in terms of cost, time of development and quality of device are identified primarily through experts’ opinions and literature review. The mutual relationship among them is established using interpretive structural modelling methodology. They are further classified based on the mutual influence and dependence using MICMAC analysis. The results show that the risk sources have mainly two groups; one has high dependence and low driving power representing the resulting actions. Another group has high driving power and low dependence indicating the need for systematic attention. Third group is of autonomous risk sources which are relatively disconnected from the system but are important when considered separately. This research is a unique effort and will be a lighthouse for the developers, decision makers and researchers to focus and deal with the risk sources which can impede the processes and may even result in harmful events related to devices. This study is focused on risk sources in MDD process but can be applied to product development in other areas to improve the development processes.

The Research of Wearable Electronic Medical Devices

Wearable electronic medical devices can realize non-intrusive and non-invasive monitoring of human body, which has the characters of removable operation, easy to use, long-lasting work, smart display diagnostic results, abnormal physiological condition alarms, wireless data transmission, achieve treatment data remote real-time monitoring and so on. In this paper, we collect information of the development process of wearable medical devices, and make the detailed description of the characteristics and development history about wearable electronic medical systems’ hardware and software design, pointing out the shortcomings and the development direction of existing equipment.

Combining Headroom and Return on Investment Analysis To Rank Potential Commercial Value of Six Medical Devices in Development.

Objectives: The development process of medical devices strongly depends on the financial resources available and the expected return on investment to manufacturers. The aim of this paper is to analyse the potential commercial viability of two disruptive and four incremental medical devices in different stages of development. Methods: The headroom method combined with the return on investment analysis was performed for one therapeutic and five diagnostic devices for different clinical target areas. Information regarding maximum additional benefit that could be obtained with new device, the estimated production price and expected sales volume was gathered from literature and expert opinions. A willingness-to-pay threshold for one additional QALY of € 30,000 was assumed for headroom analysis. Results: The devices were ranked according to their potential commercial viability. The analysis showed that two disruptive and two incremental devices had reasonably good balance between headroom and unit cost, and two incremental devices had no good balance. The device with the highest potential commercial viability was a disruptive therapeutic device for the cartilage repair treatment in the first clinical trial stage, with estimated headroom for the cost of the new treatment: € 74,600 and an expected production cost of the therapy: € 8,000 per unit. The market volume size was calculated based on the incidence of cartilage defects: 65% in routine knee arthroscopies. The disruptive diagnostic device for home brain monitoring of epilepsy patients in the prototype stage of development had the lowest potential commercial viability, with an estimated headroom of € 81,000 and an expected production costs per unit: € 120,000 that resulted in the unfavorable return on investment. Conclusions: The headroom method combined with a return on investment analysis, offers insight in the potential commercial viability of medical devices under development. The research on the impact of that analysis on actual R&D decision making will still be determined.