Seizing Opportunities

We Advance Value-Added,
Patient-Centered Healthcare Solutions
Delivering Solutions for Bringing the Best Minds
Customers Through Unique Together Through Cross-
Assets & Expertise Disciplinary Collaborations

• World-Class Materials and Polymer

Expertise for Medical Applications
• Award-Winning Innovative Solutions
for Invention Xceleration (ISIX)
• Strategic Regulatory Approaches
• Advanced Medical Simulation for
Medical Education, Industry Training &
Usability Testing

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 Management with
Experience and Expertise in Key Areas

Frank Douglas, PhD, MD Joseph Randazzo, MBA

President Emeritus Interim Executive Director &
CFO
Global Pharma R&D Director Skillful Healthcare Executive
Development of 20+ Drugs Proven Education Experience

Chair, Two Biotech Companies Recognized Start Up Leader

Founder, MIT Center Business Development Expert

Rob Ngungu, RAC Matt Becker, PhD

Director Regulatory Affairs Director Biomaterials

Global Regulatory Expert Biomaterials Breakthroughs

Skilled Product Developer Industrial Research Expertise

FDA Experience Regenerative Medical Skill

Medical Device Specialist Commercialization Ability

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 We Provide Comprehensive Offerings
Focused On Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Biomaterials Innovative Solutions

Strategic Regulatory Advanced Medical
Solutions For for Invention
Solutions Simulation Solutions
Medical Applications Xceleration (ISIX)

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 We Provide Comprehensive Offerings
Focused On Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Biomaterials Innovative Solutions

Strategic Regulatory Advanced Medical
Solutions For for Invention
Solutions Simulation Solutions
Medical Applications Xceleration (ISIX)

• Deep polymer and
advanced materials
expertise
• State-of-the-art analytical
equipment and
processing capabilities
• Open innovation
collaboration spanning
industry, academia and
clinical expertise
• FDA-ABIA collaboration
focused on regulatory
science for novel
biomaterials
• Talent development for
biomedical applications
• Structured ideation and • Regulatory expertise at • Functional facility that
innovation management every stage of a replicates the full range of
product’s lifecycle healthcare settings
• Market and feasibility
assessment • Regulatory solutions • Integrated Bioskills Lab
rooted in clinical, for surgical skills training
• Comprehensive product
development, product development • Scenario development to
prototyping and and business strategy support human factors
usability testing • Clinical research/ testing of products
• Integrated regulatory development • Standard and customized
and business planning • Regulatory approval curricula to advance the
• Identification of end strategies for novel skills of medical and other
materials provider teams
users and distribution
channels • Advanced competency
assessment and reporting
tools
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 We Provide Compelling Offerings Focused On
Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Biomaterials
Solutions For Business Solutions
Medical Applications

• Deep polymer and advanced materials

expertise
• State-of-the-art analytical equipment and
processing capabilities
• Open innovation collaboration spanning
industry, academia and clinical expertise
• FDA-ABIA collaboration focused on
regulatory science for novel biomaterials
• Talent development for biomedical
applications
• BioDesign for Business Management

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 We Provide Compelling Offerings Focused On
Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Innovative Solutions
for Invention Validated Performance
Xceleration (ISIX)

• Structured ideation and innovation

management
• Market and feasibility assessment
• Comprehensive product development,
prototyping and usability testing
• Integrated regulatory and business
planning
• Identification of end users and
distribution channels

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 We Provide Compelling Offerings Focused On
Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Strategic Regulatory
Solutions Demonstrated Know-How

• Regulatory expertise at every stage of a

product’s lifecycle
• Regulatory solutions rooted in clinical, product
development and business strategy
• Clinical research/ development
• Regulatory approval strategies for novel
materials

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 We Provide Compelling Offerings Focused On
Medical Innovation
Austen BioInnovation’s Unique Assets And Expertise

Advanced Medical
Simulation Solutions
Pioneering Authenticity

• Functional facility that replicates the full range

of healthcare settings
• Integrated Bioskills Lab for surgical skills training
• Scenario development to support human
factors testing of products
• Standard and customized curricula to advance
the skills of medical and other provider teams
• Advanced competency assessment and
reporting tools

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 Our Collaboration is Enhanced by Partnerships with
Hospitals, Universities and Government
Hospitals Source Real Problems Encountered Universities Provide Access To Research To Help
By The Users Of Medical Devices Advance Medical Innovation

Government Entities Influence Medical

Device & Economic Development

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 Engage to Excel
Austen BioInnovation can significantly increase
your company’s competitive edge and improve its bottom line

Ways to Connect
•Sponsored Research
•Fee-for-Service Projects
•Customized Business Solutions
•Direct Access to New Technology &
Inventions

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