Sometimes you need distance to understand the path

SmartPath's Values & Beliefs

Patient’s Quality of Life

Collaborative Team Spirit

Continuous Development

Ownership of Success

Mission Statement

At SmartPath, our mission is to accelerate the development and delivery of innovative medical technologies. We focus on streamlining complex processes to ensure that patients receive timely, affordable access to the solutions they need. By bridging the gap between innovation and real-world patient care, we help turn ideas into impact, faster and more efficiently.

Jessica Gilgenbach, PhD

CEO & Founder
20+ Years Leading Medical Device Development | TÜV SÜD Certified Regulatory Affairs Manager
Business Profile
Jessica brings extensive experience to the leadership role, having led medical device startups and larger organizations in a corporate environment. With a background in strategy definition, product portfolio management, and expertise in M&A funnel creation, she serves as an R&D subject matter expert for mid-size M&A activities. In her previous role as a Business Unit leader, Jessica was responsible for P&L management, R&D execution, and the launch of dental products. Her strengths lie in setting up R&D organizations, establishing product pipelines, and implementing project or development processes. Over the last 20 years, strategic partnerships with other companies, universities, and service providers, as well as advisory management, have been integral aspects of Jessica's daily corporate routines.
#Startupdoctor #Leadership #Strategicpartnership #RA&QAexpert

Melkys Schaub, DPM

Product/Project Manager
Usability IEC 62366 & Clinical Evaluation Expert MDR Annex XIV & MEDDEV 2.7/1 Rev. 4 | TÜV SÜD Certified Regulatory Affairs Manager
Business Profile
Melkys is a versatile medical device professional with 12 years of experience in healthcare across various sectors and dual degrees in Podiatric Medicine and Economics. She combines strong product and project management skills with international regulatory expertise. As a Regulatory Affairs Manager, she has led clinical evaluations and regulatory submissions across the EU, U.S., and Canada. Melkys excels at turning HCP and customer insights into actionable development input, ensuring products meet global standards while addressing real-world clinical needs.
#Productmanager #Usabilityengineeringexpert #ClinicalEvaluationExpert #RAInternationalManager

Emiliano Sorrentino, PhD

Product Development Engineer
Process Optimization & Scale-Up | QA Specialist TÜV SÜD Certified in Quality Management for Medical Devices (ISO 13485)
Business Profile
Emiliano has over a decade of experience working in the field of R&D participating in the discovery and development of new drugs, as well as the design of innovative antimicrobial formulations used in consumer products and medical devices. Emiliano has assumed leadership roles in several projects in both academic and industrial settings, showcasing strengths in projects and team management. His proficiency in ensuring regulatory compliance and effective implementation of quality management systems enhances his role in advancing product development in the medical device industry. Possessing a M. Sc. in Pharmaceutical Chemistry and Technologies along with a Ph.D. in Chemistry, Emiliano brings an in-depth knowledge of synthetic organic chemistry coupled with strong experience in the pharmaceutical industry working on the development and scale-up of new chemical processes.
#R&D #Chemicalexpert #eQMSimplementation #Productdevelopmentengineer

Silvia Caddeo, PhD

Sr. Project Manager |R&D | Biomaterials and Biocompatibility expert ISO 10993 Series
Business Profile
Silvia is an experienced Project Manager and R&D specialist with a strong background in medical devices, biocompatibility, and biomaterials. She has proven track record managing complex MDR-related projects in matrix organizations, leading cross-functional teams, and ensuring timely delivery of critical regulatory and technical milestones. She is skilled in stakeholder management, process optimization, and strategic decision-making. Silvia brings hands-on experience from R&D, preclinical testing, and product development, combined with the ability to translate scientific insights into actionable project plans. She is recognized for driving efficiency, improving workflows, and supporting successful regulatory submissions in highly regulated environments.
#Productmanager #Biocompatibilityexpert #R&D #Materialscientsspecialist

Customized Project Team

At SmartPath, we recognize the importance of assembling customized project teams that complement your internal strengths and help execute your development projects in a cost-efficient manner. To achieve this, we leverage our extensive network of experts.

Our large network of professionals spans various fields and disciplines within the medical device industry. These experts bring diverse skill sets, knowledge, and experiences to the table. By tapping into this network, we can identify and engage the right experts who align with the specific requirements of your project.

  • Regulatory Affairs
  • Quality Assurance
  • Design Engineering
  • Development Engineering
  • Lab Testing & Verification
  • Academic Research
  • Clinical Practice
  • Clinical Evaluation
  • Project Management
  • Intellectual Property