In this final edition of PulseLine for 2011 it is timely to reflect back over an exceptionally busy year. A significant part of MTAA’s efforts over the year have been directed to the development of policies to support access to appropriate medical technologies and to support the development of the industry in Australia. We have contributed in many areas to debates on healthcare reform, the benefits of life-saving and life-enhancing medical technologies, equitable access to funding for technologies, codes of conduct and ethical compliance, and many more.

Implementation of HTA Review

The implementation of the outcomes from the HTA Review has been a starting point for a wide range of activity. The HTA Consultative Committee is close to completing its work in grouping and listing approximately 9,600 products on the Prostheses List. MTAA’s participation has ensured that there is consistency, transparency and equity in the process. Overall I believe this has been achieved. While there have been individual benefit variations, in general there have been only small changes (up and down) from the previous minimum benefits. The Consultative Committee has agreed terms of reference which ensure discussion on more strategic issues in the coming year, such as the inclusion of coverage for beneficial technologies which do not meet the current requirements for listing on the Prostheses List, and mechanisms to review the current benefits.

We have been working with the Department of Health on the roll-out of the new MSAC arrangements and will be putting to the department in  coming days an issues paper which proposes modifications to further improve the process.

Regulatory reform

Regulatory reform will become a significant area of activity in coming months as TGA develops legislation to underpin the reforms announced in September. MTAA has contributed a paper to TGA outlining proposals for balanced implementation of these reforms which include the reclassification of Class IIb orthopaedic joints, and improved identification of products on the Australian Register of Therapeutic Goods (ARTG). We are currently waiting on the government’s response to the recommendations of the recent Senate Community Affairs References Committee inquiry into the regulation of medical devices. Once known, we will be contributing to further work to shape future reforms and to ensure that a balance is maintained between the need for sound regulatory processes and the availability to patients of beneficial technologies.

VOT project and telehealth

During 2011 MTAA has completed and published several fact sheets on the cost-benefit of specific medical technologies as part of our value of technology project. The evidence presented in these projects underpins our advocacy in support of improved access to a range of technologies in the healthcare system.  We are currently finalising a business case for the extension of MBS telehealth funding to remote monitoring of implantable cardiac devices and have developed a research paper on broader funding of remote monitoring of vital signs monitors. The growing area of telehealth provides an opportunity to transform healthcare delivery while at the same time empowering patients to assume more responsibility for their own health.

Building an Australian medtech industry

In recent months MTAA has made several submissions to the Wills review into health and medical research in NSW and into the development of a manufacturing industry action plan in NSW. These are positive developments by the NSW State Government which has identified medical technology as a focus industry. MTAA is currently preparing a white paper on the national policy levers required to support development of a strong Australian industry.

At the annual MTAA conference, MedTech 2011, I launched MTAA’s comprehensive fact book on the industry in Australia. Work is underway on development of the second edition with an initial survey of around 500 companies with medical devices registered on the ARTG.

Developing skills and capability in the industry

MTAA continues to offer to the industry a diverse learning program to ensure that employees in the industry have the necessary training for the changing demands of their roles. In 2012 I am delighted that, in conjunction with CHERE at the University of Technology Sydney, we will be offering a health economics subject tailored to the needs of the medical technology sector. Ultimately it is planned that the initial subject will evolve into a graduate diploma. Further details will be announced shortly.

I wish all readers of PulseLine a healthy, restful and re-energising break over the coming holiday season. I thank you for the support given to MTAA over the past year and look forward to working with you in 2012.

Anne Trimmer
Chief Executive Officer
Medical Technology Association of Australia

MTAA members and Associate members are invited to attend the annual Christmas Networking Function in Sydney. Please RSVP by Friday 2 December to reserve your place.

The function will provide an opportunity to network with your colleagues from industry, MTAA staff and Board. Light refreshments will be served.

Date:  Tuesday 6 December 2011
Time:    5.00 pm - 8.00 pm
Venue: Kirribilli Club, 11 Harbourview Crescent, Lavender Bay (North Sydney)
Cost:   Free for MTAA member and associate members!

Guest speaker Elizabeth Foley, Chief Executive Officer, Research Australia, will be presenting on health and medical research activities. There are currently two sector reviews underway, one led by the federal Department of Innovation, Industry, Science and Research and another in NSW referred to as the “Wills Review”. MTAA has provided submissions to both reviews.

Elizabeth Foley has over 20 years experience operating in leading corporate roles for blue chip companies (AXA, MLC, ING, Prudential and Unilever). Elizabeth’s passion in supporting the not for profit sector, in particular health and medical research has long been driven by personal and professional experience. She is passionate about the role of medical research in improving treatment options and driving health improvement, and is committed to building on the sound reputation of Research Australia as a “whole of community” voice for health and medical research.

