Lee Walsh Email & Phone Number

Canberra, Act, Au

Barton, Canberra, Act, Au

Since founding the business I have led it from being a part-time side hustle, to being a full-time and profitable small business that employs a small team of expert professionals. In that time I have supported over 20 small medical device businesses to get their regulatory and quality affairs in order. This has included implementation of risk and quality management systems, software development life cycles, and validation and verification programs.In addition to leading the consulting work, I have built a team of expert consultants to support our clients and built successful boutique consultancy focused on expert delivery and tailored service.

Leading method and product development to make quality and regualtory approachable for medical device startups and SMEs.

Canberra, Au

I lead the technical development, including researach, development and deployment, of our products. We are focussed on products that measure, analyse and improve the athletic performance of motor sport athletes.

City, Australian Capital Territory, Au

Brain Changer is an tool set for individuals with chronic pain. It assists them with pacing and putting pain science into practice. The Brain Changer tools assist with planning and monitoring through the day to manage flare ups. My role is as a scientific and engineering advisory, advising on research and validation strategy.

Barton, Australian Capital Territory, Au

Our Performance business was founded around the application of physiology and human instrumentation in motorsport. My work here aimed to apply real-time measurement and performance physiology to improve athletic performance in motorsport athletes. The outcome for the athlete was better athletic performance on track, and therefore better race results.We worked with drivers in GT endurance, TCR, Australian Supercars, Porsche Michelin Juniors and SuperUtes as well as assessing athletes in the lab or gym to support their on track performance.Ultimately this work led to the founding of a new company, Biomedical Performance Technoloiges, to develop and commercialise our product prototypes.

Kingston, Act, Au

Apis provides advisory services, delivery management and business and digital design services to government. I worked on several projects were clients require specialist advise, design or analysis relating to risk management, regulation or data review and analysis.For one large project, the client was reviewing the regulatory processes and require advice and design related to risk-based regulation. I reviewed their business practices and then worked directly with their teams to develop new process and supporting guidance. The first challenge was gaining deep understanding of the clients business in a short time frame. Then I was able to leverage my expertise in risk management, regulation and communication to co-design new processes with the client.Another large project required review, analysis and synthesis of the submissions from a large public consultation. The client engaged Apis to analyse the data, provide a synthesis report, and prepare submissions for publication within a very tight timeframe. My role was to design the analysis that would inform the report as well as being the primary contact with the client. My technical expertise in analysis and software engineering let me automate much of the submission handling and publication preparation. I then work with senior analysts and the client to design an analysis that would deliver the outcomes. The primary challenge for this project was managing the communication between the client's policy experts, the Apis analysts, and the senior leadership. My experience communicating between fields helped me here and I was able to facilitate a joint understanding and manage the differences in language. I also had to manage expectations from both sides.My success at Apis came from a strong background in communication and being able to adapt my technical skills and leadership to novel situation and problems.

Au

The medical device sector is facing multiple emerging challenges. Some of these relate to new or emerging technologies, others to existing technologies that are finding new applications in medicine and healthcare. While the Australian framework for regulating medical devices is flexible and captures novel technology and innovation well, some of the current challenges just were not foreseen.The TGA has embarked on a program of reform for the medical devices framework with the intention of improving international harmonisation and addressing gaps that are starting to form in the framework. I led work to reform the regulation that relates to medical device software and cybersecurity.For cybersecurity, I was the TGA project lead on a joint venture with the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to research best practice, engage with stakeholders, and draft regulatory guidance to support stakeholders in complying with the legislation. I then fed this work into international harmonisation efforts as Australia’s representative on the International Medical Device Regulators Forum (IMDRF) Cybersecurity Working Group.For the reform of the software regulation, I led the engagement with stakeholders and production of education material, as well as writing and reviewing policy and legislation. This included establishing a monthly webinar series on digital medical devices, publishing consultation papers, and running workshops.The cybersecurity work led to three published documents, regulatory guidance for industry, information for users and healthcare providers, and information for consumers. The latter two were international firsts and all were well received by stakeholders. The software reform work led to further policy and legislative change that will improve the safety, quality and performance of medical device software used by Australians.

