In the latest MedTech Mondays, we will be joined by experts with an understanding of how to scale up your medical device company.

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Arjun Joshi - As Senior BDM at BSI, a notified body for CE Marking and various regulatory certifications for placing medical devices in various markets i.e. global market access, Arjun understands the requirements of ISO13485 and regulatory approvals process MDR, IVDR, MDSAP, UKCA, Article 117. Arjun also has a degree in Mechanical Engineering and an MBA and has held Operations Manager roles in companies previously. Additionally, Arjun has been working in the Medical devices industry for over 12 years where he has been a Lead Auditor for various standards such as Quality, OH&S, Environmental, SMETA (Ethical standard against modern slavery), etc.

Emma Bennett - Emma has over two decades working across a diverse cross section of industries, sectors and cultures, I have developed a vast collection of knowledge, skills and experience. Emma worked as General Manager of a company that manufactured IVF pipettes which was acquired by CooperSurgical. She also worked as Ops Manager of ISO13485 accredited electronics manufacturer Entech. Emma believes if we invest time in our employees and ourselves, through training and development, good work design and a continuous improvement culture, not only will the individual thrive but the organisation will prosper.

Chris Henry - Managing Director of Actis Medical, Chris runs an ISO 13485 certified company offering the medical device industry a distinct range of services. This includes medical device manufacturing, strategic sourcing to supplement med tech product portfolios and decentralised regulatory services embodying all regulatory affairs requirements.

OOXii receives top honours for pioneering Social Impact Design

Recognizing the significant role of design in improving society, the Australian Good Design Awards 2023 has proudly honoured OOXii (formerly 4eyesVision) with the prestigious gold award in the Social Impact category together with Best In Class for their work in making a better-looking world.

Aiming to reduce the massive burden of uncorrected refractive error in remote and developing communities, OOXii in collaboration with the Medical Device Partnering Program (MDPP) based at Flinders University, have developed a manual crimping tool for their portable and affordable vision test and glasses dispensing kit.

OOXii’s founder, Dr Sarah Crowe and her colleague Edward Ko, sought the expertise of MDPP with their mechanical design engineer, John Nicholl, generating concepts, rapid prototyping, and testing a functional prototype of their crimping tool.

“The crimping tool designed by MDPP effortlessly bends laser-cut stainless-steel frames into three different sizes, making them suitable for various pupillary distances,” said Dr Crowe. “It has been such a positive experience to work with the MDPP team and we are really proud of the device we have developed.”

“It's user-friendly, suitable for all strengths, and skill levels and seamlessly integrates with OOXii’s frame production and dispensing processes, making it ideal for use in remote areas with limited technology or power resources.”

MDPP director, Professor Karen Reynolds said she was delighted her team could be a part of the development process for OOXii’s tooling and increase access to eyeglasses for people who need them most.

“Our collaborative efforts have helped OOXii achieve a user-friendly tool that will make a significant difference in providing vision care in remote and underserved areas,” said Prof Reynolds. “This project exemplifies the positive impact that innovative design and engineering can have on improving healthcare accessibility."

The MDPP fosters collaborations between researchers, industry, end-users and government and develops medical technologies with global market potential.

If you would like more information on how the MDPP can assist you with developing a proof of concept, prototyping, clinical evaluation and commercialisation planning visit www.mdpp.org.au today.

On a mission to enhance the care of pregnant mothers and their unborn babies, Melbourne based start-up Kali Healthcare have secured significant funding to help them realise their revolutionary next generation wearable pregnancy monitoring device.

Recognising an opportunity to advance perinatal care, obstetrician Associate Prof Fiona Brownfoot together with engineers, Dr Emerson Keenan and Prof Marimuthu Palaniswami (pictured right) have adapted electrical sensor technology - commonly used for measuring cardiac function in adults - to create a simple, accurate and wearable device which can easily pick up and monitor a baby’s heart rate in utero.

The trio approached the Medical Device Partnering Program (MDPP) based at Flinders University’s Tonsley Innovation District for help in developing their proof-of-concept technology into a user-friendly prototype.

Providing 250 hours of medical device and bioengineering expertise, the team at MDPP accelerated Kali’s product development and connected them with a valuable startup ecosystem including ISO13485-accredited development partners, expertise at the Australian National Fabrication Facility and links to potential funding opportunities.

“We are so happy and thankful for the support we’ve received from the MDPP team,” said Dr Emerson Keenan, Kali Healthcare’s CEO. “From technical aspects right through to commercialisation advice, the MDPP’s contributions to our fetal monitoring device have been extremely helpful and we now have a beautiful prototype to show to our stakeholders.”

Shortly after completing the MDPP program, Kali's journey to secure capital gained considerable momentum with a pre-seed investment of $500,000 from University of Melbourne followed by a commitment by LaunchVic's Alice Anderson Fund and a group of private investors, which elevated the total funding for the round to $1 million.

Overcoming the limitations of conventional cardiotocography (CTG), Kali Healthcare's fetal monitoring device accurately captures the baby's heart rate while also providing remote monitoring functionalities. This empowers patients to move about freely and, for those residing in rural or remote regions, enables them to return home while receiving high-quality supervised care with the information transmitted remotely to their healthcare provider.

Professor Karen Reynolds, the Director of MDPP, is proud of her team's contribution to the emerging field of fetal electrocardiography (fECG) and their assistance to Kali Healthcare in creating their groundbreaking monitoring device.

"MDPP's extensive range of expertise ensures that visionaries like Kali Healthcare receive the utmost support in advancing their medical technology," said Prof Reynolds. "Their fetal monitoring device addresses a crucial clinical need by directly advancing perinatal care. This innovation has the potential to reshape the global medical device market, while also championing equitable healthcare for expectant mothers and alleviating strain on healthcare systems around the world."

Supporting the development of novel, high-tech medical devices, the MDPP located at Flinders University facilitates collaboration between researchers, industry, end-users and government, providing innovators with a solid platform to advance their new product’s potential in a competitive medical devices market.

For more information on how the MDPP can support your next project or to submit your innovation to the MDPP please visit www.mddp.org.au

Happy birthday to MDPP!

MDPP celebrated 15 years with an event that showcased the history of MDPP, milestones, successes and what's next for the team.

MDPP Director Prof. Karen Reynolds shared the following stats:

💻849 enquiries
📝 207 workshops
🔬126 projects
⭐ 3 major projects

💲💲 Since the beginning of the year MDPP alumni have raised >$10M and since 2020 >$30M.

Special guests included alumni, past and present team members and representatives from our wonderful supporters.

Thanks to Department of Industry, Innovation and Skills for the continued support of MDPP in South Australia.

Thanks to the support of MTPConnect's Researcher Exchange and Development within Industry (REDI) initiative in 2019, MDPP has been able to continue delivering its program nationally.

This was a great opportunity to hear Frank share insights and strategies for entering the US market, as well as topics including:

• Medical Alley and why it is a global medtech powerhouse
• FDA and reimbursement in the US
• Emerging technology trends

When:  Wednesday 17 May, 2023

Time:    9am - 9.45am

Where:  Lecture Theatre 1
              Flinders University
              1284 South Road
              Tonsley  SA  5042