Blue Stream Bring Medical Devices to Market Faster ! UCLA CS Class - - PowerPoint PPT Presentation

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Blue Stream Bring Medical Devices to Market Faster ! UCLA CS Class - - PowerPoint PPT Presentation

Aug 20, 2022 479 likes •617 views

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

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Blue Stream

Bring Medical Devices to Market Faster !

Soumya Mahapatra | Tae Macias

UCLA CS Class Presentation

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Who Are We

The TurboTax for Medical Device FDA Submissions!

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

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Experienced Team

Deep Domain Expertise (Healthcare, IT, Medical Device Regulatory and Start-Up Operations)

Soumya Mahapatra, Founder Software and process re-engineering in Healthcare Anna Libman, Co-founder Regulatory Strategy Consulting for Medical Device firms Ross Lu Marketing Strategy, Brand and Product Management for Medical Products Tae Macias Seasoned CPA and CFO, Startup operations Frank Mikel Operations, Healthcare Technology & Facility Management

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Bio-comp. Engineering R&D Quality Assurance Clinical Proj

  • jec

ect Manager er Standards Word Templates Protocols Regulatory guidelines Regul gulat atory

  • ry

Prof

  • fessi

ession

  • nal

al

Poor r Quality High Turn Around Time Labor- intensive ive Steep Learn rnin ing Curve Siloed Teams Manual al Submissio sion

FDA Submission Management Regulatory search & strategy

Why is it complicated ?

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Medical al Devi vice e Founde der Meet with Regulatory Consultancy Gather her Device e Inform

  • rmation
  • n

Search h FDA Databases bases Search h releva evant nt, websi bsites, s, googl

  • gle

Regul gulat atory

  • ry

Prof

  • fessi

ession

  • nal

al

Iterative

Devel velop

  • p

Strategy gy

1-2 days 3-4 4 weeks

1 2 3 4 6

1-2 2 Weeks 1 day

5

1 day

4

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Medical al Device Founde der Gather her Device e Inform

  • rmation
  • n

Search h FDA Databases bases Search h releva evant nt websi bsites Regul gulat atory

  • ry

Prof

  • fessi

ession

  • nal

al Crea eate Strat ategy gy Data Entry

Strate rategy Builder der 1

2-5 days

Iterative

2 Submi mission n Manag ager

Regulat latory Profes fessio sional

Bio-comp. Engineering R&D Quality Assurance Clinical Proj

  • jec

ect Manager ger

Regulatory Submission Manager

Regulatory Strategy Builder +

1 day

Blue Stream Software for Regulatory

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A platform that leverages advanced analytics and intuitive user design to streamline manual processes, reducing time and cost of FDA submissions

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Product Suite

Submission Manager

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

  • Collaboration tool to manage submission prep
  • 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!

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Value to Customers

4-6 Weeks 2-4 Weeks 4-6 months Siloed 5 days 5 Days 1-2 months

Today

Sea earch Reg

  • eg. Str

trategy Submission Mgt. Over erall l Process Transparent

Value

  • Pred

edictable

  • Co

Consistent

  • Quick

icker tu turn rn around tim time

  • Co

Cost-Effective

  • Greater Con

Control

  • Col

Colla laborativ ive

  • User

er-frie iendly

Blue Stream

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Product Development Principles

Develop easy-to adopt products that users will fall in love with!

Lean development methodology Proof of concept to full-scale product Iterate to add incremental features

Develop

Discover user needs with real-time feedback Discover database types, access methodology, sync process

Discover

User-centric, simple front-end designs HL solution and architecture Refine UXD based on user feedback

Design

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Project Execution Methodology

ENG ENGAGE

1

IMM MMERSE

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PLA LAN & & PRE REPARE

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INN NNOVATE/ / DE DESI SIGN

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PROTOTYPE

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ASSE ASSESS S & & REFL REFLECT CT

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PILOT T & & LE LEARN

# Steps DELIVER A GREAT USER EXPERIENCE !

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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 Back end development Backend dev API development, DB- SQL, No SQL integration, Full text search Core functionality Natural Language processing Full text search, parsing, relevance, ranking Analytics/ ML (future) Data Analyst/ Scientists Relevance based on datasets Databases Database Designer DB modelling, NO SQL schema design, integration with API and front end.

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Access to Prototyping Tools and AWS for the best learning experience!

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What to expect from the Project

  • Gain hands-on expertise on emerging tech
  • Full-scale software development lifecycle
  • Real-time user feedback from primary research
  • Solve real-world problems in healthcare in U.S.

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Thank You

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