Au

In 2016 I accepted this role as the founding leader of the Electromedical Team. My first project was to lead a team of engineers to validate new systems, methods and equipment under an ISO 17025 quality system. One aspect was establishing a new arm of the quality system for bespoke software that is used for testing that informs regulatory decision making.For two years I led that team in the assessment and testing, of medical devices that are included on the Australian Register of Therapeutic Goods (ARTG). We specialised in medical devices that include electrical/electronic or software components. This requires me to maintain broad team capability efficiently, while ensuring that we could adapt quickly to develop novel capabilities in response to market events.In 2018, I established the TGA Laboratory’s capability to test the cybersecurity of medical devices. This included assessing best practice in other sectors, defining technical and training requirements, sourcing resources, and building collaborations both internally and externally. I then led that team through its initial work and provided technical leadership to a wider program to improve regulation of medical device cybersecurity.Standards are key to medical device regulation, especially with regard to engineering performance and quality. I represent the Therapeutic Goods Administration on Australian and international standards committees, and worked within the Department and with Standards Australia to improve the medical device standards for Australian stakeholders.I was regularly invited to speak on the regulation of medical devices in Australia (see attached media).

Au

I have acted as the Director of the Biomaterials and Engineering Section with the Department of Health for a total of 15 weeks between October 2016 and April 2018. During that time I have:- Led the negotiation of the scope of works for a $500k external consulting contract- Negotiated the capital equipment proposal for the Section in 2017/18 ($350k) and 2018/19 ($600k).- Provided joint engineering and regulatory advice to other state and federal governmentagencies- Began discussions regarding collaboration on cybersecurity and signal monitoring withother federal government departments and agencies, academia, and industry stakeholders.

Au

In July 2016 I accepted a promotion to Senior Engineer in the Laboratories Branch of the Therapeutic Goods Administration. My current section (Device Conformity Assessment) asked me to delay taking up the new position to act as a Technical Leader/Senior Assessor for 6 weeks to train a new cohort of engineering assessors.My task was to develop a training program for new engineering assessors that had just joined the Section. This program needed to provide training on the engineering assessment of medical devices for safety and performance while adapting to the diverse background of the individual engineers that had been recruited.I developed a program to cover conformity assessment specifics, including approaches to engineering problems that are common in conformity assessment. I then sought feedback from the recruits on which areas they felt they needed training in. I responded to that feedback by developing sessions, and finding appropriate experts, to cover those topics. In addition to developing and running this training program, I reviewed draft engineering reports to provide technical feedback, provided mentoring to some of the recruits, completed engineering assessments, and provided expert technical advice to the wider section and the Medical Device Branch.My training program accelerated the development of this cohort of new engineering assessors and setup a framework for sharing of expertise between engineering assessors.

Au

This was the same role as below, but I was made an ongoing staff member of the Therapeutic Goods Administration. I was in this position for 2 days before being offered a promotion to Senior Engineer in the Laboratories Branch.

Sydney, New South Wales (Nsw), Au

In 2015 I delivered guest expert lectures on proprioception (our body's sense of itself and its actions) for the NEUR3221 Neurophysiology course. I delivered 2 x 1 hour lectures and ran a 3 hour practical. The practical demonstrated some of the key scientific evidence that informs the current scientific view of proprioception. Students experienced this scientific evidence first hand by performing experiments using current research equipment.In 2015 I begun co-supervising a PhD student in this area of research.

Sydney, New South Wales (Nsw), Au

In this role I delivered guest expert lectures and a practical session for the NEUR3221 course. My lectures covered the neurophysiology of human proprioception.

Sydney, Nsw, Au

I spent 5 months as an external contractor with the Therapeutic Goods Administration (TGA). I worked in the Device Conformity Assessment Section of the Medical Devices Branch.In this position my roles were, 1) to provide expert recommendations to decision makers regarding the safety and performance of medical devices, 2) pre-assess new medical device conformity assessment applications to recommend assessment pathways to decision makers, and 3) provide engineering and physiological expertise to the section and branch.During my time in this role I wrote 7 expert reports that assessed the engineering safety and performance of new medical devices before they entered the Australian market. I wrote 5 expert reports recommending assessment pathways for new conformity assessment applications. I also reviewed other expert reports and provide expert advise on active implantable medical devices and the MRI safety of implantable medical devices.The quality of my reports, the speed with which I learned the regulatory processes, and my broad expertise with medical devices led to an offer of ongoing employment with the section and, shortly after, an offer to act as a technical leader.

In 2011 my research excellence was recognised by the National Health and Medical Research Council with the award of a CJ Martin Research Fellowship.These fellowships are awarded to send leading Australian post-doctoral researchers overseas to exchange knowledge with a laboratory outside their field of research, thus extending their expertise into a new field. The goal is to both share Australia's expertise and to bring new knowledge, expertise and skills back to Australia.Thus, in 2012 I moved to University College London to work Patrick Haggard, a world-leading experimental psychologist and cognitive neuroscientist. While working in Patrick's lab I provided physiological and technical expertise and training to UK psychologists. In exchange I learned advanced electroencephalography techniques and analysis methods.This interaction of researchers from complementary fields led to the first study investigating the effect of sensory loss on the perceived shape of the fingers (see link). We also discovered a new sensory phenomenon which is the subject of a manuscript currently in preparation, and an ongoing international collaboration.

