The CCH offers end-to-end MTP capability with a proven track record spanning 87 years (Whiteley Corporation established 1933) and a large, skilled and adaptable workforce. The CCH’s MTP ecosystem is a diverse mix of mature and start-up companies supported by people and organisations with a collaborative, and future-focused mindset that inspires innovation, growth and competitiveness.

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CENTRAL COAST HUNTER MTP INDUSTRY CAPABILITY WEB VERSION

CENTRAL COAST HUNTER MTP INDUSTRY CAPABILITY PRINT VERSION

CORE CAPABILITY

Medical technology, as expected, is well represented by established firms such as Logikal as well as newer success stories such as Holland Healthcare. Twelve companies or 26% of the participants identify with medical technology as being their primary market. Much of this capability is built on the historical proficiency of the region for advanced manufacturing and the capability of firms to address needs in the health industry. Demonstrating this proficiency and the continuation of its long-term commitment to the CCH, Whiteley recently announced development of a human therapeutics plant.

Biotech with its long lead times to market and capital costs such as laboratory space, is represented by three firms in the region (Jurox, Whiteley and ImmVirX).

Importantly, much of this capability is assisted by the facilities and expertise of Hunter Medical Research Institute (HMRI), University of Newcastle (UON) and two local health districts (CCLHD & HNELHD).

Recent developments in eHealth and digital health provide opportunities for fast growing digital companies to join with health professionals to address unmet medical needs. This area is especially relevant in regional and rural communities where delivery of services is challenged by distance, isolation and limited infrastructure.

Innovative products such as Mobito and FaceMatch are developing business models and leveraging close collaboration in the region. It is expected that given the increasing digital capability combined with a focus on health beyond COVID-19 this area will continue to expand.

Similarly, NSW Health Pathology continues to investigate innovation beyond pathology services into areas like digital health through its Point of Care Testing (PoCT) and Hospital in the Home (HitH) projects.

There is an opportunity, given the proximity of healthcare and innovation providers, for the rapid validation and clinical input into ehealth solutions that quickly adapt and translate solutions into the health system. The strong bridge between idea and clinician is key to success – often times, determining what does not work is just an important as validating what does.

While not as regulated as other medical areas, several firms offer solutions focussed on general wellness which are designed to improve the health and wellbeing of people. Examples include Compeat Nutrition, Stryke Recovery, Chezleon and Shiane Wellness that offer solutions designed to improve quality of life and general wellness.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

ENABLERS

While there is an impressive diversity of companies, the support and presence of both a vibrant and innovative health system, and a strong research capability, underpins the successful CCH ecosystem.

The health system comprises two local health districts (Hunter New England LHD & Central Coast LHD), private hospitals and the Hunter New England Central Coast Primary Health Network (HNECCPHN). Significant hospital and clinical trials resources and infrastructure exist in the region to support world-class clinical trials for technology approvals.

These systems and a variety of institutions such as the Ideas Lab at Gosford Hospital and the NSW Regional Health Partners support the development of the health system. We note that the John Hunter Health Innovation Precinct will increase this capability further.

Both HMRI and the University of Newcastle provide capabilities and world leading expertise in the areas of research, teaching and laboratory space that can be utilised for discovery, as well as to support established and emerging firms.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

SUPPORTERS

Supporting the CCH’s vibrant ecosystem are several support service companies who are specifically located in the region because of the opportunities it presents for MTP. For example, companies that address regulatory (e.g., Critical Compliance), and commercial strategy (e.g., Global Edge MedTech Consulting) offer bespoke services to firms in the region with sector specific capability.

Genesis Research Services and Paratus Clinical provide services to enable the delivery of clinical trials services for companies both in and outside of the region who wish to conduct trials according to GCP and ISO14155.

The innovation ecosystem is well supported through at least five incubators and accelerators (I2N, The Melt, Ideas Hub, FastLab, Eighteen04). Newie Ventures, after three years in Eighteen04, recently ‘graduated’ and is now operating independently in new state-of-the-art facilities. These incubators and accelerators offer both the opportunity for incubation of ideas and early-stage companies as well as programs and events designed specifically to build and attract innovation capability in the region.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

REGULATORY SYSTEM COMPLIANT & ACCREDITED COMPANIES + PEOPLE

Companies and organisations in the CCH have the required certifications to conduct business in a compliant method according to international regulations and required certifications. Several have the required clearance from the TGA, FDA and other international bodies for the sale and distribution of their medical products and services.

