R-009-001 Hospital del Mar 20240709
- Governed by
GP-009 Sales - Comes from template
T-009-001 Implementation plan
Contract sign date
Not signed.
Project plan
This project consists of the following phases:
- Phase 1: Conception and initiation
- Phase 2: Definition and planning
- Phase 3: Pilot execution
- Phase 4: Results analysis and report
- Phase 5: Project close
Phase 1: Conception and initiation
First steps: Initial NIPPLE Questionnaire
The following table contains the information we need to know from the client before starting a "Non-Invasive Prospective Pilot in a Live Environment" project.
warning
NIPPLE should never be the first option presented to the customer.
Our solution is widely validated and certified. The first option should be to explain this to the customer, but in case he still insists on doing a Pilot, NIPPLE would be the fastest way to do it.
info
NIPPLE is the abbreviation we use in this document and internally but it is NOT the formal or proper way to call it for the client.
| Question group | Question | Explanation why we want to know this | Example of expected answer |
|---|---|---|---|
| Starting point overview | - Please indicate if you are a Care provider, Hospital, Clinical trials, Insurance, Pharma /Other,... - How many patients would you see per month? Per year? - Number of in-person patients? - Number of teledermatology patients? - Describe briefly teledermatology system used - Number of Primary Doctors - Number of Dermatology Doctors - Referral (Yes/No) - Describe briefly referral system used | Brief summary about the current situation. The goal is to know what works for them and what does not. Read more info about customer segments | Telederma dermatologists in outpatient clinics. |
| What you would like to achieve with our solution. | Brief summary. | ... | -Diagnostic support for primary and secondary care physicians. - Improved referrals (reduce unnecessary referrals to dermatology). - Save time for physicians and patients. - Avoid loss of time in teledermatology flows due to poorly taken images. |
| Objetives | - What do you expect to achieve from this pilot? - What would constitute successful results? - What would constitute unsuccessful results? | The objective of this questions is to make sure that we are aligned before conducting the Pilot on what results we expect to obtain and what we can expect from this Pilot. | Examples: - I expect the results of the pilot to demonstrate how this solution helps professionals in diagnostics and referrals. - Professionals improve their diagnostics thanks to the solution, and the number of unnecessary referrals decreases. - Professionals do not improve their diagnostics due to the solution, and the number of unnecessary referrals increases. |
| Timelines | When do you want to do the pilot? | ... | September 2024 |
| Timelines | When would you like to have the results? | ... | October 2024 |
| Dataset | How many images? | Example 1: N=30 images. Time: 1-1,5h. Global results. Example 2: N=100 images. Time: 2,5-3h Global results and by pathology. | |
| Dataset | Who will provide the images for the pilot? When? | - [ ] Company - [ ] Legit.Health. | - [X] Company - September 1st |
| Dataset | - How many pathologies? - What pathologies? - How many images per pathology? | Define the pathologies for which you want to evaluate how AI helps the professional in the diagnosis and referral. It will depend on the objectives to be assessed. We recommend a minimun of 5 pathologies and 10 images per pathology. | Example: For example, if we want to evaluate the impact of AI in the diagnosis and referral of Melanoma in clinical practice, in the questionnaire we will show cases of Melanoma, Nevus,... |
| Participants | - How many participants will take part of the pilot? - How many primary care (PC)? - How many dermatologists? | The choice of participants will depend on the objectives to be assessed. We recommend a minimum sample size of 6 participants; however, the larger the sample, the better | Example 1: 10 participants (all primary care) Example 2: 15 Participants (10 primary care and 5 dermatologist) |
| Participants | - Who will manage the participation of the participants? | - [ ] Company - [ ] Legit.Health. | -[X] Company |
| Logistics | - Will the pilot be conducted remotely or in person? | - [ ] Remotely - [ ] In person. | -[X] In person. |
| Logistics | If remote, - Where? - Who will manage the additional logistical details (tablet rental if necessary, etc.)? | - [ ] Remotely - [ ] In person. | -[X] In person. |
