Platypus MedTech Consultants are experts in design, validation and regulation for Health and Medical Technology.
Our skill in finding and creating knowledge, measurement and experimentation, data and analysis and communication is second to none. We specialise in applying international research, knowledge, and best practice to your questions, challenges, product or business. If it is a medical device or research and development problem Platypus MedTech Consultants can lead you to a solution.
Our principal, Dr Lee Walsh, is an engineer, medical scientist, author and speaker who is internationally recognised in his fields.
With over a decade of experience in research and development, Dr Walsh has established an international reputation for excellence and is regularly invited to speak. His work is published in highly ranked international journals, and systems he has designed and built are still in use around the world 15 years later.
Dr Walsh has contributed to policy and regulation as well as Australian and international standards for medical devices, Internet of Things (IoT) and cybersecurity. This includes representing the Australian Government on standards committees and international working groups.
In science and engineering Dr Walsh specialises in measurement, instrumentation and software development, for data analysis and communication. In regulation he specilises in medical devices, including engineering, risk management and clinical validation.
He is known internationally for his work in the measurement of human physiology, psychophysics and performance as well as medical device testing and validation.
Dr Walsh is an athlete and motorcyclist and has recently focused his research and development work on solutions to optimise athletic performance in motor racing. When he is not at work, he is likely riding or working on his motorcycle, gardening, training (martial arts) or building furniture.
DR TAHSEEN KAMAL
PhD(Engineering) FHEA MSc(CSE) BSc(CSE)
Senior Regulatory Scientist
IBM Data Analyst Professional Certification (Python)
SGS Internal Auditor Training on ISO 9001, ISO 14001, ISO 45001
Dr. Tahseen Kamal is a professional with 16+ years of work experience in academia, research, and regulatory environment.
Her background is broadly in engineering which includes Computer Science and Engineering (CSE), electrical, electronic engineering, applied optics, implementation of optimization algorithms etc. She worked on developing low-cost imaging systems during her PhD using in-house lenses. Her postdoctoral research work was on “free-space laser communication”, where she was working on building an adaptive optics system for space communication.
Tahseen worked at the Therapeutic Goods Administration (TGA) mainly in the facemasks team contributing significantly to the pandemic affected facemask industry in Australia. Her work included post market review that encompassed technical, regulatory and QMS reviews. Tahseen also briefly worked in the environmental compliance area.
Tahseen is a Fellow of Higher Education Academy (FHEA) of UK, recognised by the British organisation Advance HE. This recognition demonstrates that she offered international quality of teaching in the higher education industry. Tahseen has taught Electrical and Electronic Engineering students at different universities over a span of 14 years.
Tahseen is an extrovert with strong leadership and communication skills. She single-handedly organised national level events during her career in Bangladesh. She also loves spending leisure time working on promoting diversity. Other than reading, her main hobby is cooking, and she loves singing but casually!
DR ANTHEA DOWNS
BSc PhD
Senior Regulatory Scientist
Certified Lead Auditor ISO 13485
Regulatory Affairs Professionals Society (RAPS)
TGA External Scientific Evaluation Panel
Uni Western Australia - Coordinator of TGA External Clinical Evaluation
Perth Biodesign Entrepreneurial Development Program
Anthea is a collaborative, strategic and solutions-orientated regulatory affairs professional .
Anthea was awarded her PhD by the University of Western Australia in her home town of Perth. After a career in medical research which took her to Sydney and the UK, she decided to take up an offer to join the Therapeutic Goods Administration (TGA) as a medical device evaluator.
At the TGA she discovered that regulatory affairs was a natural fit for her abilities and ethics. She spent the next several years building regulatory expertise across multiple areas and building relationships with many talented and committed colleagues with the shared aim of safeguarding public health. She enjoys a continued association with TGA as an external scientifical evaluator.
Back in Perth, and working on the commercial side of the industry, Anthea has used her knowledge of TGA regulations and processes to assist companies to find the most efficient regulatory route to product approval, to build the appropriate technical documentation and to interact productively with the TGA during the process.
She has extended her knowledge and experience to FDA regulatory processes and has interacted with the FDA to achieve 510(k) approvals. She is also well-versed in the new European Medical Device Regulation (MDR) as well as medical device quality management (ISO 13485).
Prabha studied a double degree in Chemical Engineering and Biochemistry at Monash University.
After taking a break from work to focus on family, she returned to the workforce after completing a Diploma in Business Administration.
In March 2019 she started her own business which provide business administration services. In 2020, she also joined Platypus MedTech Consulting as Operations Manager.
Prabha loves reading, especially Golden Age detective fiction from the likes of Agatha Christie, Edmund Crispin, and Dorothy L. Sayers. She also loves animals, particularly dogs, and especially greyhounds. In addition to volunteering with greyhound rescue groups, she is the Secretary for the ACT Keyboard Association, and does volunteer work for her church.
Level 1, The Realm, 18 National Circuit Barton, ACT 2600
Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngarigo and Whadjuk Nyoongar peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise their connections to land and waters, the sophistication of First Nations knowledge and their contributions to engineering and science. We pay respect to their Elders, engineers and scientists, both past and present.
