COVID-19 challenge: Low-cost sensor system for COVID-19 patient monitoring

From: Innovation, Science and Economic Development Canada

NRC is seeking a low cost system (unit cost <$25) that can continuously measure temperature, peripheral capillary oxygen saturation (SpO2), blood pressure (BP), pulse and respiration rates, and transmit this information wirelessly to a base station for COVID-19 patient monitoring in locales including ERs, general wards, communities and homes.

Challenge Sponsor: National Research Council of Canada (NRC)

Funding mechanism: Grant

Opening date: April 5, 2020
Closing date: April 21, 2020, 17:00 Eastern Daylight Time

Prospective applicants should refer to the Innovative Solutions Canada Grant Instructions and Procedures document.

Phase 1 award recipients

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Challenge

Problem statement

As part of the Government of Canada's response to the COVID-19 pandemic, the National Research Council of Canada has revised this challenge. The revisions are highlighted.

Temperature, SpO2, BP, pulse and The following section has been added as a new requirement.respiration ratesEnd of section. are used to assess a patient's health. With some exceptions (e.g. in an ICU), these are not measured continuously in a healthcare facility nor at home. This has consequences: sudden changes that signify rapid deterioration may not be caught in time; subtle trends indicating health changes may not be found until an egregious impact occurs. The following section has been added as a new requirement.This is especially relevant to the COVID-19 pandemic, where rapidly increasing numbers of patients and long hospitalization durations are imposing an extreme workload on the healthcare system. While some sufferers do require hospitalization, most do not. To support those at home, accurate data is vital. Such data offers individual and collective benefits. Individually, it will allow home-bound patients and their caregivers to make better decisions as to whether care should be escalated while offering reassurance to those whose condition is stable. Collectively, accurate information will allow public health authorities to determine the characteristics of the disease's progression that will in turn inform deployment of scarce resources and guide development of better treatment.End of section.

The following section has been added as a new requirement.To be truly effective during the COVID-19 pandemic, monitoring equipment needs to be widely available.End of section. Thus low cost is of utmost importance. Advances in materials science and micro-printed electronics have resulted in devices capable of unobtrusively measuring the The following section has been added as a new requirement.fiveEnd of section. parameters. While impressive individually, a low cost integrated solution that allows patients to remain at home while still being monitored is yet to be developed.

Desired outcomes and considerations

Essential (mandatory) outcomes

The proposed solution must:

  1. directly measure or indirectly determine temperature, blood pressure, peripheral capillary oxygen saturation (SpO2), pulse rate and The following section has been added as a new requirement.respiration rateEnd of section.
  2. wirelessly transmit results to a base station
  3. use commercial off-the-shelf (COTS) equipment (e.g. tablet) for the base station
  4. send measurements from the base station to a networked computer
  5. include a software development kit (SDK) to allow for third parties to develop software to access the measurements
  6. be able to be worn while asleep
  7. sense and report motion occurrence and intensity
  8. be water resistant
  9. have a sync-able real time clock
  10. have time stamped measurements
  11. last 24 hours on a single charge
  12. have a per unit cost The following section has been added as a new requirement.$25End of section. for quantity  1k (excluding GPS) for on-patient portion
  13. support a medical device license application to Health Canada

Note to applicants. The following Essential (Mandatory) Outcome has been moved to the Additional Outcomes section: withstand patient exercising at an intensity equivalent to a brisk walk (~5 kph). Please also note revisions to Essential (Mandatory) Outcomes #1 and #12. 

 

Additional Outcomes

The proposed solution should:

