Globizz Corporation
A Winning Strategy for Sustainable US Operations

Based on FDA reports, Japanese medical device companies are less successful compared to other Asian or European firms when it comes to FDA 510k approval. Looking deeper, it can be said that Japanese firms have been failing to crack the code at the business level, not at the FDA or other regulatory levels. Addressing this longstanding problem is Los Angeles, CA-based Globizz Corporation, an international consulting company with extensive experience in cross-border business. Globizz has a successful track record of bringing Japanese medical devices into the US while benefiting both Japanese companies and the US populations. Unlike other companies that offer point solutions, Globizz is a unique Japanese-English Bilingual FDA consulting firm that has a separate division of business consulting for Japanese firms carrying out business in the US. What differentiates the company in the market is its proven ability to marry diverse aspects. That includes knowledge of the medical device market and the US corporate culture, the latest FDA regulations, and the clients’ unique needs. So Japanese firms can not only set up their business but also thrive, broadening their portfolio of offerings and bottom line along the journey.

“That said, for an overseas company to succeed in the medical device market in the US is easier said than done,” says Takahiro Haruyama, founder of Globizz. It requires a different ball game altogether. It not only requires a good product but also the know-how of the intricacies in the medical device market, including the local insurance framework, and a trusted partner in the US for fruitful outcomes.

To that end, Haruyama brings to bear his decade-long experience in the industry and a team of talented and skilled professionals that has in-depth knowledge of the FDA regulations as well as the medical device business in the US. In helping its clients with a winning strategy for the US market, Globizz makes it a point to gather crucial information about them. The first criteria is to discern the size of the client’s company and their potential in terms of finance and HR resources. Subsequently, Globizz imparts the necessary knowledge to the client, aiding them in filling the strategic gaps, and building an efficient game plan. The information it provides includes the latest FDA regulatory requirements and insights on the culture in most of US-based medical devices companies. This is crucial because most of the Japanese firms believe having high-value medical devices from a patient perspective is enough to succeed in the US. Certainly, it is not. Globizz guides its clients to follow a strategy where every stakeholder involved in the business, including the patient, payer, and the local partner, benefits from the product.

With Globizz, Japanese firms can not only set up their business but also thrive, broadening their portfolio of offerings and bottom line along the journey

Apart from top-level management businesses and financial planning, as well as market research, Globizz offers services such as overseas base auditing, and cross border M&A advisory between the US and Japan. The FDA regulated areas include food, cosmetics, medical devices, drugs, and animal foods.

For the future, Globizz plans to expand its services to deliver higher value to its clients. The company is aiming to undertake a clinical study in the US that will help Japanese companies bolster their business opportunities through new collaborations, accelerating the project execution eventually. It also looks to collaborate with other service providers and testing laboratories in the future with a mission to be the go-to partner for the end-to-end business needs of its clients.