Transforming Healthcare through Strategy & Innovation
Let’s grow your ideas, prototypes and products to disrupt the healthcare
Luca Bogoni, Ph.D.
Principal, Leader & Innovator, AI & Digital, HealthTech Executive, Portfolio & Product Owner, Clinical & Regulatory
Our Mission
Bridge the gap between innovation and healthcare solutions that matter. We help companies develop and transform ideas into impactful solutions by providing expert guidance in value-based care, clinical studies and regulatory clearance, and strategic partnerships. Our commitment is to drive better outcomes for patients, providers, and the broader healthcare ecosystem.
Key Services
Our Expertise, Your Succes!
Solutions for Healthcare Transformation
- Strategic Consulting for AI Products and Medical Devices
- Clinical Collaborations & Evidence Generation
- Development and Implementation of Clinical & Regulatory Strategies
- Business Development & Partnerships
Why Choose us
- Innovation Leadership: guiding healthcare organizations through cutting-edge technology and AI, regulatory, and operational advancements.
- Competence: we combine deep industry knowledge with a proven track record in delivering impactful solutions.
- Tailored Solutions: No one-size-fits-all and every engagement is designed to your unique needs and challenges.
News and Updates
Agile Regulatory Engagement
The Benefits and Considerations of FDA Pre-Submission Meetings Navigating the regulatory landscape for medical devices can be complex and challenging. One invaluable tool to streamline this process is the FDA’s Pre-Submission (Pre-Sub) program. This program offers medical device manufacturers an…
IMDRF Guiding Principles
On January 29, 2025, IMDRF released a significant document titled “Good Machine Learning Practice for Medical Device Development: Guiding Principles.” This publication outlines ten guiding principles designed to promote the development of safe, effective, and high-quality medical devices that incorporate…
FDA Guidance for AI-Enabled Medical Devices
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance aimed at developers of artificial intelligence (AI)-enabled medical devices. This document offers comprehensive recommendations to ensure the safety and effectiveness of AI-driven devices throughout their…
RSNA-24 AI Trends & Innovations
Trends & AI Innovations Trends & AI Innovations This year’s RSNA showcased innovations which are bound to transform radiology redefining diagnostic precision, workflow efficiency, and cross-specialty collaboration. From multi-modal diagnostic acceleration to AI-powered workflow orchestration, the event underscored how cutting-edge…
RSNA-24 AI-Solutions Orchestrators
The Rise of AI Solution Orchestrators: Bridging the Gap Between Innovation and Implementation The Rise of AI Solution Orchestrators: Bridging the Gap Between Innovation and Implementation As artificial intelligence continues to transform medical imaging, healthcare providers face an increasingly complex…
RSNA-24 Multi-Modal AI Solutions
Multimodal AI Solutions Multimodal AI Solutions As AI adoption in medical imaging accelerates, multi-modal integration is emerging as a game-changer, enhancing diagnostic speed, accuracy, and clinical efficiency. This blog highlights leading AI companies delivering integrated solutions that seamlessly combine automated…
FDA PCCP for AI-Enabled Device SW
On Dec. 4, 2024, the U.S. Food and Drug Administration (FDA) issued a final guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions.” This guidance provides a framework for manufacturers to…