...Let us define your success
N2VATE: verb \ in´– tū – vāt \

1: to provide comprehensive business management
to develop a product through the lifecycle process.
2: to produce wealth from product innovation.

Call Us 714.655.0781
  • Business Development & Product Management:
    Medical Device & Scientific Instrument


    Comprehensive Front-End Management:
    • Business Planning & Funding
    • Patent & Intellectual Property
    • Product Design and Engineering
    • Regulatory Compliance, FDA
    • Contract Manufacturing
    • Sales & Marketing

    N2VATION for your INNOVATION!
  • Our Services

     

    The N2VATE process is simply about 'getting it done' and taking your innovation to market. This is outsourced business management that combines technical and engineering know-how with marketing, sales, and business acumen – a comprehensive product management service. Regardless where you are in the product development cycle, N2VATE can provide the most effective expertise to ensure your rapid success. N2VATE 'one-stop-shop' is all you need from concept to market….. and profitable exit!



    Sales and Marketing


    N2VATE showcases its core competency with nearly 30 years of experience in domestic and international sales, marketing, and comprehensive product management involving over a dozen product and business launches. $300M in commerce has been the result.



    • Direct focused sales campaigns
    • Sales force and customer training
    • Development and set up of domestic & international distribution channels
    • Market research and validation
      • Market size, characteristics, product appetite, target customer feedback, competitor analysis, and more
    • Market strategy and development
      • Promotion campaign strategy, product 'crusading', product awareness and need creation
      • Business plan strategy and creation
    • Product P&L and budget analysis; Pro-forma for investors
    • Branding: PR, KOL (key opinion leader), logo and company / product name development, internet presence
    • Collateral development: brochures, application briefs, ads, promotional and training video, internet emailing / advertisement , tradeshow booth development, graphical artwork & design
    • Website creation, development, and Search Engine Optimization

    Product Design & Engineering


    N2VATE provides the complete array of technical and engineering expertise for the various design phases involved in creating a truly market-worthy quality product - from idea to production-ready prototype.



    • Product Specifications: Marketing / Engineering Interface
    • Feasibility Study
    • DFM, Design for Manufacture
    • Engineering
      • Industrial design: ergonomics, human factors, and aesthetics
      • Mechanical engineering
      • Electronics engineering
      • Software engineering
    • Prototyping
      • Rapid prototyping: SLA, SLS, PolyJet, FDM, CNC, DMLS. Short-Run Production: urethane casting, composite tooling
      • Assembly, testing, engineering feedback
    • Documentation
      • BOM, bill of materials
      • Manufacturing Instructions
    • Product Compliance Testing and Documentation

    Contract Manufacturing


    N2VATE offers trusted domestic or overseas resources for prototyping, tooling, and contract manufacturing that are proficient and economical.



    • Tooling & Injection Molding Services: domestic and overseas
    • Domestic and Overseas Manufacturing, Assembly, Packaging
    • Product Packaging Development
    • ISO Product Manufacturing
    • ISO 13485: 2003 Certification
    • ISO Class 7 (10,000) Clean Room
    • Advanced Quality and Regulatory Control System
    • Complete Supply Chain Management

    Legal Services


    N2VATE delivers legal services for intellectual property (IP) management including.



    • Patent Searches
    • Patentability Evaluation
    • Patent Submission and Prosecution
    • Trademark, Copyright
    • International and Domestic IP Registration and Protection

      In addition, we offer legal services covering general corporate matters including:

    • Incorporation
    • Contracts
    • Taxes
    • Capitalization Strategy

    Regulatory Compliance Process, Medical Devices


    N2VATE offers the highest expertise in compliance solutions to medical device manufacturers and support, assistance, and training for all Center for Devices and Radiological Health/FDA compliance needs including:



    • QSR/CGMP Implementation and Audits
    • Product and Process Validation for Hardware and Software
    • Investigational Device Exemptions (IDEs)
    • Premarket Approval (PMAs)
    • Premarket Notifications, 510(k)
    • FDA 483 or Warning Letter Recovery
    • Radiological Health
    • ISO 13485 Implementation and Audits
    • Product Testing, Characterization, Safety, Evaluation, and Certification
    • On-site Quality Engineering Management and Implementation

    Business and Funding Advisory


    Perhaps the most crucial ingredient to business success is… experience. Through this resource, N2VATE brings decades of high C-level acumen involving funding resources and business and corporate development strategies required to attain your goals. N2VATE provides a variety of channels for startups and early stage companies to seek funding necessary for growth.



    • Project Funding Strategy
      • N2VATE funding network
      • Executive placement network search and match
      • Investor search service
    • C-Level Team Placement
    • Global Strategy Advisory Services
    • Business Development Strategy
    • Mergers and Acquisition
    • Corporate Partnering and Licensing
    • C-level Coaching
    • Government Economic Advisory
    • On-site Quality Engineering Management and Implementation

    Working with N2VATE


    N2VATE is an outsourced one-stop management consulting service for bringing a medical device through the product lifecycle. There are number of ways to work with N2VATE:

    • Fee or retainer: hourly, daily, weekly, monthly, or quoted by project
    • Reduced fee or retainer, plus a success fee and/or sweat equity
    • License model: Client licenses IP or project to N2VATE for commercialization. N2VATE uses its federation of resources as 'share providers' to buy-in and execute the commercialization process against a set of timed milestones, or it reverts back to licensor. Ideal for MD's, RN's, engineers, inventors and inexperienced, who want to keep their day jobs.

    Disclaimer: This is not an offer for the sale or purchase of securities