Clinical Engagement: Who? When? Why? POOJA KADAMBI SYSTEMS DESIGN ENGINEER- INNACCEL CAMTECH BOOTCAMP 2016

Clinical Engagement: User Driven Engineering and Development  The need for your product  The features you must/should/can incorporate  Target price and payee capacity  Usability and environment of use factors  Gaps in current process/products  Customer base  Clinical trial conduction  Training other doctors  Publication and publicity for product

Project Introduction  Chronic Rhinosinusitis (CRS) affects over 100 Mil in India  Over 30 Mil require surgical intervention  Fnctional Endoscopic Sinus Surgery (FESS) is invasive  Balloon Sinuplasty is suitable for in-office but expensive  SinuCare will be a single user system that will be affordable, accessible and minimally invasive

SinuCare Development Timeline POC Concept Tested Dec 14 Jun 15 V 1.5 Specs Drafted Aug 15 V 2.0 Custom Prototype Dec 15 V 2.5 Integrated Prototype 1-5 Doctors 15 Doctors 50 Doctors 50+ Doctors Doctors Apr 16 V 3.0 Clinical Evaluation Aug 16 V 4.0 CE Certified Nov 16 Product Commercial Sales 5-10 Doctors 100+ Doctors Idea Need Criteria Jan 13

Specification Evolution Examples POC Concept Tested Dec 14 Jun 15 V 1.5 Specs Drafted Aug 15 V 2.0 Custom Prototype Dec 15 V 2.5 Integrated Prototype 1-5 Doctors 15 Doctors 50 Doctors 50+ Doctors Doctors Apr 16 V 3.0 Clinical Evaluation Aug 16 V 4.0 CE Certified Nov 16 Product Commercial Sales 5-10 Doctors 100+ Doctors Idea Need Criteria Jan 13

Ongoing Engagement: Optimize Resources and Time  EVERYTHING not covered in one feedback  Feedback on an idea VS a physical product  Information Given  influence Information received  Careful about bias  Group feedback VS one on one feedback  Know what your end user DOES NOT WANT  Difference of opinions

Thank You! QUESTIONS?

1: Clinical Engagement on Need  ENT Immersion yielded 250 needs from which definitive and affordable solution for CRS was among the top 5  Clinician (ENT specialist) involved in immersion and second ENT surgeon involved in validation and concept generation  Need defined and criteria outlined for any solution product with  Concept created by multidisciplinary team  Inputs from 2-5 clinicians were taken for various activities during this phase  A lot of secondary data from literature, websites and doctor experience was gathered  12 months including immersion

2: Clinical Engagement on Concept  Concept designed by engineers and designer with some inputs from inventing doctor  Feedback taken from 15 doctors on the need and features of the concept  Market and Product specifications drafted  Rough POC prototypes created  2 Clinicians involved in Cadaver and anatomical model testing of early prototypes  Specifications refined and further defined  IP final specifications filed  6 months duration

3: Clinical Engagement on Prototype  Repeated short immersion in ENT for 1 month to re-validate need 1 year later.  10 clinicians feedback gathered with mock-ups of product  Refined prototype tested and evaluated in a focus group with 5 doctors  50+ ENT feedback across 12 cities and 20 healthcare settings on need, product idea, specifications (price point, reusability, size etc.)  Key opinion leader interviews and buy in for the final product (still under development)  Ongoing engagement with 2-5 clinicians outside of development team  6-12 months (In Progress)

4: Clinical Engagement on Trials  IERB protocol drafting with input from 2 external physicians  PI and Co-I engagement at site hospital not part of development team to avoid bias  ANY TESTING OF A NEW DEVICE IN/ON HUMANS IS CONSIDERED A TRIAL  Phase wise testing approach to minimize variables and maximize safety  Trial not required for regulatory purposes for this product but will help with freezing specifications and driving adoption  6-12 months (In Progress)

5: Clinical Engagement on Product  Plan to hold training sessions across 3-5 locations and train around 100 ENT surgeons to use SInucare  Will conduct product specification validation at conferences and ENT meetings  Endorsements from KOLs prior to commercial sales  Re-engage with database of doctors we have interacted with once product is ready  Post market clinical study data and publications with different clinicians  On and off for 12 months