AusMedtech Conference 2009

Brandwood Biomedical is a proud sponsor of the upcoming 2009 AusMedtech National Medical Technology Conference, to be held on the 15th and 16th June in Sydney.  We would like to highlight some specific sessions being featured by this premier national event for medical devices and diagnostics.

A Comprehensive Approach to Clinical Evaluation

Brandwood Biomedical is the sponsor for this devices regulatory affairs session which focuses on an integrated approach to clinical trials that includes initial regulatory approval, cost effectiveness assessments to support reimbursement and market acceptance. Three first class speakers will present:

Dr Peter Havel, TUV SUD Japan Ltd will describe the recent revisions to the EC Medical Device Directives (MDD) which considerably strengthened the requirements for clinical evaluation of medical devices.

Dr Jonathan Sackier, President, Paradigm Shift Healthcare Consulting, will describe the current US reimbursement environment and the importance of well framed clinical studies to support reimbursement.

Dr Martin Devitt, Medical Director, Perficio Clinical & Regulatory was previously Medical Director at Cook and Chief Medical Officer for Devices at TGA. He brings a wealth of experience in designing clinical trials to support all of the phases of product development from initial regulatory approval through to market acceptance by the clinical users.

In Vitro Diagnostics

This dedicated session on IVDs will feature an update from TGA on implementation of the new regulations and takes a look at the challenges of getting IVDs to market, in particular asking the question “is the real value of IVDs in health economics truly recognized?”

Chair: Caroline Beasley, Engagement Manager in Commercial Effectiveness, IMS Health

Speakers:

Dr Rob Danby, Manager IVD, Biomedical Instruments & Devices

Dr Jenny Harry, Managing Director, Tyrian Diagnostics

Dr Andrew Campitelli, Manager Diagnostics, MiniFab

Want to talk? Just drop by our stand at the conference exhibition where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.

The full program for the conference can be found here.

ARCS (Association of Regulatory and Clinical Scientists) 18th Annual Scientific Congress 2009

Brandwood Biomedical will be exhibiting at this premier event to be held at the Sydney Convention and Exhibition Centre, June 1st-3rd 2009.

The ARCS conference will address the most pressing regulatory issues facing manufacturers of therapeutic goods today, these include post market surveillance in the new Australian regulatory environment and manufacturing process changes for biotech products.  Visit the Brandwood Biomedical team at Booth Number 66 or contact us to arrange a specific meeting.

Click here for more information and to register.

New TGA IVD Regulatory Framework by years end

TGA is proceeding with implementation of the new regulatory framework for IVDs. This will bring about an end to the widespread current exemptions for regulation of IVDs with the introduction of a four tier classification system and co-regulatory arrangement with NATA for oversight of in-house tests offered by single laboratories. The regulations are in a broad sense on par with the European IVD framework terms, but of course, the devil is always in the detail. Visit our blog for more details a comparison between the two systems.

AdvaMed reveals proposal for improved U.S regulation of IVDs

US Industry association AdvaMed has set forth a proposal to the FDA to update the regulation of in vitro diagnostics (IVDs) and lab-developed tests (LDTs). The proposed risk-based strategy recommends applying the same regulations to all diagnostics, regardless of location of manufacture.

The proposal details a number of recommendations including:

data submission requirements for pre-market approval to be determined from the level of risk of a diagnostic

test for rare diseases or test used very rarely should not be subject to premarket submission, instead requiring more intense adherence to the Clinical lab Improvements Act (CLIA) and adverse event reporting

exemption of well standardised and low risk tests from premarket review

A risk-based tier system has also been proposed, to be used along with the existing classification system for IVDs, to determine the depth of pre-market review required for certain diagnostics. AdvaMed plan to submit a separate proposal for the necessary criteria of IVDs for exemption from pre-market submission requirements.

The proposal has been put together with continuous consultation with the FDA and further discussions are on the agenda. The proposal can be viewed here.

ASEAN on track with Harmonisation of Medical Device & IVD Regulations

The Association of Southeast Asian Nations (ASEAN) is making moves to harmonise medical device and IVD regulations in all its member states, which include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.

ASEAN is an organisation dedicated to advancing the economic development and competitiveness in South East Asia by developing a free trade area for local manufacturers and harmonising industry regulations, comparable to the set up in Europe with the European Community (EC).

Because healthcare integration remains a top priority for ASEAN, the Medical Device Product Working Group (MDPWG) was established in 2004 to develop a harmonised Medical Device and IVD regulatory framework for the ten ASEAN nations. This regulation is known as the ASEAN Medical Device Directive (AMDD) and is closely modelled on the Global Harmonisation Task Force (GHTF) recommendations. Although yet to be finalised, it is planned that the Directive will be implemented by most members by 2010 and in all member nations by 2015.

