AGILE Product Development®

Our diverse technical experience and rapid-turn mindset will provide a creative force to drive the development of your next therapy. Our engineers are well-versed in ISO 13485 Design Control and ISO 14971 Risk Mitigation practices. We support your team while addressing engineering and manufacturing challenges at all phases of development.

Our goal is to collaborate seamlessly with your team while striving to be flexible and attentive to the changing demands of your project. As your full-service partner, we can prepare the design documentation your project needs for regulatory approval and increase speed to market. Our AGILE Product Development team works directly with Lightspeed Lab® engineers to seamlessly integrate the latest advancements in processing capabilities and achieve a targeted, efficient, and scalable solution for your product. By considering manufacturability and unit cost upfront, we help ensure your product launches on time and on target.

• Minimally invasive therapeutic and diagnostic medical products for:
  • Electrophysiology
  • Structural heart
  • Peripheral vascular
  • Neurovascular
  • Cryotherapy
  • Drug delivery
  • Interventional cardiology
  • Interventional pulmonology
  • Endoscopy / Gastroenterology
  • Pain management
• Implant design and development
• Catheter-orientated manufacturing process development
• Supply chain selection, management, and technical oversight
• In-vivo study protocol development, execution, reporting
• Clinical site initiation, physician training, and case support
• In-vitro test method development and fixture fabrication

• Shaft lamination and complex catheter reflow operations (horizontal and vertical arrangements)
• Dedicated lab and laser welders for pull wire attachment and articulated systems
• Tipping stations and assorted secondary ops (skiving, hole punching, etc.)
• Overmoulding for custom hub and dilator tip configurations
• UV curing stations (metal halide and LED sources)
• 3D printing (SLA, FDM) and laser cutting for quick turn handle form evaluation, test fixture componentry, anatomical modeling, etc.
• Automated tensile/compressive test stand for bond strength analysis and trackability testing
• Assorted wet lab and vascular model performance testing capabilities
• Dedicated lab with laser welders for full wire attachment
• Pad printing
• Hydrophilic coating on an R&D basis
• Mobile fluoroscope for rapid simulated use evaluation