Power and Value of Consumer Product Development Techniques when Applied to Medical Devices

2016 ◽  
Vol 5 (1) ◽  
pp. 72-75
Author(s):  
Keith S. Karn ◽  
Andrew Golaszewski
Keyword(s):  
Product Development ◽  
Medical Devices ◽  
Healthcare Providers ◽  
Medical Product ◽  
Home Healthcare ◽  
Insurance Companies ◽  
User Research ◽  
Medical Issues ◽  
Doctor's Office ◽  
Tools And Techniques

Insurance companies, healthcare providers, and patients are realizing we can treat many medical issues at home and avoid expensive and often inconvenient visits to the doctor’s office or hospital. As a result, many medical devices are now in the hands of untrained patients and caregivers, creating a growing market of consumer medical (or “medsumer”) products. This medsumer product market is exploding, along with the increased spending on home healthcare. This paper explores the benefits and value of looking at medical product development through the lens of this medsumer trend by applying typically consumer-oriented tools and techniques to the development of medical devices. We recommend specific consumer-driven techniques and tools we have used recently in developing medical products. The techniques include a greater emphasis on up-front user research, technological augmentation to ethnography, interdisciplinary design approach, integrated physical & digital prototyping, and more iterative user feedback.

scholarly journals Reluctance to Accept Palliative Care and Recommendations for Improvement: Findings From Semi-Structured Interviews With Patients and Caregivers

2021 ◽  
pp. 104990912110126
Author(s):  
Valeria Cardenas ◽  
Anna Rahman ◽  
Yujun Zhu ◽  
Susan Enguidanos
Keyword(s):  
Palliative Care ◽  
Controlled Trial ◽  
Insurance Coverage ◽  
Healthcare Providers ◽  
Health Condition ◽  
Insurance Companies ◽  
Structured Interviews ◽  
Care Services ◽  
Home Based ◽  
Palliative Care Services

Background: Despite some insurance plans now paying for home-based palliative care, recent reports have suggested that insurance coverage for palliative care may be insufficient in expanding patient access to home-based palliative care. Aim: To identify patients’ and caregivers’ perceived barriers to home-based palliative care and their recommendations for overcoming these barriers. Design: We conducted a qualitative study using semi-structured individual interviews. Our interview protocol elicited participants’ perspectives on home-based palliative care services; positive and negative aspects of the palliative program explanation; and suggestions for improving messaging around home-based palliative care. Setting/Participants: Twenty-five participants (patients, proxies, and their caregivers) who were eligible for a randomized controlled trial of home-based palliative care were interviewed by telephone. Results: Themes related to home-based palliative care referral barriers included reluctance to have home visits, enrollment timing, lack of palliative care knowledge, misconceptions about palliative care, and patients’ self-perceived health condition. Themes related to recommendations for overcoming these obstacles included ensuring that palliative care referrals come from healthcare providers or insurance companies and presenting palliative care services more clearly. Conclusion: Findings reinforce the need for additional palliative care education among patients with serious illness (and their caregivers) and the importance of delivering palliative care information and referrals from trusted sources.

scholarly journals User knowledge factors that hinder the design of new home healthcare devices: investigating thirty-eight devices and their manufacturers

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Fan Yang ◽  
Abdullah Al Mahmud ◽  
Tao Wang
Keyword(s):  
End Users ◽  
Home Healthcare ◽  
Success Factor ◽  
User Research ◽  
The Public ◽  
Root Cause ◽  
Potential Applications ◽  
User Knowledge ◽  
Key Success Factor ◽  
Innovation Processes

Abstract Background The demand for home healthcare devices arises; however, many home healthcare devices on the market are not designed to reflect the needs and features of the end-users. This study explored the user knowledge factors that hindered the design of new home healthcare devices and the interrelationships between the factors. Methods The abovementioned factors were identified from analysing the project documents of thirty-eight carefully selected home healthcare devices produced by five manufacturers; followed by interviewing the thirty stakeholders playing key roles in developing the devices. Results The design of the home healthcare devices was influenced by (1) the user insights utilised in formulating project strategies; (2) the sources of user information; (3) the execution of user research; and (4) the formulation of the manufacturers’ principal innovation processes. Conclusions The users’ characteristics and needs were not sufficiently reflected in developing new home healthcare devices. One root cause was that the end-users were not perceived by the manufacturers as a key success factor in most cases, given that most of the devices were initiated following the public sector’s requests. Actual or potential applications of this study include the facilitation of the appropriate application of human factors methods in developing new home healthcare devices and the improvement of the user performance of the end-devices.

scholarly journals Towards a conceptual model for the use of home healthcare medical devices: The multi-parameter monitor case

PLoS ONE ◽  
2018 ◽  
Vol 13 (12) ◽  
pp. e0208723
Author(s):  
Pablo Reyes ◽  
Dominique Larée ◽  
Alejandro Weinstein ◽  
Álvaro Jara
Keyword(s):  
Conceptual Model ◽  
Medical Devices ◽  
Home Healthcare

scholarly journals Container Closure and Delivery Considerations for Intravitreal Drug Administration

2021 ◽  
Vol 22 (3) ◽  
Author(s):  
Ashwin C. Parenky ◽  
Saurabh Wadhwa ◽  
Hunter H. Chen ◽  
Amardeep S. Bhalla ◽  
Kenneth S. Graham ◽  
...  
Keyword(s):  
Adverse Events ◽  
Product Development ◽  
Drug Product ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Volume Determination ◽  
Common Procedure ◽  
Drug Products ◽  
Fill Volume ◽  
Container Closure

AbstractIntravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product stability, safety, and efficacy for the intended shelf-life. Careful design of primary container configuration is also important to accurately deliver small volumes (10-100 μL). Over- or under-dosing may lead to undesired adverse events or lack of efficacy resulting in unpredictable and variable clinical responses. IVT drug products have been traditionally presented in glass vials. However, pre-filled syringes offer a more convenient administration option by reducing the number of steps required for dose preparation there by potentially reducing the time demand on the healthcare providers. In addition to primary container selection, product development studies should focus on, among other things, primary container component characterization, material compatibility with the formulation, formulation stability, fill volume determination, extractables/leachables, and terminal sterilization. Ancillary components such as disposable syringes and needles must be carefully selected, and a detailed administration procedure that includes dosing instructions is required to ensure successful administration of the product. Despite significant efforts in improving the drug product and administration procedures, ocular safety concerns such as endophthalmitis, increased intraocular pressure, and presence of silicone floaters have been reported. A systematic review of available literature on container closure and devices for IVT administration can help guide successful product development.

Medical Device Regulation and Cybersecurity: Achieving ‘Secure by Design’ for Regulatory Compliance

2020 ◽  
Vol 9 (2) ◽  
pp. 12-17
Author(s):  
William S ENNS-BRAY ◽  
Kim ROCHAT
Keyword(s):  
Medical Devices ◽  
Rapid Evolution ◽  
Healthcare Providers ◽  
Regulatory Compliance ◽  
Healthcare Sector ◽  
Security Risks ◽  
The Past ◽  
Smart Hospitals ◽  
Personalized Health ◽  
Medical Device Regulation

The rapid evolution of information technology over the past 50 years is transforming our healthcare institutions from paper-based organizations into smart hospitals, a term now used by European Union Agency for Cybersecurity (ENISA). These changes are also associated with the systematic reliance on medical devices by both patients and healthcare providers. While these devices have the potential to advance personalized health solutions and improving the quality and efficacy of care, they nevertheless present significant security risks and challenges throughout the healthcare sector.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

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