OPINIONS FROM ACROSS THE MANUFACTURING INDUSTRY QMS for manufacturing MedTech

Understanding Quality Management Systems (QMS) for commercial success in MedTech/Biotech.

The medical technology, biotechnology, pharmaceutical and digital health (MTP) sector is critical to Australia’s economy, the health outcomes of the population and the innovation ecosystem. In 2019 there were nearly 1,300 companies in the MTP sector that employed approximately 68,000 workers and contributed $5.2bn to the economy. The MTP sector added an additional 5,000 jobs across 2020 and 2021 and contributed around $5.5bn to the economy, respectively. The market capitalisation of MTP companies continued to grow strongly at 20% p.a. and MTP companies raised nearly $3.4bn in capital through 2020/21, as markets realised how resilient and vital the sector was to the broader economy.

MTPConnect is an independent, not-for-profit Growth Centre established to drive connectivity, innovation, productivity and competitiveness in Australia’s MTP sector.

In May 2020, MTPConnect was contracted by the Australian Federal Government to operate the Researcher Exchange and Development within Industry (REDI) program. This four-year initiative is backed by $32m in funding from the Medical Research Future Fund (MRFF) that aims to build an industry-ready workforce with the skills and capacity to keep pace with the demands of a rapidly changing sector – for now and the future – deploying an integrated three-pillar plan as per the figure below.

Within Pillar Two, REDI delivered a forward-looking 'root and branch' analysis of the MTP workforce to provide a deep understanding of current and future skills gaps. The November 2020 Interim Report identified skills gaps that need to be addressed across the sector in the near-term following assessment against four key metrics:

1. Alignment of the skills gaps with sector priorities

2. Alignment of the skills gaps with global megatrends

3. Breadth of impact across the MTP value chain

4. Depth of impact and estimated value from addressing the gap

The top three priority skills gaps were identified as those that can unlock significant value for the MTP sector if addressed, impact a broad cross-section of the MTP sector value chain, are not currently addressed by existing REDI programs and can be reasonably addressed within a short timeframe.

Priority Skills Gap One was identified as “Understanding of Quality Management Systems (QMS) and protocols” within the “Advanced manufacturing & supply chain” theme.

Overview

The MTP sector is highly regulated with manufacturers needing to be verified by government regulators (e.g. TGA in Australia and FDA in the USA) as meeting relevant quality standards before they are eligible to market products. Applicable international Quality Management System (QMS) Standards for manufacturers of MTP products include ISO 9001 (generic Quality Management), ISO 13485 (medical device Quality Management), ISO 17025 (competence of testing and calibration laboratories) and Good Laboratory Practice (GLP - quality control for non-clinical health, safety and environmental studies).

Stakeholder consultations highlighted that universities, start-ups and Subject Matter Experts within the MTP sector often lack the following skills related to quality management:

• Understanding of the importance of adopting and maintaining appropriate quality management systems among business leaders; and

• Lack of staff members with sufficient training in quality management systems to:

- Define best-practice quality management principles and protocols that are aligned to relevant industry standards;

- Design and implement a path for achieving greater alignment to industry accreditation; and

- Maintain quality procedures and quality systems to ensure high standard facilities

Although it is a core capability for commercial success in the MTP sector, adoption of QMS processes and maintaining informal alignment or formal certification to standards can be considered too time consuming and difficult.

Large and established companies tend have sufficient in-house capabilities due to their scale and deep knowledge of the regulatory requirements of the MTP sector. However, the QMS skills gap is particularly evident within start-ups and SMEs noting the emergence of more MedTech, Biotech and digital health businesses.

Value and nature of addressing the gap

Broader adoption of Quality Management Systems and standards by start-ups and SMEs will drive greater commercialisation success, as companies will be better positioned for investor / partnering discussions, regulatory submissions and becoming preferred suppliers in a global market.

Developing greater quality management at the basic research level will also drive greater commercialisation outcomes long-term. Researchers will gain greater credibility among big MTP companies and increase the likelihood of obtaining licensing deals if the assets and data have been processed in compliance with international quality standards. There were instances highlighted in interviews where research was required to be repeated under GLP processes, slowing commercialisation.

Furthermore, the COVID-19 pandemic highlighted the value of appropriate quality certifications when responding to global supply chain disruptions. A number of potential domestic manufacturers of medical equipment and supplies were unable to effectively pivot their operations and contribute to the pandemic response because they didn’t have ISO 13485 certification.

Closing the gap

SeerPharma, a consulting and training organisation servicing life science industries, was selected by MTPConnect as the REDI Partner to deliver a range of QMS training courses across Australia addressing ISO 9001, ISO 13485, ISO 17025 and GLP. To date, over 700 Australians have undertaken the free online and ondemand QMS Primer while over 300 people have undertaken a three or four-day deep-dive workshop learning the requirements of ISO 9001, ISO 13485 and GLP QMS Standards as well as how to meet them.

seerpharma.com/REDI