For medical device manufacturers, this means that regulation in the Southeast Asian market promises to become more closely aligned with the global GHTF model. On the one hand the process will be potentially simpler and streamlined, as product approval for all ASEAN countries can be obtained with a common submission dossier. However, the reality may be an increase in the level of regulation as the existing arrangements are upgraded to a comprehensive GHTF style regulation. Leading the way in ASEAN is Singapore, which is in the late stages of implementing a fully harmonised regulatory system. Singapore will require full conformity assessment of higher risk products with attendant substantial fees and projected 210 day review cycles.

Need advice on how to enter the Southeast Asian market? Contact us to discuss your needs.

Australian Third Party Assessment back on the Table...

At the end of last year, the TGA released a consultation paper on the use of Third Party Conformity Assessments for medical devices in Australia.

Currently, the TGA is the only Conformity Assessment Body for Australian manufacturers of medical devices. Industry has long been calling for the introduction of third party assessment for medical devices, a view echoed by the 2006 Australian Productivity Commission Banks Review. For detailed information on the benefits of third party assessment and international practices see this paper prepared for Ausbiotech as part of TGA consultations on 3^rd Party Assessment.

The consultation paper poses questions relating to the responsibilities and roles that should be given to the TGA as the medical device regulatory authority and to a third party assessor.  The paper outlines various factors that would need to be considered, including the class and material composition of the device. TGA are now seeking input on using third party assessment and what role they should have in the assessment and approval processes. Submissions are being accepted until Friday 27 March 2009. TGA is also holding free workshops open for all interested in voicing and sharing perspectives. These workshops are to be held on Tuesday 17^th March in Sydney and Wednesday 18^th March in Melbourne.

Click here to read the consultation paper and to submit your comments and input.

New TGA IVD Regulations to start this year

At the end of February, TGA published its proposed new regulations for In Vitro Diagnostic Devices (IVDs). These regulations follow the overall approach of the European IVD directive. However there are differences in the detailed classification rules and the regulations also include “in house” IVDs developed within a laboratory or laboratory network and are not supplied in a commercial context. TGA has teamed with NATA for the regulation of these “in house tests”

We will be publishing a more detailed review of the new regulations shortly. Meanwhile the following are key points to note.

• A new set of Australian classification rules which broadly follow the European approach but with some important differences in detail.
• A new national database for notification of “in house” tests to TGA. This will be combined with cross checking with NATA audits to confirm that pathology and hospital labs have notified tests to TGA and that NATA has certified all tests on the TGA database.
• The current proposal has TGA as the monopoly authority for regulation of Australian IVD manufacturers. This is of concern in context of current moves to introduce 3^rd Party assessment for medical devices in Australia.
• A total ban on any home use device intended to test for pathogens, notifiable diseases or serious disorders or determine genetic traits
• Clinical trial arrangements will be essentially as apply to medical devices.
• Postmarket “vigilance” arrangements will apply and a postmarket surveillance regime including TGA sampling and testing.

See the TGA consultation document here.

Significant Confusion over Significant Change

In all major jurisdictions, a significant change to a medical device design or to a manufacturing process triggers additional regulatory review. Identification of a significant change and when it’s necessary to notify a regulator can be perplexing at the very least. To complicate things, a change which is considered significant in one product may not be considered significant in another, due to differences in intended use, classification and other factors.

In general terms, a significant change is one which introduces a new design feature, intended purpose or production process and which alters the risk profile. Examples include:

• Any change to manufacturing process, facility or equipment used for the device, affecting the risk of the product. This includes any change to a “special” process which requires revallidation. For example, the addition of a new subcontractor for the “special process” of ethylene oxide sterilisation requires validation of the process and the subcontractor. On the other hand, a new supplier of straightforward components or materials with well defined specifications would not usually be considered a significant change.
• Some changes to manufacturing quality control procedures, including introduction of new methods for testing of quality and sterility of materials and the device.
• A significant design change can include a change in a component material of the product to improve performance which requires new clinical testing to confirm safety and efficacy of the product. A change in design for aesthetic reasons is not considered a significant change.
• Any changes to theintended use of the device, including new or additional uses, removal of uses or changes to shelf life.

