Common Ground between Japan and Switzerland JETRO Seminar – Feb 12, 2015

Bern, Switzerland

Ary Saaman – Director, Regulatory Affairs Debiotech S.A. – Lausanne, Switzerland

Brief company overview

Debiotech and Japan : common grounds ?

Debiotech and Japan : common accomplishments

Debiotech and Japan : common grounds !

On a personal note …

Presentation outline

Medical device «research and development» company

Based in Lausanne, Switzerland

Founded in 1990

Privately owned

Currently ca. 50 staff, mostly r&d

Operating under a certified quality management system (ISO 9001, ISO 13485, and 21 CFR 820)

Brief company overview

To identify breakthough technologies …

To develop them into innovative medical devices …

That contribute to the progress of medical practice …

And that improve the patient’s quality of life …

With manufacturing and distribution partners (license partners) worldwide …

Europe, North America, … Japan !!

Company mission and business model

Miniaturized multi-mode IV infusion pump

Multi-dosing CT contrast media injector

MEMS-based insulin infusion pump with blood glucose meter

Device system for (home) peritoneal dialysis

Device system for home hemodialysis

Other …

Drug delivery devices and fluid management devices

Debiotech and Japan : our common grounds

We search for : high tech components and materials Miniaturized

High quality and suitable for medical device applications

E.g., motors and piezoceramics

Japan has long and strong technology tradition

We search for : high tech manufacturing partners Japanese manufacturing is world class

Japanese quality is world class

We search for : Japanese license partners for Debiotech developed devices a Japanese company to market the devices in Japan

not an extension of worldwide license agreement with a non-Japanese partner

Debiotech and Japan : our common grounds

We offer : innovative technologies For medical applications

For non-medical applications

Japan loves innovation

We offer : innovative medical devices For hospital use and for home use

High quality (safe, reliable, effective)

User friendly

Japan has a need for such medical devices

We offer : willing to invest in long term relationships We support the total product life cycle

After an initial success, we like to build a new success with you

Relationships in Japan are for the long term

Debiotech and Japan : common accomplishments

Debiotech’s IV Exprès multi-mode infusion pump RoW : distributed by Kimal (UK-based company) as «IVantage» In Japan : distributed by JMS (Japan Medical Supplies) as «i-Fusor» Noteworthy : first generation of pumps contained Japanese motor («critical component») from renowned Japanese electronics manufacturer

Debiotech and Japan : common accomplishments

JMS own successor : i-Fusor Plus

Debiotech and Japan : common accomplishments

• Successful product line for JMS in Japan

• Result of excellent, longterm collaboration – Japanese expectations for high quality devices

– communications via videoconference, phone, e-mail (responsiveness)

– face-to-face meetings (visits)

– training of JMS engineers and service technicians by Debiotech

– etc.

• Medical device registration obtained by JMS in their own name – Debiotech supporting the registration process

– fair and timely

– based on international standards (IEC, ISO) as applicable to Japan

– plus a few issues more specific to Japan

Collaboration with high tech manufacturing partner Our first collaboration (early 1990s)

Non-medical devices manufacturer seeking to enter the medical devices market

Development and manufacture of disposable infusion pump based on innovative technology

Up to and including clinical investigations (in Europe)

We brought them new technology

They impressed us by their commitment and their quality

Debiotech and Japan : common accomplishments

Debiotech and Japan : common accomplishments

Other collaborations

• We enjoyed other collaborations with Japanese manufacturers of medical devices ….

• … but not all lead to a product on the Japanese market

Our assessment of common grounds

• High technology to serve society – high tech can come from Japan or Switzerland

– miniaturization

– materials

• Quality driven – Japanese quality and Swiss quality

• Long term relationship driven – Stability, commitment, and trust

– Long life cycles of medical devices

• Accessible for Small and Medium Sized Companies

On a personal note

• First visited Japan in August 1991 …

• «Made in Japan» and «Created in Japan»

On a personal note

Akio Morita «Made in Japan» (1986) Sheridan Tatsuno «Created in Japan» (1990)

On a personal note

On a personal note

On a personal note

• Ever since … an admirer of Japan …

• A privilige to have had the opportunity to work with them …

• And hope to work with them for many years to come !