Medical and Diagnostic Devices

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  • We have developed expertise in the medical devices industry which derives from our deep understanding of, and long track record in, the pharmaceuticals and healthcare sectors, and from the experience of our specialists in the corporate, commercial, IP and litigation practice groups. We advise on all matters relating to this industry, including development consultancy; licensing and partnering; regulatory issues; enforcement, defence and challenges of intellectual property; filing and prosecution of patents; manufacturing and distribution; antitrust and competition; and litigation.

     

    Our team has unrivalled expertise advising medical device developers and manufacturers, ranging from large international concerns to start-ups, on the full spectrum of legal and commercial issues relating to the industry. Our expertise spans the whole technological cycle of a medical device company, ranging from research and development to financing and from regulatory to marketing. We are one of the few firms in Israel that can offer medical device companies, as well as their financiers, a one-stop shop that addresses the issues they face during the entire life span of medical devices, including:

     

    • Ownership and royalty entitlements regarding underlying rights in respect of medical devices
    • Advising on regulatory issues arising from the testing, registration, marketing and commercialization of medical devices in Israel; we regularly act for clients on complex product registrations and clearances involving the Israel Ministry of Health
    • Regulatory matters relating to safety with respect to product recalls and adverse events
    • Product liability claims (including defending against individual and class action claims)
    • Protection, licensing and commercial exploitation of medical device technology
    • Distribution and manufacturing, anti-trust and competition, brand protection, exploitation
    • Conducting legal due diligence of medical device companies
    • Acting for founders, investors and funds on the formation, investment, operation and eventual sale of medical device companies

     

    • Representing Teva, the world’s largest manufacturer of generic medicines, listed for trading on both NASDAQ and the Tel Aviv Stock Exchange, in the enforcement of its patents in the medical device sector
    • Representing Neusoft Group Ltd. (China’s largest IT and software company) on its acquisition of a controlling interest in Aerotel Medical Systems Ltd., a leading medical device company which designs and manufactures digital patient monitoring systems
    • Representing Spectranetics Corporation, a world leading manufacturer and supplier of medical equipment for use in minimally invasive interventional procedures, in its acquisition of Upstream Technologies Ltd., an Israeli company which specialises in developing new technologies for the manufacturing of medical equipment
    • Representing the Manufacturers Association of Israel in discussions with the Ministry of Health and in connection with the drafting of Israel’s new law on the registration of medical devices
    • Representing Amtac Certification Services Ltd., a UK Notified Body under the EC Medical Devices Directive, against a third party notice filed against it by the Israel Standards Institute for allegedly issuing CE Standard certification for a substandard transfusion pump.  A settlement was negotiated within eight months of the filing, providing the client with a waiver form against any further suit with respect to the faulty products and a substantially lower payout than anticipated by the plaintiff
    • Representing Photothera Inc., a California-based company, which develops medical devices for the treatment of strokes, in multi-jurisdictional litigation in Israel and California (the latter in cooperation with local counsel
    • Representing Medial Cancer Screening Ltd., a medical device and analytics start up:

     

    (i) on a US$ 15 million (based on a company pre-money valuation of US$80 million), Series A Preferred round financing made by the Chinese VC fund Horizon Ventures;

    (ii) on a US$ 5 million Series B Preferred round financing; and

    (iii) on all the company's day-to-day corporate and commercial legal requirements

     

    • Representing Worthy Venture Resources LLC on its Series D Preferred investment in EarlySense Ltd., a medical-device company which developed a patient monitoring system

Practice Contacts