Medineers
Consultancy and contract manufacturer serving the medical device industry. Provides device design engineering, prototyping, process development, validation, and contract manufacturing under FDA QSR and ISO 13485 frameworks, plus marketing, sales, and M&A advisory services for medical device companies.
Industries
Nr. of Employees
small (1-50)
Medineers
Oak Brook, Illinois, United States, North America
Services
Engineering, prototyping, process development, tooling, molding, assembly and contract manufacture of medical device components and finished goods in FDA- and ISO-aligned environments.
Market analysis, positioning, branding, launch planning, clinical marketing support and sales channel strategies including domestic and international representation.
Transaction advisory including valuation, deal structuring, due diligence, acquisition integration and funding introductions for buyers and sellers in the medical device sector.
Access to industry-specific insurance and risk management solutions via a partner organization experienced in life science and medical device placements.
Engineering, prototyping, process development, tooling, molding, assembly and contract manufacture of medical device components and finished goods in FDA- and ISO-aligned environments.
Market analysis, positioning, branding, launch planning, clinical marketing support and sales channel strategies including domestic and international representation.
Transaction advisory including valuation, deal structuring, due diligence, acquisition integration and funding introductions for buyers and sellers in the medical device sector.
Access to industry-specific insurance and risk management solutions via a partner organization experienced in life science and medical device placements.
Expertise Areas
- Medical device product development
- Contract manufacturing and scale-up
- Regulatory compliance and quality systems (FDA QSR, ISO 13485)
- Process engineering and validation
Key Technologies
- Injection molding
- Insert molding
- Tooling design and fabrication
- Prototyping and pilot production
News & Updates
Case study describing engineering, prototyping, pilot production and commercialization of an anesthetic device that achieved market profitability within 12 months.
Case study describing development and contract manufacture of a line of substantially equivalent tracheotomy products for an early-stage company.
Case study describing completion of design, prototype development, patent-related design contributions and long-term contract manufacturing of an enteral feeding device.
Case study describing product development, obtaining an FDA 510(k), establishment of an ISO 13485 quality system and contract manufacturing for a balloon catheter.
Case study describing engineering, prototyping, pilot production and commercialization of an anesthetic device that achieved market profitability within 12 months.
Case study describing development and contract manufacture of a line of substantially equivalent tracheotomy products for an early-stage company.
Case study describing completion of design, prototype development, patent-related design contributions and long-term contract manufacturing of an enteral feeding device.
Case study describing product development, obtaining an FDA 510(k), establishment of an ISO 13485 quality system and contract manufacturing for a balloon catheter.