With more than three decades in the healthcare sector, I offer a wealth of expertise divided between pharmaceuticals and the medical device industry. My career features leadership positions within several SMEs, where I gained comprehensive experience in Design Controls, QA, and Regulatory Affairs. I specialize in manufacturing validation, sterilization protocols, and ISO 14971 risk management. My background also includes establishing ISO 13485 Quality Management Systems and serving as a Technical Specialist at BSI to ensure total regulatory compliance.
Case Study 1
At a small start-up company I held 2 management positions and was also the project manager responsible for taking the first medical device to CE Mark. This was a Class III implant that was created using novel regenerative medicine technology to repair tissue and restore function. The launch deadline was met 2 years earlier than expected, and over £0.5 million remained in the company budget. When asking investors to fund the second product for £3 million, they offered £25 million based on the progress and performance achieved.
Case Study 1
I joined an SME at the start of my career in medical devices, as a project manager. My project was to complete all required work to take the first injectable Class III medical device to CE Mark that same year. The intended use was for treatment of female urinary incontinence, by bulking the tissue around the neck of the bladder with a suspension of sterile, acellular pig collagen in saline. This was done on an outpatient basis, and so provided a much simpler treatment than implantation of surgical mesh for the same indications.
When I joined the company, I knew absolutely nothing about Design Controls or medical devices, and I had never worked as a project manager before. It was a tremendous learning curve!
My first task was to write the Validation Master Plan, and learn how to make the product myself. At that point, the manufacturing plant was still under construction. I had 6 months in which to complete the EU launch.
All tasks were completed on time, including process and product verifications and validations. The device was sterilised using gamma irradiation and presented in a 7ml glass vial. I worked closely with all departments and took part in making the validation batches, among many other activities.
Seeing the improvement to the patients' quality of life when they no longer leaked urine when coughing, sneezing or exercising was so wonderful!
The product was successfully launched on time in the EU, and was later developed into a more concentrated paste, to be used for treatment of anal fistulae.
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