1. Biomedical Implants & Devices
Lecture *****: Invention & Regulation
3rd lecture in Need to remove IP material due to Adrain Hockney’s talk
SESM6036 Biomedical Implants and Devices
Prof. Neil W. Bressloff

2. Invention & regulation
What is the approximate value of the medical devices industry in the EU?
How many employees are there in the medical devices industry in the EU?
Please use the dd month yyyy format for the date for example 11 January The main title can be one or two lines long.

3. Overview Invention Novelty and “not obvious” Regulation
Safety of implants and devices

4. Intellectual property
Invention
A new device, method, or process developed from study and experimentation.
A new process, machine, improvement, etc., that is recognized as the product of some unique intuition or genius.
Innovation
Something newly introduced, such as a new method or device.
Intellectual property
Ownership of an invention, idea or method.
An invention can be protected through the patenting process such that the intellectual property owner can benefit from exploitation of the invention.

5. EU product rules Open and look through contents

6. EC legislation for medical devices

7. EC legislation for medical devices

8. EC legislation for medical devices
See Annex 1 starting on P15: Essential requirements.
Follow directive 90/385 and then Annex 1 point 9

9. Medical devices and in vitro diagnostic medical devices
See page 6. The medical device and in vitro diagnostic medical devices sectors — key drivers for the European Union’s economic growth.
Go to page 6 (summary on next slide) Papers\MedDev_com_2012_540_revision_en.pdf

10. Medical devices and in vitro diagnostic medical devices
Approximately 500,000 medical devices in the European Union
Approximately 500,000 employees in 25,000 companies
The majority of companies are SME or micro-enterprises (<10 employees)
Valued at over £100 billion in 2009 (approximately £10 billion in the UK)
Nearly 10% of profits invested in R&D “…usually through collaboration with healthcare professionals and academia, in order to better identify and respond to emerging medical needs.”
“Innovation in medical devices and in vitro diagnostic medical devices has gained pace in recent years. Scientific and technological progress, such as progress in drug-device combination products, tissue engineering, information and communication technologies (ICT), nano-science, personalised medicine and genetics, are creating new opportunities or improving healthcare and could culminate in a revolution in how healthcare services are delivered.”

11. Borderline medical devices
See page 22. Section 3.1
Bone anchored hearing aids.
Go to section 3.1 (and consider cochlear implant device)

12. CE (Conformité Européenne) marking

13. CE marking The CE marking is required for many products and it:
shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
is a key indicator of a product’s compliance with EU legislation
allows the free movement of products within the European market
By placing 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. The manufacturer is thus ensuring validity for that product to be sold throughout the EEA. This also applies to products made in third countries which are sold in the EEA and Turkey.
Not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked.
CE marking does not mean that a product was made in the EEA, but states that the product is assessed before being placed on the market. It means the product satisfies the legislative requirements to be sold there. It means that the manufacturer has checked that the product complies with all relevant essential requirements, for example health and safety requirements.

14. CE marking If you are a manufacturer it is your responsibility to:
carry out the conformity assessment
set up the technical file
issue the EC Declaration of Conformity (DoC)
place CE marking on a product
If you are a distributor you must check the presence of both the CE marking and the necessary supporting documentation.
If you are importing a product that is from a third country you have to check that the manufacturer outside the EU has undertaken the necessary steps. You must check that the documentation is available.

15. CE marking See page 4. Six steps to CE marking.
Click on image to open local copy. Go to page 5 and show the 6 steps.

16. Six steps to CE marking
STEP 1 - Identify the directive(s) and harmonised standards applicable to the product
STEP 2 - Verify the product-specific requirements
STEP 3 – Identify whether an independent conformity assessment is required from a Notified body
STEP 4 – Test the product and check its conformity
STEP 5 – Draw up and keep available the required technical documentation
STEP 6 – Affixation of the CE marking to your product and EC Declaration of Conformity

17. MHRA

18. The MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates a wide range of materials from medicines and medical devices to blood and therapeutic products/services that are derived from tissue engineering.
The main difference between how medicines and medical devices are regulated lies in how a product gets onto the market.
All medicines are directly approved by the MHRA which issues a 'marketing  authorisation', or licence.
Manufacturers and distributors are also licensed directly by MHRA.
Medical devices are approved by private sector organisations called 'notified bodies'.
Their approval is needed before a CE mark can be put on the device, though the manufacture of low risk devices is simply registered with the MHRA.
The MHRA audits the performance of notified bodies.

19. Device classification
Medical devices may be classified as Class I,  IIa, IIb or III, with Class III covering the highest risk products.
Medium and high risk devices require the use of a notified body to carry out a compliance assessment before manufacturers can place their products on the market.
Typical activities that can be undertaken by a notified body include:
Full quality assurance – The notified body will carry out an assessment of the manufacturer's quality system, including design. They will sample across the range of products and processes to ensure that the requirements are being met.
Examination of the design - The notified body will assess the full design dossier relating to each type of product to ensure that they meet the requirements.
Type examination - The notified body will assess the full technical information relating to each type of product and carry out appropriate testing of a representative sample of production to ensure that it meets the requirements.
Verification - The notified body will either test every unit or every batch of product to ensure that they are meeting the requirements before the manufacturer can place them onto the market.

20. BSI Healthcare (notified body)

21. MHRA Devices industry

22. U.S. Food and Drug Administration(FDA)
See the recent device approvals
Go to 2014 Device approvals: Highlight Medtronic, De Puy and cochlear implant device

23. Recalls! Check out the Cook CloverSnare in Medical Device Safety
Look at the Cook CloverSnare in Medical Device Safety
Check out the Cook CloverSnare in Medical Device Safety

24. From invention to regulatory approval: stent design example
The Arterius Biodegradable Scaffold
Q3 2009: invention in The Cowherds!
Q4 2009: first study for Arterius Ltd
April 2011: initial filing & prototype 1
April 2012: PCT filing
April 2014: worldwide publication
April 2014: prototype 5
Q3 2014: pre-clinical trial
Q3 2015: prototype 6
H1 2016: pre-clinical trial?
H2 2016: first in man trial?
H2 2016: CE marking?

25. Protection of intellectual property: the patent process
Ensure, as far as possible that your invention is novel and “not obvious”
File a UK patent and request a search for prior art by the UK patent office.
After one year, apply for a PCT (patent co-operation treaty) protection plus additional search of the prior art.
After approximately three years, decide whether to apply to patent offices in individual countries.
Note: without a patent, a company may struggle to offer itself in a trade sale at a stage when its market value may be attractive to the original and early stage investors.
The UK Intellectual Property Office
The United States Patent and Trademark Office

26. Learning outcomes You need to have knowledge about the following.
The difference between invention and innovation.
How medical devices are classified.
How to obtain regulatory approval for a medical device.
The steps needed to obtain regulatory approval.
What is the role of a notified body?
Distinguish between CE mark and FDA approval.
How is the medical device industry regulated in the UK?
Understand why protection of intellectual property is important.
The patent process.