Stay current with MiRXES
Newsroom > Insights
TeamTalk: Jeremiah Decosta
In the world of medical diagnostics manufacturing, there’s no room for error. Even the smallest slip-up could lead to ineffective tests, leading to inaccurate results and misguided diagnoses. To prevent these mistakes from occurring, companies must have validated manufacturing processes and products—as shown by regulatory compliance.
Though managing regulatory affairs is often associated with mounds of paperwork, going through its rigors guarantees patients of the quality of medical devices and diagnostics—ensuring that lives can indeed, be saved. At MiRXES, such matters are deftly handled by Jeremiah Decosta, Vice President of Manufacturing and Regulatory Affairs
With the successful launches of GASTROClear and the Fortitude series of COVID-19 test kits, Decosta’s prowess in managing manufacturing and regulatory affairs has since been tried and tested. But he’s not resting on his laurels—today, Decosta is leveraging the innovative approaches of Industry 4.0 to transform MiRXES’ current operations into smart factories of the future.
In this interview, dive into a day of Decosta’s life and read how MiRXES keeps up with the latest technological trends to ensure the best diagnostics for patients.
1. Tell us how you first came to join MiRXES.
I had a casual meet-up with Zhou Lihan, our CEO, just to get to know each other better—but we soon realized MiRXES’ business needs aligned with my aspirations. More importantly, I felt very attracted to the nature of the business and the brilliance of its co-founders and was excited about the technology. I guess the timing was perfect as MiRXES was searching for a manufacturing guy to look into the plant’s needs and I happened to have the skillset to get the engine running. One could say I was a believer of the business right from the start!
2. Can you describe what a typical day in your life as MiRXES’ VP for Manufacturing & Regulatory Affairs is like?
I typically start with meetings to catch up with everything that requires my attention like product tech transfer, Industry 4.0 project catch ups, department challenges and updates and more. By noon, I speak to collaborators to look at new technologies and form partnerships while keeping abreast with the manufacturing and regulatory landscape both locally and in the region.
Towards the afternoon, I look at the plant outputs in terms of efficiency, product quality and spend time on individual functions of quality assurance, quality control, production, process reviews and others.
I dedicate late afternoons to looking at money matters. I look at project budgets and their relative values and outcomes, approve purchase requisitions for the plant and once in a while, look at the amount of inventory in stock to ensure a healthy flow of incoming materials and outgoing goods. Towards the evening , I attend to my emails and review my to-do list which I visit over the week to ensure I stay on track with my goals and action items.
3. With the rise of Industry 4.0, what steps is MiRXES taking to digitalize and improve its manufacturing operations?
Industry 4.0 has presented itself to MiRXES in a slightly different way—we use it to look into flexible manufacturing. We take on Industry 4.0 with our product quality and manufacturing efficiency in mind as well as to contribute to the in vitro diagnostic medical device (IVD) regulations and supply chain ecosystem in Singapore.
Through careful planning, we now invest in automation for all our functions to allow us to pivot processes based on customers’ needs. We are also moving towards a smart factory setting by deploying an integrated electronic quality management system (EQMS), manufacturing execution system (MES), warehouse management system (WMS) and enterprise resource planning (ERP) system with a factory digital twin for us to have real-time manufacturing data for quick decision making.
4. Having now released GASTROClear and the Fortitude series of test kits, what were some challenges the team encountered in the process of obtaining regulatory approvals? How did you overcome these challenges?
GASTROClear is the first of its kind—because we embedded miRNA technology in an IVD it had to undergo more scrutiny to meet high safety standards. However, the regulatory bodies were very supportive of innovation and new technology. They provided clear and precise explanations until we managed to get the device registered. This also resulted in the birth of Singapore’s first ever miRNA Singapore Standards (SS 656) of which MiRXES is very proud to be a part of drafting!
For the Fortitude series of tests however, we, along with the rest of the world, faced an unprecedented time in the regulatory stratosphere. It was a global expectation that COVID-19 related test kits received quick clearance to be deployed in their respective countries. We were faced with very new registration requirements that differed from the normal regulatory clearance process. The regulatory affairs team was also tasked to have the Fortitude kits registered in more than 10 countries at one time.
This took a lot of coordination, preparation of different submission dossiers and close working relationships with our commercial team and distributors to pull off all these registrations. With perseverance, the team managed to pull it off while upholding device quality and safety.
5. What are some manufacturing or regulatory milestones you hope to achieve with MiRXES in the next few years?
I would love to see the MiRXES manufacturing and regulatory team maintain its consistent efficiency and high quality products. Through our investments in flexible manufacturing technologies, I would like to see the team soar to even greater heights and contribute to the local and regional ecosystem for IVD manufacturing. This will directly help our local and regional start-ups and SMEs bring their innovations from bench to bedside while being ever prepared for a crisis through supply chain resilience.
At the regulatory front, I’ve always believed that the regulatory affairs team goes beyond product registration. We strive to have a team that’s well connected and informed and hopefully has a role in supporting more harmonized regulatory clearance systems.