Medical Device design and manufacture quality management certification, ISO 13485, and the non-medical device specific quality management certification, ISO 9001, has been achieved by a variety of large and small companies in the CCH while others are examining the business case to undertake it.

Importantly, there is a strong history and expertise in heavy industry and engineering in adjacent highly regulated fields (e.g. mining, defence) which increases the motivation and speed at which industry can transition into the highly regulated medical and bio technologies fields.

HIGHLIGHT: ISO 13485 certification is in place at manufacturers such as Logikal and Whiteley Corporation. Logikal is also accredited with a TGA conformity assessment as well as a TGA GMP licence. The non-medical device specific quality management certification, ISO 9001 has been obtained by Whiteley and Humanomics and AmpControl.

HIGHLIGHT: Logikal is also accredited with a TGA conformity assessment as well as a TGA GMP licence. The non-medical device specific quality management certification, ISO 9001 has been obtained by Whiteley, Humanomics and AmpControl.

HIGHLIGHT: NSW Health Pathology is NATA accredited against ISO 15189. lau, a veterinary pharmaceutical company is accredited and audited by the USA FDA CVM as well as the TGA. The University of Newcastle has a desire to achieve NATA accreditation to complement its PC2 laboratories operated in combination with HMRI.

HIGHLIGHT: Various service providers have relevant qualifications in Good Clinical Practice and/or ISO 14155 (Genesis Research Service, Global Edge MedTech Consulting, and Paratus) enabling the provision and support of clinical trials for global markets. Electronic and eHealth is well supported through companies such as Assemblient being an Atlassian solutions partner.

HIGHLIGHT: HMRI is a registered Medical Research Institute, with both the University of Newcastle and Newie Ventures accredited as a Commonwealth Research Services Partner. Similarly, plans for the Central Coast Medical Research Institute focusing on integrated care solutions will further increase the regional health research capability.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

SIZE OF COMPANIES

The 50 companies that currently comprise the CCH MTP sector directly support 8,187 jobs. This excludes the tens of thousands of people who are employed delivering public and private health services to the population – in the health system and in enabling and support organisations.

There is a combination of sole traders (e.g., Critical Compliance, Global Edge MedTech Consulting, NewEye Business), start-ups and SMEs (e.g., Chezleon, Creatures & Co, Holland Healthcare, MyoMunchee, Genesis Research Services, Mollii Australia, Stryke Recovery, Laughing Mind) and larger organisations (e.g., Whiteley, HMRI, NSW Health Pathology, Jurox, Ampcontrol).

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting 2020

CCH WORKFORCE CAPABILITY

Large, Skilled, Adaptable Workforce

The CCH workforce is large. Hunter data supplied by the Australian Government’s Labour Market Information Portal suggests 209,600 are employed full-time, 99,400 are employed part-time and 24,100 are unemployed.

January 2021 https://lmip.gov.au/default.aspx?LMIP/EmploymentRegion/NewSouthWalesACT/Hunter

The Hunter’s MTP sector is represented across the region’s largest employers by industry:

  • HEALTH CARE AND SOCIAL ASSISTANCE employs 48,500
  • PROFESSIONAL SCIENTIFIC AND TECHNICAL SERVICES employs 23,100
  • MANUFACTURING employs 16,900

January 2021 https://lmip.gov.au/default.aspx?LMIP/EmploymentRegion/NewSouthWalesACT/Hunter

The Australian Government projects that the country’s employment will increase in 16 of its 19 broad industries in the years to May 2024. Health Care and Social Assistance is projected to make the largest contribution to employment growth (increasing by 252,600), followed by Professional, Scientific and Technical Services (172,400)

Source: https://lmip.gov.au/default.aspx?LMIP/GainInsights/EmploymentProjections

ENGINEERING PEDIGREE AND MANUFACTURING HISTORY

The region’s long history in traditional industries and regulated fields such as heavy manufacturing, mining and defence, means it has an increased concentration of people with engineering skills at both technical and trade levels.

