MEDICAL DEVICE COMMERCIALISATION TRAINING PROGRAM (MDCTP)
The Medical Device Commercialisation Training Program (MDCTP) is delivered by Cicada Innovations in partnership with NSW Health, the program funder. The program is designed to accelerate commercialisation of medical technologies in NSW to bring lifesaving healthcare innovations to patients, hospitals and governments around the world.
The MDCTP offers an invaluable opportunity to NSW based medical device technologists to build knowledge, skills and network needed to successfully commercialise medical device technologies.
There are three course streams available as part of the MDCTP to meet the needs of medical technologists at different stages of their journey that build upon each other:
CORE, our flagship course;
IP / Regulatory / Clinical Trial Workshops; and
Applicants may apply from Startups, Universities, Research Institutes, the NSW Health System and Industry.
MDCTP CORE (FLAGSHIP COURSE) – 12 WEEKS
MDCTP CORE is designed for healthcare entrepreneurs from diverse backgrounds of medicine, engineering, science and business, and provides a tailored curriculum on how to transform their visionary concepts into viable businesses.
Since 2014, 66 graduates of CORE have launched 13 companies and raised over $43M to commercialise their ideas. Graduates of CORE are eligible for post-program support with the following awards available (total value >$1000,000):
2 x Scholar Program Awards to relocate to the Rosenmann Institute QB3 California Institute for Quantitative Biosciences, USA, for 2 years
Product Development Award
International Discovery Grants
Intellectual Property Strategy Award
Regulatory Strategy Award
Cicada Innovations Incubation Award
Through a series of workshops and events, CORE candidates will learn to “search” for the right business model for their technologies based on Lean LaunchPad methodologies and gain insights from over 30 mentors and domain experts on every facet of running a health related business:
Regulatory and Reimbursement Strategies
Financial Modelling and Pricing
Negotiation and Influence.
The course is modelled on experiential learning and a flipped classroom approach to engage candidates with real world entrepreneurship. This involves experimentation; getting out of the classroom and talking to customer, partners and competitors.
MDCTP CORE is structured in two parts; the “search” for the right business model and the ‘structural’ of aspects critical to medical device commercialisation. Candidates are expected to work in teams for the “search” component of the course, conducting customer interviews on the Team Lead’s technology, to develop skills to apply to their own technology. Candidates will work on their own technologies for the “structural” component of the course.
MDCTP CORE requires a commitment of attending 1 full day per week for 12 weeks at Cicada Innovations in Sydney, up to 20 hours per week of customer interviews and homework and attending the graduation showcase in May 2018.
Free! There is no cost for participants or their institutions as the Medical Device Commercialisation Training Program is funded by NSW Health, Office for Health and Medical Research.
Applications for CORE 2019 are open now
Sep 18 – Applications Open
23 Oct 18 – Applications Close
12 Nov 18 – Selection Interviews
04 Feb 19 – CORE Start
22 Apr 19 – CORE Finish
May 19 – Graduation and Showcase
MDCTP CORE GRADUATES
The MDCTP has proven its strategic value to the development of medical technology commercialisation capability within NSW over the past four years. In this short time graduates have launched new businesses, secured investment, developed and launched devices into the market, created skilled jobs and advanced their skills as professional innovators.
MDCTP HEALTH DISCOVERY – 12 WEEKS
MDCTP Health is a half-day training course for 12 weeks for researchers, clinicians and graduates interested in creating maximum impact through their medical technology or research. The course guides candidates through customer discovery in the “search” for the correct business model to achieve social, health and economic impact in the global marketplace. MDCTP Health is based on Lean LaunchPad® methodology – based on the ‘search’ for the right business model using experimentation; getting out of the classroom and talking to customers, partners and competitors. The course goes beyond static case studies or fixed models and challenges candidates to create their own business models based on information derived from personal engagement rather than second hand market research.
Eligibility for MDCTP Health requires applicants to be NSW-based who are interested in creating impact through their medical technology or research. Applicants need to commit to the half-day course for 12 weeks plus up to 12 hours of homework each week. Applicants do not need their own intellectual property.
Course Expectations and Culture
Developed by Jerry Engel and Steve Blank, Lean LaunchPad® (LLP) has been taught at Stanford, Berkeley, Columbia, UCSF and was adopted by the National Science Foundation to increase the economic impact of research. It emphasises experiential learning, a flipped classroom and immediate feedback as a way to engage candidates with real world entrepreneurship. Lean LaunchPad® has a strong focus on the SEARCH for the correct business model. This involves experimentation; getting out of the classroom and talking to customers, partners and competitors.
Getting out of the lab/building is what the SEARCH effort is about. It’s not about the lectures. You will be spending a significant amount of time in between each of the lectures outside the lab/hospital talking to customers and testing your hypotheses. If candidates can’t commit the time to talk to customers, then this course is not for them.
Startups communicate very differently to communication inside a university, lab or hospital. It is dramatically different from the university or hospital culture most of the candidates are familiar with. Feedback at times will feel brusque and impersonal, but in reality, is focused and oriented to create immediate action in time and cash-constrained environments.
MDCTP Health 2018 is currently in session and ends Monday 5th November 2018.
