US Medical Device Manufacturer

US Medical Device Manufacturer Expands to
5 Countries Simultaneously

Case Study

Medical device company in the US with a large product portfolio, looking to launch new audiometry device in Asia

Needs

Product launch of a new product from a recently-acquired company, prefer to be agnostic to the distributors, and needs flexibility over the number of distributors per country -been challenging to deal and negotiate with various distributors.

Very few companies have the physical resources to provide multi-country product launch capabilities including regulatory, logistics, post market care, and can remain neutral to the financials

X months?

Referral

Connected with Access-2Healthcare through a referral, learns of the capability of the multicountry physical entities

8 months

Action!

Allowed the medical device company to understand our physical infrastructure, assigned resources for support in regulatory and logistics, executed simultaneously.

Provided authorized representative services + executed activities to gain regulatory approvals in these countries

Managed the post market surveillance activities and provided importation support

2 months

Results

Product launched in 5 countries

Other Examples

Neurology software-as-a-medical device launched in Thailand, Philippines