This paper discusses some considerations for European medical device companies wishing to make their first step into the US marketplace. Advantages and disadvantages of various corporative structures are presented, and the American legal environment and its implications are discussed in some detail. Operational and marketing considerations are considered in some depth, and financial and tax consequences briefly. Preferred options are suggested for the smaller company to whom this discussion is directed.
SeningerS.HerlingD. (2005). Health care costs. Montana Business Quarterly, 42(1), 23–26.
2.
AnastD.G. (2001). Marketing and regulatory requirements in some emerging medical device markets, International Journal of Medical Marketing, 2(1), 13–17.
3.
SmithB. (2000). Lessons for CEOs from the consolidation of the medical device and diagnostic industries, International Journal of Medical Marketing, 1(2), 148–160.
4.
AtunR.ShahS.BosanquatN. (2002). The medical devices sector: Coming out of the shadow. European Business Journal, 14(2), 63–74.
5.
MilmoS. (2005). Strong Euro is manageable for now. Chemical Market Reporter, 267(3), 6–7.
6.
SchmittJ.M. (2002). Innovative medical technologies help ensure improved patient care and cost-effectiveness. International Journal of Medical Marketing, 2(2), 174–179.
DaddinoM. (2001). The prognosis for medical equipment. Area Development Site and Facilities Planning, 36(5), 24–32.
10.
FriesR.C. (1998). The FDA, in FriesR.C. (ed.) Medical Device Quality Assurance and Regulatory Compliance, Marcel Dekker, Inc., New York, NY.
11.
de JongM.G.DuijstP. (1997). Clinical Regulatory Environment, in PieterseH.de JongM.G.DuijstP. (eds.) International Medical Device Clinical Investigations: A Practical Approach, Interpharm Press Inc., Buffalo Grove, IL.
12.
BradleyD.B.LuyetE. (2004). Entrepreneurial Requirements for Legal Forms of Business, Presentation at the 2004 National Small Business Entrepreneurship and Small Business Educators Conference, Clearwater, Florida, February 12–14.
13.
Medtronic v. Lohr, 318 US 470, 135 L. Ed.2d 700, 116 S. Ct. 2240 (1996).
14.
Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1999 US App. LEXIS 2507 (11th Cir. Fla. 1999).
15.
Steele v. Depuy Orthopaedics, Inc., 295 F. Supp.2d 439, 2003 US Dist. LEXIS 211155 (D.NJ. 2003).
16.
Gilleon v. Medtronic USA, Inc., 2002 US Dist. LEXIS 20154 (N.D. Cal. Aug. 28, 2002).
17.
Tydings & Rosenberg, L.L.P. (2000). Circuits split over federal preemption of state claims against medical device manufacturers, FindLaw for Legal Professionals.http://library.findlaw.com/2000/Feb/1/128333.html. Accessed 8 July 2005.
18.
Liebeck V McDonald's Restaurants, P.T.S. Inc., No. CV-93-02419, 1995 WL 360309 (N.M. Dist. Aug. 18, 1994).
19.
PittaD.A.FungH.-G.IsbergS. (1999). Ethical issues across cultures: Managing the differing perspectives of China and the USA. Journal of Consumer Marketing, 16(3), 240–256.
KnauppB.D. (2004). Guide to US taxation of international business entities, transactions, and persons, http://www.Knaupplaw.com/taxguide2.htm. Accessed 12 July 2005.
23.
SchnollL. (2001). Corrective and preventive action in medical device manufacturing. Quality Progress, 34(11), 75–80.
