Our track record reflects the breadth and depth of our experience across the BioMedTech landscape. From diverse clinical domains to a wide range of medical device categories, we have worked on solutions spanning cardiovascular, neurovascular, gastrointestinal, orthopedics, and more, covering both simple and highly complex systems. This includes expertise in mechanical, electromechanical, electronic, and combination devices, as well as software-driven (SaMD) with artificial intelligence (AI), and biomaterial-based innovations.
Across these domains, we support the full product lifecycle with a strong understanding of global regulatory pathways, including US FDA, EU CE Mark, and Singapore HSA classifications. This integrated capability allows us to guide innovations from early development through to regulatory approval and commercialization, delivering solutions that are both technically sound and market-ready.
Across these domains, we support the full product lifecycle with a strong understanding of global regulatory pathways, including US FDA, EU CE Mark, and Singapore HSA classifications. This integrated capability allows us to guide innovations from early development through to regulatory approval and commercialization, delivering solutions that are both technically sound and market-ready.
REPRESENTATIVE PRODUCT DEVELOPMENT EXPERIENCES
Projects are designed, developed, and delivered with full regulatory and quality compliance, supported by robust ISO 13485 documentation and a clear pathway to manufacturing transfer. We enable successful product registrations across multiple key markets, including US FDA, EU MDR/IVDR, and Singapore HSA. Our work spans diverse stages of innovation from early academic development to fully commercialized products, each aligned to our partners’ specific performance indicators and success metrics. Every program is not only built on strong technical foundations, but also strategically planned to ensure meaningful outcomes. With a proven track record across numerous projects, we consistently deliver solutions that meet regulatory requirements, achieve commercialization goals, and ultimately create real-world impact for our partners.
Clinical Monitoring and Decision Tool
Class II, AI, Software as Medical Device (SaMD)
- Provided regulatory submission package strategies.
- Strategized manufacturing plans for SaMD products.
- Built the Quality Management System (QMS) and supported the team in achieving ISO 13485 certification.
Tactile Quantification Device
Class II, Electromechanical + AI, Rehabilitation
- Served as a key partner, providing leadership and strategic guidance whenever the team needed support.
- Built the Quality Management System (QMS) and supported the team in achieving ISO 13485 certification.
- Provided fractional quality expertise and leadership as the Management Representative.
Body Fluid Analyzer
Class II, Electromechanical + AI, Biotechnology
- Strategized project management to align the team, priorities and delivery milestones.
- Established manufacturing setup plans to support product transfer and scale-up.
- Built the Quality Management System (QMS) and supported the team in achieving ISO 13485 certification.
- Provided fractional quality expertise and leadership as the Management Representative.
Blood Collection Needle
Class II, Mechanical, Phlebotomy
Class II, Mechanical, Phlebotomy
- Key inventor and lead designer.
- Four international design awards: iF, Red Dot, German Design, and GOOD DESIGN™.
- Completed design freeze and manufacturing transfer.
- Successfully commercialized as a premium, safety-engineered device.
Neurovascular Embolization Coils
Class III, Electromechanical, Neurovascular
Class III, Electromechanical, Neurovascular
- Co-designed electromechanical system with external partners.
- Completed design freeze and manufacturing transfer - 120+ SKUs.
- Optimization electrolytic detachment via failure analysis and statistical studies.
- Led complex cross-regional, cross-functional project execution.
Non-Contact Health Monitoring AI Device
Class I, Electromechanical + SaMD + AI, Patient Assessment
Class I, Electromechanical + SaMD + AI, Patient Assessment
- Led strategic planning across technical, quality, and commercialization
- Advised on quality and clinical documentation strategy.
- Established Quality Management System (QMS).
Bioabsorbable Implantable Orthopedic Screws
Class III, Mechanical, Orthopedic
Class III, Mechanical, Orthopedic
- Led design transfer into local manufacturing site.
- Drove site setup and project execution from ground up.
- Established Quality Management System (QMS) and achieved ISO 13485 certification.
- Secured EU MDR approval; commercially available in market.
Mitral Valve Replacement Prosthesis
Class III, Mechanical, Cardiovascular
Class III, Mechanical, Cardiovascular
- Led innovation and design of novel mitral valve prosthesis.
- Completed design for manufacturing (DFM) for US production.
- Supported commercialization through fundraising activities.
- Delivered pre-design freeze documentation package.
Gastric Balloon Implants
Class III, Mechanical, Gastro-Intestinal
Class III, Mechanical, Gastro-Intestinal
- Led innovation and design from clinical insights to engineering requirements.
- Commercialized two different products across two regions in Phase I rollout.
- Led patent documentation, submission, and acceptance.
Drug Coated Balloon Catheters
Class III, Combination Device, Vascular
Class III, Combination Device, Vascular
- Led drug-coating process development for balloon catheter.
- Established facility for drug handling, control, and disposal.
- Drove documentation, regulatory submission, and approval.
- Completed design transfer to production; commercially available.
Trans-Radial Access Catheters
Class II, Mechanical, Neurovascular
Class II, Mechanical, Neurovascular
- Conducted competitor benchmark, market research, and KOL engagement.
- Establish test methods for trackability and push-ability.
- Translated research insights into functional prototype.
- Design transfer to external partners.
Total Ankle Replacement
Class III, Mechanical, Orthopedic
Class III, Mechanical, Orthopedic
- Conducted research to optimize initial bone-prosthesis interface and reduce micromotion for implant survivability.
- Developed design concepts supported by finite element analysis (FEA).
- Designed and validated bench testing to verify optimal performance.
- Presented findings at conferences and publications.
Radial Sheath Catheter
Class II, Mechanical, Neurovascular
Class II, Mechanical, Neurovascular
- Conducted competitor benchmarking, and market research.
- Established neurovascular models and testing setups.
- Generated engineering data to support design decisions.
Aortic Abdominal Aneurysm Flow Diverter
Class III, Mechanical, Vascular
Class III, Mechanical, Vascular
- Designed implant based on clinician-driven insights.
- Applied fluid dynamics principles to optimize flow reduction.
- Conducted computational fluid dynamic (CFD) analysis.
- Completed 3-months chronic animal studies.
Various Packaging
Class II, Mechanical, Multiple Clinical Domain
Class II, Mechanical, Multiple Clinical Domain
- Designed and developed customized packaging (pouches, deep-drawn blisters).
- Conducted packaging validation to ensure sterility barrier system.
- Prepared documentation for regulatory submission.
Guidewire
Class II, Mechanical, Vascular
Class II, Mechanical, Vascular
- Designed and developed new sizes to expand product portfolio.
- Defined regulatory strategy and compiled testing data and documentation.
- Completed regulatory submission with approval.
- Commercially available.
Arterial Cannula
Class II, Mechanical, Critical Care
Class II, Mechanical, Critical Care
- Defined end-to-end project strategy from concept to regulatory approval.
- Designed and developed novel cannula concept.
- Conducted benchmark studies to establish technology baseline.
Neuro Microcatheter
Class II, Mechanical, Neurovascular
Class II, Mechanical, Neurovascular
- Translated market needs and design input into engineering requirements.
- Led project strategy and execution.
- Completed design transfer to oversea manufacturing.
- Delivered design verification testing for regulatory approval.
