EXPERTISE

Concept to Production

At Resolution Medical our expertise is wrapped in deep anatomical experience, underpinned by a distinct understanding of how to seamlessly transition from concept to our formal phase gate development process to production.

From the initial spark of design concepts to manufacturing execution, we’re deeply committed to ensuring that your medical device is of high quality, repeatable, and competitive in your market.

Areas of Expertise

Click below to see examples of our experience

Active Implantable Programs	System
Peripheral Nerve System	IPG/Lead
Tibial Nerve System	IPG/Lead
Heart Monitoring System	IPG
Novel Cardiac Pacing System	Lead
Heart Monitoring System	IPG
Inter-atrial Shunt with Electronics	Implant/Delivery System
Neuromodulation System (ENT)	IPG/Header/Lead
Neuromodulation System (DBS)	IPG/Lead
Percutaneous LVAD (long-term)	Pump/Driveline/Implants
Percutaneous LVAD (short-term)	Pump/Driveline
Percutaneous LVAD (short-term)	Pump/Driveline
Percutaneous RVAD	Pump/Driveline
Total Artificial Heart	Pump/Driveline
LVAD (long-term)	IPG/Header
Pulmonary Hypertension System	Implantable Can & Anchor
Novel Cardiac Pacing System	Lead
Implantable Port w/Electronics	IPG

Structural Heart Programs	System
Transcatheter Aortic Valve Replacement	Delivery System
Transcatheter Pulmonary Valve Replacement	Delivery System
Transcatheter Mitral Valve Replacement	Delivery System
Transcatheter Mitral Valve Repair (DMR)	Implant/Delivery System
Transcatheter Mitral Valve Repair (DMR/FMR)	Delivery System
Transapical & Transcatheter Mitral Valve Repair (FMR)	Implant/Delivery System
Transcatheter Tricuspid Valve Repair	Implant/Delivery System
Transcatheter Tricuspid Valve Replacement	Implant/Delivery System
Percutaneous LVAD	Implant/Delivery System
Percutaneous RVAD	Implant/Delivery System
Inter-atrial Shunt	Delivery System
Inter-atrial Shunt	Implant
Pulmonary Hypertension	Implant/Delivery System
LAA	Delivery System
PFO Closure	Implant/Delivery System
Embolic Protection	Implant/Delivery System
Structural Heart Accessory System	Delivery System

Neuromodulation Programs	System
Peripheral Nerve System	IPG/Delivery/Externals
Peripheral Nerve System	Lead/Delivery/Externals
Tibial Nerve System	IPG/Lead/Delivery
Neuromodulation System (ENT)	IPG/Lead
Neuromodulation System (ENT)	Lead
Neuromodulation System (DBS)	IPG
Neuromodulation System (DBS)	Lead
Neuromodulation System (SCS)	IPG
Neuromodulation System (SCS)	Header
Neuromodulation System (SCS)	Lead
Lead Implant Kit	Delivery system

Cardiology & Vascular Programs	System
Neurovascular Stent Delivery System	Implant/Delivery System
Peripheral Intravascular Ultrasound (IVUS)	Delivery System
Optical Coherence Tomography (OCT)	Delivery System
Pulmonary Biopsy System	Delivery System
Transapical Mitral Valve Repair	Implant/Delivery System
Tricuspid Valve Repair – Surgical	Implant/Delivery System
Aortic Disease Tissue Repair	Implant/Delivery System
Heart Monitoring System	Implant
LAA	Delivery System
PFO Closure	Implant/Delivery System
Embolic Protection System	Implant/Delivery System
Valved Introducer Kit	Delivery System
Thrombectomy System	Delivery System

Electrophysiology Programs	System
Pulsed Field Ablation System	Delivery System
RF Ablation System	Delivery System
Heart Monitoring System	IPG
Esophageal Ablation Protection System	Delivery System
Cardiac Pacing System	Lead/Delivery
Temporary Pacing Lead	Lead/Delivery
Heart Monitoring Device	IPG
Heart Monitoring Device	IPG
Cryo Ablation System	Delivery System
RF Ablation System	Delivery System

Heart Failure Programs	System
Percutaneous LVAD (long-term)	Implant/Delivery System
Percutaneous RVAD	Implant/Delivery System
Percutaneous LVAD (short-term)	Implant/Delivery System
Total Artificial Heart	Implant
Total Artificial Heart	Driveline
Inter-atrial Shunt	Implant
Inter-atrial Shunt	Delivery System
Left Ventricular Biopsy System	Delivery System
Transcatheter Aortic Valve Replacement	Delivery System
Transcatheter Pulmonary Valve Replacement	Delivery System
Transcatheter Mitral Valve Replacement	Delivery System
Transcatheter Mitral Valve Repair (DMR)	Implant/Delivery System
Transcatheter Mitral Valve Repair (DMR/FMR)	Delivery System
Transapical & Transcatheter Mitral Valve Repair (FMR)	Implant/Delivery System
Transcatheter Tricuspid Valve Repair	Implant/Delivery System
Transcatheter Tricuspid Valve Replacement	Implant/Delivery System

Additional Markets	System
Peripheral Vascular – Atherectomy	Delivery System
Endoscopy – GI	Delivery System
ENT – Cochlear	Implant/Delivery
ENT – Cochlear	Consumable/Capital
ENT – Cochlear	Lead
Urology – Prostate	Implant/Delivery
Urology – Prostate	Delivery System
Oncology – Pancreatic	Implant/Delivery
Oncology – Pulmonary	Delivery System
Robotics	Delivery System

Your Guide Through the

Full Product Lifecycle

Our team becomes your team, and we partner throughout the entire product lifecycle – from conceptualization to manufacturing and beyond.

With our formal phase gate process, we ensure transparency and direction at every juncture. Need to navigate regulatory milestones or secure funding approvals? We’re by your side (even co-locating if needed), guiding every step of the way. Our experience allows us to sidestep potential challenges and anticipate obstacles in advance, ensuring a smoother path and clearer destination.

NPI Process Development: Structured Product Transfer

Select the transfer structure that best fits your needs. Each pathway is designed to accommodate distinct timelines and objectives, ensuring your transfer is customized and highly effective.

Direct Transfer

“Same as Same”

Achieve consistency with the existing setup by transferring all components, suppliers, and documentation without a hitch, ensuring minimal disruption.

Transfer with Process Improvements

Process Improvements

Refinements and supplier enhancements optimize cost and quality, leading to a larger return on investment. Focus on process development without impacting design.

Transfer with Design Improvements

Design and Process Improvements

Delve into process improvements and design modifications, resulting in the most comprehensive transformation with the potential for significant returns.

Manufacturing Expertise

At Resolution Medical, we have a 36,000 square foot facility dedicated to manufacturing, FDA registration, and decades of experience. Our team is well-prepared to accommodate a wide range of manufacturing needs from low to high volume, and our collaborative process emphasizes transparency and open communication to ensure the success.

We have multiple ISO Class 7 Cleanrooms providing a controlled environment for precise finished goods assembly, sterile barrier packaging, product labeling, inspections, and cleaning. We also offer a UL certified electrostatic discharge area, non-clean room manufacturing, and a distribution center designed for efficient logistics, all aimed at assisting you in the most effective way possible.

Click through each of our capabilities to learn more:

Laser Cutting & Welding

Molding

Additive Manufacturing