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
2851 Charlevoix Dr. SE Suite 327, Grand Rapids, MI 49546
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
Consulting and execution across ideation, engineering, prototyping, verification/validation, regulatory strategy, manufacturing scale-up and commercialization.
Human-centered concept development, computer modeling, prototyping, product drawings, specifications and preclinical testing support.
Selection and coordination of contract manufacturers, process development, and production ramp strategies including additive manufacturing and traditional processes.
Regulatory strategy, submission support for FDA pathways, ISO 13485 quality system alignment and audit readiness.
Commercialization planning, distribution network development, KOL engagement, clinical training, and market operations support.
Financial strategy, cap table management, bookkeeping, ERP implementation and fractional C-suite services tailored to medical device startups.
Consulting and execution across ideation, engineering, prototyping, verification/validation, regulatory strategy, manufacturing scale-up and commercialization.
Human-centered concept development, computer modeling, prototyping, product drawings, specifications and preclinical testing support.
Selection and coordination of contract manufacturers, process development, and production ramp strategies including additive manufacturing and traditional processes.
Regulatory strategy, submission support for FDA pathways, ISO 13485 quality system alignment and audit readiness.
Commercialization planning, distribution network development, KOL engagement, clinical training, and market operations support.
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
News & Updates
Genesis hosted a workshop at the 2019 ASAP Meeting covering product management, regulatory pathways, funding, and clinical goals.
Press release announcing new website and branding.
Press release announcing appointment of Chance Leonard as CEO.
Press release describing FDA 510(k) clearance for a shoulder implant system supported by Genesis' development activities.
Announcement of peer-reviewed long-term clinical follow-up data for an inset glenoid design.
Operates with an ISO 13485-2016 certified quality management system.
Genesis hosted a workshop at the 2019 ASAP Meeting covering product management, regulatory pathways, funding, and clinical goals.
Press release announcing new website and branding.
Press release announcing appointment of Chance Leonard as CEO.
Press release describing FDA 510(k) clearance for a shoulder implant system supported by Genesis' development activities.
Announcement of peer-reviewed long-term clinical follow-up data for an inset glenoid design.
Operates with an ISO 13485-2016 certified quality management system.