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How do you bring digital therapeutics to the market?
I discussed it with the Chief Medical Officer of @hyfeapp, Dr. Peter Small. The full interview is available on our exclusive Patreon channel: patreon.com/posts/exclusiv…
𝟏. 𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐚𝐜𝐡𝐢𝐞𝐯𝐞 𝐩𝐫𝐞𝐬𝐜𝐫𝐢𝐩𝐭𝐢𝐨𝐧 𝐬𝐭𝐚𝐭𝐮𝐬 𝐟𝐨𝐫 𝐚 𝐝𝐢𝐠𝐢𝐭𝐚𝐥 𝐭𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜?
- Assessing DTx/SaMD requirements from regulators based on past experience - Clinical trials to demonstrate safety, efficacy, and cost-effectiveness
- Compliance with relevant software-as-a-medical-device (SaMD) regulations, and data privacy and security requirements, which are evaluated as part of the SaMD review
- Regulatory clearance or approval from bodies like the FDA in the US, EMA in EU, PMDA in Japan
- Peer-reviewed dissemination / real world evidence to reinforce clinical credibility and facilitate reimbursement pathways
- Working with KOLs to establish new clinical standards
- Educating and training clinicians working with chronic cough patients, so they can properly prescribe the DTx

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