Improving Product Value & Patient Outcomes.

Be ready for the paradigm shift

Implementation of HTA bodies and increased regulatory requirements results in a paradigm shift for medical devices. Each individual device must deliver tangible and quantifiable value e.g. addressing an unmet need, improving efficiency or effectiveness, or reducing costs.

Therefore, it is important to incorporate these value outcomes in your clinical trials and align these with your overall value generation- and communication strategies to achieve market access- and commercial success.

Market Access Activities

At NHTA we can support your MedTech market access activities from strategy to
implementation. Our services include:

Support early integration of HEMA models into product stage-gate models and clinical development plans to ensure market access success and prepare for HTA processes.

Health economic support from early modeling to advanced cost-effectiveness models.

Support with the evidence & value generation plans to ensure the right outcomes are taken into consideration for the optimal market access process.

Market analysis and market access strategy ensuring optimal launch and faster market update.

Early HEMA support to guide and support on product value drivers, pipeline prioritization and market potential.

Pricing analyses to support and guide in product development, define the right product price, and guide pricing & reimbursement strategy.

Identify, map and analyze the pricing and reimbursement landscape and conduct the right strategy to enable product success.

Effective value communication strategy and tools to engage with internal and external stakeholders.

Six reasons why devices differ from drugs

While medical technologies and pharmaceuticals share some similarities, it is import to acknowledge the differences between the two on several key elements. E.g. research and development models vary greatly between the two industries. Further, the regulatory, payment, and reimbursement landscape for MedTech is equally different from Pharma, making the device market much more diverse. Therefore, your HEOR and market access processes, from strategy to implementation, are crucial to obtain and secure long- term market access success.

Below are six reasons why devices differ from pharmaceuticals and why you need to approach the HEOR and market access process for devices different compared to pharmaceuticals.

1. No steady State Period
2. Operator State => Learning Curve
3. Devices are often diagnostic
4. Difficult to make blinded studies
5. No need for RCT to get a CE or FDA approval
6. Devices frequently undergo product modifications