  1. have temperature accuracy ±0.1°C
  2. have an SpO2 accuracy of ±2%
  3. have a blood pressure accuracy as per the Association for the Advancement of Medical Instrumentation (AAMI) criteria, sensitivity of 0.005 Pa, response time of 0.1 ms, carotid artery pressure preferred, absolute pressure preferred, P (difference in pressure between systolic and diastolic) only is acceptable
  4. have pulse rate accuracy ±10%
  5. The following section has been added as a new requirement.have respiration rate accuracy ±3 breaths per minute (bpm)End of section.
  6. accuracy can be downgraded during motion (see Note 1)
  7. acquire a blood pressure waveform over several cycles and send the acquired data, or analyze the waveform and send results
  8. sense motion
  9. have a power saving hibernate mode
  10. acquire data at least once every 15 minutes (continuously for heart The following section has been added as a new requirement.and respiration ratesEnd of section.)
  11. last up to one week on a single charge
  12. ideally be one piece (however, several are allowed)
  13. have disposable sensor portions if in several pieces (see note 2)
  14. have an on-patient portion that comes in a comfortable, non-obtrusive form (e.g.: bracelet, pendant, or comfortable patch)
  15. be disposable, however, if not disposable, be disinfectable by being wiped with a 70% solution of ethanol (see note 2)
  16. locate position by GPS
  17. The following section has been added as a new requirement.withstand patient exercising at an intensity equivalent to a brisk walk (~5 km/h); End of section.

Note to applicants. Additional Outcome #5 is new; Additional Outcome #10 has been revised; and Additional Outcome #17 was previously located under Essential (Mandatory) Outcomes.

Explanatory Notes

Note 1. Accuracy and Motion

The effect of motion on the sensing of physiological parameters is well known. It varies depending upon the sensing method (e.g. electrical methods are generally less susceptible than optical ones) and the motion's intensity and duration. To allow for a wide range of possible responses to this challenge, the expectation is that the range of downgraded accuracies will be in the same order as that of off-the-shelf (current market existing) medical grade (FDA/Health Canada/EU approved) sensors. Once the patient has returned to a quiescent state, the system should return to the stated desired accuracies within 5 seconds. Additionally, the system should indicate when a patient is in motion, and the intensity of this motion. In any event, for BP, the AAMI criteria requires the patient to be at rest.

Note 2. Disposability

Ideally the entire on-patient device (or devices if comprised of multiple pieces) should be disposable. To be disposable, the device needs to be inexpensive. However, what is sufficiently inexpensive to be considered a throwaway by one organization may be considered prohibitively expensive by another. In anticipation of this, the portion of the device which is not in intimate contact with the patient (which is expected to be the main portion of the electronics (and particularly the battery), and which is also expected to be the most expensive portion of the device) should be able to be disinfected by being wiped with alcohol thus allowing for reuse by other patients.

A second concern related to disposability is environmental sustainability. A device that is cheap enough to be thrown away after one use may possess material that should not be indiscriminately tossed into the trash. Again, the expectation is that the main portion of the electronics (and particularly the battery) will constitute the bulk of the environmentally unfriendly material. Therefore having this portion be reusable by many patients following disinfection with alcohol is highly desirable.

Background and Context

The following section has been added as a new requirement.The COVID-19 pandemic has resulted in unprecedented challenges to Canadian society and particularly the health care system. The rapidly increasing numbers of patients and the long duration of hospitalization of each is imposing great stress on the existing healthcare system. Widely agreed observations for the COVID-19 disease are: mild manifestation among most patients; small proportion of severe cases with long duration of hospitalization; and rapid propagation. Social distancing and self-isolation have been recommended as a strategy. Within this context, continuous monitoring for patients in need of care, particularly those at home, becomes crucial to prevent rapid deterioration.End of section. To be truly effective, it needs to be widely available and therefore low cost. The advances mentioned in the Challenge Statement, combined with those related to the Internet of Things, promise to make low cost a reality. However, in order to be truly useful even a very low cost sensor needs to be part of a well-integrated solution, as mentioned previously. 

The work described in http://dx.doi.org/10.1126/science.aau0780 is an example of a well-integrated solution. It did have the advantages of non-ambulatory patients (neonates) in a configurable environment (the NICU). However, such advantages do not exist for this challenge. Use of COTS equipment is an advantage as it removes the cost of displays and keypads or touchscreens, albeit adding the constraint of a hospital or patient supplied device. This is not considered to be onerous given the rates of adoption of such devices amongst Canadians. 

