Pocket Colposcope

Duke University and 3rd Stone Design.

The Pocket Colposcope is a handheld microscope and imaging device for the cervix.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

The Pocket Colposcope is a handheld microscope and imaging device for the cervix developed by biomedical researchers at Duke University and 3rd Stone Design.

Target region(s) Target region for distribution/implementation (listed by country if specified)

United States, Peru, Kenya, India, Honduras, Zambia, and Tanzania

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Unknown

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

500 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Eva System, Lutechmedical

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Health care workers and women who suffer from cervix cancer.

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is currently in the prototyping phase and not yet manufactured at scale.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

The designers have not yet selected their user provision model.

Distribution to date Number of units that have been deployed, downloads or users to date

None

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

None

Detection sensitivity

75% of standard-of-care colposcope

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

Number of Tests Performed

Over 20,000 tests performed

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Continuous

Time required for procedure (minutes)

5 minutes

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

Pocket colposcope is consist of a probe, USB cord, camera, light, focus slider, and shutter button. The product weighs less than 1 kg. The device enables healthcare providers to optically zoom in and capture acetic acid, Lugol’s iodine, and vascular images (green light imaging) by pressing a button with their thumb. Images taken with the Pocket Colposcope are transmitted instantly to a smartphone, tablet, or laptop.

Product schematics Design and assembly illustrations

Technical support Technical support provided by

Provided by manufacturer

Replacement components Availability of replacement components (in-country, by order,...)

Replaceable components include the probe of the product.

Lifecycle Disposal and warranty

5-10 years

Manufacturer specified performance targets Designer / Manufacturer specified targets

Designer specified performance targets include: lightweight, portable, and low-cost.

Vetted performance Findings of manufacturer evaluations or independent testing centers

The level of agreement between the Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24).

Testing organizations Independent lab, academic research centers, etc.

Testing has been completed by Duke, KCMC (Peru), and La Liga (Tanzania).

Safety Potential hazards / risks related to operation of this product

Potential hazards related to the operation of this product include hygiene and electric leakage.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Christopher, T., Marlee, S., Jennifer, E., et al., 2015, Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. Plos One.

Mercy, N., Anish, S., Usamah, C., et al., 2018, Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope. IEEE, pp. 2306-2318.

Jenna, L., Elizbeth, A., Christoper, T., et al., 2017, International Image Concordance Study to Compare a Point of Care Tampon Colposcope to a Standard-of-Care Colposcope. HHS Public Access, 21, pp. 112-119.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

The product is certified by US FDA and complies to standards for colposcope. The regulation and testing includes electrical safety and essential performance requirements, electromagnetic compatibility, software verification and validation testing.

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The product is evaluated by comparing with standard of care colposcope and pathology in certified third-party health care centers.

Other information

None

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Snapshot

Product description Brand name and product description

The Pocket Colposcope is a handheld microscope and imaging device for the cervix developed by biomedical researchers at Duke University and 3rd Stone Design.

Target region(s) Target region for distribution/implementation (listed by country if specified)

United States, Peru, Kenya, India, Honduras, Zambia, and Tanzania

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Unknown

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

500 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Eva System, Lutechmedical

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Health care workers and women who suffer from cervix cancer.

Manufacturing & delivery

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is currently in the prototyping phase and not yet manufactured at scale.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

The designers have not yet selected their user provision model.

Distribution to date Number of units that have been deployed, downloads or users to date

None

Performance & use

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

None

Detection sensitivity

75% of standard-of-care colposcope

Indispensable equipment for function (Y/N)

Yes

Maintenance or calibration required by user at time of use? (Y/N)

Number of Tests Performed

Over 20,000 tests performed

Power supply type: Continuous, Recharging only (V, time required, battery life), Other

Continuous

Time required for procedure (minutes)

5 minutes

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

Product schematics Design and assembly illustrations

Technical support Technical support provided by

Provided by manufacturer

Replacement components Availability of replacement components (in-country, by order,...)

Replaceable components include the probe of the product.

Lifecycle Disposal and warranty

5-10 years

Manufacturer specified performance targets Designer / Manufacturer specified targets

Designer specified performance targets include: lightweight, portable, and low-cost.

Vetted performance Findings of manufacturer evaluations or independent testing centers

The level of agreement between the Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24).

Testing organizations Independent lab, academic research centers, etc.

Testing has been completed by Duke, KCMC (Peru), and La Liga (Tanzania).

Safety Potential hazards / risks related to operation of this product

Potential hazards related to the operation of this product include hygiene and electric leakage.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

None

Research & standards

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Christopher, T., Marlee, S., Jennifer, E., et al., 2015, Design of a Novel Low Cost Point of Care Tampon (POCkeT) Colposcope for Use in Resource Limited Settings. Plos One.

Mercy, N., Anish, S., Usamah, C., et al., 2018, Development of Algorithms for Automated Detection of Cervical Pre-Cancers With a Low-Cost, Point-of-Care, Pocket Colposcope. IEEE, pp. 2306-2318.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

The product is evaluated by comparing with standard of care colposcope and pathology in certified third-party health care centers.

Other information

None

Feedback

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

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Pocket Colposcope

Duke University and 3rd Stone Design.

In context photographs (0)

In context files & documents (0)

Feedback from users, customers & distributors