MDCTP IP – 1 DAY WORKSHOP
MDCTP IP is a one-day workshop delivered together with Australia’s leading intellectual property firm, Davies Collison Cave, that focuses on intellectual property management strategies for medical devices. It is designed to equip candidates with the necessary knowledge to protect their intellectual property through trademarks, patents and design registration. Candidates will learn about the different types of intellectual property, protection strategies and how to speak about their medical research or technology without giving away their secret sauce.
MDCTP IP workshops are free to participants.
MDCTP IP courses run four times per year. The next available IP workshop will be held at Cicada Innovations on 21st November 2018 from 9:00-17:00.
MDCTP REGULATORY AFFAIRS – 1 DAY WORKSHOP
This workshop will take a deep dive into the global regulatory requirements for medical devices and diagnostics. We will look at the technical requirements and international standards based framework for regulation, and how this is implemented through different international regulatory regimes including Conformity Assessments for Europe/Australia/Canada and 510(k)/PMA processes for the US FDA. Attendees will come away with a Global perspective on regulation including:
How to do product development right - so that the process delivers regulatory compliance
How to engage with regulators – including premarket consultations – to make sure you are on the right track\How to put together a technical file and how to prepare a regulatory dossier
The central importance of clinical evidence
How postmarket regulatory responsibilities continue on after registration – including adverse event reporting, advertising compliance and safety alerts and recalls processes.
Arthur Brandwood is Founder and Principal Consultant of Brandwood Biomedical: an international medical device and IVD regulatory consultancy headquartered in Sydney and with offices in US and across Asia Pacific.
Arthur has spent more than 30 years in the devices industry. He has worked on biomaterials and device developments for both startup and large multinational companies and in university applied research.
Arthur has held senior roles in government including Director of Device Registrations and Assessment at TGA, represented the industry to government as Chair of the Regulatory expert panel for AusMedtech and for the last 18 years has provided expert consulting services and training to companies and to regulatory agencies across the Asia Pacific. He is currently visiting Professor at the University of Sydney where he teaches regulatory affairs to biomedical engineers.
Arthur combines his deep knowledge and experience of global regulatory processes with a passion for communication and training to deliver what will be an engaging training event.
The next Regulatory workshop will be held at Cicada Innovations on Monday the 29th April 2019 and is now fully subscribed. Please stay tuned for the next workshop dates.
MDCTP CLINICAL TRIALS – 1 DAY WORKSHOP
Designed for medical entrepreneurs, researchers and clinical staff who want to understand more about the steps in developing a clinical trial from idea through to protocol, this 1-day workshop with Southern Star Research and Cicada Innovations will explore concepts such as:
Regulations Governing Clinical Trials in Australia
Setting up a Clinical Trial – insight into clinical trial protocols, site and CRO selection, ethical approval, budgeting and contracts
Device vigilance in the context of clinical trials
Biometrics departments and why you need them. Key roles and responsibilities
What you need to effectively resource a study and;
Hints and tips on where to find funding to get your trial off the ground.
At completion, participants will recognise the key milestones in progressing a clinical trial from idea through to clinical trial reporting.
The next available Clinical Trails Workshop will be held at Cicada Innovations on 22nd November 2018 from 9:00-17:00.
Registrations are now closed for the Clinical Trials Workshop. Stay tuned for 2019 Workshops
“The MDCTP course has been an incredibly valuable opportunity both for Sheridan and myself, giving us a sound basis from which to build our business, especially noting the importance of customer validation. The course has taught us not only what we should be doing now, but also what we should be preparing for. In the world of startups, timing can be critical and being aware and prepared helps to avoid falling into unwarranted regulatory, legal or other pitfalls down the track.
The commercialisation game is hard enough to play, and flying blind without a comprehensive understanding of the fundamentals is a recipe for failure. The MDCTP course gave us the momentum we needed to get out of the research facility and amongst the people we are trying to help and those that can help us make it happen.”
Michael Weaver, Co-founder at Cenofex Innovations (Awarded the NSW-QB3 Rosenman Institute Program scholarship, MDCTP 2014).
“The MDCTP was invaluable in teaching me how to commercialise a medical device and putting me in touch with key contacts within the field. I also learnt how to ‘pitch’. During the course my team worked on the ‘business model canvas’ for Kleer-i a sutureless surgery for the eye which helped with our successful application to the Medical Devices Fund.”
Stephanie Watson, Eye Surgeon at Save Sight Institute, Founder at Kleer-i (Awarded with $50,000 Seed Funding, MDCTP 2015).
“The MDCTP provided me with, not only the knowledge, but the experience of testing the validity of your idea in a market. We learnt the basics of many aspects necessary in commercialising a product and became familiar with the language used – this has already been of value in my role. But the key value of the course to me is that I now feel enabled to take an idea and systematically ask – does it solve a problem? for whom? and specifically what do I need to do to get it to them, and make a profit? I would certainly recommend it to people interested in commercialising their ideas, in fact I already do.”
Stephen Bradford, Research Scientist in Genomics at CSIRO/Garvan Institute of Medical Research.
How is ‘medical device’ defined?
Any type of device, instrument, diagnostic, app, software or processing technology that aims to improve patient or health system outcomes. We do not accept pharmaceutical drugs.
What happens to my intellectual property during the course?
Non-disclosure agreements are signed by all parties involved in the course, and we do not require you to reveal any sensitive information. Background intellectual property remains with their original owners.
For further information please contact Ben Wright via firstname.lastname@example.org. Applications will only be accepted via the application form and will not be considered if they are sent via email.