For this Challenge, the preferred artery to be utilized for BP measurement is the carotid. Most non-invasive BP devices (that is, those using cuffs) measure peripheral pressure; yet it is central pressure that major organs encounter. As people age, their arteries, in particular the aorta, become less compliant. Aortic stiffness is the best predictor of all-cause and cardiovascular mortality in hypertensive patients. The gold standard to determine aortic stiffness is carotid-femoral Pulse Wave Velocity (cfPWV) which requires the measurement of carotid pressure. Currently, the only method to non-invasively measure carotid BP that could conceivably be deployed at home is applanation tonometry (AT). AT is used clinically outside of North America (NA) and for clinical research purposes, including in NA. However, AT requires well-trained, experienced operators and compliant patients. An alternative to AT for determination of carotid BP is highly desirable.

Maximum grant value and travel

Multiple grants could result from this Challenge.

The maximum funding available for any Phase 1 Grant resulting from this Challenge is $300,000.00 CAD for up to 3 months.

Estimated number of Phase 1 grants: 2

The maximum funding available for any Phase 2 Grant resulting from this Challenge is $2,000,000.00 CAD for up to 12 months. Only eligible businesses that have completed Phase 1 could be considered for Phase 2.

Estimated number of Phase 2 grants: 1

This disclosure is made in good faith and does not commit Canada to award any grant for the total approximate funding. Final decisions on the number of Phase 1 and Phase 2 awards will be made by Canada on the basis of factors such as evaluation results, departmental priorities and availability of funds. Canada reserves the right to make partial awards and to negotiate project scope changes.

Travel :

For Phase 1 it is anticipated that two meetings will require the successful bidder(s) to travel to the location identified below:

Kick-off meeting

Montreal, QC or virtual kick-off by videoconference

Progress Review Meetings

One to three design/progress review meetings by teleconference/videoconference

Final Review Meeting

Montreal, QC or Winnipeg, MB

All other communication can take place by telephone, videoconference (e.g. Zoom, WebEx)

Eligibility

Solution proposals can only be submitted by a small business that meets all of the following criteria:

  • for profit
  • incorporated in Canada (federally or provincially)
  • 499 or fewer full-time equivalent (FTE) employeesFootnote *
  • research and development activities that take place in Canada
  • 50% or more of its annual wages, salaries and fees are currently paid to employees and contractors who spend the majority of their time working in CanadaFootnote *
  • 50% or more of its FTE employees have Canada as their ordinary place of workFootnote *
  • 50% or more of its senior executives (Vice President and above) have Canada as their principal residenceFootnote *

Evaluation Criteria

The applicant must complete the Challenge Stream Electronic Submission Form with a degree of information sufficient to enable Canada's assessment of the proposal against the criteria and the Evaluation Schema. The information must demonstrate how the proposal meets the criterion.

Part 1: Mandatory Criteria

Proposals must meet all mandatory criteria identified by achieving a "Pass" in order to proceed to Part 2. Proposals that do not meet all mandatory criteria will be deemed non-responsive and given no further consideration.

Mandatory Criteria

(Applicant's proposal must address)

Question 1 a: Scope

Describe the proposed solution and demonstrate how it responds to the challenge. Include in your description the scientific and technological basis upon which the solution is proposed and clearly demonstrate how the solution meets all of the Essential (Mandatory) Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice.

Evaluation Schema (Mandatory - Pass/Fail)

Pass

The Applicant's proposed solution is clearly articulated, within the scope for the challenge and addresses all Essential (Mandatory) Outcomes (if identified) in the Challenge Notice.

Fail

The proposed solution is articulated as out of scope for the challenge.
OR
The proposal does not clearly demonstrate how the proposed solution addresses all Essential Outcomes listed in the challenge.
OR
The proposed solution is poorly described and does not permit concrete analysis.
OR
There is little to no scientific and/or technological evidence that the proposed solution is likely to meet the challenge.

Question 2: Current Technology Readiness Level (TRL)
  • Indicate the current TRL of the proposed solution. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
  • Describe the research and development activities that have taken place to bring the proposed solution to the stated TRL.
Evaluation Schema (Mandatory - Pass/Fail)

Pass: The Applicant has demonstrated that the proposed solution is currently between TRLs 1 and 6 (inclusive), and provided justification by explaining the research and development (R&D) that has taken place to bring the solution to the stated TRL.

