GO-Pen ApS is a start-up company established in 2019

Ambition and Founders

GO-Pen ApS is a start-up company established in 2019 by Ole Kjerkegaard Nielsen and Michael Ejstrup Hansen.

Our ambition is to develop safe, affordable medical devices that can help the many people for whom modern medical products today are unattainable.

The flag-ship product is the first price neutral and climate friendly insulin pen for the resource poor.

GO-Pen is a DK-based medical device company that delivers affordable, safe medical devices to people with few resources. 

We have deep experience with the global, unmet needs for patients with diabetes and medical device development provides.

Our team has unique competencies to develop a product that can be mass produced with unique differentiation and market appeal.

We hope to make insulin injection easier and better and thereby addressing unmet health needs in the world’s most resource constrained populations.

Ole Kjerkegaard Nielsen

  • CEO, GO-Pen ApS 2019 -
  • Director, Sustainability, Novo Nordisk A/S 2010-2019
  • Director, Clinical Development, Coloplast A/S 2007-2010
  • Medical Writer, Coloplast A/S 2005-2007
  • MMPI Diploma, SIMI/CBS 2009
  • PhD, Faculty of Life, Copenhagen University 2001-2004

Ole is partner and founder of GO-Pen Aps.

With 9 years as head of department at Novo Nordisk, Ole has deep insight into the unmet needs of the most disadvantaged people with diabetes in developing countries.

As head of Coloplast A/S's clinical development department, Ole focused on the development of medical devices in relation to current and future regulatory requirements in the EU and the US, made medical due diligence in connection with external product purchases, and adapted the development programs to take into account international marketing requirements

Michael Ejstrup Hansen

  • CTO, GO-Pen ApS 2019 -
  • CEO, ProductInnovation, main client Novo Nordisk 2002-2019
  • Co-author on 29 patents on insulin administration devices

Michael is partner and founder of GO-Pen Aps.

Michael has a solid background in medical device development, has co-authored 29 patents through his 18 years as an external developer for the Novo Nordisk device department.

Over the years as a developer for Novo Nordisk, Michael has had roles as project manager for a specialist in mechanical development of medical devices.

Michael has a unique insight into, preparation of IPR documentation, mechanical design / analysis, prototype and design of injection molding tools, design stability analysis of tools, development of quality assurance systems, plastic biocompatibility protocols and planning and implementation of production maturation

Executive Management

Ole K. Nielsen
CEO, Project Management

GO-Pen

Michael E. Hansen
CTO, Development

GO-Pen

Advisory Board

Jeppe Øvlesen
Funding & finance

Synact Pharma ApS

Nicolai Buhl Andersen
Marketing and medical device

Coloplast A/S

Jakob Kragh Nielsen
Legal, IP & M/A assis

Horten

Mette Schou-Hansen
Regulatory

ALK-Abelló A/S

Lars Bo Poulsen
Manufacturing Partnership

Consultant

Project Management

  • Leads funding and commercial development
  • Approves budget and timelines
  • Leads the advisor board
  • Leads stakeholder engagement
  • Signs on behalf of the company

Development

  • Leads technical development
  • Leads development of device
  • Leads stability testing
  • Leads biocompability testing
  • Leads manufacturing ramp up

Marketing and medical device

  • Strategy and medical device commercialisation
  • Deep knowledge of diabetes marketing
  • Deep knowledge of diabetes market dynamics and key players both in US but also internationally

Funding & finance

  • Helps develop funding strategy
  • Helps implement the funding strategy
  • Commercial agreement with distribution partners

Legal, IP & M/A assis

  • Guides on how to ensure compliance with relevant codes, standards and legal requirements
  • Guides on IP strategy (with Ström and Gullagson)
  • Guides in mergers and acquisitions negotiations if relevant

Regulatory

  • Guides project on regulatory approvals in countries
  • Develops regulatory strategy

Manufacturing partnership

  • Leads partnership development with manufacturing
  • Guides on mould and assembly strategy