Breath Analyzers are one of the modern innovative devices that have emerged with the intent to improve healthcare and revolutionize the conventional diagnostic methods.
FDA substantiates that there are no known direct risks to patient’s health with such devices. However, failure of these tests which results in an error in interpretation of results may lead to improper patient management and a delay in an appropriate patient care and intervention.
Breath Analyzers used for diagnosis – associated risks and apprehensions:
- Will a falsely low ‘bio-marker potentially delay the treatment of diseases and can it contribute to a decision to decrease the dose of further therapies?
- Will a falsely high ‘bio-marker measurement result in unnecessary additional testing such as biopsy, chemotherapy which may cause unanticipated adverse effects to the patient? How can Innovators address such apprehensions?
Firstly, a thorough research needs to be conducted to understand which bio marker could be used for detection of which targeted disease. This must also be clinically proven by standard bodies or extensive retrospective clinical data.
- Secondly, verifying and validating the device and the algorithm, plays a vital role in ensuring an accurate and precise detection of bio-marker related to the targeted disease.
- Thirdly, all the design controls must be in place to oversee that the output of the device meets the user needs and every modification is assessed thoroughly before implementation.
- Last but not the least, effective integration of design controls, development, and testing against proper standards shall result in a device that is safer and has less issues or adverse events associated with its use.
- Conform to the general and special controls of the Federal Food, Drug & Cosmetic Act, including the premarket notification or other requirements as applicable.
- Perform thorough risk assessment, and address the specific risks to health associated with the breath test systems.
- Get marketing authorization from the regulatory bodies of your target markets (Australia, Canada, Europe, USA or India), so the patients and healthcare providers get the confidence that the benefits associated with your device outweigh its potential risks. No predicate? Consider a Denovo submission!
As rightly stated – “The starting point of all achievement is desire.”
The desire of Innovators to innovate and overcome the challenges and apprehensions of the healthcare providers shall determine how Breath Analyzers develop in the future.
What the future of breath analyzers could be?
Just how a diagnostic IVD kit today or an active device can evaluate multiple conditions, breath analyzers could evolve to detect as many diseases as those for which specific bio markers can be identified. While the future is promising for this technology there is a good amount of due diligence and consistent efforts that will be required to make this a big success.
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