Fail: The Applicant has not provided sufficient evidence to demonstrate that the current TRL is between 1 to 6 (inclusive) including:

  • There is insufficient/no evidence provided for TRL judgment.
  • The solution involves the development of basic or fundamental research.
  • The solution is demonstrated at TRL 7 or higher.
  • Insufficient/unclear/no justification explaining the R&D that took place to bring the solution to the stated TRL.
  • The explanation simply paraphrases the description of a given TRL level.
Question 3a: Innovation

Demonstrate how the proposed solution meets one or more of the ISC definitions of innovation below:

  • An inventionFootnote *, new technology or new process that is not currently available in the marketplace.
  • Significant modifications to the application of existing technologies/components/processes that are applied in a setting or condition for which current applications are not possible or feasible.
  • An improvement in functionality, cost or performance over an existing technology/process that is considered state-of-the-art or the current industry best practice.
Evaluation Schema (Mandatory – Pass/Fail)

Pass:

The Applicant has demonstrated that the proposed solution meets one or more of the ISC definitions of innovation.

Fail:

  • Applicant has not provided sufficient evidence to demonstrate that the proposed solution meets any of the ISC definitions of innovation; OR
  • Applicant has demonstrated that the proposed solution is an incremental improvement, "good engineering", or a technology that would go ahead in the normal course of product development (i.e. the next version or release).
Question 3b: Advance on State of the Art

Describe in detail the competitive advantages and level of advancement over existing technologies. Where appropriate, name existing technologies as well as potential substitutes or competitors.

To demonstrate this, proposals should include the following information:

  • Improvements (minor or major) over existing technologies or substitutes. Use direct comparison.
  • How the proposed innovation will create competitive advantages in existing market niches or market spaces.
Evaluation Schema (Mandatory Criteria – Pass/Fail + Points)

0 points/Fail:

  • The Applicant has not demonstrated that the proposed solution advances the state-of-the-art over existing technologies, including available competing solutions; OR
  • The proposed solution improves minimally upon the current state of the art, though not sufficiently enough to create competitive advantages in existing market niches; OR
  • The stated advancements are described in general terms but are not substantiated with specific, measurable evidence.

5 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers one or two minor improvements to existing technologies, including available competing solutions, that have potential to create competitive advantages in existing market niches.

12 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers three or more minor improvements to existing technologies, including available competing solutions, that together are likely to create competitive advantages in existing market niches; OR
  • The Applicant has demonstrated that the proposed solution offers one significant improvement to existing technologies that is likely to create competitive advantages in existing market niches

20 points/Pass:

  • The Applicant has demonstrated that the proposed solution offers two or more significant improvements to existing technologies, including available competing solutions that are likely to create competitive advantages in existing market niches and could define new market spaces; OR
  • The Applicant has demonstrated that the proposed solution can be considered a new benchmark of state of the art that is clearly ahead of competitors and that is likely to define new market spaces

Part 2: Point-Rated Criteria

Proposals must meet the overall minimum pass mark of 50% to be deemed responsive. Proposals that do not achieve the minimum pass mark will be declared non-responsive and given no further consideration.

Point-Rated Criteria

(Applicant's proposal to address)

Question 1b: Scope

Demonstrate the scientific and technological basis of how the proposed solution addresses the Additional Outcomes (if identified) in the Desired Outcomes section in the Challenge Notice. If no Additional Outcomes are identified in the Challenge Notice, text entered in this section will not be considered.

If no Additional Outcomes are identified in the Challenge Notice, Applicants will receive 10 points.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the solution will address any of the Additional Outcomes. 0 points
  2. Information provided clearly demonstrates that the solution will address some (<50%) of the Additional Outcomes. 3 points
  3. Information provided clearly demonstrates that the solution will address most (50% or more) of the Additional Outcomes. 6 points
  4. Information provided clearly demonstrates that the solution will address all (100%) of the Additional Outcomes. 10 points
Question 4: Phase 1 Science and Technology (S&T) Risks

Describe potential scientific and/or technological risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 5: Phase 1 Project Plan

Demonstrate a feasible Phase 1 project plan by completing the table.

