Deavin Associates March 2014 1 · The device category is the broadest level of the GMDN data. It...

Deavin Associates March 2014 1

What is Medical Technology?

The Medical Device Industry- EU and Global

The Classification of Medical Devices in EU

Factors in the naming of Medical Devices

◦ GMDN

◦ UMDNS

Current Regulation of Medical Devices –EU

High Profile Safety Issues

Future Regulation of Medical Devices in the EU

Regulation of Medical Devices in the US and Global

Future trends in Medical Device Technology


A technology that diagnoses ,monitors, and treats virtually every disease that affects us.

It includes familiar objects such as plasters, syringes, latex gloves, or spectacles/contact lenses, wheelchairs, hearing aids, whole body scanners, heart valves, replacement knees hips and breasts, and includes in vitro diagnostic medical devices.

Medical devices improve the quality of care and sustainability of healthcare systems.


Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings.”

"Devices are to be used for the purpose of:

Diagnosis, prevention, monitoring, treatment or alleviation of disease

Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap

Investigation, replacement or modification of the anatomy or of a physiological process

Control of conception

This includes devices that do not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”


Europe

Medical Devices: Market size €100 billion and 4% growth per annum

Pharmaceuticals: Market value retail prices €238 billion(€128 billion reimbursement value) and 1.5% growth per annum

US Medical Devices: Market value $120 billion

and 6% growth per annum Pharmaceuticals: Market value $420 billion

and 4% growth per annum



Top technical fields in patent applications. Number of patent applications filed with EPO, 20122

Medical technology 10.412

Electrical machinery, apparatus, energy 9.799

Digital communication 9.592

Computer technology 8.288 Transport 6.633

Measurement 6.428 Organic fine chemistry 6.002

Engines, pumps, turbines 5.668 Pharmaceuticals 5.364

Biotechnology 5.309

Distribution of health technology fields by patent applications filed with EPO, 2012 Pharmaceuticals

5,309

5,364

10,412 38%

5,309

5,364

10,412 38% 62%

Pharmaceuticals

Biotechnology

Applications

filed from EU28, Norway and Switzerland

Medical technology


Based upon manufacturer prices the European medical technology market* is estimated to comprise around 30%9 of the

world market. It is the second largest medical technology market after US (40%9).

World medical technology market*

by region, based upon manufacturer prices, 20129

European medical technology market*

by region, based upon manufacturer prices, 20129

12%

39%

Germany 14%

2% 2%

2%

5%

10%

28%

US

Europe

Japan

China

Russia

Canada

Brazil

Other

3%

3%

3%

4%

4%

5%

10%

11%

27%

16%

France

United Kingdom

Italy

Spain

Netherlands

Switzerland

Sweden

Belgium

Austria

Other


Breakdown of total healthcare expenditure in Europe13

17%

0.8%

Inpatient & outpatient care, other

Phamaceuticals & other medical non-durables

75.5%

7.5%

6.7%

Medical technology

Medical devices (incl. imaging)

In vitro diagnostics

US approx 525000 people

Europe > 575000 people ◦ Germany has largest share of total employment

◦ Switzerland has highest number per capita

European Pharma industry has 675000 employees



Companies in Europe

Companies in Europe

There are almost 25,000 medical technology

companies in Europe. Most of them are based

in Germany, followed by the UK, Italy,

Switzerland, Spain and France. Small and

medium-sized companies (SMEs*) make up

almost 95% of the medical technology

industry, the majority of which employ less

than 50 people (small and micro-sized

companies).6

95% SMEs

There are more than 500,000 technologies in 20,000 generic groups as defined by the Global Medical Device Nomenclature (GMDN)Agency


• Annex IX of Directive

• Definitions I

• Implementing rules II

• Classification rules III

- 18 rules

- More than one may apply

- Highest classification if several rules apply


Non Invasive Devices Rules 1-4

Invasive Devices 5-8

Active Devices 9-12

Special Rules13-18



Low risk

High risk

Global Medical Device Nomenclature (GMDN)

The GMDN is a system, as defined in the ISO 15225 standard, having a general structure of three levels. Each level differs in the breadth of the sets of devices represented by the terms defined within that level. The levels have a relational structure in the following order:

Device Category

Generic Device Group

Device Type



GMDN is mandated by the EC to provide tools to meet the obligations required by the Medical Devices Directive:- • to give a common generic description for every general

term that describes characteristics of a medical device. • to identify a device, using the generic term • to serve as a basis for E-commerce • UDI : Global Medical Device Nomenclature (GMDN)

preferred code/term (valid at the time of the UDI submission);


Device Category The device category is the broadest level of the GMDN data. It divides the entire medical device product market into highest-level groups based on device application, technology, or other common characteristics. The standard(ISO 15225) allocates codes for 20 categories. These are: Category Description 01 Active implantable devices 02 Anaesthetic and respiratory devices 03 Dental devices 04 Electro mechanical medical devices 05 Hospital hardware 06 In vitro diagnostic devices 07 Non-active implantable devices 08 Ophthalmic and optical devices 09 Reusable devices 10 Single use devices 11 Assistive products for persons with disability 12 Diagnostic and therapeutic radiation devices 13 Complementary therapy devices 14 Biological-derived devices 15 Healthcare facility products and adaptations 16 Laboratory equipment

Universal Medical Device Nomenclature System (UMDNS)

a standard international nomenclature and computer coding system for medical devices. It contains medical device concepts and definitions and 25000 terms to facilitate classifying of biomedical information.

UMDNS includes relationships among related devices (i.e. component devices versus the overall system). The US National Library of Medicine has

incorporated UMDNS into the Unified Medical Language System (UMLS).


