Developing digital medical products for rehabilitation purposes may face the following challenges, with examples:

Regulation and approval process: Medical devices must meet strict regulatory requirements and standards, which can be time-consuming and expensive. For example, the FDA (Food and Drug Administration) in the US has a rigorous approval process that can take years and cost millions of dollars.

Clinical evidence and validation: Developing and gathering evidence to support the efficacy of the product can be difficult, as well as securing approval from medical organizations and insurance providers. For example, conducting clinical trials to prove the effectiveness of a digital rehabilitation product can be expensive and time-consuming.

User acceptance and adoption: Despite the potential benefits, patients may be hesitant to use new technology in their rehabilitation process. Ensuring that the product is user-friendly and can be easily integrated into their treatment plan is crucial. For example, a product may be technologically advanced, but if it’s difficult for patients to use, they may be less likely to adopt it.

Competition: There may already be established players in the market, making it challenging to stand out and gain market share. For example, if a new digital rehabilitation product is entering a market with several well-established competitors, it may be difficult to differentiate the product and convince customers to choose it over others.

Cost and reimbursement: Developing a digital medical product can be costly, and securing reimbursement from insurance providers can be a challenge, particularly in countries with a publicly funded healthcare system. For example, a digital rehabilitation product may be deemed too expensive by insurance providers, making it difficult for patients to access it.

Data security and privacy: Digital medical products handle sensitive patient information, and ensuring that this information is secure and protected from potential breaches is critical. For example, if patient data is not properly secured, it could be vulnerable to cyber attacks and potential breaches of privacy.

Technical challenges: Developing and maintaining the technology behind the product can be complex, and ensuring that the product works effectively and reliably can be a challenge. For example, the product may require ongoing updates and maintenance to ensure it continues to work properly and meet the needs of patients.

In conclusion, developing digital medical products for rehabilitation purposes requires overcoming several significant challenges in order to succeed. By addressing these challenges, developers can help to bring new, innovative products to the market, improving the rehabilitation process for patients.

一樣，以上的文字是chatGPT所生成的，我的提問是"開發數位復健產品會遭遇那些問題"，看完他秒回的內容，霎時間覺得整理得相當清楚。現在人類(我)只能幫他潤飾排版，或是錦上添花的附和一些個人經驗與案例。

開發數位醫療會遇到的挑戰與困難包括了

Regulation and approval process: 法規

一般取證要花上一兩年，日本取證可能兩年可能四年。大家都說這是數位醫療或是醫療器材的門票，的確如此。但也僅僅是門票，但也僅僅是開始。後面的幾個問題更為重要。

Clinical evidence and validation:臨床驗證

有效性這是產品的根本與基礎。所需花費的時間從設計到執行，也是要以年作為時間單位。

User acceptance and adoption:使用者的接受度(compliance)

我覺得這個很難，尤其是數位醫療，這值得專門在寫一篇(先挖坑)

Competition:競爭

除了現有的龍頭老大之外，也包括後進者的競爭與…致敬。

Cost and reimbursement:成本與保險給付

怎麼讓自己的產品是有性價比，成本怎麼定，跟經銷商大大們的分潤合作討論是門藝術。當然，已經確定好可以有保險給付的話，在這個產品涉及的所有重點人物都能獲得利益的話，事情就會通暢很多。

Data security and privacy:資安問題

這個很重要，不過可以歸在法規的類別中，現在在歐盟的MDR裡，資安問題是個需要先解決或是自證可以解決的問題。

Technical challenges:技術問題

科技日新月異，尤其軟體大約三兩年就有一個大的躍進，怎麼樣找到適當而的技術來運用，或是自行研發，都考量著主事者的智慧。