Discussion on the Deployments of Digital Therapy — Product Realization
This chapter explores the specifications of DTx products by incorporating successful elements of DTx products and the previously discussed Pre-cert organization design. Finally, we discuss the appropriate roles for developing the ecosystem of the industry.
DTx Product Specification Discussion
The product specifications can be explored using the DTx-Value-Assessment-Guide. Although the purpose of this guide is to provide health care providers with a reference criterion for assessing the value of DTx, these value assessments can also express how product specifications should be developed and planned.
1. Specification Development
The product can be classified according to the five general principles of medical device development requirements: product requirements, functional compliance, safety compliance, regulatory approval, and post-market follow-up.
Why use post-market follow-up rather than post-market surveillance? This is mainly because post-market surveillance is a major direction that the quality system must execute, but for DTx products, the most important task under the quality system’s post-market surveillance framework is post-market follow-up.
Figure 1 classifies the 18 considerations of the DTx Product Evaluation Considerations in the DTx-Value-Assessment-Guide. For details on each item, please refer to the DTx-Value-Assessment-Guide [Note 1].
2. Six Key Elements for Successful DTx Products
In addition to the basic requirements for product launch, according to [Reference 3], six key factors are proposed to ensure the success of DTx products: interoperability, socialization, outcomes, engagement, intelligence, and integration.
Interoperability refers to the use of advanced technology to allow data sharing across multiple platforms.
Intelligence involves using advanced technologies such as machine learning, deep learning, and artificial intelligence to generate personalized and evolving systems and interventions.
Socialization allows for the exchange of patient data in real-time with other affiliated institutions.
Integration involves using DTx products as part of a patient’s lifestyle, spending more time managing their own care and reducing the time spent with clinical doctors.
In addition, outcomes are crucial for building successful DTx products, from preliminary research to randomized controlled trials.
Finally, gaming principles should be applied to DTx interventions to meet engagement levels.
From all of these factors, interoperability should be the focus because it enhances big data processing, communication, qualified research, and international cooperation [Reference 2].
Therefore, it is clear that compared to general medical devices or drugs, these types of products emphasize more on user interaction and engagement, whether it is using artificial intelligence to assist healthcare service providers or other forms of engagement. Linguistic validation, which has been increasingly valued in medical device regulations, would also be an important requirement if the product is to be sold in different language regions.
Discussion of Roles in the Development of DTx Products
1. Ideal Participating Companies
Ideal participants in DTx product development According to Deloitte’s report “Cross-border exploration — exploring digital medical regulations and response strategies”, the digital medical device ecosystem can be represented as shown in Figure 2.
The ideal “iron triangle” for DTx development includes medical device manufacturers, pharmaceutical companies, and information analysis service providers, as shown in Figure 3.
From the perspective of market approval, the ideal combination of medical device manufacturers and pharmaceutical companies is complementary in terms of regulations. Medical devices and drugs are subject to different regulatory frameworks, and the regulatory requirements for DTx products are mainly based on SaMD, which falls under the category of medical devices. However, the methodology for clinical trials is more similar to that for drugs.
In terms of the qualifications required of medical device manufacturers, their products require long-term third-party research, as well as reference data from other applied research, such as observational studies, to ensure the credibility of the clinical trial results.
After market approval, tracking and even customer service are critical roles played by information analysis service providers.
Furthermore, if it is a behavioral therapy (CBT, Cognitive behavioral therapy), in addition to the combination of pharmaceutical companies with medical equipment, the combination of medical centers and medical equipment companies is another option to consider. Another advantage of this combination is that the service side can directly make use of the resources of healthcare providers.
It can be seen that DTx is actually a product that requires cross-industry collaboration.
2. Organizational Implementation
As the basic regulatory requirements are structured similarly to the US FDA’s Pre-Cert Program or AI/ML Framework, discussions on relevant specifications can be referred to in the following column.
The requirements related to regulations are presented inside, and in addition to explaining the relevant frameworks, the requirements of the regulations are also explained through the use of specification documents.
Regarding the implementation of the organization, the author proposes the following designs for the relevant organizations based on the requirements of the regulations presented above.
In addition, for the organization, as this is an organization that requires cross-industry collaboration among medical device companies, pharmaceutical companies, and information analysis services, the lead will be the medical device or pharmaceutical company, as this is a specialized area of pharmaceutical regulations.
(1) Pharmaceutical company leads, integrates medical device companies and information analysis service companies: The advantage of this approach is that digital therapies can be viewed as a type of medication, so it may be easier to conduct clinical trials, and in some therapies, pharmaceutical companies may be the most suitable for creating digital therapy content.
However, the potential drawback is that if the pharmaceutical company does not establish a GMP system for medical devices separately, the regulations theoretically need to be applied through the medical device company, as digital therapy is SaMD, and software is a medical device category.
(2) Medical device company leads, integrates pharmaceutical companies and information analysis service companies: The advantage of this approach is to directly utilize the medical device company’s GMP system to develop products, with the pharmaceutical company as the content provider.
However, the potential drawback is that the current model of medical device companies may not be suitable for clinical trials and may require the assistance of pharmaceutical companies.
In addition, if the medical device company is not primarily focused on SaMD, a separate unit dedicated to SaMD needs to be established within the organization. Although it can be included in the current Notify Body scope, whether the additional business unit is appropriate for current operations and whether it will cause resource exclusion is a consideration.
(3) Pharmaceutical companies and medical device companies jointly establish a new company: The advantage is specialized division of labor, without affecting current organizational management, and the drawback is the need to invest additional resources.
In addition, the timing for the new company or new business to achieve break-even is also a consideration factor.
The advantages and disadvantages of the three methods are shown in Fig 4 and depend on the resources of the cooperating parties.
Summary
In summary, to develop a digital therapeutic product, it requires an organization that combines the characteristics of medical devices, pharmaceutical companies, and information analysis services.
Although it is a type of drug, GMP is structured under medical devices. Additionally, post-market surveillance and in-depth user interaction are also important aspects.
In the author’s opinion, since this is a new type of product, there is no existing ecosystem with a completely suitable organization. Therefore, setting up a dedicated company is a more reasonable approach.
As for the challenge of balancing profitability, practical operations may consider seeking medical device companies that specialize in SaMD products or those that have a backbone in telehealth, remote monitoring, and other software.
For this particular company, the resources required to add a DTx product are much lower than setting up a new business for a pharmaceutical company or a hardware medical device company. The operational efficiency may even be much higher.
Reference:
1: https://dtxalliance.org/advancing-dtx/dtx-value-guide/
2： Accelerating Biopharmaceutical Innovation With Digital Therapeutics To Improve Patients’ Quality Of Life
https://www.biofourmis.com/life-sciences
3：Hong, J. S., Wasden, C., & Han, D. H. (2021). Introduction of Digital Therapeutics. Computer Methods and Programs in Biomedicine, 106319
