The MTPConnect Podcast – Details, episodes & analysis

Jeff Gibbs is a Director at Hyman Phelps and McNamara – the largest law firm specialising in FDA issues, based in Washington DC. With four decades of FDA expertise he delivers crucial insights for medical technology companies aiming to crack the US market. Peaking to the podcast during his national tour for the MTPConnect seminar series, this US-based regulatory veteran shares his strategic tips on the FDA submission process, and discusses the dramatically shifting FDA landscape that could make or break your US market entry strategy. 

Whether you're developing breakthrough medical technology or refining existing solutions, this episode delivers essential knowledge for anyone considering the US market. Subscribe to the MTP Connect podcast for more insights that will help your innovation journey from bench to bedside to global markets. 

Medical Alley is a powerhouse in global healthcare innovation, connecting startups and Fortune 100 companies to transform healthcare solutions. Headquartered in Minnesota, it’s one of the world’s largest medtech clusters.

At the 2024 MedTech Conference in Canada, MTPConnect and Medical Alley renewed an MOU to strengthen collaboration and support for Australian medtech companies looking to expand internationally.

Now, Medical Alley is launching a game-changing online training program, Medical Alley Academy, designed to help innovators move into the US market - a great opportunity for Australian companies to tap into.

Joining Caroline Duell to talk about this exciting initiative are Medical Alley CEO Roberta (Bobbie) Dresson and MTPConnect CEO Stuart Dignam.

What’s in this episode?

·       How Medical Alley is shaping the future of medtech

·       The changing trends and challenges in the US medtech ecosystem

·       All about Medical Alley’s new online Academy training 

·       Key opportunities for Australian medtech companies to expand to the U.S.

Tune in for expert insights and actionable advice for taking your medtech innovation global! 🎧✨

Omico is leading Australia’s largest cancer genomics initiative –giving 23,000 Australians nationwide with advanced or incurable cancers, access to genomic profiling to detect unique genetic variations in their tumours to identify potential matches to new targeted treatments options. It is opening up new treatment pathways, extending lives and attracting more international trials to Australia.

Professor David Thomas, renowned for his groundbreaking work in precision oncology, is the founder and Chief Science and Strategy Officer of Omico - the Australian Genomic Cancer Medicine Centre. 

In this episode, host Caroline Duell speaks with Professor Thomas to find out more about his mission to open up new treatment options for all cancer patients using genomics, the impact of pan tumour therapies on our healthcare system, and why we need to change the way we look at cancer care and cure right now before more people die unnecessarily.

Brisbane-based Ellume Health’s Founder and CEO Dr Sean Parsons joins the MTPConnect podcast this week to share the full story behind developing the first #COVID-19 Home Test to be given FDA Emergency Use Authorisation in the United States. Ellume recently signed a $300 million deal with the US government to supply the over-the-counter diagnostic which uses smart-device connectivity and ramping-up Australian manufacturing will be critical to meeting demand. This is a must-listen episode for medtech innovators keen to understand more about commercialisation success in America. Sean shares his ten-year journey from physician to founder, including tips for fellow entrepreneurs and his views on how to boost sovereign capabilities by growing medical products manufacturing in Australia.

To stimulate collaboration across industry, research and clinical organisations we’re allocating $20 million to support the establishment of two new Research Centres through the Targeted Translation Research Accelerator (TTRA) initiative for diabetes and cardiovascular disease, supported by the Medical Research Future Fund. MTPConnect is calling for Expressions of Interest (EOI) to establish one centre focused on diabetes-associated complications and the other on cardiovascular disease-associated complications and each funded for up to $10 million over four years. The program has the potential to transform diabetes and cardiovascular disease outcomes and reduce the burden of disease on patients, families and the community. This Information Session provides valuable information to those considering submitting an EOI. Dr Dan Grant, MTPConnect Managing Director & CEO discusses the Research Centres opportunity. Lauren Kelly, MTPConnect Senior Director TTRA program and Dr Mana Liao, MTPConnect Director TTRA program outline the priority areas, submission process and provide relevant information about preparing an application. You will also hear from our TTRA Expert Advisory Board Chair Professor Ian Frazer AC FRS who contributes to the question time.

