Going Global: Growth and Export Strategies for Healthtech

  • Are you the founder or executive of a Victorian company with a healthtech product (incorporating biotech, medtech & digital health) that treats, diagnoses or prevents human diseases?

  • Do you have strategic intent to export your product to global markets?

  • Would you like to access international expertise (in Melbourne) to inform your strategy?

Brought to you by BioMelbourne Network with the support of LaunchVic, the Going Global program is designed to support you by bringing international experts to Melbourne, to deliver skills-based workshops on global regulatory, reimbursement, market access and commercialisation strategies, with a focus on key export markets in the UK, North America, Europe, China and India.

Outcomes for participants include:

Enhanced competitive advantage for startups seeking global export opportunities
Greater understanding of key target markets, potential channels to market and timelines for market approvals
Increased intelligence on pricing, regulatory and reimbursement strategies
Informed geographic specific market access export strategies, including competitor assessments and prioritisation
Improved refinement of your product’s value propositions for different geographic regions for investment pitches
Comprehensive understanding of customer perspectives, cultural barriers and the skills required for building strategic relationships in-market
Decisive analysis of the resources, finance capital and human capital required to support export activities
Expansion of business networks and connectivity to global markets.

The Going Global program consists of six international market Modules, and six local entrepreneur roundtable lunches.

Each of the international market Modules comprises one introductory seminar event (BioBriefing), one focussed market-access workshop and a personalised advisory session for each participating company.  These components take place over a 4-day schedule in Melbourne.

The Entrepreneur Roundtable Lunches are relaxed and intimate gatherings with local founders and experienced executives from biotech, medtech and healthtech companies who have experience in taking Victorian health innovations into global markets.

Register for the Module(s) that are most relevant to your global business aspirations and international market strategies.  

Each Going Global Module includes:

  • 2 registrations for the Module BioBriefing
  • A full-day intensive workshop for one company representative
  • A 30-minute advisory session with the Module leader
  • A discounted fee for participation in multiple Modules – $550 (incl. GST) for your first Going Global Module, then $440 (incl. GST) for any subsequent Module(s).

Entrepreneur Roundtable Lunches
Also included is an invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets. These will run in May, July, September and November 2018.

FILL IN THE APPLICATION FORM HERE

*Please note that that the primary participant must be a founder, CEO, or Senior Executive in a leadership role.

If you are unable to participate in a full Module, you can register for the Module BioBriefing 


Going Global Module #1 – UK – Doing Business with the NHS

Dates: Tuesday 17th – Friday 20th April 2018


Going Global Module #2 – India – Accessing Healthcare Markets in India: Building Business Partnerships

Dates: Tuesday 26th – Friday 29th June 2018

Visiting India Expert:

Swami Swaminathan, Chairman & Co-Founder of CIIQ Healthcare Catalysts Private Limited.

CIIQ (Continuous Innovation & Improvement in Quality) is focused on helping healthcare delivery institutions to deliver affordable and accessible quality healthcare in underserved areas. Collaboration across the healthcare network to foster continuous innovation and improvement in the delivery of quality healthcare is the bedrock of CIIQ’s platform.

More information about Swami can be found here

1. BioBriefing: Healthy India, Wealthy India – Accessing Healthcare Opportunities in India
Tuesday 26th June – Registration at 3.45pm, presentation & discussion 4.00pm – 5:00pm, followed by networking until 6.00pm
Venue: KPMG, Tower Two, Collins Square 727 Collins Street, Melbourne

This seminar will provide an overview of the biggest challenge facing the Indian healthcare sector – the inequity that exists in terms of accessibility and affordability of quality healthcare between the top and bottom of the pyramid for the billion plus population in India.

The objective of the seminar is to provide the attendees with a macro level perspective of the Indian healthcare ecosystem for the compassionate healthcare capitalists to explore growth opportunities by contributing to the Indian growth journey.

The Government of India and other leading Indian policymakers are now recognizing (as never before) the need to ensure “Health for ALL” as a key critical component of its Economic Growth journey. This universal health coverage focus of the policy makers seeks to address the needs of the underprivileged sections of the population. While these are extremely challenging times, inspiring possibilities exist for growth & differentiation by providing innovative solutions for this Mega challenge in the Indian healthcare scenario.

If you are unable to participate in the full Module, you can register for the Module BioBriefing here 

2. Workshop:  Bridging the Health Divide – Leveraging Frugal Innovation & Technology
Wednesday 27th June – 8.45am – 5.00pm
Venue: Dexus Place – Southbank 3 Room, Level 14, 385 Bourke St, Melbourne VIC

Attendees will leave with an in-depth knowledge of the sector, how it functions and what it is seeking from suppliers. This should enable a more intelligent approach to meeting market needs.

Swami’s full-day workshop will provide participants with a wide-ranging perspective on the Indian Healthcare sector, the present challenges and opportunities it provides over the short and medium term for professionals and entrepreneurs in healthcare to harness.

