Services
Medical Device Consulting, Dipl. Ing. Wolfgang Merkle
Often, the lack of qualified human resource is a limiting factor for business expansion and growth. Recruiting new personnel is time consuming and costly,
and business opportunities may be lost because of the time factor. This is an issue, particularly for small- midsize companies.
A solution to that problem is to seek qualified external support or to outsource certain activities.
How can I help you to better develop your business ?
I am working since 2007 as an independent consultant for the medical product industry. My experience is based on 25 years in the medical product industry,
covering all relevant fields of product design, clinical evaluation and studies, regulatory compliance, marketing and sales.
I have particular experience in managing the interfaces between various departments.
During these 25 years I have gained access to a global network of partners, whether in regulatory, clinical or in the distribution field. Through this network,
I can easily add capacity to tasks if needed. This approach eliminates widely overhead costs, so that my consulting services are very competitive and affordable.
I offer competent consulting services for the following medical product areas:
- Regulatory service and medical writing
- Clinical device evaluation-clinical studies
- Marketing and sales support
- Hospital equipment planning
Regulatory services
Preparation of Pre Market Notification (510(k)) approval submissions and follow up with regulatory authorities
CE conformity assessment - literature studies for conformity assessments
Representation of medical device manufacturers outside the European Community /CE representation)
Assistance with Chinese SFDA approval
Canadian Medical Device Licence: preparing documents and filing approval
FDA - Classification of devices
The Food and Drug Administration (FDA) groups devices in 3 classes. Class 1 is exempted from filing a so called 510(k), which is generally required for class 2 devices. Class 2 devices, which are reviewed under a 510(k) process, are substantial equivalent devices, i.e. there exist a predicate device, the new device can be compared to. Usually there are no clinical data required under a 510(k). If the device is not substantial equivalent to a predicate device, it is a class 3 device and must follow the Pre Marketing Approval (PMA) process.
The scope of my regulatory service covers class 1 and class 2 devices. An example of the FDA decision process to determine substantial equivalence of a device is shown on the left side.
FDA charges fees for manufacturing establishment registration and for reviewing 510(k) submissions.
Fees for small businesses (small = < 100 mln USD revenue) are as follows:
- Regulatory service and medical writing
- Clinical device evaluation-clinical studies
- Marketing and sales support
- Hospital equipment planning
About GMP compliance
Medical device manufacturers who want to sell their devices in the United States must comply with 21 CFR Part 820 of US law, which is commonly known as GMP (Good Manufacturing Practice). GMP requires a quality system for the design, manufacturing, packaging, labeling, storage and delivery of medical devices, compliant to relevant standards.
Compliance with ISO 13485 will require additional elements to be integrated into the quality system in order to comply also with GMP.
Marketing & Sales
Marketing and sales support
- Preparing market surveys for specific products and fields
- Preparing marketing and business plans
- Building a distribution network globally
- Building clinical reference sites and taking care of clinical partners
- Regional representative for medical products
- European / CE representative for foreign manufacturers
Clinical
Clinical evaluation of medical products
- Preparation of clinical investigation plans and review / adjustment with clinical investigators and statisticians
- Coordinating statistical planning and evaluation
- Recruiting clinical partners for studies and evaluations
- Search and acquisition of clinical partners
- Clinical study monitoring and coordination
- Clinical study reports and evaluations
- Preparing literature based device assessments for new medical devices (safety and effectiveness analogy conclusion)
OT Planning
Operating Theatre planning; hospital equipment planning
- Defining requirements with surgeons and staff
- Preparing equipment proposal incl. floor plans, installation planning
- Preparing tender specification for equipment
- Independent tendering and tender process monitoring
- Coordination of site preparation and equipment installation
Career Development
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Since August 2007
Independent Medical Device Consultant with focus on the following consulting areas:
- Regulatory consulting for medical devices
- Clinical studies - clinical evaluations
- External product management and marketing support
- Global medical device marketing and sales
- Project management for modular operating theatres
-
1997 - 2007
Working in a medium size company with focus on urology, orthopedics and veterinary medicine with the following responsibilities
- Technical Director, Director Product Management
- Responsible for international regulatory medical device approvals, incl. design and management of related clinical studies
- Key account responsibility for urology clients
- Managing key opinion leader relation, assuring congress presentation and publication continuity
- Responsible for a new therapy PMA (Pre-Marketing-Approval with FDA / USA; project management of a multicentric, randomized, placebo controlled clinical study (pain treatment device); PMA approved July 2006
Clinical application research and new device design
- Novel combination lithotripter for faster stone clearance; European patent no. EP 1163884,Sales record 2001-2007: > 1500 units
- Device for high pressure liquid ejection, European Patent EP0771219; device used as a new non-viral vector for gene transfer; conducting animal trial series with Institute of Human Virology, Baltimore, USA (UMAB); present status: phase 2 clinical study
- Novel method for endoscopically controlled bone cement removal, European patent EP 0910317
- 1992 - 1997
Development of the medical branch within an international, Swiss based corporation
Area sales manager for lithotripter systems for Europe, Middle East, Asia; achieving market leadership in the endoscopic lithotripsy device market segment- 1990 - 1992
Shareholder and general manager of a medical start-up company; designing and marketing special technical hospital equipment; market introduction in Germany of a high pressure water jet tissue dissector
- 1988 - 1990
International Group Product Manager in a large size medical and pharmaceutical company
project management of a special dialysis systems for the Japanese market and for new generation of physiologically controlled hemodialysis system- 1985 - 1988
Medical division of a large size leading technology company.
System consulting and project management of lithotripter installations in Europe and Asia, sales engineer Far East- 1983 - 1985
Project management department of a large size leading technology company; schedules for space satellite projects; member of the project management team of a large linear accelerator at a nuclear research centre in, Germany
- 1978 - 1983
- University of Applied Science, Ulm Germany
- Diploma in Manufacturing Engineering
- Diploma thesis: Optimization of large industrial air conditioning at Daimler Benz AG Stuttgart; grade: 1
Inquiry
Please send me your inquiry. I will reply usually within 24 hours.
Location:
Alter Ortsweg 10, 88709 Meersburg, Germany
Email:
info@meddec.com
Call & FAX:
+49 75 32 49 58 39