Changes to a revised EU Medical Device Directive, which are to take effect in March 2010, include that even one significant change to a product after receipt of CE approval requires that product to undergo the approval process again. The European Notified Bodies association has released guidance for manufacturers, “Reporting of design changes and changes of the Quality System”. In Canada the manufacturer is required to have a procedure in place to identify a significant change and for amending a license in the event of a significant change for Class III or IV devices. Also available are a Canadian Guidance for the Interpretation of Significant Change and an FDA guidance to help with deciding when to submit a 510(k) for a change to an existing device. Still confused? Contact us for advice – we can advise you in determining if changes are significant and assist communications with regulators regarding the change.

Electronic Medical Devices to face harsher laws in Europe

For those marketing electronic medical devices in Europe, even more stringent laws may be faced in the near future.

The European Commission are currently drafting a revised Waste Electrical and Electronic Equipment (WEEE) Directive and Restriction of Hazardous Substances (ROHS) Directive to work towards meeting higher targets for the collection and recycling of waste electricals.

ROHS, introduced in July 2006, regulates the levels of hazardous substances in electrical and electronic products, while the WEEE Directive, first issued in June 2003, provides regulation for the treatment, recovery and recycling of electric and electronic equipment.

Before the revisions, medical devices and monitoring & control instruments were excluded from the scope of the ROHS Directive. The draft revision now covers both categories, so will apply to these products. In this context, medical devices include in vitro diagnostics, but not active implantable medical devices. Provisions for the inclusion of active implantable medical devices will be reviewed by 2020. The proposed revisions for the WEEE Directive include an annual waste collection target rate of 65% of the average amount of electrical and electronic equipment put on the market in the two preceding years.

Changes to both the ROHS and WEEE are in response to studies which have found less than half the electrical waste collected in the EU is subsequently treated and target levels are being increased to meet expectations in terms of protecting the environment and health.

and continuing on environmental matters...

Europe REACHing for Greener Solutions

Closely related to ROHS and WEEE is REACH, the Registration, Evaluation, Authorisation & Restriction of CHemical substances. REACH is a relatively new European regulation, introduced in June 2007 and addresses the management of risks associated with the production and use of chemical substances. The regulation aims to improve protection of human health and the environment against potentially harmful chemicals. REACH is also involved in promoting “green chemicals” and encourages manufacturers to work towards the gradual replacement of unsafe chemicals with safer, greener chemicals.

The regulation affects all manufacturers and importers of chemical substances, mixtures of chemical substances or chemical substances that make up an article. Medical devices affected by REACH range from dental filling materials and bone cements to catheters and pace makers. Any chemical substance used in a medical device which is not registered with the EU will need to go through an extensive registration process, requiring detailed technical data and results of testing for the safety of its use.

A number of REACH Annexes, which include technical guidances, are currently being reviewed. More information about REACH can be found on the European Chemicals Agency (ECHA) website.

Worried about compliance with European environmental regulations? Contact us for advice on how these changes may affect your business.

Are you in control of your suppliers...

This month the Global Harmonisation Task Force (GHTF) Study Group 3 released the final guidance on Control of Products and Services Obtained from Suppliers. The document is part of a series that cover quality management systems and describes the various controls that are to be exercised over the products and services of suppliers. The GHTF guidance details the responsibilities of the manufacturer to control its suppliers and vendors. Click here to view the GHTF document.

Manufacturer control over the supplier is addressed in Section 7.4.1 of ISO13485:2003 and Sec. 820.50 (a)(1) of 21CFR820, which require the manufacturer to exercise the right amount of control over the supplier based on the criticality and effect of the supplied product to the quality of the final product. By defining the risk associated with the supplied product, the correct level and type of control can be exercised. Multiple options exist, including vendor on site audits, incoming inspection processes, mandatory testing to your specifications at the supplier, and supplier certification.

At Brandwood Biomedical we can help you understand what methods of control are suitable for your needs and provide direct assistance with supplier controls, including conduct of on site vendor audits on your behalf. Contact us to discuss your needs.

Paul Cohen joins Brandwood Biomedical

Brandwood Biomedical is delighted to announce that Paul Cohen has joined us as Senior Consultant. Paul comes to us with a wealth of experience, including 15 years in the diagnostics industry, plus senior roles in pharmaceutical and medical device regulatory affairs. Paul has particular expertise in clinical trials management and in product development of high risk implantables. See Paul's full profile

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AusMedtech Conference 2009

Brandwood Biomedical is proud to be supporting the 2009 AusMedtech National Medical Technology Conference to be held in Sydney on 15th and 16th June. This is the premier national event for medical devices and diagnostics. The exciting and relevant programme provides many opportunities to learn and to network with industry colleagues. Some highlights include the latest developments on the new TGA IVD regulations and proposals for introduction of 3rd Party conformity assessment in Australia. Don’t miss the opportunities to build your strategies and networks for a successful business through the wealth of information and experience offered by some of the leading individuals and businesses of the international industry.

