June 17, 2013

Stryker SWOT

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

Medical Device Markets

from Kruger and Kruger p. 382pp

Medical Device Market (2009 worldwide revenues in $USm)

  Revenues Growth Rate in %
Orthopedics 33.9 4.8
Cardiovascular 28.0 4.5
Opthalmology 10.5 3.0
General surgery 8.3 4.5
Diabetes care 7.6 -1.4
Neurological products 3.2 10.9
Urology 1.2 8.0
Subtotal 92.7 4.2

Orthopaedic product details 2009 revenue (Stryker Fact Book)

  Revenue Growth Rate in %
Spine 6.9 11.3
Extremities and bone cement 1.1 10.0
Hemophilic arthropathy 1.1 10.0
Biologics 2.9 7.4
Trauma 5.4 5.9
Hips 5.5 1.9
Knees 6.6 1.5
Operating Rooms Equipment 3.3 0.0
Arthroscopy 2.8 -6.7
Other 1.4 7.7
Total 37.0 4.2

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 %
J&J 53
Medtronic Inc. 38
Boston Scientific 43
Covidien 42
Becton Dickinson 55
Baxter 58
Stryker 36

Sources and Consumption of medical products (AdvaMed, Lewin Group)

in 2009, in $US billion




Outside US



in mio

Consumption per

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
Total 133.7 101.9 234.6 6,810 $ 34

Product Registration

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.

March 28, 2013

Medical Device Sales in middle–income Countries 2009


Top 30 MD Manufacturers 2008


from: Kruger and Kruger - The medical device sector (p. 377 in The Business of Healthcare Innovation, edited by Lawton Burns)

Revenue 1995 2000 2005 2009
Medical Devices 57.8 85.0 125.4 145.9
Hospital supplies commodities 54.8 67.6 80.3 88.7
Total 112.6
152.6 205.7 234.6


Standards can serve different purposes. They can:
1. Provide reference criteria that a product, process or service must meet.
2. Provide information that enhances safety, reliability and performance of products, processes and services.
3. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace.
4. Give consumers more choice by allowing one firm’s products to be substituted for, or combined with, those of another.

Figure: Process for Standard development


In general, good standards have the following attributes:
1. Their development has been overseen by a recognized body, thus ensuring that the process is transparent and not dominated by vested interests.
2. The development process has been open to input from all interested parties and the resulting document based on consensus. Consensus, in a practical sense, means that significant agreement among the stakeholders is reached in the preparation of the standard, including steps taken to resolve all objections. This process implies more than the votes of a majority, but not necessarily unanimity.
3. Good technical standards are based on consolidated results of science, technology and experience, and are aimed at the promotion o optimum community benefits.
4. Standards do not hinder innovations and must be periodically reviewed to remain in tune with technological advances.

From : http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf

Global Overview of Medical Device Regulatory Agencies


Source: http://gamapserver.who.int/mapLibrary/Files/Maps/Global_DIM_Indicator3_20110211.PNG

WHO – Baseline country survey on medical devices


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