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June 17, 2013
Stryker Corporation SWOT, published December 1, 2012 - http://encore.lib.warwick.ac.uk:50080/ebsco-web/bsi/pdfviewer/pdfviewer?sid=ea861aed-a3eb-494d-8e32-1f3b55f4d3a8%40sessionmgr111&vid=2&hid=119
Geographic concentration exposing business to dependency risks
Stryker’s dependency on the matured US market could make its business and operations vulnerable to country-specific trends.Although, the company has its presence in Europe and other regions of the world, it depends heavily on its domestic market for most of its revenues (63.4% of total revenues from the US).Such geographic concentration increases the risk that, should any adverse economic, regulatory, environmental or other developments occur in the US, the company's business and financial condition will be materially affected. Stryker may be substantially affected by the political or cultural changes that occur due to the geographical concentration in only one region.
March 29, 2013
from Kruger and Kruger p. 382pp
Medical Device Market (2009 worldwide revenues in $USm)
|Revenues||Growth Rate in %|
Orthopaedic product details 2009 revenue (Stryker Fact Book)
|Revenue||Growth Rate in %|
|Extremities and bone cement||1.1||10.0|
|Operating Rooms Equipment||3.3||0.0|
According to the FDA there are more than 20,000 companies registered as medical device manufacturers worldwide. However the majority of these companies have annual revenues of less than $5m dollars.
The top 10 manufacturers in 2009 had collective revenues of $90.6 billion representing roughly 62% of worldwide product revenues.
56% of worldwide medical devices consumed on a worldwide basis is produced by american companies.
47% of the revenues of the major US device manufacturers is derrived from oversea markets.
|in 2009||Oversea Mix in %|
Sources and Consumption of medical products (AdvaMed, Lewin Group)
|in 2009, in $US billion||
captia per year
|Consumed US||81.4||8.1||89.5||307||$ 292|
|Consumed Outside US||52.3||93.8||146.1||6,503||$ 22|
Source: Global Harmonization Task Force - Study Group 1 ghtf_sg1_registration.pdf
Registration of Manufacturers and other Parties and Listing of Medical Devices - GHTF/SG1/N065:2010
Registration: the process by which a party submits information to the Regulatory Authority in a jurisdiction, regarding the identification and establishment location(s) of the manufacturer and other parties, responsible for supplying a medical device(s) to the market in that jurisdiction.
- Registration provides information on the parties that are or will be, supplying medical devices to the market that is within the RA’s jurisdiction.
- The RA should identify unambiguously which parties are required to provide it with registration information.
- Providing registration information to the RA does not remove from that party (i.e. the registering party) its obligation to comply fully with other regulatory requirements that apply to it within the jurisdiction.
- Medical device manufacturers, authorised representatives, importers and distributors may be subject to registration requirements.
For the purposes of registration, and irrespective of device classification, each registering party should submit the following infor mation to the RA:
1. An indication of whether the registering party is a manufacturer, an authorised representative, an importer or a distributor of medical devices supplied to the market of the jurisdiction where the information is being collected. Some registering parties will fall into more than one of these categories.
2. Name and contact details of the place of business of the registering party, together with the name and post held of the person within that organisation responsible for the registration.
3. Where the registering party has contracted another party to complete the registration process on its behalf, the name and contact details of the place of business of that other party, together with the name and post held of the person providing the required information.
4. An indication that the information provided is either a new entry or an update of previously submitted information. If the second situation applies, the registration code previously allocated to the registered party should be provided.
5. The date when the information is submitted.