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NTUitive-incubated Startup Osteopore: Building Growth Overseas with Standards
Date: 17 Oct 2017
When Osteopore was set up in 2004, its goal was to commercialise 3D printed bioresorbable scaffolds for tissue regeneration – in other words, materials that can be broken down by the body and do not require mechanical removal, such as sutures – which is useful for bone healing.
Osteopore became the first company in the world to do so, soon after attaining US Food and Drug Administration (FDA) clearance in 2006.
When entering the world of medical device manufacturing, top of the local company’s agenda was to ensure compliance to standards, as safety and quality are non-negotiable in the industry.
“We wanted to make sure consistent processes were in place and that we could meet international quality benchmarks. These would make it easier for us to obtain the certification needed to bring the product to market in various countries,” explains Mr Goh Khoon Seng, CEO, Osteopore.
The company’s processes were designed from day one to meet the quality and manufacturing specifications required of ISO 13485, a quality management system that focuses on improving patient safety. ISO 13485 is the world’s most widely used medical device quality management system standard. Meeting this was essential to ensure compliance with the requirements expected of major medical technology companies.
Solving a problem
It can be a painful and expensive journey to recovery for patients suffering from head injuries that require surgical repair to their bones. The damaged skull is usually mended with either bone harvested from another part of the body or a titanium plate. Still, it is often not easy to find a replacement bone.
While titanium implants are more readily available than harvested bone, they carry the risk of infection and can be very costly in the long run if there is a need to treat the complications or conduct revision surgery.
A safer and more efficient solution lies in the products developed by Osteopore. The company develops implants that work as natural scaffolds. These encourage bone tissues to regenerate, while the scaffolds gradually get absorbed by the body as it heals. This significantly reduces the risk of infection as well as the potential for revision surgery which adds to costs.
Osteopore took two years to design its processes, such as ensuring that its manufacturing methods met safety and hygiene criteria. In achieving ISO 13485, the company also met the requirements for other standards like ISO 11137 for sterilisation, ISO 11607 for packaging, ISO 14644-1 for CleanRoom and ISO 10993 for biocompatibility.
These achievements not only helped Osteopore obtain the ISO 13485 certification, but also helped the company build the credibility of its products in new markets.
Certified quality
In 2006, after achieving ISO 13485 certification, Osteopore attained the US FDA certification – an important milestone as the certification is one of the world’s most widely recognised quality benchmarks.
“With each certification, it became easier to obtain the next one for new markets as the track record helps build trust and serve as references. This cuts down on compliance and paperwork significantly – allowing us to go to market without much difficulty,” says Dr Lim Jing, Chief Technology Officer, Osteopore.
In 2007, Osteopore applied for a Health Sciences Authority certification in Singapore, followed by the CE Mark in 2009 that opened access to European Union markets like Germany. It also obtained the Korea FDA certification in 2011.
The adoption of standards raises the confidence of customers and the industry. “Having these standards definitely helped in successfully applying for certifications,” adds Dr Lim.
Both Dr Lim and Mr Goh believe that having both standards and the necessary certifications helped the company gain traction globally, especially in clinical sales.
Since acquiring the US FDA and CE Mark certifications, Osteopore has been able to go beyond the United States and Europe markets, and step up its presence in Indonesia, Thailand, Malaysia, Korea, Vietnam, Myanmar, and the Philippines. The company’s clinical sales grew three times in 2016 compared to 2015, and expects to triple its growth again in 2017.
On the right track
Moving forward, Osteopore believes maintaining standards will be just as important as meeting new ones. It undergoes audits for re-certification of its various standards and licences every few years and, in some cases, annually.
The current processes in place also mean that it will be easier for the company’s newly developed products to meet standards. It is currently developing new materials and technology to enable their scaffolds to be implanted in other parts of the human body.
“It typically gets easier because we already have everything in place. That is why it is important to have the right processes designed from the start, and to regularly keep your staff updated with the latest industry trends and criteria,” Mr Goh says.
Article Credit: SPRINGnews – SPRING's monthly corporate publication for SMEs, start-ups and partners (September 2017 issue; Pages 10 & 11)
