Concept Screening Worksheet

Overview

Need statement:

Description of concept: Concept sketch:

Need Criteria

Must-Haves Confidence in Ability to Satisfy

 High  Medium  Low

 High  Medium  Low

 High  Medium  Low

 High  Medium  Low

 High  Medium  Low

 High  Medium  Low

Greatest Concerns About Concept’s Ability to Satisfy Need Criteria

 Technical Feasibility
Favorability Disease Process/ Key Concept Concept Feasibility
Mechanism of Action Mechanism
Well Understood Well Established Similar Devices in
Technology Related Fields
Mostly Understood Demonstrated in Similar Devices in
Related Fields Disparate Fields
Partially Understood Demonstrated in Novel Approach
Disparate Fields
Not Understood or Well Technology Not Yet Novel, Risky Approach
Known Available

Critical Questions to Answer to Demonstrate Technical Feasibility*

Estimated Time and Resources Needed to Demonstrate Technical Feasibility*

*Refer to your prototyping plan for the key take-aways to include in these sections

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 Intellectual Property

Favorability IP Landscape Comments

No existing prior art

Little existing prior art

Some existing prior art

Extremely crowded

In specific terms, what does your concept do?

What aspects of your solution are useful (utility)?

What aspects of your solution are non-obvious?

What aspects of your solution are novel?

CONCEPT SCREENING WORKSHEET V1, © 2021 STANFORD UNIVERSITY 3

 Regulatory
How is your technology likely What is its likely regulatory What is the magnitude of the
to be classified initially? pathway? clinical data that’s likely to be
initially required?
Class 1 Exempt Benchtop and/or Animal Data

Class II 510(k) Limited Human Data

Class III De Novo 510(k) Moderate Human Data

PMA Substantial Human Data

Describe the initial regulatory path, with an emphasis on critical risks

(if a 510(k), include likely predicates)

Describe the initial outcomes you need to prove before marketing

Estimate the size, duration, and cost of the studies required to provide those initial outcomes

Describe the regulatory roadmap if additional approvals/clearances will be required over time,
with an emphasis on critical risks

CONCEPT SCREENING WORKSHEET V1, © 2021 STANFORD UNIVERSITY 4

 Business Model

Type of Technology Revenue Stream

Low-Cost Disposable One-time fee/license

High-Cost Disposable Service/support/maintenance fees

Implantable Recurring/subscription fees

Reusable Program fees

Capital Equipment Freemium

Software Ancillary fees/in-app purchases

Wearable Combination/Other

Service
Will your product be reimbursable?
Combination/Other
If yes, complete next section on Reimbursement

Characteristics of Your Offering

Price  High  Medium  Low

Margin Structure  High  Medium  Low

Sales Investment  High  Medium  Low

Customer Training Requirements  High  Medium  Low

Importance of IP Protection  High  Medium  Low

Clinical/Regulatory Hurdles  High  Medium  Low

Financial Requirements  High  Medium  Low

Motivation of Target Customer to Make a

Initial Target Customer
Change from Current Standard of Care
 High  Medium  Low

How will this business model create mutual value

for the company and your initial target customer

CONCEPT SCREENING WORKSHEET V1, © 2021 STANFORD UNIVERSITY 5

 Describe your justification for choosing this initial business model,
addressing precedents, validation, and scalability

Who are your biggest competitors and what are your greatest competitive risks?

How will your initial business model expand and evolve over time?

CONCEPT SCREENING WORKSHEET V1, © 2021 STANFORD UNIVERSITY 6

 Reimbursement (if applicable)
Favorability Fit with Existing Coverage Status for Payment Level for
Codes Related Technologies Related Technologies
Strong Fit NCD Generous

Possible Fit LCD Adequate

Unlikely Fit No Coverage Inadequate

No Fit Not applicable Not applicable

Describe your initial reimbursement strategy,

with an emphasis on critical risks

Describe the initial outcomes you need to prove to secure reimbursement

Estimate the size, duration, and cost of the studies required to provide those initial outcomes

Describe the reimbursement roadmap if taking a blended or staged approach,

with an emphasis on critical risks

CONCEPT SCREENING WORKSHEET V1, © 2021 STANFORD UNIVERSITY 7