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The Observation Experience

Members of the Biodesign Fellowship discuss what it’s like to conduct clinical observations.

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Preparing for and Documenting Observations

Members of the Biodesign Fellowship share their advice for preparing for, conducting, and documenting clinical observations.

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Reflections from an Observation: Optimizing the Experience

Biodesign Fellows discuss ways in which an observer can optimize the experience in the clinical setting in order to gain the most insights.

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Reflections from an Observation: Looking Broadly for Insights

Biodesign Fellows note how one has to look beyond the immediate elements of a scene to ensure the best observation.

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Reflections from an Observation: Adapting to the Environment

Biodesign Fellows reflect on how one adapts to the environment of a clinical setting and the steps that observers need to take to ‘fit in.’

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Reflections from an Observation: Capturing What You See

Biodesign Fellows comment on how to best capture what you see in an observation.

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Reflections from an Observation: Challenges, Benefits and Advice

Biodesign Fellows reflect on their period of observations, discussing the challenges they face in the cath lab as well as benefits and offer advice to others facing observations.

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Need Statement Development

Members of the Biodesign Fellowship review the key components of a need statement and provide examples of how their teams approached the challenge of developing need statements.

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Problematic Needs Statements

One team of Biodesign Fellows shares examples of some of the suboptimal need statements they developed and explains what made them problematic.

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Need Scoping Example 1

Todd Brinton, Director of the Biodesign Fellowship, evaluates one team’s effort to scope a need statement.

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Need Scoping Example 2

Another team of Biodesign Fellows shares an example of how they scoped a need statement.

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Market Analysis Example 1 – The Need and Approach

In a series of three short clips, a team of Biodesign Fellows presents and then discusses its approach to performing a market assessment.

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Market Analysis Example 1 – Market Landscape

In a series of three short clips, a team of Biodesign Fellows presents and then discusses its approach to performing a market assessment.

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Market Analysis Example 1 – Segmentation and Sizing

In a series of three short clips, a team of Biodesign Fellows presents and then discusses its approach to performing a market assessment.

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SSB4 Team: Needs Selection Tool

A team of Singapore-Stanford Biodesign Fellows (called SSB4) discusses the limitation of available tools for aiding needs selection and presents the approach the members chose for managing this challenge.

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SSB4 Team: Needs Selection Approach

A team of Singapore-Stanford Biodesign Fellows (called SSB4) demonstrates the process its members used to move from 200 to three top needs.

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Defining Need Criteria

Todd Brinton, Director of the Stanford Biodesign Fellowship, shares tips for creating need criteria with a group of Biodesign Fellows.

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The Brainstorming Experience

Members of the Biodesign Fellowship discuss what it’s like to start brainstorming and share advice from their experiences.

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•  3.1 Ideation •  Biodesign Fellows • 

Prompts for Structuring a Brainstorm

Todd Brinton, Director of the Stanford Biodesign Fellowship, explains to a group of fellows the use of prompting for helping structure a brainstorming session.

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•  3.1 Ideation •  Biodesign Fellows •  Todd Brinton • 

Using the Need Specification to Guide Brainstorming

Todd Brinton, Director of the Stanford Biodesign Fellowship, explains to a group of fellows how the needs specification should be used to guide ideation.

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•  3.1 Ideation •  Biodesign Fellows •  Todd Brinton • 

Warm-Up Exercises 1

Members of the Biodesign Fellowship demonstrate how their teams warm up for ideation sessions.

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•  3.1 Ideation •  Biodesign Fellows • 

Warm-Up Exercises 2

Biodesign faculty member James Wall and a team of fellows demonstrate how a “mini-brainstorm” on a fun topic can help stimulate creative energy.

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•  3.1 Ideation •  Biodesign Fellows •  James Wall • 

Brainstorming Example 1

A team of Biodesign Fellows demonstrates what goes on in brainstorming and then comments on the session.

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•  3.1 Ideation •  Biodesign Fellows • 

Brainstorming Example 2

A team of Biodesign Fellows demonstrates what goes on in brainstorming and then comments on the session.

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•  3.1 Ideation •  Biodesign Fellows • 

The SSB4 Team: Organizing Concepts

A team of Singapore-Stanford Biodesign Fellows (called SSB4) demonstrates the process its members used to organize concepts into mind maps after brainstorming to identify gaps and identify the most compelling ideas.

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Comparing Concepts to Need Criteria

A group of Biodesign Fellows demonstrates how to use the team’s need criteria to evaluate ideas after brainstorming.

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What do FDA Reviewers Look for in 510(k) and IDE Submissions?