  • Indicate if any milestones and activities will be completed concurrently
  • Indicate the estimated exit TRL at the completion of Phase 1. (Drop Down Menu of the Challenge Stream Electronic Submission Form)
Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate a feasible project plan for Phase 1 and/or the project plan exceeds the maximum duration indicated in the Challenge Notice. 0 points
  2. Project plan for Phase 1 is conceivably feasible but not clearly demonstrated and/or includes gaps. 10 points
  3. Information provided clearly demonstrates a feasible project plan for Phase 1. 20 points
Question 6: Phase 1 Project Risks

Describe potential project risks to the successful development of the proof of feasibility and how they will be mitigated in Phase 1.

Applicants should address the following risks, as applicable:

  • Human Resources
  • Financial
  • Project Management
  • Intellectual Property
  • Other project-related risks

Note to Applicants: S&T risks should not be included in this section. Question 4 addresses S&T risks.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has considered potential risks and mitigation strategies and/or information provided contains significant gaps. 0 points
  2. Information provided demonstrates that the Applicant has considered some potential risks and associated mitigation strategies but there are minor gaps in risks and/or associated mitigation strategies. 5 points
  3. Information provided clearly demonstrates that the Applicant has sufficiently considered the risks and defined associated mitigation strategies. 10 points
Question 7: Phase 1 Implementation Team

Demonstrate how the project implementation team has the required management and technological skill sets and experience to deliver the project plan for Phase 1 by completing the table. A member of the implementation team can have more than one role.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 0 points
  2. Information is provided but there are minor gaps in required management and/or technological skill sets and/or experience to deliver the Phase 1 project plan. 10 points
  3. Information provided clearly demonstrates that the project team has the required management and technological skill sets and experience to deliver the Phase 1 project plan. 20 points
Question 8: Inclusivity

If your business were to receive funding from Innovative Solutions Canada, describe what actions (e.g., recruitment strategy, internships, co-op placements, etc.) might be taken in Phase 1 to support the participation of under-represented groups (e.g., women, youth, persons with disabilities, Indigenous people, visible minorities) in the research and development of the proposed solution. Each Applicant in their response to this question must focus only on describing relevant programs, policies, or initiatives that it currently has in place or would put in place to support the R&D effort in Phase 1.

Note: Do not provide any personal information of individuals employed by your company or that of your subcontractors in the response.

Evaluation Schema (Point-Rated)
  1. No description and/or concrete examples of actions provided that would be taken to encourage greater participation of under-represented groups. 0 points
  2. A description and concrete examples of actions to encourage greater participation of under-represented groups provided.5 points
Question 9: Phase 1 Financial Proposal

Demonstrate a realistic financial proposal for the Phase 1 project plan by completing the table.

Evaluation Schema (Point-Rated)
  1. Insufficient information provided and/or information provided significantly lack credibility. Does not demonstrate a realistic financial proposal for the Phase 1 project plan. 0 points
  2. Information is provided but some costs lack credibility and/or are unclear for the Phase 1 project plan. 7.5 points
  3. Information provided contains credible elements to clearly demonstrate a realistic financial proposal for the Phase 1 project plan. 15 points
Question 10: Phase 1 Financial Controls, Tracking and Oversight

Describe the financial controls, tracking and oversight that will be used to manage the public funds throughout Phase 1. Applicants should indicate if an individual or firm will be managing the public funds and provide their credentials and/or relevant experience.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate the Applicant's ability to manage public funds in Phase 1. 0 points
  2. Information provided is vague and/or contains gaps. The Applicant has some controls, tracking and/or oversight in place to manage the public funds in Phase 1. 5 points
  3. Information provided clearly demonstrates that the Applicant has strong financial controls, tracking and oversight to manage public funds in Phase 1. 10 points
Question 11: Phase 2 Overview

Demonstrate a realistic overview for the prototype development plan if selected to participate in Phase 2.

Responses should include:

  • key tasks
  • estimated cost for materials
  • human resources
  • project risks and mitigation strategies

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the Applicant has contemplated a realistic overview for the Phase 2 prototype development. 0 points
  2. Information provided demonstrates a conceivably realistic overview for Phase 2 prototype development, however there are gaps and/or the strategy is vague. 6 points
  3. Information provided demonstrates that the Applicant has a clear and realistic overview. 12 points
Question 12: Commercialization Approach

Demonstrate a realistic overall commercialization approach/business model that can successfully take the technology/service to market, and how the technology/service will help you develop and sell other products.

