StudyConnect provides CRO and fractional leadership to help medical device companies design, manage, and execute the clinical, regulatory, reimbursement, and operational work needed for FDA engagement, evidence generation, and market readiness.
From FDA strategy to clinical evidence generation, we do the work that moves medtech companies forward.
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Defined project scope and deliverables.
Tailored to your stage and budget.
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For rapid scaling needs
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Boutique delivery. Senior judgment. No unnecessary overhead.
WHAT MEDTECH LEADERS SAY
Study Connect helped us turn a vague FDA plan into an executable clinical and regulatory roadmap.
Actionable guidance for medtech leaders.
Have a medtech product that needs clinical, regulatory, or trial execution support? Start with a 30-minute discovery call.
Senior clinical, regulatory, and operational professionals with deep medtech experience. We work as operators, not consultants.
Direct, expert guidance for leaders.
We collaborate with medical device companies preparing for FDA interactions, including 510(k), De Novo, or Breakthrough Device submissions. Our team has extensive experience across various FDA device classes, as well as in medtech investing and board governance and stakeholder management.
Yes. This is our sweet spot. We act as a fractional clinical and regulatory team for companies that need senior judgment and hands-on execution but aren't ready to build a full internal function.
Our scientific leadership brings deep expertise in cardiology and cardiometabolic medicine, having overseen some of the largest MedTech trials in recent years. The team includes professionals with backgrounds in Artificial Intelligence and machine learning, oncology, diagnostic imaging, and implantable devices.
We understand that cash flow is crucial for early-stage companies, so we set our prices competitively, whether it's hourly, monthly retainers, or milestone-based payments. Our goal is to deliver quality service, not to overcharge. Since every case is different, we are dedicated to providing value for your trust in us.
Yes. Everything we do is yours to use. Since our team collaborates with you more extensively than a typical CRO or advisor, we can share knowledge across a broader range of topics, offering you actionable insights to keep.
We understand that plans don't always go as expected, and healthcare pathways can change for various reasons beyond our control. We guarantee that whether we continue collaborating or not, our team will ensure you're supported for success. No hard feelings and no contractual hurdles.
We focus on the areas you need most to achieve a milestone, including strategy, study design, go-to-market, funding, regulatory affairs, and research networks.
Book a discovery call or send us an overview of your project to get started by using the links on this page or emailing us at hello@studyconnect.world
Still have questions? Contact us.
Book a discovery call or tell us about your project. We respond within one business day.
Schedule a free 25-minute discovery call with Matthew Ian Mace to discuss how StudyConnect can accelerate your medtech journey.
Open Booking CalendarShare details about your medtech product. We respond within 1 business day.
