Markets General Healthcare Primary & Secondary care, - PowerPoint PPT Presentation

Vitalograph Founded in Buckingham in 1963 Privately owned ≈350 employees – Buckingham – Ireland – US – Germany – Hong Kong – Japan Data you can rely on. 04757_1 People you can trust.

Markets General Healthcare – Primary & Secondary care, – Spirometers, – ECG etc Home Markets – Peak Flow meters – Electronic lung monitors Clinical Trials – Spirometry & Lung FuncNon measurement – Cardiac Safety – Over-reading – Data & Project Management – Services Data you can rely on. 04757_1 People you can trust.

Product Range Data you can rely on. 04757_1 People you can trust.

Inhaler Compliance History IniNated by Prof Richard Costello of RCSI and Beaumont Hospital & Prof Richard Reilly of TCD Licensed by Vitalograph in 2011 Data you can rely on. 04757_1 People you can trust.

Background Two Types Of Inhaler; – Dry Power Inhalers (DPI) & – Metered Dose Inhalers (MDI) Market is forecast to be $44Bn in 2016 at a CAGR of 16% MDI sales forecast to be $29Bn in 2016 and DPIs $15Bn Data you can rely on. 5 04757_1 People you can trust.

The Problem Up to 85% of Inhaled Drugs are wasted Lavorini SystemaNc review of DPI literature - between 4 & 92% of user had incorrect Technique NHS study showed that 91% of HCPs could not demonstrate correct technique Two dimensions to correct technique- Temporal & Technique Adherence- Correct Technique – DPI; Exhale, Prime, Inhale sharply, Breathhold, Exhale – MDI; Inhale slowly, Fire, Inhale, Breathhold, Exhale Data you can rely on. 6 04757_1 People you can trust.

INCA Architecture SQL Automated DB & Analysis Web Semi- Portal Automated FTP Clinic Analysis Server PC Data you can rely on. 7 04757_1 People you can trust.

INCA Inhaler Compliance • Measures Temporal & Technique Inhaler Compliance Audio Analysis Methodology • Exact Nme and date of usage • Dosage • Correct Technique • – ExhalaNon – Inhaler acNvaNon or Priming – InhalaNon Nme – Breath hold Nme – ExpiraNon Deployed in several current & upcoming • studies Data you can rely on. 8 04757_1 People you can trust.

Semi-Automated Analysis Breath Hold Prime InhalaNon ExhalaNon Data you can rely on. 04757_1 People you can trust.

Recording Device • MKI is single use, MK II can be reused up to six Nmes MK II is much smaller • Plans in place to add BT to transmit from home • Data you can rely on. 10 04757_1 People you can trust.

Overview Data you can rely on. 04757_1 People you can trust.

Detailed Data Data you can rely on. 12 04757_1 People you can trust.

Combined with other Data Data you can rely on. 13 04757_1 People you can trust.

Licensing Process • Went very smoothly despite being a 3 way agreement Dr Gordon Elliot of TCD led the Colleges iniNaNve • No major issues along the way • Plenty conversaNons and phone calls • Overall process took about six months • Data you can rely on. 14 04757_1 People you can trust.

Progress since then Redesigned the hardware twice – Added a true RTC, SS Memory – Made smaller Third iteraNon in the pipeline Put the design through a medical device design process for MDD & FDA CE approved FDA Pending Developed a Web ApplicaNon Spent €450K in further development Sponsored a PhD in TCD in the area of acousNc analysis with SFI Provided hardware and soeware for clinical trials, total of 1500 devices Commenced an InnovaNon Partnership Program (IPP) Data you can rely on. 15 04757_1 People you can trust.

Three Hurdles to get a medical device to the market Market Route Regulatory 16 Data you can rely on. 04757_1 People you can trust.

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The two benefits of licensing • You get the InnovaNon Adding on regulatory compliance & market route is essenNal • More importantly (oeen unseen), Create the market pull • Respected clinicians/academics behind the innovaNon • Clinical validaNon • Papers & PublicaNons • Tradeshows and conferences • Speaking OpportuniNes • Present to Customers • Don’t license and walk away, you need to stay engaged and partner with • the inventors Data you can rely on. 18 04757_1 People you can trust.

Summary • We sNll have work to do on commercialisaNon Incredibly difficult problem we’re trying to solve • Fully commiked to being successful • Licensing works if the innovaNon is truly innovaNve and differenNated • Engage with the inventors early and stay engaged • Use them to create the market pull • Data you can rely on. 19 04757_1 People you can trust.