Nicholas Medcalf

Bioengineering Consultant, Biomatics

Nick is an engineer with wide experience in the research, development, and manufacture of healthcare products. He has worked on projects to develop pharmaceuticals, advanced therapeutics,
medical devices and combination products with input at each stage of the product lifecycle from preparation of candidate products and prototypes to process design, quality management, manufacture and process troubleshooting.

Nick has led projects in academia, industry and the public sector. His main motivation is to get safe, effective, innovative products to market, using robust, durable and economical operations. Nick designs and improves manufacturing and business processes in the context of the whole operation. He has managed international projects with teams in Italy, Japan, the Republic of Ireland and South Africa.

At the Royal Academy of Engineering Nick is an active member of the Enterprise Hub. He also supports the Bioindustry Association as a member of the Manufacturing Advisory Committee and the Cell and Gene Therapy Advisory Committee.

Key Achievements

  • Project Leader for a process re-engineering project that reduced the batch failure rate for a valuable biomedical polymer from approximately 30% to less than 5% and which later received the Queen’s Award for Technological Achievement.
  • Identified human factors responsible for increasing rate of batch loss in manufacture of an established polymer and coached the staff to monitor and improve their own compliance practices. Savings in the first year exceeded £600k.
  • Conducted independent evaluation of the trial implementation of OptiMed-ID, an automated single-dose dispensing system at University Hospitals of Leicester Trust. Demonstrated a cost reduction of approximately 25% for Lord Carter’s report into potential NHS savings.
  • Initiator, co-investigator and coach to the EPSRC Re-distributed Manufacturing in Healthcare Network which set the agenda for Research Council funding in de-centralised manufacturing for advanced therapeutics, drugs and medical devices.
  • Elevated the quality management system at a US medical device manufacturing operation from ISO 13485 compliance alone to permit manufacture of medicated combination products.
  • Working with company directors, re-designed the R&D portfolio management system to use a combined Expected Current Value and Real Options method, allowing a balanced approach.
  • Co-Investigator on the ‘3DP’ feasibility study into anti-counterfeiting measures for additive manufacture of healthcare products with the University of Sussex, Brighton.
  • Set up, validated and managed cleanroom facilities for advanced therapy development.
  • Successfully mentored several early-career entrepreneurs in commercial development of medical devices, smart materials and drug delivery devices.
  • Excellent network of contacts nationally and internationally in academia, industry, government agencies and regulatory affairs.

21 September 2023, GLASGOW