The flourishing Australian life sciences industry is a major contributor to this country’s economic growth. According to an article in the July edition of the ‘Australasian Biotechnology’ from AusBiotech, the industry generates around $4.4bn in gross economic value-add, and employs more than 48,000 people at medical technology, biotechnology and pharmaceutical companies. By Carole Goldsmith.

The article – entitled ‘Attracting Investors To Realise Australian Life Sciences Full Potential’ – also reveals that investment in life sciences is increasing, with the sector raising $1.384bn in capital in 2016, and with Federal Government programs like the Biomedical Translation Fund (BTF), stimulating private sector investment. The BTF comprises of $250m in Commonwealth funding, matched by private sector investors contrubutions, and will be used to invest in promising biomedical discoveries.

MTP Connect – Accelerating growth in life sciences

MTPConnect (The MedTech and Pharma Growth Centre) is one of the Federal Government’s six Industry Growth Centres. The Department of Industry, Innovation and Sciences states that the Industry Growth Centre Initiative enables national action on key issues such as collaboration, commercialisation, international engagement, skills and regulation reform. The Federal Government has allocated $250m for the Growth Centre Initiative over four years from 2017/18 to 2020/21. Alongside medical technologies and pharmaceuticals (MTP), the other five industry growth centres operated in: advanced manufacturing; cyber security; food and agribusiness; mining equipment, technology and services; and oil, gas and energy resources.

MTPConnect’s CEO and Managing Director Sue MacLeman is excited about Australia’s innovative MTP industry and the work of MTPConnect and its partners. She explains: “MTPConnect is a not-for-profit organisation which aims to accelerate the growth of the Australian medical technology, biotechnology and pharma sector to achieve greater commercialisation. We also want to establish Australia as an Asia-Pacific hub for MTP companies.”

MacLeman is also busy planning international projects. This November, she is speaking at the APAC MedTech forum in Singapore and leading a healthcare mission to South Korea. She will also lead a MedTech mission to Israel in May next year.

MTPConnect is based at Monash University in Melbourne’s east, with hubs at Sydney University’s Engineering Department and at South Australia’s Flinders University’s Tonsley site. MacLeman explains: “Flinders at Tonsley is the old Mitsubishi auto manufacturing plant which has been converted to house a Medical Devices Research Institute, the Centre for NanoScale Science and Technology, and a number of other faculties.”

She adds that MTPConnect collaborates closely with CSIRO, university research centres, other Growth Centres, and with professional bodies such as AusBiotech, Medicines Australia and the Medical Technology Association of Australia (MTAA).

The MTPConnect’s Project Fund of $15.6m awarded grants to 14 initial projects in 2016. These projects received a total of $7.4m over the following two years, with matched sector funding of around $32m. The projects funded in 2016 are exciting collaborative efforts in which universities, hospitals, research organisations, businesses and industry bodies are working together for successful outcomes.

Among the projects funded were:

  • $1.1m in support (with a $1.1m partner contribution) for BioFab3D@ACMD, a robotics and biomedical engineering centre at St Vincent’s Hospital Melbourne (lead applicant), with other participants including Stryker Australia and the Universities of Melbourne, Wollongong, RMIT and Swinburne.
  • $150,000 in funding support (with a $150,000 partner contribution) for initial scoping of the National Medical Device Partnering Program (NMDPP), to bring together research, clinical and industry partners for collaboration and product development. The lead applicant is Flinders University with participation from CSIRO, STC Australia and MTAA.
  • A $100,000 Fund contribution (with $300,000 in partner support) for a Biofabrication Research Centre at Queensland University of Technology (lead applicant). This Centre will utilise 3D digital scanning, modelling and advanced manufacturing technologies to develop ears for children with microtia. Hear and Say, Metro North Hospital and Health Service are the project partners.

MacLeman advises that MTPConnect is currently reviewing the second round of expressions of interest for collaborative, industry-led projects through the dollar-for-dollar matched Project Fund Program, with recipients to be announced at the AusBiotech Conference in Adelaide in late October. Further details on the life sciences sector, funding, events and workshops, can be found on the MTPConnect website.

On the Australian MTP industry, MacLeman says proudly: “Australia has a wonderful world class infrastructure and we are very good at knowledge generation. What we need to do is transfer this knowledge to product commercialisation.”

Two Victorian life sciences’ companies, MDI and Taylor Surgical Instruments are just two examples of businesses that are successfully transferring knowledge to product commercialisation.

Medical Developments International – Taking on the world

Victorian pharmaceutical and medical devices manufacturer Medical Developments International (MDI) is already taking the world by storm, selling its products in 30 countries.

“We are in the process of getting EU approval (expected first quarter of next year) and that will bring us an additional 37 countries to sell our products to,” says MDI’s CEO, John Sharman. “MDI is one of Australia’s leading pharmaceutical and medical devices companies specialising in emergency medicine solutions.”

The ASX-listed healthcare company manufactures a leading range of products for pain management, asthma and resuscitation, plus veterinary equipment. Sharman reports that the company’s bestsellers worldwide are its emergency pain relief device Penthrox and a range of respiratory devices for asthma and chronic obstructive pulmonary disorder (COPD). Penthrox, a methoxyflurane inhalation device, is commonly known as ‘the green whistle’, for its whistle-like shape, with a hole near the mouthpiece.

