We can support you with a range of services
We provide Market Development, Clinical Evidence & Business Development services to wound care businesses around the globe.
As International Wound Care Industry Experts with decades of experience & market-tested skills we can provide services to support you at every stage of your wound care product’s lifecycle.
Some of Our Network
More than 30 years’ experience in bringing wound care products of many and diverse technologies to market across a range of European countries.
Experienced in start-ups and product development as well as in bringing mature products to new markets. Previous roles and experience include Regional Vice-President for ConvaTec for Scandinavia and Central & Eastern Europe; Managing Director of Insense Ltd (biotech and woundcare), non- executive director on medical device start-ups, fund-raising for new businesses.
Member of the European Wound Management Association (EWMA)
Clinical & Regulatory Affairs Co-ordinator
Stacy has a degree in pharmacy with experience in domestic and international business development in the Indian pharmaceutical industry. Since moving to the UK, Stacy has worked for the NHS and has now taken up the role of Clinical and Regulatory Affairs Co-ordinator where she is using her scientific knowledge to perform literature reviews, compiling clinical evaluation reports and clinical research management.
Wound Market Consulting’s associates have backgrounds in major woundcare companies such as ConvaTec, KCi, Smith & Nephew, in technology-based start-ups and in regulatory and health provider organisations.
We continue to expand our network of associates and welcome approaches from anyone who can demonstrate a results-orientated track record in any field of the woundcare industry including the prevention of wounds.
Dr Jonathan Hughes PH.D
Dr Hughes has more than 32 years of worldwide regulatory and clinical affairs experience across medical devices, combination products and human / veterinary pharmaceuticals.
Following completion of his PhD in veterinary pathophysiology, Jonathan began his career in regulatory affairs at A H Robins. He subsequently held regulatory affairs positions in drug and device companies, including Smith & Nephew, Glaxo, Bristol-Myers Squibb and ConvaTec. Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. With 23 years of combined regulatory experience in wound care companies, Jonathan specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has worked with all the major international regulatory agencies, in particular US FDA, Japanese PMDA, Chinese NMPA, Notified Bodies and EU Competent Authorities.
Jonathan is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes, delivering lectures and acting as advisor for two medical technology MSc courses (at the University of Hertfordshire and Cranfield University) and a MRes course with Newcastle University.’
Patrcyja Buczak Kula
Patrycja has 17 years of clinical trial experience and has extensive knowledge and expertise in designing and deploying innovative and transformative strategies concentrating on clinical trial execution. Over years she specialized in Regulatory/Start-up of clinical trials with various medical devices (and investigational medicinal product).
Previous roles and experience include Head of Regulatory Department/ Clinical Operations Director at Clinscience (CRO), co-owner and founder of ClinMed Pharma (CRO).
RN Dr. Jiři Letal
Dr Letal is a Statistician with more than 30 years’ experience in biometrics, including 15 years in clinical trial statistical analyses and 15 years in biometrics research & lecturing.
He has worked at several international CROs and pharmaceutical companies including Advanced Drug and Device Services (France), Janssen Pharmaceuticals of JNJ ‘(Belgium) and Grünenthal (Germany) in a variety of therapeutic areas including; immunology, neurology, physiology, oncology, gastroenterology, haematology, dermatology, podiatry and pain management. He manages the statistical tasks across clinical trials phase I-IV., including interactions with regulatory authorities, acting as a trial biostatistician ensuring that clinical trial deliverables meet: state-of-the-art statistical methodology, regulatory requirements, operational efficiency and full alignment with the overall clinical strategy of the respective project. He has been the principal statistician for more than 20 multicentre clinical projects and a primary administrator of two analytical Euro Conferences. He is also a long standing member of the International Society of Clinical Biostatisticians (ISCB).
His strengths include SAS programming and statistical methodologies of generalized mixed models, linear and nonlinear regression analysis, survival analysis, categorical analysis, multivariate methods, FDA and ICH guidelines (including CDISC standards) and the design of data processing, programming and statistics SOPs. He is also a long standing member of the International Society of Clinical Biostatisticians (ISCB).
Dr Joanne James
Consultant: Pre-Clinical / Clinical Development
Joanne is a multi-award-winning scientist focussed on strategic development for start-ups/ SMEs. She has a proven innovation track record across medical devices/pharmaceuticals.
With >22 years of experience in translational medicine, specialising in wound healing, tissue repair and inflammatory disease, she maintains a thorough knowledge of the wound cascade and the global competitor landscape.
Joanne gained her PhD from the University of Aberdeen, as Piper Alpha Research Scholar, with a secondment to the Academic Medical Centre, Amsterdam. She has held lectureships and led research programmes at the Wound Healing Research Unit, University of Wales, and the Institute of Dentistry, Barts & the London School of Medicine. She retains an Honorary Senior Lectureship (Associate Professor) at the William Harvey Research Institute, Queen Mary University London.
She previously led a multi-project portfolio from raw patents through prioritisation of clinical development strategy, pre-clinical studies and product development, to successful completion of a multi-centre RCT of healing in the diabetic foot. Expansion of the patent portfolio, together with positive results allowed a £4.2M equity-raise in 2014 and a further £20M in 2018.
Joanne advises on pre-clinical evidence and clinical study design towards regulatory approval and commercialization. She is an associate member of the CCRA.
Giuseppe Mancullo has more than 28 years business experience in the Medical Devices arena. He developed his carrier within Smith and Nephew Italy managing various departments; logistics, customer care, marketing & market access and serving different business areas: Wound Care, Ortho- Reconstructive, Ortho-Arthroscopy, Ortho-Trauma.
For the past 18 years he focused on the wound care industry leading product launches projects, development of communication platforms (Quaderni di Forum), supporting the development of new therapeutic concepts (TIMECare) and participating to Board of Clinical Associations (past lay member of Board Committee of CORTE). In the last 5 years, his roles have included Market Access and BI management for Wound Care and Orthopedic businesses.
His areas of expertise also include strategic marketing and institutional relations with clinical referents and health governance.
A result driven global executive with extensive healthcare experience to support start-up and early-stage companies to get products to market. Founded GR Consulting which includes a team of senior-level industry and healthcare professionals to support early-stage medical device and biotech companies, with a specific focus on wound care and surgery (sales, market access, market data/analytics, marketing, strategy, product development, regulatory, reimbursement, legal, finance, IP analysis, technical due diligence). GRc has a proven track record of executing winning strategies for start-up and early-stage companies.
Areas of expertise include.
- Transaction, due diligence, and M&A process experience
- Strong network of senior executive contacts within the US and Globally
- Organized a team of senior-level professionals to support early-stage medical device and biotech companies in all aspects of getting wound care and surgical products to market
- A deep knowledge of business strategy with the ability to drive through to execution
- Highly creative in developing successful tactics and activities
- Leadership, a demonstrated ability to direct complex projects from concept to fully operational
Prior to starting GR Consulting, I worked with a variety of US Multinational Medical Device companies both in the US and internationally in a variety of senior-level roles, including Covidien, Haemonetics, CR Bard, Convatec, Sigvaris, and Camp International.