Co-Creation in the Development of Digital Therapeutics: A Narrative Review
Abstract
:1. Introduction
2. Methods
3. Narrative
3.1. Digital Therapeutics
3.1.1. Digital Health vs. Digital Medicine vs. DTx
3.1.2. DTx vs. mHealth
3.1.3. Evaluation, Regulation, and Approval
3.1.4. Major DTx Products and Companies
3.1.5. DTx Advantages and Disadvantages
3.1.6. User Perceptions and Experiences
3.1.7. Healthcare Professional’s Perceptions and Experiences
3.2. Co-Creation: Co-Design
3.2.1. Co-Design Activities
3.2.2. Benefits and Challenges Associated with the Use of Co-Creation in DTx Development
3.2.3. Examples of How Co-Creation Has Been Used in the Development of DTx
4. Conclusions
5. Future Directions and Recommendations
Author Contributions
Funding
Conflicts of Interest
References
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Product Name | Classification | Company | Therapeutic Area | Approval Status | Website |
---|---|---|---|---|---|
Dario® Platform | Non- Prescription DTx | Dario | Diabetes (type 1 and type 2) Hypertension | FDA-cleared Class II device; CE mark received by European Notified Body | https://www.dariohealth.com (accessed on 5 June 2024) |
Insulia | Prescription DTx | Voluntis | Type 2 diabetes | FDA-510(k) EU-CE Mark | https://insulia.com/ (accessed on 5 June 2024) |
Daylight® | Non- Prescription DTx | Big Health | Generalised anxiety disorder | EU-CE Mark FDA enforcement discretion | https://www.bighealth.com/daylight/ (accessed on 5 June 2024) |
EndeavorOTC® | Non- Prescription DTx | Akili | Attention-deficit/ hyperactivity disorder (ADHD) | FDA-authorised Class II Medical Device | https://www.akiliinteractive.com/ (accessed on 5 June 2024)) |
Freespira® | Prescription DTx | Palo Alto Health Sciences | Post-traumatic stress disorder (PTSD), panic disorder, panic/anxiety attacks | FDA-cleared Class II Medical Device | https://freespira.com/ (accessed on 5 June 2024) |
GameChange® | Non- Prescription DTx | RealizedCare | Agoraphobic avoidance and distress | Class I CE mark | https://www.realizedcare.com/ (accessed on 5 June 2024) |
HelloBetter® Chronic Pain | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Chronic Pain | Class I CE mark (MDR) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
HelloBetter® Diabetes | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Diabetes | Class I CE mark (MDD) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
HelloBetter® Panic | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Panic disorder with or without agoraphobia | Class I CE mark (MDR) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
HelloBetter® Sleep | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Insomnia | Class I CE mark (MDR) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
HelloBetter® Stress and Burnout | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Stress and burnout | Class I CE mark (MDR) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
HelloBetter® Vaginismus Plus | Non- Prescription DTx (Eligible in ‘DiGA’) | HelloBetter | Vaginismus, dyspareunia, and genito-pelvic pain/penetration disorder | Class I CE mark (MDR) | https://hellobetter.de/en/ (accessed on 5 June 2024) |
JOGO-Gx® | Non- Prescription DTx (Reimbursed by Medicare) | Jogo Health | Migraine and chronic lower back pain | FDA 510K exempted (reviewed by the FDA and registered) | https://www.jogohealth.com/ (accessed on 5 June 2024) |
Leva® | Non- Prescription DTx | Leva | Urinary and faecal incontinence | FDA-cleared Class II Medical Device | https://www.levatherapy.com/ (accessed on 5 June 2024) |
Propeller® | Non- Prescription DTx | ResMed | Asthma and chronic obstructive pulmonary disease (COPD) | FDA-cleared Class II Medical Device and EU Class I Medical Device | https://propellerhealth.com/ (accessed on 5 June 2024) |
Sleepio® | Non- Prescription DTx | Big Health | Insomnia | FDA enforcement discretion; Class I CE mark | https://www.bighealth.com/sleepio/ (accessed on 5 June 2024) |
Welldoc® App | Non- Prescription DTx | Welldoc | Type 1 and 2 diabetes, pre-diabetes, hypertension, heart failure, weight and obesity management | FDA-cleared Class II Medical Device; Class IIa CE mark; Health Canada-licenced Class II Medical Device | https://www.welldoc.com/ (accessed on 5 June 2024) |
reSET® | Prescription DTx | Pear Therapeutics | Substance-use disorder (SUD) | FDA-cleared Class II Medical Device | https://peartherapeutics.com/products/reset-reset-o/ (accessed on 5 June 2024) |
Natural Cycles | - | Natural Cycles | Birth control | FDA-de novo | https://www.naturalcycles.com (accessed on 5 June 2024) |
Oleena | Prescription DTx | Voluntis | All cancer | FDA-510(k) | https://oleena.com/ (accessed on 5 June 2024) |
CureApp-SC | Non- Prescription DTx | CuraApp Inc. | Smoking cessation | MHLW (Japan) | https://sc.cureapp.com/d/ (accessed on 5 June 2024) |
PainChek® | Non-Prescription DT | PainChek | Pain in people living with dementia | Class I CE Mark | https://www.painchek.com/ (accessed on 5 June 2024) |
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Mimoso, I.; Figueiredo, T.; Midão, L.; Carrilho, J.; Henriques, D.V.; Alves, S.; Duarte, N.; Bessa, M.J.; Facal, D.; Felpete, A.; et al. Co-Creation in the Development of Digital Therapeutics: A Narrative Review. Int. J. Environ. Res. Public Health 2024, 21, 1589. https://doi.org/10.3390/ijerph21121589
Mimoso I, Figueiredo T, Midão L, Carrilho J, Henriques DV, Alves S, Duarte N, Bessa MJ, Facal D, Felpete A, et al. Co-Creation in the Development of Digital Therapeutics: A Narrative Review. International Journal of Environmental Research and Public Health. 2024; 21(12):1589. https://doi.org/10.3390/ijerph21121589
Chicago/Turabian StyleMimoso, Inês, Teodora Figueiredo, Luís Midão, Joana Carrilho, Diogo Videira Henriques, Sara Alves, Natália Duarte, Maria João Bessa, David Facal, Alba Felpete, and et al. 2024. "Co-Creation in the Development of Digital Therapeutics: A Narrative Review" International Journal of Environmental Research and Public Health 21, no. 12: 1589. https://doi.org/10.3390/ijerph21121589
APA StyleMimoso, I., Figueiredo, T., Midão, L., Carrilho, J., Henriques, D. V., Alves, S., Duarte, N., Bessa, M. J., Facal, D., Felpete, A., Fidalgo, J. M., & Costa, E. (2024). Co-Creation in the Development of Digital Therapeutics: A Narrative Review. International Journal of Environmental Research and Public Health, 21(12), 1589. https://doi.org/10.3390/ijerph21121589