Want to talk? Just drop by our stand at the conference exhibition where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.

Regulatory reform moving ahead – but IVD upgrades still a work in progress

On Wednesday 3rd December 2008 the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 was introduced to the Senate. This bill is a mixture of some housekeeping measures, plus some widening of TGA’s ability to publish and share information about therapeutic goods.

The bill will:

• Provide for medical devices to be exempted in certain circumstances, as medicines are currently, from provisions in the Therapeutic Goods Act 1989. This will allow medical devices to be stockpiled to deal with possible emergencies or be made available quickly in the case of actual emergencies;
• Clarify the 'fit and proper person' test and ensure it is applied more effectively and directly to matters relevant to manufacturing therapeutic goods in Australia. In clarifying this test the TGA aims to reduce any unnecessary regulatory requirements;
• Adopt the European Pharmacopoeia or the United States Pharmacopoeia as additional default standards under the Act;
• Expand the range of therapeutic goods information that can be released to the public and provide a wider range of circumstances where the TGA can release information to Commonwealth agencies or international authorities to support safety and quality in therapeutic goods;
• Apply more consistency to the regulation of advertisements in all media that include restricted representations to apply requirements to both those that require pre-approval and those that don't.

The bill principally implements enhancements identified during the development of the Australia New Zealand Therapeutic Products Authority (ANZPTA) and is the first of a package of reforms. Further legislative amendments are to follow. This current Bill does not address the forthcoming introduction of In Vitro Diagnostics Regulations to align with international practice, particularly the European IVD Directive. That regulatory change is still being drafted and TGA hopes to introduce the regulations in the autumn sitting of Parliament.

Changes to documentation requirements for medical device application audit process

Despite these changes, further documentation may still be requested to clarify any concerns, especially for higher risk devices.  The normal documentary requirements for pre-market medical device application audits have been reduced by the TGA, effective from the 1st December 2008, as detailed in Guidance Document Number 2:Application Audits.  The changes have been implemented to reduce regulatory burdens for sponsors.  Changes include:

1. Only one copy of the documentary evidence for mandatory audits will need to be submitted to the TGA.
2. The following documentary evidence will not need to be routinely provided for a mandatory application audit:
   • Third party quality management system audit reports
   • Third party design examination or type examination audit reports
   • Essential principles checklist
   • Sterilisation process validation report

Despite these changes, further documentation may still be requested to clarify any concerns, especially for higher risk devices. Processing time will not consequently reduce as there will be a more focussed assessment of remaining primary sources of evidence such as clinical evidence, risk analysis and the manufacturer’s Declaration of Conformity to Australian requirements. Guidance Document Number 2: Application Audits is still currently undergoing review regarding broader changes. The current version of the document can be viewed here.

CDRH Learn – Online training from US FDA

FDA’s Center for Devices and Radiological Health (CDRH) has recently uploaded free e-courses on their website here. “CDRH Learn” offers information about medical device and radiological health regulation in the USA. The courses provide introductory information about requirements for medical devices, ideal for those who are looking to gain a basic overview of the regulatory environment for medical devices in the States.

A Challenging Economic Climate – The importance of doing it right the first time

The current financial crisis has led to a slow down of activity in the biotech and medical devices sector. As companies reassess their finances, expenditure and time constraints, they are realising that now more than ever, it is important to ‘do it right the first time’.

The product development and regulatory process is a much more dynamic situation than many companies are aware of or truly understand - quality systems and regulations are dimensions of a company that should interface throughout the entire process.

With issues involving new technologies, complexity of devices such as combination products, and changing regulations, seeking regulatory advice at the end of the process will result in substantial time and dollar costs. Hence is it vital to have the right tools in place to meet regulatory requirements and gain approval efficiently. This is an important step in ensuring the success of a product and sometimes even a business.

Don’t Forget the Reason for the Season

During these tough financial times some are finding it hard, but please spare a thought for those who are finding it even harder. At Brandwood Biomedical we support the dedicated efforts of World Vision and the Smith Family and we encourage you to do them same. Please visit World Vision and the Smith Family to make a real difference this festive season.

Brandwood Biomedical Closed for Christmas. See you in 2009!

Brandwood Biomedical will be closing the office from the 19^th of December for a well earned holiday. We will re-open on the 5^th of January. We wish you all a Happy Christmas and New Year and we’ll see you again soon!

