Roundtable is next week!

Join the Roundtable at the Australian Catholic University from 8:30am – 10:30am on Tuesday 18th July.

This is a great opportunity for people across the industry to share insights into the challenges they face and the resilience required to address these challenges from a personal and a company wide perspective. 

The Roundtable also provides the opportunity to network with your industry colleagues and build on some of the key recommendations from the Medical Technology Industry Workforce & Skills Review.

MedTech2017 Annual Conference Speakers announced

MTAA is pleased to announce the following high profile speakers for the MedTech2017 Annual Conference on 1-2 November 2017.

• Glen Cross, CEO AusBioTech
• Dr Rachel David, CEO Private Health Australia
• Tim Kelsey, CEO Australian Digital Health Agency
• Sue MacLeman, CEO MTP Connect
• Michelle Price, COO Australian Cyber Security Growth Network
• Cathie Reid, Digital Advisor, ICON Group
• Michael Roff, CEO Australian Private Hospitals Association
• John Skerritt, Deputy Secretary, Health Products Regulation Group
• Andrew Stuart, Deputy Secretary, Department of Health
• Dr Melanie Thomson, GM Education, Skills and Events, MTPConnect
• Alison Verhoeven, CEO Australian Healthcare & Hospitals Association
• Plus many more speakers to announce soon.

MedTech2017 will bring together the brightest and most informed speakers to help you better add value in this complex and changing landscape.  The theme "The Value of Medical Technology to a Healthier Australia" will focus on patients, customers, HR/people, systems, processes and a future outlook for the industry.

Nominations for MedTech Awards

MTAA invites the Australian medical technology industry for nominations in the 2017 Kerrin Rennie Award for Excellence in Medical Technology & Outstanding Achievement Award.

The winners will be announced at the MTAA Conference Awards Dinner in Sydney on Wednesday 1 November 2017.

Closing deadline for nominations is Friday 25 August 2017.

Webinar on Restraint

Employees are often your best asset; however, they present significant risks on exit. When they leave, your staff may try to take your customer lists, trade secrets, confidential information and intellectual property?

The webinar is a reminder of restraint basics and case examples to demonstrate how you can protect the business when employees move on. There will also be the opportunity for questions and follow up discussion with Caitilin Watson of Atkinson Vinden Lawyers.

2.2 Complying with the Code of Practice

MTAA is running a half day face-to-face training course on September 26th 2017 which is designed to provide an opportunity for participants to further develop their understanding of the Code of Practice. 

Some of the main topics that will be covered include:
- Advertising
- Interactions with healthcare professionals
- Administration of the Code
- Monitoring Activities
- Complaints, Sanctions and Appeal Procedures

This course is ideal for Medical technology industry employees who interact with healthcare professionals or consumers.  Participants should have completed the online module 2.1 Introduction to the Code of Practice.

TGA implements new arrangements of Medical Device Regulations

The Therapeutic Goods Administration (TGA) announced it is implementing new arrangements to simplify and improve the handling of complaints about the advertising of medical devices to the public.

This follows a number of reforms TGA has recently highlighted including:

• Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates
• Electronic signatures to replace 'wet ink' signatures

MTAA continues to support and provide feedback to key recommendations of the Medicines and Medical Devices Regulations Review and the Therapeutic Goods Amendment Bill 2016.  Val Theisz, Director of Regulatory Affairs presented an Update on the Australian Regulatory Framework in April 2017 which is available to download.

Arthur Brandwood from MTAA Associate Member, Brandwood Biomedical recently wrote the following article "TGA Puts Custom Devices Under the Microscope" which shares valuable advice for medical device sponsors & manufacturers on what some of the reforms will mean for future applications.

Senate inquiry into the affordability of Private Health insurance

The Senate Community Affairs Committee inquiry into the value and affordability of private health insurance and out-of-pocket medical costs held its first public hearing last week (Wednesday 5th July)

 
Amongst those appearing before the Committee included the Royal Australasian College of Surgeons, Australian Healthcare and Hospitals Association, Medibank Private and HIRMAA.

Submissions to the Committee should be received by 28 July 2017.

Department of Health released circulars

The following circulars are among the most recent to have been released by the Commonwealth Department of Health (DoH):

• PHI 28/17 Prostheses List Management System (PLMS) updates the PLMS on 14 June impacting both external and internal users. Changes to all applications can be found here.
• PHI 29/17 August 2017 Prostheses List provides critical dates regarding publishing of the August 2017 Prostheses List. It cites 28 July as the closing date for ARTG/MBS Numbers, Duplications, Transfers and Deletions. The Private Health Insurance (Prostheses) Rules No. 2 2017 will be published on 28 August and will come into effect on 25 September, with an initial draft sent to sponsors and suppliers in early July.
• PHI 33/17 Private Health Insurance (Benefit Requirements) Amendment Rules 2017 (No. 5) reflects increases in CPI with regards to overnight and same day accommodation benefits, with new rates applying from 1 July.
• PHI 33/17 also encompasses the Private Health Insurance (Complying Product) Amendment Rules 2017 (No. 2) updating the patient contribution rates for nursing home-type patients in the ACT to a level more in line with the majority of states and territories.

New Clinical Investigations Research Agreements

The Clinical Investigations Interest Group (CIIG) of the MTAA, working alongside NSW Health and Southern & Eastern Border States (SEBS) Review Process, has finalised the Clinical Investigations Research Agreement (Standard Form) which has been uploaded onto the MTAA website.

This marks the first in a series of reforms to CIRAs for medical devices, with a brief statement on transitional arrangements also publicly available on the MTAA website. This latest body of work represents another success for the CIIG after the recent 2017 Clinical Trials Forum hosted by Medtronic in Macquarie Park, and highlights the continued focus of the MTAA and of industry on clinical trials, medical research and innovation in Australia.

Emails using MTAA in subject

We have had a number of reports about emails using "Medical Technology Association of Australia" as the subject and going to our members asking if they are interested in contact data.

These emails have not been sent by MTAA.

The issue has been investigated and there has been no breach of data.  Rather it is simply using generic emails from websites.  If you have any concerns please contact Allison Fox, Director of Business Operations at afox@mtaa.org.au

Earn your Graduate Certificate in Regulatory Science online in 12 months

Developed by industry experts, the University of Wollongong Graduate Certificate in Regulatory Science is a 12 month, online course that will give you the qualification you need as a regulatory affairs specialist.  It’s the perfect health-kick for:

• Your career. This course is perfect for those who want to broaden their scope for employment and gain the knowledge to advance and future-proof their regulatory affairs career.
• Public health. By focusing on the entire product life cycle, this course will equip you with the skills to protect the health of the public, bring new products to market faster, and more efficiently managing regulatory affairs.
• The business. Help navigate the complex regulatory environment to improve investment outcomes for your business by learning a quality management system approach to managing regulatory compliance.

It’s not too late to apply. Course starts 24 July.

Healthcare Leaders Forum

Gathering senior leaders from across the public and private healthcare spectrum, the annual Healthcare Leaders Forum equips executives with the insights they need to adapt and succeed in a dynamic climate. 

Harness the latest insights and opportunities surrounding personalised healthcare, industry reform and innovation – delivered by and designed for the leading influencers in healthcare.

MTAA members receive an additional 10% off the registration pass. Simply enter the code MTAA10 on registering.