Swami will share with the participants his views on how by leveraging frugal innovation & disrupting the technology divide, the big health divide in the country can be bridged bringing in smart profits and returns for the healthcare players in the country. A key component of the daylong session will also be on understanding the importance of Private-Public Partnership and ideas on navigating the governmental and regulatory dimensions in healthcare.

3. A 30-minute advisory session with Swami 
Meetings will be held on Thursday 28th and Friday 29th June – We will contact you to arrange a suitable time for your 30-minute meeting.  You are not required outside of this time on these 2 days.
Venue: BioMelbourne Network, 25 Flinders Lane, Melbourne

4.  Entrepreneur Roundtable Lunches
Also included is priority participation at BioMelbourne Network Entrepreneur Roundtable Lunches held throughout the year with local business leaders who have succeeded in taking products to global markets. These will run in May, July, September and November 2018.


Going Global Module #3 – US – US Regulatory Environment: Finding your way through the FDA

Dates: Tuesday 21st – Friday 24th August 2018

Visiting US Expert:

Dr Mary Beth Henderson, Ph.D., MBA, Vice President of Regulatory Affairs and Quality Systems and Senior Principal Advisor, RCRI (US)

Mary has worked for over 30 years in medical device and biotechnology industries. She brings experience in strategic regulatory, quality, R&D, and business development roles to her project work. As a Senior Principal Advisor for RCRI, Mary has worked with clients to develop domestic and international regulatory strategies, draft submissions, and negotiate their approval by FDA and/or other regulatory agencies.

Leveraging her years of R&D and product development experience, Mary often works with product development teams or early-stage companies during initial phases of product design to provide regulatory support and guidance. Her chemistry and biotechnology expertise help to efficiently support projects involving combination products or medical devices incorporating biological materials. Mary has an MBA from the University of Massachusetts and a PhD in Chemistry from Northwestern University.

1. BioBriefing: 21st Century Cures Act – US Regulatory Impact
Tuesday 21st August – Registration at 3.45pm, presentation & discussion 4.00pm – 5:00pm, followed by networking until 6.00pm
Venue: Melbourne TBC

The 21st Century Cures Act (Cures Act), signed into US law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. The law focuses on incorporating the perspectives of patients into the development of drugs, biological products, and devices in FDA’s decision-making process. Additionally, the Act seeks to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products.
The seminar will review the current impact of the Act for sponsors and FDA and the status of the programs that have been initiated as a result of the Act.

If you are unable to participate in the full Module, you can register for the Module BioBriefing here soon.

2. Workshop:  Pathways to the US Market: De-mystifying FDA
Wednesday 22nd August – 8.45am – 5.00pm
Venue: Melbourne CBD

The workshop will aim to provide attendees with an understanding of the nuances of the FDA clearance/approval processes.  An overview of the steps and requirements necessary for US market access will be provided, including a discussion of when R&D should shift to design control, importance of risk files in developing a medical device, approaches to US regulatory strategies, pathways to market, key FDA guidance documents to consider, and when clinical evidence will be needed to support a submission.

Although the focus will be on the medical device pathways, biologics, drugs, and combination product pathways will also be discussed.  Finally, a discussion of how to leverage information across worldwide geographies will be presented.

The workshop will provide the attendee with a background and overview of US quality, regulatory and clinical considerations for medical product development for the US market.

3. A 30-minute advisory session with Mary Beth
Meetings will be held on Thursday 23rd and Friday 24th August – We will contact you to arrange a suitable time for your 30-minute meeting.  You are not required outside of this time on these 2 days.
Venue: BioMelbourne Network, 25 Flinders Lane, Melbourne

4.  Entrepreneur Roundtable Lunches
Also included is priority participation at BioMelbourne Network Entrepreneur Roundtable Lunches held throughout the year with local business leaders who have succeeded in taking products to global markets. These will run in July, September and November 2018.


Going Global Module #4 – US – Go-to-Market Commercial Strategy: Positioning for US sales success

October 2018 – Details coming soon…


Going Global Module #5 – Europe – Pathways to Europe: Entry points and barriers for healthcare technologies

March 2019 – Details coming soon…


Going Global Module #6 – China – Strategies for China: Growing market opportunity

May 2019 – Details coming soon…


Cost:

$550 (incl. GST) for your first Going Global Module, then $440 (incl. GST) for any subsequent Modules.

Inclusions:

  • 2 registrations for the Module BioBriefing
  • A full-day intensive workshop for one company representative
  • A 30-minute advisory session with the Module leader
  • A discounted fee for participation in multiple Modules – $550 (incl. GST) for your first Going Global Module, then $440 (incl. GST) for any subsequent Module(s).

Entrepreneur Roundtable Lunches
Also included is an invitation to attend the exclusive BioMelbourne Network Entrepreneur Roundtable Lunches with local business leaders who have succeeded in taking products to global markets. These will run in May, July, September and November 2018.  We will send you an invitation when full details become available.

Cancellation Policy:
A full refund is given up to 14 days prior to the Module.
No refunds within 14 days of the Module.

FILL IN THE APPLICATION FORM HERE

*Please note that that the primary participant must be a founder, CEO, or Senior Executive in a leadership role.


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