Budget Submission Feedback for Department Leaders

Overview

This document provides feedback on the 2026 budget submissions from all four departments: Regulatory and Compliance, Medical Data Science, Other Software Development, and Clinical Evidence. The feedback focuses on strategic alignment with grant application requirements, timeline distribution, and budget justification.

Total Combined Budget: €1,073,840.76

Budget Distribution:

• Other Software Development: €539,900 (50.3%)
• Regulatory & Compliance: €317,760 (29.6%)
• Medical Data Science: €118,399.56 (11.0%)
• Clinical Evidence: €97,781.20 (9.1%)

Medical Data Science Department

Budget: €118,399.56 (11.0% of total)

Key Feedback Points

What's Working Well

Excellent work overall. I particularly appreciate how most projects are directly tied to specific scoring systems or medical conditions (AWOSI, ALADIN, AIHS4, PASI/SCORAD, ASALT, AVASI). This clear alignment with clinical outcomes makes the strategic value immediately apparent and is perfect for grant applications.

The projects demonstrate:

• Clear clinical relevance
• Measurable outcomes
• Direct patient/clinician value
• Innovation in medical AI/ML

The projects seem realistic and aligned with the growth strategy of the company.

Timeline Distribution

Main Issue: All tasks are currently scheduled to start in January 2026.

Please spread these out over the year according to when the work will actually begin. This will:

• Create a more realistic budget forecast
• Demonstrate thoughtful project planning
• Improve cash flow management
• Make the timeline more credible to grant reviewers

Recommendations

1. Revise project start dates to reflect actual planned commencement throughout 2026
2. Maintain the excellent strategic focus on specific scoring systems and clinical applications
3. Consider staggering projects to allow for learning and iteration between initiatives

Regulatory and Compliance Department

Budget: €317,760 (29.6% of total)

Key Feedback Points

What's Working Well

The budget looks reasonable and well thought out. The organization around specific regulatory challenges is excellent and clearly demonstrates the necessity of each initiative for market access and compliance. Projects like:

• Japan Market Entry (REG-01)
• FDA 510(k) Annual Compliance (REG-07)
• CE Marking & ISO 13485 Maintenance (REG-08)
• Saudi Arabia Market Access (REG-02)

These are all well-justified and strategically important for company expansion.

Timeline Distribution

Similar to other departments, all tasks are slated to start in January 2026. This needs to be addressed.

Please distribute the start dates more evenly throughout the year to reflect actual project timelines. Regulatory processes often have specific windows or dependencies - your timeline should reflect this reality.

Task Naming and Description Clarity

Some task names and descriptions are not easily understandable at a glance. This is inconsistent across projects.

Best Practice Examples:

• Some of your projects do this perfectly (e.g., clearly labeling fees, consultant services, etc.)

Areas for Improvement:

• If something is a fee, it should be clearly called a fee in the title (e.g., "PMDA Registration Fee" not just "PMDA Registration")
• If something is a consultant service, label it as such (e.g., "Regulatory Consultant Services for SFDA" not just "SFDA Support")
• Task titles should allow readers to quickly understand:
  • What type of expense it is (fee, service, equipment, etc.)
  • What it's for
  • Who provides it (if relevant)

This clarity is important when:

• Presenting budgets to grant reviewers
• Explaining expenses to stakeholders
• Tracking and reporting on spending

Recommendations

1. Redistribute start dates throughout the year based on actual regulatory timelines and dependencies
2. Review all task titles and descriptions for clarity
3. Standardize naming conventions across all projects (following your best examples)
4. Ensure each task title immediately communicates its nature (fee vs. service vs. internal work)

Clinical Evidence Department

Budget: €97,781.20 (9.1% of total)

Key Feedback Points

What's Working Well

Pretty good work overall. I particularly appreciate that expenses are registered on the dates where they will actually happen, rather than everything being dumped into January. This demonstrates:

• Realistic project planning
• Understanding of actual timelines
• Good financial forecasting practice

Projects like:

• CLN-01 starting in March 2026
• CLN-03 starting in June 2026

This temporal distribution is exactly what we need to see.

Project CLN-03: FDA 510(k) Clearance (€94,600)

This is 97% of your total budget and a critical strategic initiative.

Timeline Concern: While the project has the right start date (June 2026), all task expenses within the project start at once. The tasks could potentially be spread more accurately across the 6-month project duration.

Budget Concern - IMPORTANT: This cost may be too low. For a grant application, it's strategic to:

• Forecast more budget than minimally expected
• Build in contingency for unforeseen requirements
• Demonstrate comprehensive planning

The FDA 510(k) clearance process can involve:

• Additional rounds of review
• Supplementary clinical data requirements
• Extended regulatory consultation
• Unexpected administrative requirements

Recommendation: Consider increasing this budget allocation, particularly for:

• Regulatory consultancy services (potential for additional hours)
• Clinical research team (potential for extended timeline)
• Administrative and legal review (potential for additional complexity)

This is especially important when asking for grants - better to request adequate funding upfront than to run short during a critical regulatory process.

