Regulatory Landscape - Overview

Smart inhalers Regulatory Landscape: Product Overview

Smart inhalers are the advanced medical devices designed to help patients with respiratory conditions like asthma and chronic obstructive pulmonary disease (COPD) manage their treatment more effectively. These inhalers have digital sensors that track and monitor medication usage and collect data that can be shared with healthcare professionals for optimizing treatment plans.

Most common health issue worldwide is lung related health condition, about 25 million people are suffering with asthma in United States, and 16 million people are suffering with Chronic obstructive pulmonary disease (COPD). Both the conditions lead to breathing problems in the affected patients lowering the quality of their life. Currently FDA has given clearance to two smart inhalers, which basically comprises smart sensors connected to the traditional inhalers which is helping to improve the quality of life for the patients with respiratory related health problems.

Food and Drug Administration (FDA) is responsible for ensuring the safety, efficacy and quality of the smart inhalers to be used by the patients.

Smart inhalers type

Smart inhalers are classified into Metered Dose Inhalers, Dry Powder Inhalers, Nebulizers, and based on the technology used for its working they are further classified into Bluetooth Enabled, Sensor Based, Mobile Application Integrated.

• Metered dose inhalers are also known as puffers, have facility to hold the medication in pressurized canister, which even has mouthpiece, this inhaler helps to send a puff of medicine out of mouthpiece, and patient can pull the medicine into the lungs, it delivers 1 dose at a time.
• Dry powdered inhalers has the facility to hold and store the medicine in powder form in the capsules, quick deep break by the patient will pull the powder out into the lungs of the patient
• Nebulizer is medical device used to administer medication directly to the lungs in quick mode, they have ability to turn liquid into fine mist which the patient can inhale through mouthpiece, allowing the medication to directly go into lungs or respiratory system wherever it is required to create therapeutic effect.

Smart inhaler Applications

Digital therapeutics are the future of healthcare landscape, allowing personalization in management of chronic diseases effectively, completely giving importance and focusing on wellness and treatment compliance.

Digital inhalers help the patients with respiratory issues like asthma and COPD to identify the triggers, and share the information with their healthcare professionals, it is helpful for adhering to the treatment schedules, reminding the dosage regularly so the patient will not miss the medication cycle, also allowing to track the usage of inhalers, by setting alerts or notifications. Some have the ability to track the pollutants or pollen in the environment and alert the patient regarding it and prevent further health problems.

They even contribute to relieve stress of the patient of having to remember the time of taking the medicines, specially when they are prescribed with many drugs. They even optimize inhalation technique and efficacy, they also help in tracking symptoms of patients and allowing doctors to understand reason and time of symptoms becoming worse, and to monitor the use of the rescue inhaler for immediate short-term relief.

Smart Inhalers Product Development Steps:

Figure: Key components involved in Development and Regulatory Approval of the Smart Inhaler

Smart Inhalers Market size Overview

As per MRFR analysis, the US Smart Inhalers Market Size was estimated at 436.1 (USD Million) in 2023. The US Smart Inhalers Market Industry is expected to grow from 488.04(USD Million) in 2024 to 1,208 (USD Million) by 2035. The US Smart Inhalers Market CAGR (growth rate) is expected to be around 8.588% during the forecast period (2025 - 2035).

                                             Smart Inhalers Regulatory Landscape:

There are several key regulatory agencies who oversee the approval and monitoring of Smart Inhalers to ensure their safety, efficacy, and quality.

Smart Inhalers Guidelines:

Eligibility: people diagnosed with Asthma, or chronic obstructive pulmonary disease (COPD), or any other respiratory illness requiring inhaled medication, patient suffer with medication adherence, frequent hospital visits or poor control on Asthma or COPD are all ideal for administering their drugs using these smart inhalers.

Smart Inhalers Classification of the Product:

Smart Inhalers Regulatory Process Overview, By Country:

Smart inhalers integrate traditional inhalation therapy with digital technologies for monitoring and improving medication adherence are subjected to regulatory oversight to ensure safety and efficacy, in US smart inhalers are regulated by food and drug administration (FDA).

Fda has classified all medical devices into…

Key regulatory steps involved in the regulatory process of smart inhalers is as follows:

Device classification – Medical devices are classified into three categories based on evaluation of risk they can pose to the patient, including class I, II, III. Class I is of low risk and needs only general control submission, class II is of moderate risk and needs general and special controls typically need 510(k) clearence. Class III poses high risk and is strictly regulated and requires Premarket Approval (PMA). Identifying the class of the device under development is important if it is class II than premarket notification 510 (k) is required which needs evidence of substantially equivalent device already legally marketed to prove the efficacy of new product.

