All entries for March 2013
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.
March 28, 2013
from: Kruger and Kruger - The medical device sector (p. 377 in The Business of Healthcare Innovation, edited by Lawton Burns)
|Hospital supplies commodities||54.8||67.6||80.3||88.7|
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