These skills, coupled with a track record of adaptability due to economic shocks like we saw when BHP’s steelmaking ceased in 1999 and the steady transition to Industry 4.0 processes, has increased the ease with which CCH industry is able to pivot and apply transferrable skills and knowledge into new, high-tech industry sectors like medical technology. The region’s engineering pedigree delivers an experienced approach that results in smart, technically sophisticated solutions.

The regulatory/governance/quality management systems skills essential in the CCH’s traditional industries is another set of transferrable skills and a key asset.

MATURE WORKFORCE DEVELOPMENT PROGRAMS + PROVEN INDUSTRY & EDUCATION PARTNERSHIPS

The CCH has a pro-active approach to workforce skilling and an established industry-education partner culture. Since 2009, RDA Hunter’s Skilled Workforce Initiatives have partnered industry and schools to develop a cohort of future employees that have technical and enterprise skills, are familiar with industrial workplaces and are motivated to pursue STEM careers.

The initiatives build a skilled, job-ready, homegrown workforce tailored to industry’s needs. They provide students with contextualised skills that Hunter industry has specified it requires, in-industry experiences, and pathways to real jobs, while providing industry with a pool of local, qualified and motivated people from which to choose its staff.

Programs have partnered companies from the defence, mining and health sectors with students from Hunter schools, TAFE NSW and University of Newcastle.

HIGHLIGHT: Whiteley Corporation’s $10 million-plus investment in a human therapeutics plant to be built at its expanding Tomago base has been bolstered with a research collaboration with the University of Newcastle. A $100,000 federal government research grant will see UoN assist Whiteley to develop an “Industry 4.0 solution” – using the Internet of Things, digitisation and automation – to boost advanced manufacturing processes at the plant, set to open in 2022. Read the Newcastle Herald article

The CCH has access to all the key MTP specialty areas of expertise:

  • Advanced Manufacturing
  • AR/VR
  • Sterilisation
  • Drug Synthesis
  • Project Management
  • Chemistry
  • Clinical Trials and Ethics
  • IVD
  • Regulatory
  • R&D
  • Marketing/Product Management
  • Supply Chain/Procurement/Inventory
  • Reimbursement
  • Health Economics/HTA
  • Market Access/Business Development
  • Training and Workforce Readiness
  • App Development
  • Human Centred Design
  • Start-up Incubation/Acceleration
  • Image Processing
  • QMS

And applies this expertise in:

  • Electronic and Industrial Design
  • Digital (including cloud)
  • Project Management
  • MedTech
  • BioTech/Pharma
  • Digital/eHealth
  • General Wellness
  • Research
  • Health Providers

Importantly, although the region boasts all the key areas of expertise, there is a need for companies to collaborate on big ‘problems’ as no single company has a complete set of skills across all application areas. Consortia can and have been effortlessly created to partner on nationally competitive grants and specific initiatives, evidenced in times of high need like COVID-19.

See Central Coast Hunter expertise by company here HCC MTP Expertise

Matching the CCH’s industry capabilities with its research and health system enables a vibrant setting where ideas with commercial potential can be rapidly identified and supported. This match-up can also help solve unmet medical needs and convert University inventions into revenue positive health innovations.

Source: HUNTER AND CENTRAL COAST CAPABILITY AUDIT OF THE MEDICAL TECHNOLOGY AND PHARMACEUTICAL SECTOR, by Mark Flynn, PhD, MBA of Global Edge MedTech Consulting

GLOBALISED ECONOMY

Australia is a highly globalised economy, with trade accounting for 44% of nominal GDP. The Asian region saw almost three quarters of the two-way trade in goods and services in 2019–20 with the value of exports reaching almost A$475 billion. Central Coast Hunter (CCH) is contributing nationally with the region’s MTP companies having both local and global reach.

Firms offer products and/or services throughout NSW with most also trading Australia-wide. Importantly, 58% of firms offer products and/or services beyond Australia, primarily to New Zealand, USA, and Europe (incl UK) (e,g., Whiteley, Jurox, MyoMunchee).

The importance of this is crucial given the logistical and regulatory hurdles required for the export of highly regulated medical devices and biotechnology products to overseas markets.