Strategic Panel Sessions: Clinical Trial Design for US Market Entry

Biotech — Connected Care/Digital Health — Diagnostics — Digital health — eHealth (ICT) — Medical device — Pharma —

Project partners

Medtech-Innovation

Funding partners

Innovation Norway

Contact info

ane.solesvik.oppedal@norwayhealthtech.com

Clinical data is the hallmark of evidence for new medical devices, used for regulatory approval, reimbursement, marketing, to draw investors and convince physicians and other users to adopt new products and services. The design of a clinical trial is a vital element in the success or failure of the study outcome. Norway Health Tech organizes strategic panels of clinical, regulatory, design and reimbursement experts to assist Norwegian health technology companies design the most cost – and time effective clinical trials.

Norway Health Tech members with that are developing medical products or solutions for the US healthcare market can apply to enter the program. Selected companies will travel with Norway Health Tech to Minneapolis, US, to work with a tailored panel of experts that together will help the company design the most effective clinical trial for US market entry. Norway Health Tech will provide some funding for the selected companies to cover some of the costs of the panel sessions.

This half-day Strategic Business Session will bring together the appropriate experts to discuss the current state of the project and help craft the strategy for a customer looking to align their stakeholders early in the development process.

You will go through:

  • 4-hour meeting to include early stage strategic discussions that establish clear commercial objectives by bringing critical stakeholders to the table early:
  • Regulatory, Clinical, Reimbursement, Scientific Communications, Marketing and Engineering strategies to provide proper guidance and appropriate first step to ensure a “smart” start.
  • Break out Session to meet with SME’s to refine strategy and identify next steps
  • Testing discussion to prepare for pre-submission strategies, feasibility/ Pre-Clinical/ Clinical discussions to ensure proper data gathered to support Regulatory, Reimbursement and Marketing Claims.
  • Strategic Business Canvas exercise to help organize the specific strategic needs of the client with market/client focus and understand where the gaps are.
  • Final deliverable: Strategic Business summary with high level timeline and next steps. The beginnings of a strong road map.

Aditionally, basecd on the needs of the companies, Norway Health Tech can assist in scheduling relevant one-to-one meetings during the stay in Minneapolis. Norway Health Tech together with our Danish cluster partner Medtech-Innovation and their danish startups will host a networking event to provide more visibility for the participating companies.

We also recommend that companies attend the Medical Alley Innovation Summit on the 18th and 19th September.

The cost of the program is $7,500. Norway Health Tech will cover $2,500. This does not include travel and accomodation, or the Medical Alley Innovation Summit.

Limited spaces available – secure your participation now!

 

 

For questions or to sign up, contact Ane Oppedal at ane.solesvik.oppedal@norwayhealthtech.com