TGA streamlines Class 1 electronic lodgement

The long anticipated changes to the TGA's online application process are about to be implemented as part of the launch of the new e-business (eBS) website. The changes apply only to Class 1 Devices that are non-sterile and do not contain a measuring function. This means that if your device falls into this category, you can start selling your product as soon as the online application is complete - no need to wait for the TGA to review. The online system will validate the application and trigger automatic entry onto the ARTG. Manufacturers - be warned that entries are subject to both random and targeted post market review. For more information click here.

Congratulations - Nanosonics Canadian Approval, Sunshine Heart IDE, Romar Engineering ISO 13485

Brandwood Biomedical is very proud to have supported three of our clients in their recent passing of some very significant milestones and we congratulate them on their achievement.

• Nanosonics have achieved Canadian approval for their Trophon Ultrasound Disinfector device. This in addition to the CE Mark they received earlier this year. Not content with this, Nanosonics has also recently applied for TGA approval, anticipates lodging US FDA 510(k) application before year end and in early 2009 commencing regulatory processes for Japanese market approval.
• Sunshine Heart Company, after an exhaustive FDA review, have received an IDE approval to conduct a US pilot clinical trial of their C-Pulse^TM non-blood contacting heart assist device. Sunshine expects to begin the trial very shortly.
• Romar Engineering have been successfully audited to ISO 13485 - completing the upgrade of their quality system from ISO 9001:2000. This achievement will strengthen Romars abilites as a specialist manufacturer of moulded medical device components.
• UniLife have achieved FDA approval for their UnitractTM 1mL Insulin Syringe giving Unilife a green light to commence product launch activities within the world's largest healthcare market, where the use of needlestick prevention devices is mandatory.

BioKorea

Brandwood Biomedical Principal Arthur Brandwood recently participated in the NSW trade delegation to Gangwon in the Republic of Korea, and the 2008 BioKorea conference and exhibition, which attracted over 20,000 delegates.

Korea has implemented a nationally funded and co-ordinated industry development programme which provides strong incentives for researchers to develop spin-out technologies and well targeted support for new companies from early R&D through to patenting, fund raising, regulatory, manufacturing and marketing. This has created a national pipeline for new company and product developments. The result - Korea is growing its research based industries (including Medical Devices) at breakneck pace.

We particularly acknowledge NSW Department of State and Regional Development, Austrade and the Gangwon Proviincial Government for their support of the trade mission.

See you at Ausbiotech!

We will be attending AusBiotech's annual conference to be held in Melbourne from 26-29 October. Our Principal, Arthur Brandwood will be co-presenting a Workshop on Clinical Evidence Requirements on Sunday afternoon and presenting in the session on Reimbursement on Tuesday 28^th at 4pm. Click here for the full conference programme.

If you would like to meet with us in Melbourne - please do contact us

Walking the Talk - Brandwood Biomedical Achieves ISO 9001

We are proud to announce that we have achieved AS ISO:9001 certification for our technical, regulatory and quality consultancy services. ISO certification demonstrates our commitment to professionalism and integrity as well as to consistently provide you with the highest quality service and advice. When selecting an advisor to advise you on quality or regulatory compliance – ask the question – what level of certification or compliance have they achieved for their own operations? Copies of our certification, quality policy and quality manual are available on our website.

Human Factors

The US FDA has recently highlighted the contribution of human factors to adverse events in medical devices. The pertinent issue is where does the responsibility lie in ensuring correct device usage? In answer to this question, we have to look at both sides of the fence. With the rapid development of new technologies and advancement of medical devices, users are not only faced with of increasing complexity, but a greater range and diversity of devices, all of which add to the problem of incorrect usage. Medical device manufacturers need to go back to Engineering-101 and deliver device interfaces that are appropriate to the user training and skill level. So, to answer the question, both the user and manufacturer have responsibilities, but the root problem of adverse events involving human factors is often poor user interface design. Designs should also accommodate considerations for the environment where the device will be used as well as user expectations for the device. Click here to see the FDA article.

All Change at TGA...

Big changes are afoot at TGA as the national regulator struggles to cope with workloads while nursing a hangover from the transition to new medical device regulations. The changes will see priority for speedier assessments of new devices and a wholesale redesign of TGA’s electronic lodgement portal with a move to true notification of Class I devices. On the international front a new MOU with Canada will allow TGA to conduct manufacturer audits in support of Canadian applications. These changes promise faster market access especially for Australian manufacturers, although there remains more to be done, particularly on implementation of 3^rd party assessment. Click here for a review of the TGA changes.

Careers at Brandwood Biomedical

Brandwood Biomedical is growing rapidly and we are currently recruiting for new positions. If you have a regulatory, quality or product development background and are excited by the prospect of contributing to the growth of a specialist advisor working with some of the most innovative companies in the industry please contact us for a confidential chat.