Customising biomaterial solutions for the medical device industry
31 October 2013
Author: Colm O’Dowd, co-founder and CEO, Vornia Ltd
Biomaterials are materials commonly used in medical devices, and intended to interface and interact with biological systems with the aim of treating and/or regenerating damaged tissue, organs or functions of the body. Vornia Ltd is a medical technology company specialising in the development of biomaterials-based clinical solutions. It designs, develops and fabricates customised biomaterial solutions for medical device manufacturers and providers who need to add differentiation to their products in the marketplace.
“These materials can be natural, synthetic or a combination of both and we develop and manufacture all our own materials in-house,” said Colm O’Dowd, co-founder and CEO of Vornia. “What we want is to produce superior quality natural and synthetic biomaterials for our customers and for ongoing research and development [R&D] of new medical technologies.”
O’Dowd ‘spun out’ Vornia in May 2010 with colleagues from the National University of Ireland Galway. The company’s expertise includes the adaption of biomaterials to facilitate the linking or incorporation of therapeutics including drugs, genes and cells – the intention being to stimulate the incorporation of these materials into the body to promote tissue formation and regeneration. A significant proportion of Vornia’s budget funds in-house research and development, according to O’Dowd, allowing it to provide innovative platform technologies with the aim of improving clinical outcomes.
The team at Vornia includes specialist biologists, chemists and biomedical engineers, who combine with regulatory, production and operational staff to take research concepts through the regulatory process to scale up and manufacture of a finished product at GMP (Good Manufacturing Practice) level.
Currently, there is a total of 12 staff working in Vornia, with an additional two employed on a part-time basis. “This is set to increase to 17 next month, due to a recent recruitment drive resulting from successful EU FP7 grant awards, said O’Dowd. Due to the nature of biomaterials development for medical devices, a broad range of skills are required across the sciences, engineering, regulatory and operational specialties. The current breakdown of staff in these specialities is scientists including six chemists and biologists, four engineers, one regulatory and one operational.
“To recruit staff in this industry, we search globally,” according to O’Dowd. “While 50 per cent of our staff is recruited locally, a significant proportion is recruited internationally including China (15%), the UK (15%), Canada (10%) and the Middle East (10%). We also host several international secondees annually through EU FP7 awards such as the Marie Curie programme.”
Vornia is currently involved in six EU FP7 collaborative projects involving the development and scale-up of innovative materials and medical device technologies. “We have 40 partners in 13 countries in the Eurozone,” he continued. “Our position within these projects as developer of the materials means that we can deliver across this bandwidth as many of the platforms are interchangeable. This R&D focuses on niche areas including spinal cord and peripheral nerve regeneration, musculoskeletal regeneration, soft tissue repair [hernia], tendon regeneration and stent coating technologies.
“We believe that we produce higher quality materials than what’s available on the market currently and these materials have, with some development, a wide range of applications.”
LICENSING OPPORTUNITIES FOR TECHNOLOGIES
Vornia is currently ISO13485 approved for the manufacture of collagen- and polymer-based products. In mid-November, the company expects to have full ISO13485 certification from Lloyds UK for design and development of medical devices. It currently holds design history files (DHF) for two medical devices – one a spinal cord device and the other a tendon regeneration device. According to O’Dowd, Vornia is also searching for other licence opportunities for technologies within Irish and European universities.
“One of those DHFs is NeuroGraft, an EU FP7 project aimed at the repair of the spinal cord following contusion or transection injury,” he said. “The project is designed in three stages – design of the scaffold, a stage in which this scaffold loaded with a slow release immunomodulator and a final stage, where the loaded scaffold is seeded with transplanted mesenchymal cells to reduce initial inflammatory response and enhance axonal regeneration in the damaged cord respectively.”
Typically the device would be implanted immediately following decompression of the spinal cord. The function of the first-stage device is to provide structural support while also facilitating the directional guidance of axons across the injury site. Regenerating axons usually need this guidance to prevent a condition known as polyinnervation, due to misdirected axonal growth.