Shreya Mehta, a Biodesign Fellow and former FDA lead reviewer, provides her view of what reviewers expect to see in 510(k) and IDE submissions.

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What Common Submission Mistakes Did You See as an FDA Lead Reviewer?

Shreya Mehta, a Biodesign Fellow and former FDA lead reviewer, discusses common submission errors that innovators should actively seek to avoid.

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What Is It Like to Work as an FDA Lead Reviewer?

Shreya Mehta, a Biodesign Fellow and former FDA lead reviewer, talks about her experience working within CDRH.

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Caydian: Prototyping & Early User Testing

Biodesign fellows Andy Rink and Varun Boriah describe their experiences developing and testing early prototypes to address a need related to sleep terrors in children.

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Caydian: Preparing for User Studies

Biodesign fellows Andy Rink and Varun Boriah share their experiences in seeking IRB approval and conducting a scientific user study.

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Caydian: Institutional Review Board Approval

Biodesign fellows Andy Rink and Varun Boriah share their experiences in seeking IRB approval and conducting a scientific user study.

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Madorra: Developing an Elevator Pitch

Biodesign Fellow, Holly Rockweiler, shares tips and pointers for developing an effective elevator pitch.

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Madorra: Elevator Pitch Example

Biodesign Fellow, Holly Rockweiler, demonstrates an elevator pitch for her company Madorra.

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Elevator Pitch 1: Example and Critique

Seasoned medtech investor Hank Plain watches a Biodesign Fellow delivering an elevator pitch and then provides his advice for strengthening it.

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Elevator Pitch 2: Example and Critique

Seasoned medtech investor Hank Plain watches a Biodesign Fellow delivering an elevator pitch and then provides his advice for strengthening it.

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Elevator Pitch 3: Example and Critique

Seasoned medtech investor Hank Plain watches a Biodesign Fellow delivering an elevator pitch and then provides his advice for strengthening it.

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Stage 1 Needs Finding

Faculty and fellows from the Stanford Biodesign program describe the importance of needs finding and what innovators should expect as they undertake this stage of the biodesign innovation process.

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•  1 Needs Finding •  Biodesign Fellows •  Paul Yock •  Todd Brinton • 

Stage 2 Needs Screening

Faculty and fellows from the Stanford Biodesign program explain how needs screening works and share pointers for navigating this stage of the biodesign innovation process.

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Stage 3 Concept Generation

Faculty and fellows from the Stanford Biodesign program describe the concept generation stage of the biodesign innovation process and how to make the most of these activities.

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Stage 4 Concept Screening

Faculty and fellows from the Stanford Biodesign program outline the fundamentals of concept screening and provide advice for deciding which solution to take forward in the biodesign innovation process.

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•  4 Concept Screening •  Biodesign Fellows •  Paul Yock •  Uday Kumar • 

Stage 5 Strategy Development

Faculty, fellows, and advisors to the Stanford Biodesign program discuss challenges and opportunities associated with the strategy development stage of the biodesign innovation process.

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Stage 6 Business Planning

Faculty, fellows, and advisors to the Stanford Biodesign program describe the business planning stage of the biodesign innovation process and offer guidance for pursuing opportunities in the medtech sector.

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Navigating the Business Environment in China

Former Biodesign Fellow Dorothea Koh shares cautionary tales about working in China and elaborates on some of the things that surprised her when she first started doing business in the country.

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Needs Finding in China

Former Biodesign Fellow Dorothea Koh describes aspects of what healthcare delivery looks like in China and offers guidance to innovators interested in addressing needs within the country.

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The Need for Business Model Innovation in China

Former Biodesign Fellow Dorothea Koh talks about the vast opportunities available in China and why it’s essential to get creative when defining a business model for any solution intended for this market.

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Advice When Designing for China

Former Biodesign Fellow Dorothea Koh, who works in product innovation in China for a major multinational corporation, shares tips for designing healthcare products for that market.

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IP and Competition in China

Former Biodesign Fellow Dorothea Koh discusses intellectual property protection in China and other ways that innovators can construct competitive barriers for products they intend to sell within the country.

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Advice When Needs Finding

Former Biodesign Fellow Santiago Ocejo shares tips to help innovators be successful during their needs finding experience.

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Needs Finding in Mexico’s Public Healthcare Sector

Former Biodesign Fellow Santiago Ocejo describes aspects of what healthcare delivery looks like in Mexico’s public healthcare sector and shares an example from his own needs finding experience in the country.

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Universal Healthcare in Mexico

Former Biodesign Fellow Santiago Ocejo talks about the universal healthcare system in Mexico, the system’s pros and cons, and how this can affect innovators seeking to identify and address clinical needs within the country.

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