Digital Therapeutics Regulatory Process, Updates and Trends

Digital Therapeutics Regulatory Process, Updates and Trends


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The market for digital therapeutics (DTx) is expanding tremendously, aided by the increased popularity of decentralized medicine that the pandemic brought about. The global market for DTx was predicted to be worth $3.35 billion in 2021 and would grow to $12.1 billion by 2026.

CATEGORY: Digital Health GEOGRAPHY: Global

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There is a huge amount of uncertainty as a result of this rapid rise I n its Action Plan for Digital Health Innovation. The main thing that needs to be determined for early regulatory planning is whether a gadget even fits into this regulatory category. Sponsors need to be certain of how regulators will recognize their products in order to avoid starting a regulatory process that may take a lot of time and money. 

Digital Therapeutics: Overview

Digital Health

  • Definition: Technologies, platforms, and systems that engage users for lifestyle, wellness, and health-related reasons, collect, store, or transmit health data, and/or support life science and clinical operations are all considered to be part of the field of digital health
  • Clinical Evidence: Typically do not require clinical evidence
  • Regulatory Oversight: These products do not meet the regulatory definition of a medical device and do not require regulatory oversight

Digital Medicine

  • Definition: Evidence-based hardware and/or software products that monitor, treat, or otherwise contribute to human health are included in digital medicine
  • Clinical Evidence: Clinical evidence is required for all digital medicine products
  • Regulatory Oversight: Regulatory requirements may vary. Digital medicine products that are classified as medical device require clearance or approval

Digital Therapeutics (DTx)

  • Definition: Digital therapeutics (DTx) products deliver evidence-based therapeutics interventions to prevent, manage or treat a medical disorder or disease
  • Clinical Evidence: Clinical evidence and real world outcomes are required for all DTx products
  • Regulatory Oversight: DTx products needs to be certified by regulatory bodies so as to support product claims of risk, efficacy and intended use

Digital Therapeutics: Definition by FDA (US)

Digital therapeutics are generally regulated as software by the FDA under the agency’s software-as-a-medical-device (SaMD) category and are subject to regulatory obligations much like conventional medical devices.

  • Development of a Software Precertification Program (Pre-Cert) aimed to replace the need for a premarket submission for certain products and allow for reduced submission content and/or faster review of the marketing submission
  • The FDA’s vision for the future is that companies taking advantage of the Pre-Cert program will also be able to utilize the National Evaluation System for health Technology (NEST) system
  • This aims to generate better evidence for medical device evaluation and regulatory decision making across the device lifecycle by collecting post-market, real-world data in order to affirm the regulatory status of the product and support new applications of the technology
  • Section 3060 of the Cures Act excludes from the definition of “device” software functions intended for activities such as healthcare facility administrative support, healthy lifestyle maintenance, or serving as electronic patient records, so long as the function is not intended to interpret or analyze them for the purpose of condition diagnosis, cure, mitigation or treatment

US FDA Medical Device Classifications for DTx

FDA medical device classification

Digital Therapeutics Regulatory Process in Germany

  • Germany passed the Digital Care Act (‘Digitale Versorgung Gesetz’ or ‘DVG’) in 2019, it created a pathway for doctors to prescribe digital therapeutics to publicly-insured patients and receive reimbursement in much the same way as a traditional treatment
  • Germany’s Federal Institute for Drugs and Medical Devices ('BfArM') has issued guidelines relating to the evaluation process digital health apps (DiGAs) must go through to be eligible for reimbursement

Regulatory Process

  1. For any app to be eligible it must of the risk class I or IIa under the EU's Medical Device Directive (MDD) or, more importantly, the incoming Medical Device Regulation (MDR)
  2. Most apps that self-classify as class I under MDD will be "up-classed" to class IIa under MDR, which means they'll have to adhere to stricter requirements in order to acquire a CE mark
  3. BfArM's guidelines define further requirements for issues such as safety and efficacy, and the timeframe DiGA developers must meet for their DTx to be approved
  4. Process has been dubbed the ‘Fast-Track’, as it allows DiGAs to be granted preliminary approval following an evaluation, after which developers have 12 months to generate sufficient evidence for full approval

1. Executive Summary
1.1 Digital Health Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Digital Health Policy in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain a high level of accuracy and consistency. The market data is analyzed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, and market share as well as a segment-level analysis of the specific market. Our report includes precise, to-the-point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and their impact on the different segments within the market.

Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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This report addresses

  • Intelligent insights to take informed business decisions
  • Qualitative, acute and result oriented market analysis
  • Market size and forecasts from 2022 to 2030
  • Opportunities for expansion and in-depth market analysis
  • Segmentation and regional revenue forecasts
  • Analysis of the market share and competitive landscape
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Last updated on: 13 December 2023
Updated by: Ritu Baliya

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