Research Australia is a national not-for-profit alliance of organisations and companies that are committed to making health research a higher national priority. In the current policy intense environment, Research Australia is working with the university, institute, industry and services sector to highlight the importance of research in generating solutions to healthcare and systems.

MTAA would like to thank DHL for their support for this function.

Please RSVP by Friday 2 December 2011 to events@mtaa.org.au or (02) 9900 0650 to reserve your place.

MTAA has provided input to the NSW Government's manufacturing action plan advocating for government to work more strategically with the medical technology industry as one of the few manufacturing industries demonstrating economic growth in NSW by addressing four main areas: 

• a medical device fund to assist emerging companies throughout all stages of the commercialisation process
• form an industry cluster to improve collaboration between industry, hospitals and universities in keeping with global trends
• re-train workers in declining industries such as automotive for med tech to improve the availability of skilled workers in the industry 
• establish a high value manufacturing centre providing access to state of the art technology.

Industry roundtables to progress the development of the action plan are expected to occur in the first quarter of 2012.

MTAA has welcomed a recently announced review of the National Joint Replacement Registry (NJRR).  The review will be conducted by former high profile businessman and governance advocate Mr Henry Bosch who will report to the board of the Australian Orthopaedic Association early next year. 

The purpose of the review is “to examine the current status of a number of elements of the NJRR and to provide recommendations for improvements (if any) that can be implemented to enhance the role and functioning of the NJRR”.  A previous but internal review of the NJRR was conducted five years ago but this time, external stakeholders are also being consulted for their views. 

MTAA has met with members for their views in preparing a submission to go to Mr Bosch by 16 December.  Industry’s support for the NJRR goes beyond its financial underwriting of the registry as it provides its proposals for governance and process improvements.

The external review is currently in its final stages and will lead to an 8th edition of the Code in 2012. 22 submissions were received to the MTAA Code of Practice external review. The Code Review Panel held three all-day meetings to consider submissions and prepare its report.

The Panel’s report has been considered by the Code of Practice Committee and will be considered by the MTAA Board this month. MTAA will publish the report on its website and write to all parties who made a submission.

The current 7th edition of the Code is available from the MTAA website.

E-learning

5.16 Customer Focus
MTAA has just launched module 5.16 Customer Focus. This training is available as online self-paced learning. It is aimed at medical technology industry employees that work directly with customers and need to develop skills and knowledge for implementing a customer focused approach. The module has been developed to align with the unit of competency BSBCUS402A Address Customer Needs.

2.1 Introduction to the Code of Practice
Module 2.1 Introduction to the Code of Practice (Edition 7) is now available incorporating changes to the latest 7th edition of the code. To register your company to complete code training, please click this link.

3.6 Operating Theatre Protocol Update
More healthcare facilities are become stricter with MCRs providing evidence of ACORN approved training. Don’t forget, experienced MCRs who regularly enter the perioperative environment can complete module 3.6 Operating Theatre Protocol Update online. To register your company for module 3.6, please click here. Following the successful completion of the module, MTAA will issue participants an e-Certificate of Participation and photo ID card valid till July 2012, in line with the next review of the standards.

Contact Details

If you would like to know more about other training opportunities that are available through MTAA, please access the website. For all professional development enquiries, please contact Fiona Shipman, Professional Development Manager by E: pd@mtaa.org.au or P: (+612) 9900 0650.

The Department of Innovation, Industry, Science and Research has just published a range of case studies about medical devices on their website. Thank you to the companies that participated following the MTAA article in Pulseline. Companies wishing to contribute a case study can contact the department on (02) 6276 1221 or medtech@innovation.gov.au

The Health Market Validation Program (Health MVP) is a $15 million competitive grants program that encourages innovation in healthcare by supporting the pre-market development of innovative healthcare-related products, processes or services by small to medium enterprises (SMEs) working in partnership with Victorian public health agencies.

The Health MVP offers an opportunity for universities, research organisations and others to collaborate with hosts or SMEs in the development of innovative solutions to improve health or healthcare service delivery and reduce costs.

A media release announcing the call for Technical Requirement Specifications (identifying health technology problems) and further details about the Health MVP, including guidelines and how to become involved, can be found here.

The 21st Global GS1 Healthcare Conference When Supply Chain meets eHealth - the importance of laying the foundations in Healthcare will be on 20 - 22 March 2012 in Sydney.

This conference will provide a unique platform for healthcare colleagues from around the world to meet, exchange experiences and advance the implementation of global standards – to inclrese supply chain efficiency and patient safety.

More information is available here.