Home > Achievements
Our Achievements at a Glance
56 approvals for worldwide clients
Premium Reimbursement Listings: 5*
The fields we cover
We focus on Class III and IV approvals.
After a decade of operations,
Vorpal has become the market leader in Japan for
new category medical device approvals.
Christopher A. Ball
Director, International Sales & Marketing
NeoTract | Teleflex
Interventional Urology Business Unit
Vorpal has been our trusted partner in Japan from project planning through regulatory approval and all steps in between. We consider them a part of our team.
As a highly innovative new category medical device, we wanted to emphasize our unique benefits and at the same time correlate overseas clinical experience with Japanese patient physiology and treatment practices. Vorpal helped us navigate the process with the PMDA through to shonin approval without having to conduct additional in-Japan clinical trials.
In addition to in-person meetings with our team in the US and Japan, Vorpal hosts bi-weekly web conference discussions with our team. These meetings are run by Vorpal’s Project Management group and supported by management and specialists depending on the stage of our program. Frequent and clear communication with Vorpal’s bilingual team ensures mutual understanding and adherence to timelines.
Another key factor for our success has been the strong support we have been able to enjoy from Key Opinion Leaders and medical societies in the US as well as in Japan. Vorpal has been a strong supporter in helping us maintain these relationships on the ground in Japan.
Selecting Vorpal as our partner enabled us to obtain our regulatory approval according to our ideal timeline and in our own name.
I enthusiastically recommend Vorpal to any MedTech company looking to significantly grow their enterprise value through Japan market access. Vorpal has a deep understanding of the needs of innovative companies of all stages and offers a full range of services that enable companies to start their Japan journey early and avoid uneconomical investment.
Stephen J. McGill
VP & GM International
SpaceOAR Business Unit
Choosing Vorpal as our partner for Japan market entry ended up being an ideal solution for our company. We were able to achieve regulatory approval and successful new category reimbursement listing in record time and importantly under our own control, significantly augmenting our enterprise value.
Vorpal assigned a highly effective project team of roughly 10 people including subject matter experts who were involved at different stages of our program. The team and management were not only expert in their defined roles, but creative and collaborative in providing new solutions to meet our evolving needs.
Vorpal’s experienced management team helped us search and evaluate potential distribution partners, and when we decided to set up distribution ourselves, Vorpal supported us every step of the way. They helped us identify and hire our country manager and incubated our growing company in their office. We achieved sales throughout Japan through a combination of direct-to-hospital and local area dealer networks, utilizing Vorpal’s warehousing and supply chain management services and connections.
Having Vorpal as our virtual subsidiary in Japan enabled us to establish an independent operation without a large investment and still providing connectivity to our US parent company. We were able to build sustainable market traction in our independent phase and achieve an efficient and successful transition to Boston Scientific management after our acquisition.
I believe other innovative MedTech companies should seriously consider Vorpal’s unique range of end-to-end services and will surely benefit from their enthusiasm and creativity.
Vice-President Quality & RA,
Motiva Breast Implants | Establishment Labs
Vorpal has been an invaluable partner for Establishment Labs’ (ESTA) objective of introducing our products to the Japanese market. As a medium-sized corporation, we could not afford to have our own entity in the country, and because of this Vorpal has been just the right solution for our needs.
From the very beginning, Vorpal’s Project Management Team demonstrated a highly professional and reliable work standard, defining the correct process that needed to be followed, as well as guiding us towards an almost flawless execution, in a very reasonable timeframe, until we obtained PMDA’s approval for our devices and reimbursement listing.
They clearly demonstrated to us they know how to navigate throughout the country’s regulatory framework and were able to keep delivering on each of the milestones through the project. They displayed all the time a high level of engagement with our own team, including but not limited to a highly effective communication process, clear requests for information, the correct set of expectations, as well as timely feedback. All this combined made ESTA’s Leadership Team feel very confident with the process as well as our Project Team very comfortable with the interaction with their experts.
After the approvals of our products were obtained and now in their role as Designated Marketing Authorization Holder (DMAH), they have kept their level of effectiveness and work ethics; they are always willing to support our company in any way needed and keep the flow of communication required.
Establishment Labs certainly and with no doubt recommends Vorpal as the partner to have to any Medical Device or MedTech company desiring to get access to the Japanese market.