Webinar announced: How to design your medical device trial to achieve market access success.

SMART-TRIAL and Nordic HTA announced a new webinar titled How to Design your Medical Device Trial to Achieve Market Access Success, to be held Monday, May 18th, 2020 at 15:00 CET. The webinar is dedicated to introducing a proactive and holistic approach towards market access and health economics and the need for its early incorporation in clinical strategy.

The webinar will be presented by Pall Johannesson CEO of  SMART-TRIAL and Anders Maerkedahl Partner at Nordic HTA. Together they will be sharing valuable insights on initiatives that teams should practice in order to deliver product value data that is expected by a wide range of stakeholders that are imperative for market access success.

To date, the clinical strategy in most MedTech companies has been focused on collecting data on safety and efficacy to obtain the applicable CE or FDA approvals. But today’s regulators, payers, and healthcare systems expect more.  Market access and health economic evidence is often thought to be a separate activity, that doesn’t belong in clinical studies – which is why it’s often left out in early stages of clinical strategies. As a result many companies may risk having to redo studies to gather the necessary data with related costs to follow.

To illustrate product value to a wide group of stakeholders, clinical teams need to incorporate market access and health economic variables in their clinical strategy as well, this is the underlying driver behind the webinar.

“A strategic approach to data collection that is aligned with the value communication strategy, throughout the device life-cycle, can have a significant impact on the go to market success of a device. Hence, in addition to showing product safety and efficacy evidence, device companies have to demonstrate clinical and health economic value to key stakeholders to ensure market access success.”

Anders Mærkedahl, Partner Nordic HTA

What attendees will learn:

  1. Which strategic questions should you be asking your stakeholders during early development, in order to achieve commercial product success?
  2. How to ensure the clinical strategy is aligned with the overall value generation and value communication strategy?
  3. What market access data clinical teams should include in clinical investigations?
  4. How PMCF studies or other mandatory activities can be used for more than performance and safety documentation. 

Registration is now open, visit: https://info.smart-trial.co/webinar/how-to-design-a-medical-device-trial-to-achieve-market-access-success

Páll Jóhannesson M.Sc. in Medical Market Access is the co-founder and CEO of SMART-TRIAL. Páll has over 8 years’ of experience with developing eClinical tools for clinical studies in medical devices. He has hands-on experience with health economic outcome research, clinical data management, and clinical trial setup. Páll is also a board member in the MedTech startup MOTI as well as Chairman of the Board of the MedTech Cluster Life-Science Innovation North Denmark.

Anders Mærkedahl holds an M.Sc. in Medical Market Access and a BSc in Medicine with Industrial Specialization. Prior to joining Nordic HTA, Anders Mærkedahl was Global head of Health Economics & Market Access at Ambu A/S, responsible for the integration of health economics into product development (stage-gate model), clinical development plans, and launch excellence plans. Anders established the global HEMA team in Ambu A/S. Anders is an expert within the implementation of value-based procurement, developing key health economic and market access tools (BIA, CEA, GPO- IDN strategy tools, and value dossiers) within MedTech. Anders is currently representing the Danish MedTech industry in a commission under the Danish Ministry of Industry, Business & Financial Affairs, and the Ministry of Health; “Partnership for Innovation Promoting Health Care in Medical Devices” as an expert within HEMA.  

About Nordic HTA
Nordic HTA helps patients get access to healthcare products by helping healthcare companies demonstrate that their products offer value for money. Nordic HTA consists of highly skilled specialists with extensive experience in developing health economic models, submissions, medical writing, real world evidence and market access strategy to support your economic value proposition.Nordic HTA can help with all elements of the market access process, be it strategy, clinical or health economic evidence, medical writing, value communication, price negotiations, or general guidance.

Contact information:
Erika Michelle Pinto
MEDEI Aps
Marketing Manager
Phone: +45 53824546
Email: ep@medei.dk