A2P2™
The framework the medical device industry is converging on.
Mechanism-driven accelerated ageing. Authored by the Ambassador of ASTM F1980 and the UK Expert to ISO/TC 194/WG 1. Referenced in the active ASTM F1980 revision. Under FDA MDDT review. Protected by patents in the UK and EU, US pending.
For four decades, accelerated ageing has rested on a single assumption: Q₁₀ = 2.
It is not defensible at the level of physics, and the standards bodies have moved.
A2P2 is the methodology they are moving to.
The Licence
A2P2 framework licences are issued annually to qualifying organisations. The licence conveys the right to operate the patented A2P2 methodology across the licensee's regulatory pipeline, access to the validated computational A2P2 platform — physical ageing, hydrolysis, OIT, FTIR-NMR, ASAP, and the Q₁₀ Device Calculator with the integrated regulatory-output prediction engine and a foundational case study built around the licensee's lead device, issued in the structure of the FDA MDDT dossier and signed by the framework author.
Licences are not sold off-the-shelf.
Authority
Dr Nazli Gulsine Ozdemir · CEng FIMMM · PhD Materials Science Ambassador, ASTM F1980 · UK Expert, ISO/TC 194/WG 1 · Member, BSI CH/194 Inventor — UK Patent GB2404188.1 · EU Patent EP4621674 A1 Author, A2P2 Framework — FDA MDDT Submission
Deployments
Pacemaker lead insulation. Sterile barrier packaging — PET, Tyvek®, sealing films. Polyurethane implantables. Gamma-irradiated trays. Biopharmaceutical single-use consumables. Industrial polymer assemblies. Field-validated against eight years of continuous service data.
Field evidence. A2P2 has been applied to a bioreactor stability programme that compressed accelerated ageing from 337 days to 71. To an epoxy adhesive shelf-life extension that prevented £40M in projected waste. To an eight-year field-validated reverse osmosis membrane study against pharmaceutical-grade service data. Deployments are confidential by default; anonymised summaries are available to qualified licence enquirers under NDA.
Enquiries
Licence enquiries are handled directly by Dr Ozdemir.
The A2P2 Platform
Validated computational modules covering the full A2P2 framework DMA, OIT, FTIR-NMR, ASAP isoconversion, and the Q₁₀ Device Calculator with an integrated regulatory-output engine aligned to 510(k), CE-mark, MDR, and ISO 11607 expectations.
A2P2 solves complex stability challenges to reduce time, waste and energy and save resources for organisations.
A2P2 helps products last longer and promotes re-use, creating a circular economy.
We help release innovative healthcare solutions to market faster, aiding in the fight against diseases. Our technology speeds up product release and makes product validation and certification easier and more reliable by eliminating the need of years of carbon-intensive accelerated ageing tests.
We extend the shelf-life of products and create resilient supply chains, eliminating the issue of cancelled orders.
MOTIVATION
Accelerated ageing studies underpin every shelf-life claim in the medical device industry.
For four decades, those studies have been designed around a single assumption — Q₁₀ = 2 — applied uniformly across materials, mechanisms, and temperature domains.
The assumption is not supported by the physics. Different polymers, processed differently, sterilised differently, age at activation energies that differ by an order of magnitude.
A2P2 is the framework that replaces the assumption with mechanism-driven calculation, and it is the framework the standards bodies are converging on.
Some of our partners
