Instructions Please fill out the template deck as completely as possible. Note that some - PowerPoint Presentation

Slide1

Instructions

Please fill out the template deck as completely as possible. Note that some information may not be known or applicable for your application; complete all relevant sections.

Limit to 20

slides excluding the title slide.

You can use your company PowerPoint template, but please use the content descriptions and fill any tables that are provided in the template.

Hematology devices adapted FOR LMICS

Company Name

Product Name

Company Location

Title

Date

Details of the organization

GENERAL INFORMATION

Presentation of the company/institution 

and

previous experience in the field 

Commercial strategy in the

 point-of-care hematology market 

Details of the technical solution

Provide details of your technical solution, product specifications and the problem it is solving in order to address POC hematology testing in LMICs

Describe the impact of your technology and how it differs from other approaches. What are the parameters measured by the platform and what other tests can be supported now and in the future?

When applicable, include details and preliminary performance data at expected operating temperature >35°C

Provide a figure detailing the project workflow/procedural steps and reagents required

Describe the ease of use and level of training required to operate the technology

Proposal Overview

Technology readiness and time to market

Application criteria

Please describe if a version of your

product is already commercialized – if not please describe t

he technology readiness level of your proposed solution using the

definitions in the table below. Eligible applications should demonstrate with details and data which TRL level the technology solution is currently at.

https://tier7.us/biomedical-dod-trls-medical-devices/

Technology Readiness Level*

Description

TRL 1

Basic Principles Observed and Reported

TRL 2

Technology Concept and/or Application Formulated

TRL 3

Analytical and Experimental Critical Function and/or Characteristic Proof-of-Concept

TRL 4

Component and/or Breadboard Validation in a Laboratory Environment

TRL 5

Component and/or Breadboard Validation in a Relevant Environment

TRL 6

System/Subsystem Model or Prototype Demonstration in a Relevant Environment

TRL 7

System Prototype Demonstration in an Operational Environment

TRL 8

 Actual System Completed and Qualified through Test and Demonstration

TRL 9

Actual System Proven through Successful Mission Operations

Platform considerations

Fit with TPP Requirements

Characteristic 

Minimal 

Optimal 

Proposed solution

Readout parameters 

3-part differential white blood cells count  

5-part differential white blood cells count plus other parameters, including total red blood cells counts, platelets, hematocrit and hemoglobin 

Intended settings and intended users 

Primary health centers and above healthcare levels. Target users include community health workers with minimal training and any health worker or laboratorian with a similar or superior training level. 

Sample type 

Finger prick blood (without the need for a transfer device containing anticoagulant); the device should also work with EDTA venous blood. 

Sampling volume 

<40 μ

l 

<10μ

L 

Consumables and reagents 

A single reagent provided separately, as part of the kit. The rest of the reagents, if required, shall be embedded in the cartridge/cuvette 

No additional reagents required. All reagents integrated in the cartridge/cuvette 

Time-to result /test 

<10min 

<5min 

Procedural and operational characteristics

Fit with TPP Requirements

Characteristic 

Minimal 

Optimal 

Proposed solution

Operating conditions 

15-35

o

C; 25-80% relative humidity; altitude up to 1500 m 

5-40

o

C; 25-90% relative humidity; altitude up to 3000 m   Cartridge shelf life and storage conditions 12 months at 4–35°C, 80% humidity, no cold chain required at any point 18–24 months at 4–45°C; 90% humidity, no cold chain required at any point 

Transport conditions 

Transport stress with fluctuations up to 50°C 

In-use stability (for open cartridge package) 

15 min at maximum operating temperature and humidity 

1h at maximum operating temperature and humidity 

Ruggedness 

Resistance to dust, sun light, shocks, etc. 

Power supply 

Rechargeable external battery pack capable to run 20-40 tests can be provided. 

Battery operated (internal rechargeable or disposable batteries) 

Size 

Small table-top reader 

Handheld  

Calibration & QC controls 

No calibration required. Device shall be compatible with commercially available controls  

No calibration required. Device shall be compatible with control provided by the manufacturer and controls available from other commercial sources  

Procedural and operational characteristics

Fit with TPP Requirements

Characteristic 

Minimal 

Optimal 

Proposed solution

Data storage 

Internal data storage  

Expandable memory and cloud connectivity 

Result display 

On screen display + print out option 

Data extraction & Connectivity  

Possibility to export data via USB and ideally LAN. 

3G/4G/Wi-Fi/Bluetooth  

Performance 

Performance comparable to gold standard and statistically equivalent according to, CLSI guidelines EP07 or equivalent, throughout the temperature range and humidity range. 

Device failure rate throughout the operational range 

<5%  

<1% 

Price per test (ASP) 

<5 USD 

<1 USD 

Price of instrument (ASP) 

<2,000 USD  

<500 USD  

Manufacturing 

ISO 13485:2016 compliant 

Product development capabilities

Application criteria

Please describe

your organization's 

capacity and experience in all relevant development fields, including written operating procedures and phase-gate milestone review processes and if they have resulted in marketable products

.

What type of product development activities you conduct in-house versus outsource and the number of staff of the organization.

Manufacturing capabilities

Application criteria

Please describe the

current and expected

manufacturing

capacity and expertise of your organization. If this is outsourced, please provide details about the proposed manufacturing partner or the plan for manufacturing the proposed solution at scale over the timeframe in the table below.

Manufacturing Capacity

Current

6 months

1

yr

2

yrs

Test/consumable 

Instrument/platform

Strength of team

Application criteria

Please describe the staff of your organization that will be dedicated to this development project and their relevant experience in bringing products to market.

Distribution capacity

Application criteria

Please describe the current distribution capacity of your organization. This includes not only distributors in LMICs but also the number of products sold and in which countries.

Where applicable, please provide the following information: 

Market share in the hematology business and/or any other relevant related business

Number of countries where the product(s) is/are commercialized including LMICs

Extent of distribution network

Quality and regulatory strength

Application criteria

Please describe the quality

system of your organization (e.g.. ISO 13485) and plans toward IVD regulatory compliance

.

Where applicable, list the number of products that have obtained regulatory approvals by stringent regulatory authorities (e.g., CE-IVD, FDA, WHO PQ). 

Clinical evaluation plan

Application criteria

Please describe

your future strategy for the regulatory pathway and clinical evaluation plan for the product in accordance with your commercialization strategy.

Cost of goods sold (COGS)

Please

fill out the provided tables on known or projected COGS (USD) per volume produced (consumables/test and instrument, if applicable).

Number of Tests  

COGS 

Test/Consumable 

<500,000 

$ USD

500,000-2M 

2M-10M 

10M-50M 

>50M 

Number of instruments  

COGS

Instrument

<100

$ USD

100 – 1,000

1,000 

–

 5,000

5,000 

–

 20,000

>20,000 

Please describe a COGS-based pricing model and expected business model. Include the pricing structure, indicating the expected cost of manufacture, markup, royalties, expected distributor margin, and budget for service & maintenance. Click to add text

Overall project plan

Application criteria

Please provide a timeline that includes your project milestones for this 12-month development project. Also include the plans beyond product development to include clinical trials and regulatory approvals.

Detail the cost and in relation to the project milestones and realistic timeline to delivery in the 12-month period

.

Describe the major project risks and mitigation strategies.

Describe a

ny other support FIND could offer that would be beneficial for the project success (field testing, usability studies and feedback

).