Genesis Innovation Group
Medical device development firm that provides end-to-end services from ideation through commercialization. Offers engineering, regulatory/quality, manufacturing scale-up, clinical support and business/financial services backed by an ISO 13485 certified quality system and a network of industry partners.
Industries
Nr. of Employees
small (1-50)
Genesis Innovation Group
Products
Shoulder arthroplasty implant system (glenoid fixation platform)
Development and commercialization support for a shoulder replacement implant system that uses an inset glenoid fixation approach to reduce glenoid micro-motion and simplify instrumentation (portfolio project supported to clinical use and clearance).
Dynamic tensioning shoulder brace (development project)
Product development program for a shoulder brace designed to support recovery from rotator cuff and other shoulder injuries; project included prototype development and marketability testing.
Biomaterial-reinforced spinal implant concepts
Development work supporting hydroxyapatite-reinforced polymer implants with variable porosity for spinal interbody applications (portfolio technology referenced in commercialization content).
Shoulder arthroplasty implant system (glenoid fixation platform)
Development and commercialization support for a shoulder replacement implant system that uses an inset glenoid fixation approach to reduce glenoid micro-motion and simplify instrumentation (portfolio project supported to clinical use and clearance).
Dynamic tensioning shoulder brace (development project)
Product development program for a shoulder brace designed to support recovery from rotator cuff and other shoulder injuries; project included prototype development and marketability testing.
Biomaterial-reinforced spinal implant concepts
Development work supporting hydroxyapatite-reinforced polymer implants with variable porosity for spinal interbody applications (portfolio technology referenced in commercialization content).
Services
End-to-end medical device development
Consulting and execution across ideation, engineering, prototyping, verification/validation, regulatory strategy, manufacturing scale-up and commercialization.
Ideation & engineering services
Human-centered concept development, computer modeling, prototyping, product drawings, specifications and preclinical testing support.
Manufacturing partnerships and scale-up
Selection and coordination of contract manufacturers, process development, and production ramp strategies including additive manufacturing and traditional processes.
Regulatory & quality systems support
Regulatory strategy, submission support for FDA pathways, ISO 13485 quality system alignment and audit readiness.
Market strategy & commercialization services
Commercialization planning, distribution network development, KOL engagement, clinical training, and market operations support.
Business and finance operations
Financial strategy, cap table management, bookkeeping, ERP implementation and fractional C-suite services tailored to medical device startups.
End-to-end medical device development
Consulting and execution across ideation, engineering, prototyping, verification/validation, regulatory strategy, manufacturing scale-up and commercialization.
Ideation & engineering services
Human-centered concept development, computer modeling, prototyping, product drawings, specifications and preclinical testing support.
Manufacturing partnerships and scale-up
Selection and coordination of contract manufacturers, process development, and production ramp strategies including additive manufacturing and traditional processes.
Regulatory & quality systems support
Regulatory strategy, submission support for FDA pathways, ISO 13485 quality system alignment and audit readiness.
Market strategy & commercialization services
Commercialization planning, distribution network development, KOL engagement, clinical training, and market operations support.
Business and finance operations
Financial strategy, cap table management, bookkeeping, ERP implementation and fractional C-suite services tailored to medical device startups.
Expertise Areas
- Medical device engineering and design
- Regulatory strategy and quality systems (ISO 13485, FDA pathways)
- Manufacturing and scale-up for medical devices
- Preclinical testing and verification/validation
Key Technologies
- Additive manufacturing (3D printing)
- CNC machining and precision machining
- Injection and specialty molding
- Surface treatments and coatings