Sharman explains how Penthrox works: “It will take you from your worst pain to a pain-free existence within 10 breaths, and will keep you in a pain-free state for up to two hours. Penthrox, available only by prescription, is a non-opiate, non-addictive and does not depress the airways. You can’t overdose on it and there is no drug to drug interaction. Also, it does not trigger the dopamine receptor (prominent in the vertebrate central nervous system), so there is no accumulate high.”

MDI now operates two manufacturing sites. Its new $5m state-of the art manufacturing site in Scoresby, in Melbourne’s eastern suburbs, was completed this August, and the Therapeutic Goods Administration (TGA) approved the facility in September. The company’s first manufacturing site nearby in Springvale continues full production. MDI employs around 80 people across Australia, Dubai and London.

“We have taken on 26 new employees in the last 12 to 18 months to work in the new plant,” says Sharman. “Another 20 people will be engaged in the next 12 months and will include 12 process chemists, regulatory and factory staff.”

Part of the new plant’s medical manufacturing process was developed jointly with CSIRO’s researchers and MDI’s R&D team.

“Our Process Development Project (PDP) conducted over the past five years with CSIRO’s Biotech and Healthcare division, was validated by the TGA in May this year,” adds Sharman. “We have developed new manufacturing technologies that deliver cost saving, improved quality, consistency and safety standards for existing and new small molecule pharmaceuticals. MDI has spent around $5m on this project to develop innovative ways to invent pharmaceuticals.”

He explains that the project has successfully completed ‘desktop’ scientific due diligence on three molecules and is expecting positive results in the coming year.

Following the company’s recent annual report release, Sharman and his investment team went on an investor roadshow presenting MDI’s latest global successes and sales figures. For the 2016-17 financial year, the company’s gross sales were $18.9m, up 22%, and net profit after tax was $1.82m, up by 16%. Sharman says: “During the six-day Australia roadshow in August, we presented our slide show to 40 organisations including institutions and shareholder groups. In September, we also addressed our global investors in London, Hong Kong and New Zealand.”

MDI has established a network of manufacturers and distributors worldwide, to ensure both quality assurance and supply chain solutions are maintained, for servicing and delivering to the local and international sectors. Sharman explains that some components are imported from global suppliers, with all MDI products manufactured in Australia.

“Globally we have distributors covering 50 countries but we are not big yet, we are just starting,” he reveals. “The trick is to get all these companies to sell our products.”

Sharman says that the cost of doing business in Australia is very expensive, especially if you are operating a global business: “If we manufactured in Asia, it would be one-third of the costs that we’re spending now. We want to continue manufacturing in Australia. Our plans are to be a billion-dollar global company.”

Taylor Surgical Instruments – Providing innovative solutions

When AMT magazine caught up with Taylor Surgical Instrument’s Managing Director Paul McKay, he was beaming with pride and enthusiasm for the medical devices business he founded 31 years ago. Meeting at the company’s Knoxfield factory, east of Melbourne, he explains that Taylor Surgical specialises in producing quality, innovative electro-surgical instruments for local markets and internationally (currently New Zealand and Italy). The company also custom-manufactures operating table accessories for Australian hospitals and surgeries.

In partnership with a major USA instrument repair organisation – Medical Optics – Taylor Surgical also provides an endoscope and instrument repair service for Australian and international hospitals.

“We do direct product sales of our instruments to hospitals,” says McKay. “As the instrument manufacturer, and to keep our customers happy and returning, we need to offer a repair service.”

McKay proudly explains that his business has four employees: himself, sister Caroline, their father William, and son-in-law Tim. According to Caroline, her brother is very customer-focussed and the repair work sometimes leads to custom-manufacturing projects.

“We try to provide a solution for the surgeon or theatre staff, when they ask us for a custom-designed and manufactured instrument,” says McKay.

He discusses the electro-surgical handpieces that his company custom-manufactures. Among these are the monopolar and bipolar forceps, monopolar electrodes and cords, mainly used for cutting and coagulation during electro-surgery.

On a factory walkthrough, Tim is custom-manufacturing steel and aluminium operating table components using an Okuma ACE Centre MB56VA vertical machining centre. McKay says: “We invested in the Okuma machine around five years ago at a cost of around $320,000. The machine’s capabilities and Okuma’s after-sales service are excellent.”

The business uses a range of other advanced manufacturing systems, including tooling from Sandvik Coromant, software from SolidWorks and Esprit CAM, and 3D printing technology for prototyping.

“Investment in the state-of-the-art CNC milling lathes further enhances Taylor Surgical’s capabilities to manufacture a wide variety of highly specialised components and equipment with precision accuracy,” adds McKay. “With prototype and instrument development, we continue to analyse ways to improve our products, to better fit our customer’s ever-changing medical instrument needs. Among these are patient-positioning systems, clamping devices and electro surgical instrumentation.

“Recently we modified a major Melbourne based hospital’s robotic trolleys, to enhance the functionality of the system. Melbourne medical devices company Anatomics also asked us to custom manufacture a set of spinal tubes and forceps for spinal procedures.”

Running a medical devices business is expensive. McKay explains that the company went through a TGA audit this March and it’s an expensive process for a small business.

“It cost us $24,000 for the two-day audit and $23,000 for the consultant to prepare the audit report. You have the audit, and pass, or you run the risk of losing your certification and ultimately are unable to manufacture medical devices. We are very proud of our 100%-perfect record – 31 years of manufacturing and not one TGA recall or adverse event.”

On the company’s plans, McKay says: “Firstly we want to increase international sales and open distribution channels for our existing range of products, particularly theatre table products. Secondly, we hope to expand and service the non-healthcare businesses, especially those that have highly specified, quality short-run products and prototypes.”