Innovators’ views on involving users and patients in surgical device development: a qualitative interview study

Woudstra, Kas; Tummers, Marcia; Rovers, Maroeska M.; Reuzel, Rob

doi:10.1136/bmjopen-2021-050801

Cited by 6 publications

(3 citation statements)

References 33 publications

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“…Therefore, good preoperative planning is recommended when using these implants. Importantly, patients should be involved in the decision-making and evaluation of implant material, and other osteosynthesis methods, such as intramedullary nailing, should be considered before definitive treatment [ 55 , 56 ].…”

Section: Discussionmentioning

confidence: 99%

Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review

et al. 2023

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Background Carbon-fibre (CF) plates are increasingly used for fracture fixation. This systematic review evaluated complications associated with CF plate fixation. It also compared outcomes of patients treated with CF plates versus metal plates, aiming to determine if CF plates offered comparable results. The study hypothesized that CF plates display similar complication rates and clinical outcomes as metal plates for fracture fixation. Methods The study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched from database inception until June 2023: PubMed, MEDLINE, Embase, Web of Science, Cochrane Library, Emcare, Academic Search Premier and Google Scholar. Studies reporting on clinical and radiological outcomes of patients treated with CF plates for traumatic fractures and (impending) pathological fractures were included. Study quality was assessed, and complications were documented as number and percentage per anatomic region. Results A total of 27 studies of moderate to very low quality of evidence were included. Of these, 22 studies (800 patients, median follow-up 12 months) focused on traumatic fractures, and 5 studies (102 patients, median follow-up 12 months) on (impending) pathological fractures. A total of 11 studies (497 patients, median follow-up 16 months) compared CF plates with metal plates. Regarding traumatic fractures, the following complications were mostly reported: soft tissue complications (52 out of 391; 13%) for the humerus, structural complications (6 out of 291; 2%) for the distal radius, nonunion and structural complication (1 out of 34; 3%) for the femur, and infection (4 out of 104; 4%) for the ankle. For (impending) pathological fractures, the most frequently reported complications were infections (2 out of 14; 14%) for the humerus and structural complication (6 out of 86; 7%) for the femur/tibia. Comparative studies reported mixed results, although the majority (7 out of 11; 64%) reported no significant differences in clinical or radiological outcomes between patients treated with CF or metal plates. Conclusion This systematic review did not reveal a concerning number of complications related to CF plate fixation. Comparative studies showed no significant differences between CF plates and metal plates for traumatic fracture fixation. Therefore, CF plates appear to be a viable alternative to metal plates. However, high-quality randomized controlled trials (RCTs) with long-term follow-up are strongly recommended to provide additional evidence supporting the use of CF plates. Level of evidence: III, systematic review.

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Section: Discussionmentioning

confidence: 99%

Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review

et al. 2023

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“…Their involvement, not only professionals in medical fields but also patients, (although involving the use of non-negligible resources) is the approach that brings the most benefits in terms of achievable results (Shah, Robinson & AlShawi, 2009;Romero, Borga & Frausin, 2022). Even though this added value is recognised, recent studies (Woudstra et al, 2021;Yang, Mahmud & Wang, 2021) show that there is often a tendency to underestimate the importance of the patient in projects, limiting the involvement to professional users (doctors, nurses, engineers, etc.). Can this limitation be attributed to the limited involvement of the designer and design methodologies in decision-making and design processes in the medical device sector?…”

Section: Discussionmentioning

confidence: 99%

Design Considerations for Homecare Products: Towards the Digital Healthcare Transition

Romero¹,

Buffagni²

2022

Proceedings of DARCH 2022 November - 3rd International Conference on Architecture &Amp; Design

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Digital Healthcare is one of the goals of the Digital Transition. It includes the digitalisation of healthcare and the implementation of a widespread capillary network in which the patient's home becomes the core of care (telemedicine, de-hospitalization). However, the challenge lies in making this transformationand so the new domestic medical devicespatient-friendly, easily accessible, and acceptable. Shifting some medical and care practices to the patient's home requires redesigning medical devices to fulfil the broad needs of patients, family members and carersas well as medical personnel, who monitor the patient remotely. This paper introduces some design considerations for the development of homecare products (telemedical devices to be used independently by users in their home environment). It opens by laying out the context from which these considerations were drawn (an educational experience: a full-semester workshop within the master's degree in Product Design at the University Iuav of Venice, Italy) and then presents five design principles: simplicity of use, aesthetics and likeability, discretion, camouflaging, recreational (which are listed as fundamental and integrative principles of health product design) along with, where needed, references to a selection of student projects. The purpose of this paper is to emphasise that while designing healthcare devices the same attention paid to the technical function and its accuracy should also be paid to these five design principles because translating them into formal and functional aspects of the product will contribute to the final acceptance and adoption of the system by the user, hence to its success and effectiveness. Ultimately, promoting the digital health transition, the spread of telemedicine, and de-hospitalization. Finally, the article encourages the scientific community to identify new design principles in a field that needs design intervention more than ever before.

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“…design approaches to embrace user-centred methods 9. Employing formal methods to involve users in the MDD process should increase the probability that devices meet proper clinical goals, comply with technical standards, are cost-effective and meet ethical norms 75 .…”

Section: Successful Medical Device Innovation Requires Research Beyon...mentioning

confidence: 99%

User involvement in the design and development of medical devices in Epilepsy: a systematic review

Ferreira,

Peixoto,

Lopes

et al. 2024

Preprint

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Objective 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. Methods: 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. Results: 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 employed for capturing user perspectives. User involvement occurs in four out of the five stages of MDD, with production being the exception. Significance 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.

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Innovators’ views on involving users and patients in surgical device development: a qualitative interview study

Cited by 6 publications

References 33 publications

Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review

Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review

Design Considerations for Homecare Products: Towards the Digital Healthcare Transition

User involvement in the design and development of medical devices in Epilepsy: a systematic review

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