In another EU FP7-funded collaborative project, Vornia has developed and implemented a design plan for the regeneration of injured or degenerated tendons. “In this plan, biomimetic fibrous composites will be designed and developed that’ll mimic the structure of native tendons,” explained O’Dowd. “To date, strong fibrous collagen structures have been developed which facilitate the reconstruction of damaged tendons – but these structures lack the elasticity that’s required for normal tendon function.”
In this project, the company’s partners in Israel have developed a protein that is now being incorporated into the collagen material at Vornia to produce a material with unique properties of strength and elasticity. Prior to implantation, the novel materials undergo a suite of biocompatibility tests at Vornia, which confirm its suitability for implantation.
Typically following mechanical testing the materials are sterilised and seeded with human cell lines in vitro to examine its effect on the metabolism, genetic composition and ultimately colonisation of these cells on the scaffold material. A positive growth and colonisation result indicates the suitability of the material for regeneration and incorporation into the body.
“All the materials developed here are biodegradable – they’re used to assist the body in regenerating itself before been degraded,” said O’Dowd. “It’s really important to tune this degradation time, so that the body tissue has adequate time to regenerate itself prior to assimilation of the structure back into the body. So, our materials and structure are tested using degradation studies to indicate the likely life of the device in the body – the length of this can be tailored using various cross-linking regimes to extend or limit this. This is an important aspect of the tendon regeneration project.”
MATERIAL DEVELOPMENT FOR SUPPLY
Conversely, in the Green Nano Mesh EU FP7 collaborative project, the focus for Vornia is on material development for supply to a medical device manufacturer. The project is focused on the production of environmentally sustainable materials for hernia mesh repair that will replace materials currently used.
Vornia has developed a ‘green’ method for producing bio-resorbable polymers including a widely used polymer in the medical device industry – poly caprolactone (PCL). “These materials are supplied to our textile partners in Belgium, who extrude the material in continuous fibres onto spools,” explained O’Dowd. “To enhance the integration of the fibre into the body and limit inflammatory responses, the fibre is then coated with Vornia collagen, which is a highly purified material extracted from bovine tendons. While the PCL is itself highly compatible, the collagen coating masks the alien material in the body and enhances its integration.”
Vornia is positioned in ever-growing market. Polymers used in medical devices, for example, are estimated to be worth €5.7 billion annually in the US alone, while collagen and hyaluronic acid are expected to reach €2 billion annual sales by 2015, according to the Global Biomaterials Market Report 2010 – 2015.
While competition is strong in this market, Vornia has focused on developing, supplying and using quality natural and synthetic biomaterials for niche applications. Much of the company’s product is used in house or by its consortia partners – the aim is to add value to raw materials products, rather than become a raw materials supplier.
“So, we use as much of our own biomaterials as we can and we sell the rest,” O’Dowd said. “Our clients are typically R&D organisations including universities and small medical-device design and development companies. Our business is global and we supply to clients in China, the Middle East, the EU and US markets,” he concluded.
Colm O’Dowd is CEO and co-founder of Vornia Ltd. He completed his PhD in radiation physics at the FOCUS Institute, Dublin Institute of Technology, in 2010. He was awarded a Japanese Monbusho Fellowship between 1997 and 1999 at Tokyo University of Agriculture and Technology, where he worked in the Department of Marine Biotechnology. Prior to this, he worked as a research associate at Herriot-Watt University, Edinburgh. O’Dowd graduated with an honours degree from Herriot-Watt University and a diploma in aquatic science from Galway-Mayo Institute of Technology.
Before co-founding Vornia, O’Dowd worked as programme manager at the Network of Excellence for Functional Biomaterials, NUI Galway. His interests involve the translation and commercialisation of scientific research from the laboratory to the clinic.http://www.engineersjournal.ie/2013/10/31/customising-biomaterial-solutions-for-the-medical-device-industry/http://www.engineersjournal.ie/wp-content/uploads/2013/10/Spine-1024x768.jpghttp://www.engineersjournal.ie/wp-content/uploads/2013/10/Spine-300x300.jpgBiobiomedical,medical devices,NUI Galway