Responses should include:

  • Target markets (excluding Government of Canada)
  • Non-ISC funding sources
  • Transition to a commercially-ready product or service
  • Any other indicators of commercial potential and commercial feasibility

Note: A more detailed proposal will be requested if selected to participate in Phase 2.

Evaluation Schema (Point-Rated)
  1. Insufficient or no information provided to demonstrate that the proposed solution has commercial potential. 0 points
  2. Some information provided to demonstrate that the proposed solution has commercial potential, however there are gaps in the commercialization approach. 6 points
  3. A realistic commercialization approach is provided that demonstrates that the proposed solution has commercial potential. 12 points
Question 13: Resulting Benefits to Canada

Describe the benefits that could result from the commercialization of the proposed solution. Applicants should consider the potential benefits using the following three categories and provide justification for each claim:

  • Innovation Benefits: Expected contribution towards the enhancement or development of new industrial or technological innovations within your firm. Responses could include: potential spillover benefits, creation of intellectual property, impact on productivity of the new technology, etc.
  • Economic Benefits: Forecasted impact on the growth of Canadian firms, clusters and supply chains, as well as its expected benefits for Canada's workforce. Responses could include: number of jobs created, number of high-paying jobs, investment in Canada's economy, etc.
  • Public Benefits: Expected contribution to the broader public to the degree that the solution is expected to generate social, environmental, health, security or other benefits to Canada. Responses could include: solution-related environmental benefits, solution-related accessibility benefits, and solution-related impact on Indigenous communities.
Evaluation Schema (Point-Rated)

  1. Innovation Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  2. Economic Benefits

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

  3. Public Benefits.

    Benefit not identified or insufficient claim of benefit. 0 points

    Benefit has marginal increment or limited justification. 1 point

    Benefit is significant and well justified. 2 points

Questions and answers

All incoming questions regarding this specific challenge should be addressed to solutions@canada.ca.

All enquiries must be submitted in writing no later than ten calendar days before the Challenge Notice closing date. Enquiries received after that time may not be answered.

You can also consult the Frequently asked questions about the Innovative Solutions Canada Program.

A glossary is also available.

Could you please clarify the essential outcome #12, specifically what is considered "on-patient" portion to be less than $25?

For example, if the unit comprises two parts where one is a detachable strap or cuff, etc., while the second part is main electronic unit which can be reusable after disinfection, so in this case the limit is still $25 total for both parts? or $25 is just for the disposable part?

Similarly, if the module has no disposable parts due to providing best performance, but as a whole can be disinfected and reused, will it have the same price limit?

The $25 limit applies whether the unit is disposable or reusable, or one part or two.

Could you clarify what a sync-able real time clock means? Is it a clock in the sensor with the same time as the base station (or data which is transmitted with time stamps that are in sync with the base station)?

Yes, a clock in the sensor is able to be set to the same time as the base station.

Could you clarify what you mean by essential outcome #13 "support a medical device license application to Health Canada". Should an application for the license be underway when applying for this challenge?

No

Does the cost target of $25 include manufacturing assembly and testing cost? The assembly of these devices should be straight-forward, but the testing must be very strict and thorough to ensure safety for the patients, which will add at least a few dollars per device.

Yes, the $25 unit cost includes any testing required to accept the unit.

There is a part saying that a device with a GPS can exceed the $25 limit for the GPS part. What is expected?

The expectation is that the unit cost, excluding the GPS, is $25 for quantity  1k.

Do we need to have a version with GPS and a version without GPS?

No.

For the version with GPS, can we deduce all the hardware attached to the GPS (such as a controller with an embedded GPS for example)?

The per unit cost should exclude any costs related to the GPS.

What is the maximum amount of time that the on-patient module can accumulate data (with its time stamps) before sending it to the base station?

The National Research Council of Canada (NRC) did not provide an answer to this question as this is a choice that each potential applicant will have to make based upon the various constraints of their design.

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