The Targeted Translation Research Accelerator (TTRA) initiative for diabetes and cardiovascular disease, supported by the Medical Research Future Fund, is calling for Expressions of Interest (EOI) for the first round of Research Projects funding. The program is making available $18 million to support translational Research Projects that have the potential to transform diabetes and cardiovascular disease outcomes and reduce the burden of disease on patients, families and the community – with up to $6 million available in this first round. This Information Session provides valuable information to those considering submitting an EOI. Dr Dan Grant, MTPConnect Managing Director & CEO  discusses the Research Projects opportunity. Lauren Kelly, MTPConnect Senior Director TTRA program and Dr Mana Liao, MTPConnect Director TTRA program outline the priority areas, submission process and provide relevant information about preparing an application. You will also hear from our TTRA program partners who will be providing mentoring and commercialisation advice to applicants and those receiving funding:

• ANDHealth’s Co-Founder & Chief Product Officer Grace Lethlean
• MDPP’s National Program Manager Olivia White and;
• UniQuest’s Senior Director QEDDI Dr Andrew Harvey 

While Australia is getting on top of COVID-19 and Britain begins vaccinating frontline healthcare workers, the virus is still raging in the US, Europe, and many parts of the world. It all underscores the critical importance of ongoing pandemic preparedness – for policy makers, industry and the community.  To hear more about Australia’s efforts, we meet Dr Felicia Pradera who leads the DMTC Medical Countermeasures (MCM) program, which involves harnessing Australia’s capabilities to develop leading-edge, advanced technologies and to direct and deploy skills into activities that support Australian defence, health and national security outcomes. Medical Countermeasures include vaccines, therapeutics and diagnostics for the protection of military and civilian personnel against Chemical, Biological and Radiological threats, emerging infectious diseases and pandemics. They have just launched the National Health Security Resilience Assessment (open until 31 May 2021) to evaluate Australia’s research, product development and manufacturing capability in six priority areas - MCM, Medical Devices, PPE, Modelling and Simulation, Hazard Management and Sensing Systems. Find out why they need input from the MTP sector to help provide a national picture of Australia’s capability and capacity in the health security ecosystem. 

Digital evolution is the central enabling megatrend of the MTP sector. As healthcare incorporates more and more digital solutions, its important to get cybersecurity right.  Lives depend on it.  So how do we secure the digital safety and security of Australian medical technology and is the sector too complacent? MTPConnect’s Managing Director & CEO Dr Dan Grant tackled that question in his keynote at the Medical Technology Association of Australia (MTAA)’s Cyber Security Forum, in November 2020. MTPConnect was pleased to be a sponsor and support further discussion in this area. Many thanks to the MTAA for championing this issue and thanks to CSIRO’s Director of Health and Biosecurity Dr Rob Grenfell for facilitating the session. 

We’re patching you into our November 2020 Seminar Series webinar about how to craft a successful commercialisation funding application. Hear valuable tips from communications specialist and grant writer Rebecca Colless from gemaker, experienced grant assessor Dr Andy Gearing from BioComm Squared and Professor Kevin Pfleger from UWA who shares his academic and commercial experience, highlighting key differences between research and commercialisation applications. MTPConnect’s Dr Dan Grant brings insights from his own research career and administering MTPConnect’s multiple translation funding programs. They explore the steps to developing a well-executed application, share their experiences and reveal why it is so important to get the story right. The session was led by MTPConnect’s Director of Stakeholder Engagement for WA Dr Tracey Wilkinson. This episode will be of interest to researchers, research offices, start-ups & SMEs.

Happy bonus episode listeners! To mark World Antimicrobial Awareness Week, the MTPConnect podcast team caught up with OUTBREAK Managing Director & Co-founder Associate Professor Branwen Morgan from the University of Technology Sydney and Distinguished Professor Antoine van Oijen, who is OUTBREAK’s Deputy Managing Director and Director of Health Programs from the University of Wollongong, to talk about their new economic report on the impact of antimicrobial resistance in Australia released this week which shines a light on the multi-million dollar cost of drug-resistant infections and connects the overuse and misuse of antibiotics to the health and economic impact of a single disease. OUTBREAK is a national consortium whose analysis used big data and Artificial Intelligence to highlight how urinary tract infections (UTIs) are becoming more persistent and harder to treat, resulting in more people being admitted to hospital where they require longer stays and more costly medicines. Each year UTIs alone lead to 2.5 million GP appointments, 100K emergency visits and 75K hospital stays!. OUTBREAK is a member of MTPConnect’s AAMRNet, Australia’s first Antimicrobial Resistance Network launched in October 2020. The report is available to download at OUTBREAK Project’s website: https://outbreakproject.com.au/antimicrobial-resistance-publications/utis-economic-report/. For more information on AMR, follow Twitter for updates at @AAMRNet_ and @OneHealthAU.