Expert Guidance for HealthTech Growth
Novu Insights helps MedTech & HealthTech firms, Startups, and Drug Delivery Device groups accelerate progress — from regulatory strategy and program leadership to product strategy & technical due-diligence support.
Building and Launching HealthTech Is more complex Than It Looks
Navigating FDA, MDR, and global requirements is not one-size-fits-all
Growth in MedTech and HealthTech isn’t one-size-fits-all—what works for one team may stall another
Early strategy missteps in product, market, or compliance can lead to costly redesigns and launch delays
Integrated solutions—especially combination products—require cross-functional planning from day one
Experience with Industry Leaders
Our Principal has 15+ years of experience working directly with companies and Startups in MedTech, Drug Delivery, AI, and Digital Health.
capabilities
What We Do Best
Strategic Consulting. Technical Expertise. Hands-On Execution.
Regulatory & Quality Guidance
Navigate regulatory pathways in the U.S. and EU with confidence — including 510(k), Technical Files, ISO 13485 compliance, and FDA readiness. We lead technical audits, submissions, risk management, and human factors efforts.
Product & Program Strategy
From feasibility to launch, we align product vision with regulatory, commercial, and operational execution. This includes IEC 62366, 62304, AI strategy, and cross-functional milestone planning.
Design Verification & Validation
Ensure your product works — technically and for end users. We guide DV&V planning, execution, and documentation across regulatory and engineering functions
Project & Program Management
We embed into your team to drive clarity, prioritization, and momentum. From day-to-day execution to launch strategy, we ensure you hit your milestones without silos.
Innovation
We support early-stage development and white space exploration. From early prototyping and concept refinement to aligning feasibility with business strategy, we help teams shape products people actually want to use.
Operational Audits
Support for companies & firms evaluating MedTech deals. We assess product, engineering, quality, regulatory, and operational maturity
Regulatory & Quality Guidance
Navigate regulatory pathways in the U.S. and EU with confidence — including 510(k), Technical Files, ISO 13485 compliance, and FDA readiness. We lead technical audits, submissions, risk management, and human factors efforts.
Product & Program Strategy
From feasibility to launch, we align product vision with regulatory, commercial, and operational execution. This includes IEC 62366, 62304, AI strategy, and cross-functional milestone planning.
Design Verification & Validation
Ensure your product works — technically and for end users. We guide DV&V planning, execution, and documentation across regulatory and engineering functions
Project & Program Management
We embed into your team to drive clarity, prioritization, and momentum. From day-to-day execution to launch strategy, we ensure you hit your milestones without silos.
Innovation
We support early-stage development and white space exploration. From early prototyping and concept refinement to aligning feasibility with business strategy, we help teams shape products people actually want to use.
Operational Audits
Support for companies & firms evaluating MedTech deals. We assess product, engineering, quality, regulatory, and operational maturity
Our Expertise
Why Novu Insights?
– 15+ years in MedTech & Drug Delivery
– Expert across product, regulatory, ops, and quality
– Deep knowledge of ISO 13485, IEC 62366, IEC 62304
– Supporting team of 5+ industry specialists
– Led by Josh Hopkins, Director-level leader with a track record of development & commercialization success
Background
Our Results
Feel free to contact us for specific case studies!
Let's Start
Click Below to Schedule your FREE Intro Call
Email: Jvalhopkins@gmail.com
Phone: 407-434-9411