Blue Stream Bring Medical Devices to Market Faster ! UCLA CS Class Presentation Soumya Mahapatra | Tae Macias
Who Are We Blue Stream provides software platform to reduce the time and cost to navigate regulatory pathway for launching Medical Devices. Benefits: • Patients get life-saving devices sooner • Reduce the cost of health care delivery The TurboTax for Medical Device FDA Submissions! Confidential 2
Experienced Team Deep Domain Expertise (Healthcare, IT, Medical Device Regulatory and Start-Up Operations) Soumya Mahapatra, Founder Tae Macias Software and process re-engineering in Seasoned CPA and CFO, Startup operations Healthcare Anna Libman, Co-founder Frank Mikel Regulatory Strategy Consulting for Medical Operations, Healthcare Technology & Facility Device firms Management Ross Lu Marketing Strategy, Brand and Product Management for Medical Products Confidential 3
Why is it complicated ? Regulatory search & strategy FDA Submission Management Iterative 2 1 3-4 4 1 day weeks Standards Meet with Regulatory Gather her Device e Proj ojec ect Manager er Consultancy Inform ormation on 1-2 days Regul gulat atory ory 5 3 Prof ofessi ession onal al Word 1-2 2 Templates Clinical Engineering Weeks Search h FDA Regul gulat atory ory Databases bases Prof ofessi ession onal al Bio-comp. Medical al Devi vice e 6 Protocols Founde der R&D 1 day Quality Assurance Regulatory Search h releva evant nt, 4 Devel velop op guidelines websi bsites, s, googl ogle Strategy gy Labor- High Turn Manual al Poor r Siloed Steep Learn rnin ing Around Time intensive ive Quality Submissio sion Teams Curve Confidential 4
Blue Stream Software for Regulatory A platform that leverages advanced analytics and intuitive user design to streamline manual processes, reducing time and cost of FDA submissions Regulatory Strategy Builder + Regulatory Submission Manager Iterative 1 Gather her Device e Inform ormation on Clinical Engineering Data Entry Regul gulat atory ory Prof ofessi ession onal al Search h FDA Bio-comp. Databases bases Proj ojec ect Regulat latory Medical al R&D Submi mission n Manager ger Quality Device Profes fessio sional 1 day Assurance Founde der Strate rategy Manag ager Builder der 2-5 Search h releva evant nt 2 days websi bsites Crea eate Strat ategy gy Confidential 5
Product Suite Integrated Solutions Regulatory Search • Search device type, use and technology • Competitors products, risk classification • Device recalls and registration information Strategy Builder • Workflow Tool with integrated search capability • Consistent information flow from search • Decision making and easy-selection options • Determine resources and time Strategy Manager Submission • Collaboration tool to manage submission prep Manager • Custom task assignment, tracking • Automate validation, alerts and notifications • 360 degree view of submission progress • Automate 510k sections & submission Develop easy-to adopt products that users will fall in love with! Confidential 6
Value to Customers Over erall l Process Reg eg. Str trategy Submission Mgt. Sea earch Today Siloed 2-4 Weeks 4-6 Weeks 4-6 months Blue Stream 5 Days 5 days 1-2 months Transparent • Col • Quick • Co Colla laborativ ive • Pred icker tu turn rn Cost-Effective edictable Value • User • Greater Con er-frie iendly • Co around tim time Control Consistent Confidential 7
Product Development Principles Design User-centric, simple front-end designs HL solution and architecture Refine UXD based on user feedback Discover Develop Lean development methodology Discover user needs with real-time feedback Proof of concept to full-scale product Discover database types, access methodology, sync process Iterate to add incremental features Develop easy-to adopt products that users will fall in love with! Confidential 8
Project Execution Methodology Steps # 1 IMM MMERSE 6 PILOT T & & LE LEARN 0 4 PROTOTYPE ENGAGE ENG ASSE ASSESS S & & 5 REFLECT REFL CT 2 PLA LAN & & PRE REPARE 3 INN NNOVATE/ / DE DESI SIGN DELIVER A GREAT USER EXPERIENCE ! Confidential 9
A Full-Stack Product Development Components Skill Category Learning Category UI screen design UX designer Wireframes, themes, Visuals Front end development Web developer HTML, UI pages, Styles, js API development, DB- SQL, No SQL Back end development Backend dev integration, Full text search Natural Language Full text search, parsing, relevance, Core functionality processing ranking Data Analyst/ Analytics/ ML (future) Relevance based on datasets Scientists DB modelling, NO SQL schema design, Databases Database Designer integration with API and front end. Access to Prototyping Tools and AWS for the best learning experience! Confidential 10
What to expect from the Project • Solve real-world problems in healthcare in U.S. • Gain hands-on expertise on emerging tech • Full-scale software development lifecycle • Real-time user feedback from primary research Confidential 11
Thank You Confidential 12
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