Your Expert Guide for Medical Device Development

For innovators seeking to make an impact in the medical device marketplace, Genesis Innovation Group brings ingenuity, collaborative partnership, and trusted expertise to guide you to success.

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What to Expect from Genesis

What to Expect from Genesis: Expertise

Expertise

Our deeply experienced team offers a complete platform of medical device development services with a thorough understanding of every step, from ideation to commercialization.

What to Expect from Genesis: Ingenuity

Ingenuity

Clients know us for our ability to creatively and adaptively overcome challenges, keep projects on track and uncover new ways to maximize the impact of their technology on the market.

What to Expect from Genesis: Partnership

Partnership

Genesis works in genuine partnerships, side by side with entrepreneurs to both guide and support your vision. In addition, our strong relationships with researchers, manufacturers, distributors and physicians will expand your reach and accelerate development.

Medical Device Development

Getting a new medical technology designed, cleared and into the hands of clinicians is a complex and time-consuming endeavor that requires expertise, perseverance and grit. That’s why the process has largely been the territory of large medical device corporations. Until now.

Genesis Innovation Group has successfully navigated this rigorous path multiple times, and we’ll partner with you and guide you through this arduous journey, maintaining positive momentum every step of the way.

Ideation &
Engineering

  • Idea Conception
  • Prototype Formation
  • Product Validation
  • Enterprise Expansion
  • Inventory Preparation
  • Commercialization

Business &
Finance

  • Corporate Governance
  • Legal Structure
  • Board Creation
  • Funding Strategy
  • Business Planning
  • Financial Reporting

Manufacturing
Expertise

  • Additive Manufacturing
  • Molding
  • CNC Machining
  • Raw Material Supply
  • Novel Material Processing
  • Forging
  • Coating

Regulatory &
Quality

  • Class I - III
  • 510K and PMA Clearance
  • ISO 13485 Quality System
  • Essential Document Compliance

Market Strategy &
Commercialization

  • Inventory and Logistics
  • KOL & Surgeon Advisory
  • Independent Distributor Network
  • Surgeon and Sales Training
  • IRB & VA Approvals
  • Hospital and ASC Contract Approvals
  • Clinical Data Collection
More on Our Process

Medical Device Development

Getting a new medical device designed, cleared and into the hands of clinicians is a complex and time-consuming endeavor requiring grit and deep experience. That’s why the process has largely been the territory of large medical device corporations.

However, Genesis has successfully navigated this rigorous path, and we’ll help you maintain positive momentum for each step of the way.

Ideation &
Engineering

  • Idea Conception
  • Prototype Formation
  • Product Validation
  • Enterprise Expansion
  • Inventory Preparation
  • Commercialization

Business & 
Finance

  • Corporate Governance
  • Legal Structure
  • Board Creation
  • Funding Strategy
  • Business Planning
  • Financial Reporting

Manufacturing 
Expertise

  • Additive Manufacturing
  • Molding
  • CNC Machining
  • Raw Material Supply
  • Novel Material Processing
  • Forging
  • Coatings

Regulatory &
Quality

  • Class I - III
  • 510K and PMA Clearance
  • ISO 13485 Quality System
  • Essential Document Compliance

Market Strategy & 
Commercialization

  • Inventory and Logistics
  • KOL & Surgeon Advisory
  • Independent Distributor Network
  • Surgeon and Sales Training
  • IRB & VA Approvals
  • Hospital and ASC Contract Approvals
  • Clinical Data Collection
More on Our Process
“One of the best compliments I can say about Genesis is they have done every aspect of medbusiness, and succeeded at it, multiple times. Their professionalism throughout the vetting process was so far superior to any other group we had worked with. Genesis’ unique approach to investing comes from wearing every hat in the process, allowing them to know exactly where you are, where you want to go, and how to get there. It has been a pleasure working with them.”
Jeff Conroy - former CEO, Embody
"I’ve done projects like this for other companies. I’ve worked in other spaces and I can tell you that the experience of working with Genesis is totally different from anything else I’ve experienced. Even some of the really sharp design firms I’ve worked with on other projects that I liked...it still is not what Genesis is offering, which is a unique combination of experience and skill."
Benjamin Holmes - CEO, Nanochon
“Genesis played an integral role in developing the strategy for my company. Together with additional investment of time, talent, and money by Genesis, Imascap has grown beyond my expectations.”
Jean Chaoui PhD CEO - Imascap SAS
“I sought to leverage the value of my IP for years and struggled to get traction. Genesis engaged my project and within a year they did everything they said they would do, and the result was everything I hoped.”
Stephen Gunther, MD
“After being here (2019 The State of Spine Surgery Think Tank) I’m even more glad to have partnered with Genesis. Your connections, experience, and overall perspective is perfect.”
Dr. Ryan Roeder Founder and Inventor - HAPPE Spine

News/Blogs

Contact

Reach out to our team if you have a great idea that you think can serve the medical community.

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