| Content | On which of the following points are you most interested? Please rank them from highest to lowest. | (1) Diagnostics (2)Assisted diagnosis (3)Referral - [ ] Yes - [ ] No (4)Telemedicine - [ ] Yes - [ ] No (5)Treatment question (6) Other (I would like to ask other questions, please specify) | Example: 1, 2, 3, 4, 5, 6 (image quality) |
Phase 2: Definition and planning
Project details summary
| Question group | Details | Comments |
|---|---|---|
| Starting point overview | Telederma dermatologists in outpatient clinics. Current use cases: 1. Dermatologist sees image, and refers follow-up to PRIMARY (NO TREATMENT). 2. Dermatologist sees image, and refers follow-up TO PRIMARY (WITH TREATMENT). 3. Dermatologist sees image, and refers follow-up TO DERMATOLOGY (WITH TREATMENT). | TBD primary and secondary?? |
| General objetives. What you would like to achieve with our solution. | - Diagnostic support for primary and/or secondary care physicians. - Increase referral adequacy (reduce unnecessary referrals to dermatology). - Save time for physicians and patients. - Avoid loss of time in teledermatology flows due to poorly taken images. | TBD: primary and secondary or only dermatologists? |
| Pilot objetives | - I expect the results of the pilot to demonstrate how this solution helps professionals in diagnostics and referrals. - Professionals improve their diagnostics thanks to the solution, and the number of unnecessary referrals decreases. - Professionals do not improve their diagnostics due to the solution, and the number of unnecessary referrals increases. | ... |
| Timelines | - Pilot: September 2024 - Results: October 2024 | ... |
| Dataset | N=100 images. Time: 2,5-3h Global results and by pathology. | TBD: - How many pathologies? - What pathologies? - How many images per pathology? - Define who will provide the images for the pilot and when. |
| Participants | 6 dermatologist | TBD: We would recommend as much as possible better Ideally: 20 participants: 10 primary care and 10 dermatologists. |
| Logistics | - Manage the participation of the participants: Hospital del Mar - In person - No additional logistical (tablet rental,...)details | TBD Where and When? |
| Content | (1) Diagnostics (2)Assisted diagnosis (3)Referral - [ ] Yes - [ ] No (4)Telemedicine - [ ] Yes - [ ] No (5)Treatment question (6) Other | TBD Others: Add 5 images that cannot be identified with that image (dermatologist either) and have an option in the tool to mark "Image is not of sufficient quality for decision making". |
Project tasks
| Task | Description | Time | Responsible |
|---|---|---|---|
| Project definition | Define project details | 2 to 6 day(s) | JD-013, JD-008 |
| Pre-Dataset selection | Selection of images to be included in the pre-dataset | 1-4 day(s) | JD-013 |
| Dataset valid | Selection and validation of images to be included in the dataset | 1-2 day(s) | JD-005 or JD-009 or other |
| Set up of the platform | - Generate NIPPLE content (Anamensis Questionnaires, Symptom Questionnaires, Case information (gender, age, body area)) - Upload images and data into NIPPLE - Deploy the project - Validate that all the data has been loaded correctly | 1-2 to 6 day(s) | JD-003, JD-005, JD-013 |
| Training | Provide training to the participants before conducting the questionnaire. | 1 day | JD-013 |
| Customer support | Provide support to the participants to address any questions or concerns. | 1 day | JD-013 |
| Data analysis | Statistical analysis of results and drafting of the raw report | 1-2 to 6 day(s) | JD-014 |
| Final report | Analysis of the final results and preparation of the final report. | 1-2 to 6 day(s) | JD-005 |
Project leads
| Team | Code | Leader of |
|---|---|---|
| Legit.Health | JD-002, JD-008, JD-019 | Sales Manager, Business Development Manager, Sales Development Representative, Digital Health Manager |
| Legit.Health | JD-003, JD-013 | Design and Development Manager, Project Manager |
| Legit.Health | JD-018 | Clinical Research Manager |
| Legit.Health | JD-004 | Quality Manager & PRRC |
| Legit.Health | JD-007, JD-010 | Technology Manager, Software developer |
| Legit.Health | JD-005, JD-009 | Machine Learning Manager, Medical Data Scientist |
| Legit.Health | JD-014 | Data Analyst |
| Legit.Health | JD-016 | Customer Success Manager |
| Legit.Health | JD-021 | Account Manager |
| Company Name | Name Surname | Project Director |
| Company Name | Name Surname | Project lead |
Goals
Goals for the 1st year
The project was developed to achieve the following goal(s):
| Goal |
|---|
| 1 |
| 2 |
| 3 |
| 4 |
Implementation timeline
To achieve the goals, the parties agree on the following timeline.
1st year timeline
To achieve the goals, the parties agree on the following timeline.
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003, JD-004
- Approver: JD-001