Experience

Biostone Biologics

• United Kingdom
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Chief Scientific Officer

  • Jan 2017 - 7 years

  Nottingham, United Kingdom Biostone was established in 2017 at BioCity of Nottingham, UK. The aim of the company is to utilise a proprietary technology to create a new line of synthetic bone graft products to improve the clinical outcome and the life quality for the patient. Biostone received the US FDA 510K clearance for the first bone graft product, si-Mochi, in April 2021 and is in the process to gain the CE mark MDR certification. Biostone is also ISO13485:2016 certified by BSI in Feb 2021. si-Mochi contains a… Show more Biostone was established in 2017 at BioCity of Nottingham, UK. The aim of the company is to utilise a proprietary technology to create a new line of synthetic bone graft products to improve the clinical outcome and the life quality for the patient. Biostone received the US FDA 510K clearance for the first bone graft product, si-Mochi, in April 2021 and is in the process to gain the CE mark MDR certification. Biostone is also ISO13485:2016 certified by BSI in Feb 2021. si-Mochi contains a multi porous bi-phase Calcium Phosphate ceramic granules, 1~2mm, suspended in an aqueous polymer carrier gel in putty form and pre-packed in different applicators for easy use in wide range of bone graft application. Show less



Wollaton Medical Consultancy

• Director

  • Mar 2012 - 11 years 10 months

  Nottingham, United Kingdom WMC assists startup medical device companies with R&D, QMS certification and regulatory approvals in the USA, EU and the Asia. We work with experienced CRO companies in North America and Asia to provide guideline with a range of services including: * Cost efficient to bring the novel medical device into the market * Coordinate R&D strategy in line with the Regulatory requirement * Navigate through Regulatory affairs with external regulatory partner for the latest regulation… Show more WMC assists startup medical device companies with R&D, QMS certification and regulatory approvals in the USA, EU and the Asia. We work with experienced CRO companies in North America and Asia to provide guideline with a range of services including: * Cost efficient to bring the novel medical device into the market * Coordinate R&D strategy in line with the Regulatory requirement * Navigate through Regulatory affairs with external regulatory partner for the latest regulation update * Establish the Quality Management Systems according to the latest ISO13485 and MDSAP requirement * Identify the ideal R&D, commercial partner for company growth. Show less



Orthogem Ltd

• CSO

  • Jan 2001 - Feb 2012

  Biocity, Nottingham I founded Orthogem Ltd UK in January 2001 with the initial funding from Oxford Technology VC company. The aim of the company is to develop a Synthetic Bone Graft (SBG) products based on a new concept which I invented. After the initial laboratory stage to transfer the concept into scalable process, I then spent most of the time to set up the commercial scale production of this unique SBG product within Biocity Nottingham. During the process I have to scale up the manufacturing process… Show more I founded Orthogem Ltd UK in January 2001 with the initial funding from Oxford Technology VC company. The aim of the company is to develop a Synthetic Bone Graft (SBG) products based on a new concept which I invented. After the initial laboratory stage to transfer the concept into scalable process, I then spent most of the time to set up the commercial scale production of this unique SBG product within Biocity Nottingham. During the process I have to scale up the manufacturing process, write up the SOP for each single stage of the manufacturing process, assist to implement quality control system, assist to achieve ISO 13485 certificate, arrange and conduct animal trial, assist gain CE mark and FDA (US) clearance for the products and filed 4 more patents base on the concept, arrange the clinical trial to get initial clinical data for the product. All these tasks were done under very tight budget. Show less