Jaifry
Strategic Goals and Objectives: Charting Our Path to Transform Diabetes Care
Our Strategic Goals
R&D Excellence
Advancing our technology through continuous innovation in sensor accuracy, algorithm sophistication, and glucagon delivery systems to maintain our leadership in diabetes care technology.
Key Objectives:
- Develop next-gen sensor with 30-day wear duration
- Achieve 99.5% detection accuracy
- Reduce system false alarms by 75%
Regulatory Success
Obtaining all necessary regulatory approvals across global markets to ensure timely product availability while maintaining the highest standards of safety and efficacy.
Key Objectives:
- FDA approval by Q2 2026
- CE Mark for European markets
- Approvals in 5 additional countries by 2028
Manufacturing Scale-up
Establishing robust and scalable manufacturing processes to meet global demand while maintaining quality standards and reducing production costs to improve accessibility.
Key Objectives:
- Annual production capacity of 500,000 units
- Reduce manufacturing costs by 40% by 2030
- Establish two additional manufacturing facilities
Strategic Timeline
Q2 2023 - Prototype Development
Completed prototype development and established core patents for sensor technology and glucagon formulation.
Q4 2023 - Pre-clinical Testing
Started and completed animal studies to verify safety and efficacy. Achieved 99.2% detection accuracy in controlled settings.
Q2 2024 - Initial FDA Submission
Submitted pre-IDE package to the FDA. Commenced development of ISO 13485 compliant manufacturing process.
Q4 2024 - Phase I Clinical Trials
Commencement of first-in-human studies with 50 participants to demonstrate initial safety and efficacy profile.
Q2 2025 - Phase II Clinical Trials
Expanding trials to 200 participants across 5 clinical sites. Applying for CE Mark in the EU.
Q4 2025 - Pivotal Trial & FDA Submission
Starting pivotal trial with 500 participants. Preparation and submission of PMA application to the FDA.
Q2 2026 - Regulatory Approval & Launch
Expected FDA approval and commercial launch in US markets. Beginning international expansion.
Key Performance Indicators (KPIs)
Performance Goals by Year
| Metric | 2024 Target | 2026 Target | 2030 Target |
|---|---|---|---|
| Market Penetration | Pre-launch | 15% of high-risk patients | 35% of all Type 1 patients |
| Manufacturing Capacity | 50,000 units/year | 250,000 units/year | 1,000,000 units/year |
| Production Cost Reduction | Baseline | 20% Reduction | 40% Reduction |
| International Markets | US Only | 3 Additional Countries | 15+ Countries |
| R&D Investment | $25 Million | $45 Million | $75 Million |
Key Milestones
Pre-clinical Success
Completion of animal studies with 99.2% detection accuracy and establishment of the safety profile for the glucagon delivery system.
Manufacturing Facility
Establishment of a GMP-compliant manufacturing facility with an initial capacity of 50,000 units per year.
Initial FDA Submission
Successful submission of the pre-IDE package to the FDA, receiving positive feedback on the clinical trial design.
Start of Phase I Trials
Commencement of the first human studies with 50 participants across three clinical sites.
CE Mark Submission
Submission of the application for the CE Mark to enable European market entry upon approval.
Start of Pivotal Trial
Beginning the pivotal trial with 500 participants across 10 clinical sites in the United States and Europe.
Impact Goals
Patient Impact Goals
Our primary measure of success is the positive impact on patient lives and health outcomes.
| Objective | Target | Timeline |
|---|---|---|
| Reduce severe hypoglycemia cases | 90% Reduction | 5 Years post-launch |
| Improve quality of life scores | 40% Improvement | 3 Years post-launch |
| Reduce diabetes-related anxiety | 65% Reduction | 2 Years post-launch |
| Enable normal sleep patterns | 80% of Users | 1 Year post-launch |
Economic Impact Goals
Creating value for healthcare systems and society through cost savings and productivity gains.
| Objective | Target | Timeline |
|---|---|---|
| Reduce hypoglycemia ER visits | 70% Reduction | 3 Years post-launch |
| Reduce hospitalizations | 60% Reduction | 4 Years post-launch |
| Healthcare system savings | $800M Annually | 5 Years post-launch |
| Productivity gains | $300M Annually | 5 Years post-launch |
Innovation Roadmap
Future Development Goals
| Innovation Area | Development Goals | Target Timeline |
|---|---|---|
| Sensor Technology | 30-day wear duration, 99.5% accuracy, factory calibration | 2028 |
| Algorithm Development | Predictive detection of hypoglycemia 60 minutes in advance | 2027 |
| Integration Capabilities | Seamless integration with insulin pumps and CGM systems | 2029 |
| Formulation Advancements | 12-month room temperature stable glucagon formulation | 2030 |
| Miniaturization | 50% reduction in device size, fully disposable option | 2029 |
| AI & Machine Learning | Personalized algorithms that adapt to individual patterns | 2028 |