Combination product -  under 21 CFR 3.2 (e) combination products are defined as product comprising drug/device/biologic components combined in one entity, smart inhalers integrated with digital technology or sensors fall under combination product category and needs multicentered FDA review, including divisions of FDA like center for drug evaluation and research (CDER), center for devices and radiological health (CDRH),  center for biologics evaluation and research (CBER) for meeting all compliance requirements of the product.

Regulatory pathway determination- general use devices like nebulizers need 510 (k) pathway via CDRH. Drug specific devices like smart inhalers need device modules in NDA/ IND or a separate 510 (k) if drug is already approved.

Device review considerations- Smart Inhalers are evaluated based on

• Indications for use (target population, environment)
• Device description
• Performance testing- includes cascade impaction, flow rate testing, add Ons like spacers and masks.
• Biocompatibility- gas pathway contact, particulate testing.
• Software validation
• Human factor engineering- 9-% of device success depends of patient interface.
• Labelling and instructions for use.

Submission to FDA and review- submit all the data collected regarding the product performance, risk analysis, standards along with the suitable regulatory submission like PMA or 510 (K) to FDA for review, if the product is meeting or complying with all the regulatory standards set by FDA it is approved and allowed to be marketed.

Post market surveillance- FDA track the product even after marketed to ensure its safety and efficacy to patient throughout the use of product and even check for any adverse event reporting if found they immediately go for product recall.

 Smart inhalers updates

March 2024, The FDA has cleared Adherium's Hailie Smartinhaler, a Bluetooth-enabled sensor, for use with AstraZeneca's asthma and COPD inhalers, Airsupra and Breztri. This device clips onto the inhaler and transmits usage data to the cloud, helping monitor medication adherence and technique. Airsupra is used for asthma, while Breztri is for COPD. This innovation aims to enhance the management of respiratory conditions by providing real-time tracking and feedback to patients and healthcare providers, with the global market for smart inhaler devices expected to grow significantly.

July 2021, The FDA granted clearance to BreatheSuite Inc.'s smart inhaler device, which aims to improve inhaler technique and adherence for people with asthma and COPD. The BreatheSuite Metered-Dose Inhaler (MDI) V1 device converts regular MDIs into smart inhalers by monitoring and providing feedback on inhaler use. This helps users improve their inhaler technique and adherence to prescribed medication, which is crucial as many people use inhalers incorrectly. Additionally, the device, along with a mobile app, allows for remote patient monitoring, enabling healthcare teams to customize care plans based on the data collected. By promoting effective inhaler use, the device aims to reduce the economic burden associated with asthma and COPD, enhancing the quality of care and health outcomes for respiratory patients.

Smart Inhalers Regulatory Challenges and possible risk in development:

Combination products increasing complexity- smart inhalers combine drug and devices and software, so during the approval process of such medical equipment navigating both medical devices and drug and biologics regulatory framework is a must, which demands different regulatory compliance demands and can be very strict and time-consuming process. Usually in such products the center for biologics evaluation n and research and center for drug evaluation and research and center for devices and radiological health of food and drug administration all are involved in regulation review process making the process more complex.

Regulatory classification- it is often difficult to decide if product should be first classified and regulated as a device or drug or software, this even affects the type of regulatory submission like 510 (k) or PMA, NDA.

International regulation variations – different countries have different regulations for the healthcare products, making it difficult of the manufacturers of one country to market the product in other country not having same regulatory framework for the product, making the compliance process more complex.

High research and development cost and time – integration of drug with device leads to extended development cycles and high investment which is sometimes challenging for the manufacturers.

Reliability and accuracy- risk of dosage errors, data inaccuracies, sensor malfunctions can lead to clinical failure or product recalls.

Smart Inhalers Competitive Landscape Dashboard:

Companies With Marketed Smart Inhalers:

• Propeller Health
• Inspiro Medical
• AstraZeneca
• Novartis
• MannKind Corporation
• GlaxoSmithKline
• Adherium
• Smart Inhaler
• Boehringer Ingelheim
• InnovoFlow
• Respira Therapeutics
• ResMed
• Cipla
• Teva Pharmaceuticals
• AptarGroup