Recommendations

1. Consider spreading CLN-03 task expenses more granularly across the 6-month project timeline
2. Re-evaluate CLN-03 budget and consider increasing it to account for potential contingencies
3. Maintain the excellent practice of scheduling expenses on realistic dates
4. When positioning for grants, emphasize that adequate funding for FDA clearance is critical for US market access

Other Software Development Department

Budget: €539,900 (50.3% of total)

Key Feedback Points

What's Working Well

Good comprehensive project portfolio. Your submission includes five well-structured projects covering diverse technical areas.

The projects are well-written and well-described, with:

• Clear task breakdowns and cost categorization
• Detailed descriptions that make it easy to understand what each task entails
• Organized structure that shows planning effort
• Comprehensive coverage of different expense types (prototype development, consulting, hosting, licenses)

Projects like DEV-01 (Core Application Platform) and DEV-03 (Medical Device Platform Evolution) demonstrate important infrastructure and scaling work that supports the company's technical foundation.

Budget Magnitude

Your department's budget is significantly higher than all other departments, representing over half of the total requested funding. This could be okay, and maybe it reflects the strategic importance of the projects. However, the projects should be clearly justified in terms of their strategic value: how they will drive innovation, customer value, or market expansion.

Timeline Distribution

Critical Issue: All project spending is currently scheduled for January 2026. This is unrealistic and needs immediate revision. Please reassign costs more evenly across the year to match when tasks will actually commence. It's highly unlikely that all development work will happen simultaneously in January 2026.

Projects Don't Seem Very Strategic

I would expect to see more transformative features such as:

• Cool features for the iframe (e.g., interactive elements, enhanced visualization capabilities)
• LLM integration for automated report generation or insights
• Features that clearly differentiate our offering in the market
• Customer-facing innovations that solve real pain points

These types of initiatives are more likely to resonate with grant evaluators looking for game-changing innovation.

DEV-04: Data Insight & Analytics Program (€110,800)

• This project appears quite expensive and may be difficult to justify in a grant application
• The strategic value is unclear - it doesn't clearly demonstrate how this will be a game-changer for the company, add direct value to customers, or support expansion
• Please reconsider the scope or provide stronger justification for its strategic importance

DEV-05: Internal Tools & QMS Modernization (€34,600)

• Similar concerns as DEV-04 regarding strategic value for grant purposes
• Internal tooling improvements are important but may not align with grant criteria focused on innovation, customer value, or market expansion

Task CA-03 and Related Accessibility Work

• Currently presented narrowly, but could be better construed as "UI Improvements in General, Including Accessibility Enhancements"
• However, this may also suffer from the strategic alignment issue mentioned above
• Consider whether these improvements directly create customer value or competitive advantage

Overlap with Medical Data Science

DEV-03: Medical Device Platform Evolution (€298,400)

• This is your largest single project
• Some tasks appear to overlap with work planned by the Medical Data Science department
• Please coordinate with the Medical Data Science team to:
  • Eliminate duplication
  • Clarify responsibilities
  • Ensure efficient resource allocation
  • Consider whether some budget should be redistributed

Consider Expenses for the ENS or ISO 27001 Certification

In the short future, your department may need to allocate budget to purchase licenses and services necessary for ENS (Esquema Nacional de Seguridad) or ISO 27001. And then, it will be necessary to configure and install them accross the organisation. The services and software required for these certifications can be significant, solutions like:

• Security Information and Event Management (SIEM) tools
• SOAR (Security Orchestration, Automation and Response).
• IDS/IPS (Intrusion Detection/Prevention)
• WAF (Web Application Firewall).

Recommendations

1. Redistribute spending across the entire year based on realistic project timelines
2. Re-evaluate DEV-04 and DEV-05 for strategic grant alignment or consider alternative positioning
3. Strengthen strategic narrative by focusing on customer-facing innovation and market differentiation
4. Coordinate with Medical Data Science to resolve overlaps in DEV-03
5. Come up with more transformative project ideas that align with grant priorities
6. Consider future expenses related to ENS or ISO 27001 certification

General Recommendations for All Departments

1. Timeline Realism: Most departments need to revise January 2026 concentration of spending
2. Strategic Narrative: Ensure all projects clearly articulate value in terms of:
   • Customer/patient impact
   • Market differentiation or expansion
   • Innovation potential
   • Long-term company growth
3. Cross-Department Coordination: Review for overlaps and opportunities for synergy (especially between Software Development and Medical Data Science)
4. Grant Positioning: Frame all work in terms of game-changing potential, not just incremental improvements
5. Budget Justification: Be prepared to defend budget sizes, particularly where there are significant disparities between departments

Next Steps

Please review this feedback with your teams and prepare revised budget submissions that address:

1. Timeline distribution across the year
2. Strategic justification for all major line items
3. Task naming and description clarity
4. Cross-department coordination
5. Budget sizing and justification

I'm available to discuss any of these points in more detail and to review revised submissions.