As the third largest single market for medical devices worldwide, Japan can be an enormous opportunity for medical device and regenerative medicine manufacturers. However, Japan also has some unique practices and standards for clinical research and evidence generation that can make conducting local studies challenging.

We can support you with clinical studies for Japan to help accelerate development plans and to predict and navigate through the various challenges. Some of the study types that we have support with are as follows:

• Prospective cohort studies using electronic data capture (EDC) or online surveys

• Retrospective cohort studies based on chart reviews, claims data, etc.

• Patient and healthcare professional preference studies

• Patient, caregiver, and healthcare professional burden studies

• Consensus statement development

• Post-marketing research follow-on studies

• Clinical trial exit surveys

One of our core areas of expertise is market access and reimbursement evidence generation for medical devices and regenerative medicines in Japan. Our team has experience managing 100+ reimbursement assessment and evidence generation studies in Japan for medical devices and regenerative medicines.

Some of the topics covered for medical devices and regenerative medicines include the following:

• Reimbursement assessment and strategy planning

• Preference studies (e.g., discrete choice, conjoint analysis, best-worst scaling, etc.)

• Pricing and willingness to pay / use studies (e.g. conjoint analysis, Gabor–Granger, etc.)

• Economic model adaptations (e.g., budget impact analysis, cost-effectiveness analysis, etc.)

• De novo health economic model development

• Retrospective patient chart reviews

• Time-trade off (TTO) studies

• Patient-reported outcome (PRO) instrument development and validation

• Support with local model inputs through desktop research

• Validation of study models through key opinion leader interviews

We also collaborate with other companies in Japan and abroad as necessary to provide the best combination of services to meet your needs.

We offer support with market understanding and commercial assessment for medical devices and regenerative medicines in Japan. Our approach employs a variety of methods, including desktop and database research, qualitative interviews, and quantitative surveys with healthcare professionals and patients in Japan. Additionally, we offer assistance with global studies, as needed, through our collaboration with Junicon, a global research firm specializing in medical devices and biotechnology.

Some of the topics that we cover include the following:

• Treatment / competitor landscape assessments

• Reimbursement landscape assessments

• Unmet treatment need reviews

• Preference studies (e.g., discrete choice, conjoint analysis, best-worst scaling, etc.)

• Pricing and willingness to pay / use studies (e.g., conjoint analysis, Gabor–Granger, etc.)

• New product evaluations

• KOL and stakeholder mapping

• Usability / user experience studies

• Retrospective patient chart reviews

• Sales / volume forecasting

  ... and more!

We provide English-language medical writing support for survey research, literature reviews, and health economics evaluations for Japan. Services we provide include preparation of study protocols, study reports, medical / academic conference presentations, and draft manuscripts. We can also support with manuscript submission and peer review tasks (e.g., cover letters, revisions, response letters, etc.) as needed.

Below are some of the topics we have prepared manuscripts and conference materials for:

• Physician survey studies

• Patient survey research studies

• Qualitative research studies

• Database epidemiology and treatment studies

• Systematic literature reviews

• Healthcare system and access review studies

Click here to see a full list of the publications that our President (Michael LoPresti) has supported with

When it comes to the medical device and regenerative medicine market, we can also flexibly work with you to support other business needs. For example, we can support with the following services as needed:

• Bilingual facilitation of workshops

• Simultaneous interpretation

• Bilingual support with clinical study management

• Bilingual support with database research studies

• Other bilingual support, as needed

Please contact us to let us know how we can support you for Japan.