Manufacturers should avoid names that

Are confusingly similar to other device names

Imply unique effectiveness

Overstate device efficacy

Minimize associated risks

Broaden intended use

Make unsubstantiated superiority claims


A manufacturer ("Manufacturer B") contracts with a manufacturer ("Manufacturer A") already in possession of CE marking to brand the medical devices as its own. This permits identical medical devices to be placed on the market under different manufacturers.

Manufacturer B has been called Own Brand Labeller (OBL), Private Brand Labeller (PBL) or Private Label Manufacturer (PLM).

Manufacturer A could be an Original Equipment Manufacturer (OEM), Original Equipment Supplier (OES) or an "actual manufacturer.“

When any of the manufacturer’s responsibilities are subcontracted to another person, contractual arrangements should ensure that the obligations of the regulations are met.


a manufacturer or product name change requires modifications to the product labelling and regulatory re-registrations, which are increasingly complex especially with the introduction of Unique Device identification(UDI)

in the EU, the manufacturer information on the label must match the manufacturer information listed on the CE certificate and the Declaration of Conformity.


DePuy Pinnacle® Hips have a unique feature “True Glide” which allows a patient’s body to generate a thin film of lubrication between the surfaces of a replacement hip to enable a more fluid range of natural motion

Stryker ®talks about” Personalised Hip Solutions” that are “designed for your unique anatomy.

“Synvisc-One” ® from Genzyme is the only single-injection treatment that can provide up to 6-months of OA knee pain relief.” No other competitor can make that claim – at least for now.

A blind survey among cardiologists and electrophysiologists in the US proved that the Medtronic brand of pacemaker is deeply ingrained. When asked what they would choose if they had to

implant a pacemaker, 75 percent said Medtronic."


Zimmer® Knee Solutions

Zimmer® offers surgeons a comprehensive suite of innovative knee products:-

Zimmer® Persona™ Knee -the personalised knee system

Chondrofix® Osteochondral Allograft

Zimmer® Universal Power Systems


EU Based on the New Approach, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s.

The core legal framework consists of 3 directives: -

Directive 90/385/EEC regarding active implantable medical devices

Directive 93/42/EEC regarding medical devices

Directive 98/79/EC regarding in vitro diagnostic medical devices.

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC


The New Approach

Competent authorities

Notified bodies

Essential requirements

Those things manufacturer must do to comply with legislation

Standards


In order to CE mark a device, a manufacturer must

demonstrate that the device complies with the

relevant essential requirements.



CE marking is a key indicator of a product’s compliance with EU legislation. It enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the EEA, the 27 member states of the EU and European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. This also applies to products made in third countries which are sold in the EEA and Turkey.

Product Control

Class Certified GMP + Dossier


III

II

I

Registration of persons responsible for placing devices on the market (Article 14)

Manufacturer is CE mark holder

Manufacturer informs Competent Authority of address of registered place of business and devices sold in Europe

If no office in Europe designate an Authorised Representative. This person informs Competent Authority as above


Classification and general description of the device

Risk analysis List of applicable Harmonised Standards, or

other standards used to satisfy ERs EC Declaration of Conformity Design specifications and verification records Quality plan Data on any incorporated medicinal substance Clinical data – evaluation/investigation Labelling and instructions for use Post market vigilance plan



Wednesday 14 December 2011 20.46 GMT

France's faulty breast implants scandal More than 30,000 women have had breast implants filled with industrial silicone instead of medical-grade fillers

http://www.theguardian.com/uk

PIP Implant scandal Medical problems arise when breast implants rupture and cause inflammation and irritation. Further, impure gel may also release toxic substances. Removing implants "carries risks in itself", says the French government. By the end of 2011, eight cases of breast tumours had been uncovered in women after removing the implants, yet, while of concern, according to the Regulatory Authorities, there is no evidence of any increased cancer risk

Metal on Metal Hip Implants(DePuy ASR hip replacement) The concern is that as the hip replacements wear down, metal particles can be released from the artificial hip, react with the soft tissue (such as muscle and ligaments) surrounding the joint and enter the bloodstream.

Implantable defibrillator leads Defibrillators automatically monitor and administer shocks to the heart, and a malfunction can cause the device to fire unexpectedly, or fail to fire when a patient's life depends on it. Over the past decade, the heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients.


On 26 September 2012, the European Commission adopted a package on innovation in health consisting of:- ◦ The Communication on safe ,effective and innovative

medical devices and in vitro diagnostic medial devices for

the benefit of consumers and healthcare professionals

◦ the Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

◦ the Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices.


The need for a safe, transparent and sustainable legislation

The need to restore patients', consumers' and healthcare professionals' confidence

The necessity to adapt to a global market


FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating companies who manufacture, repackage, re-label and/or import medical devices sold in the United States.

CDRH also regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and colour televisions.

Basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

◦ Establishment registration

◦ Medical Device Listing

◦ Premarket notification 510k unless exempt, or Premarket Approval (PMA)

◦ Investigational; Device exemption (IDE) for clinical studies,

◦ Quality System (QS) regulation,

◦ Labelling Requirements

◦ Medical Device reporting (MDR)


(IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.


Some dramatic changes will occur in the areas of personalized medicine, implantable devices and optical techniques

Within the next two decades, a significant part of the world’s population will have the ability to monitor their own health using diagnostic devices that contain imaging- and non-imaging modalities.

Every implantable device 20 years from now will use electronics to provide non-invasive assessment.

Cell biology will be used to prevent the body from rejecting sensors as foreign objects. Biomaterial-compatible devices will become essential for all implantable devices.

Spectroscopy will become widespread over the next 20 years for early detection of rectal polyps.

No look into future medical trends is complete without a discussion of stem cell therapies, which will become commonplace in the next 20 years.


Thank you for your attention!

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