Randwick, Nsw, Au

My primary responsibility in this role is to establish and grow a unique and independent research program.In 2015 I had to establish a laboratory space and seek funding for future projects, while at the same time continuing to identify research avenues and perform experiential studies.I lodged applications for competitive grants to support larger projects, meanwhile securing local funding to build a laboratory. I designed the laboratory equipment and software to be modular so that experimental data could be collected along the way and to allow for expansion when external funding is secured.My program and laboratory space was successfully established this year and one independent project was completed and (currently under peer-review for publication). The second study is on track to be finished in 2015. I submitted two external funding applications including a $1.3M NHMRC Project Grant to fund future projects. I completed the 1st and 2nd phase of laboratory construction (see photo) and the primary software for experimental control and analysis (see links below).My research experience and reputation convinced local stakeholders to fund my strategy while I waited for external funding outcomes. This research program would not have been established so quickly without my technical capabilities and experience.

Randwick, Nsw, Au

I was a post-doctoral researcher with a PhD in sensorimotor physiology, now able to apply for my own grants and do my own research.I needed to branch out from my PhD lab and find my own unique areas of research. I also needed to be travelling, giving presentations to share my expertise and networking to establish collaborations and my independence.I chose to train in a new field, experimental psychology. To do this I secured AU$390k of competitive funding from the National Health and Medical Research Council to move to a world-leading psychology institute in the United Kingdom. I spent two years training in my new field, gaining knowledge and expertise in their experimental and analytical methods. During this time I also presented at international conferences (e.g. the prize winning poster below) and visited international labs to give talks and establish collaborative networks.In 2014 I brought my new expertise back to Australia. I also brought back access to international expertise via the networks I established during my time in the UK. Furthermore, my combined expertise in physiology, experimental psychology and engineering gives me an edge and access to unique areas of research. This became the basis for establishing my own research program in Sydney.

Randwick, Nsw, Au

My undergraduate research gave me a taste for creating new knowledge and a strong interest in movement and exercise science. To pursue a research career I needed PhD, but I enjoyed engineering and did not want to leave it completely for the life sciences.One of the top movement physiology labs in the world was at NeuRA (then called POWMRI) and they needed a new support engineer. I negotiated with the laboratory principal to work for them full-time as their engineering Research Assistant, while studying my PhD part-time in the same lab.During my 5 years in this position I consulted on a wide range of human research projects. Providing general engineering support, software development, as well as hardware design, prototyping and manufacturing. I became and expert in physiology instrumentation and measurement.I completed my PhD 3 years early (5 of 8 part-time years) and finished with a much broader expertise and research experience than if I had only done a PhD. This put me in a superior position for launching a post-doctoral research career. A lot of the equipment and software I produced is still being used for research in 2015. One example is the TAFPlotting project I consulted on (see links below). The software I wrote for that project has been used by laboratories around the world.

London, Greater London, Gb

The UCL Institute of Cognitive Neuroscience (ICN) appointed me as an expert in the neurophysiology of sensation and movement, and as a technical researcher.I was appointed with the Body and Action group. The were working to further our understanding how the brain controls movement of the body, as well as how it perceives the body and its actions. They were a group of psychologists and a key role for me was to provide expertise and training in physiology and technical research skills.During my time at the ICN I provided physiological insight into the research being performed by the Body and Action group and other affiliated research groups. I also provided general technical advise, particularly in design and prototyping. Within the Body and Action group I also provided more specific training. For example, I trained a post-doctoral psychologist in the measurement and analysis of the electrical activity of human muscles. I taught another how to temporarily paralyse a subject's hand using a pressure block. During my appointment I also provided research and technical training to an undergraduate medical student.Through my appointment Body and Action group gained access to neurophysiological techniques and interventions. The researchers I trained are now better placed to investigate the psychology of sensation and movement because they can better measure the body's actions, and can better manipulate its physiology.

London, Central London, Gb

I taught research methods to two groups of Masters in Psychology students and supervised their research projects. My groups won both available prizes between them, one for Most Interesting Project and the other for Best Presentation.

Bachelor Of Engineering (B.E. Hons), Bachelor Of Science (B.Sc Hons), Electrical And Computer Systems, Physiology And Biomedical Engineering

Doctor Of Philosophy (Phd), Physiology

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