Consulting/Supervision in Directions: Concept, Design, Prototyping, Engineering of Medical Products. Strategy for Entering the U.S. Market, Business Plan Development
Top C-level experts of the Ukrainian tech business in one place. Personally recommended by Vika Prydatko, the #1 recruitment influencer in Ukraine.
Collaborate on specific requests, prepare processes for hiring new specialists, or launch a global company transformation — whatever your plan, VP Team ensures a swift start to collaborative work, supports organizational matters, and is there for any questions.
Consultant: Lisa Voronkova
"My goal is to help companies and startups develop innovative medical solutions that improve people's quality of life. I am always open to new challenges and ready to share my experience and knowledge to achieve common goals in the shortest time, as it is known that it takes an average of 7 years to bring a product to the U.S. medical market."
Expert in the development and manufacturing of medical devices and technologies.
12 years of experience in companies, consulting projects, startups in roles such as medical device development
engineer, project leader, project manager, CEO and founder, consultant for medical startups.
Founder of OVA Solutions, specializing in the development and support of startups in the field of medicine and health. In recent years, she has helped dozens of startups and companies with the development, launch, and improvement of their products. She also provides technical assessment and production support, U.S. market entry strategy, and interactions with insurance companies and the FDA in the U.S.
You can enter short-term consulting or long-term supervision in the following areas:
— Concept Development and Market Research
Determine the potential of a new idea or product by conducting an in-depth market and competitor analysis. This includes assessing the target audience, analyzing consumer needs, and identifying market trends. We provide recommendations on product conceptual design and its potential features that meet market needs.
— Prototyping and Testing
Create functional product prototypes to test their technical and user characteristics. This includes developing and manufacturing prototypes using modern technologies such as 3D printing, laser cutting, and other manufacturing equipment. We conduct prototype testing for compliance with technical requirements and safety standards.
— Medical Device Engineering and Design
A full range of services for the development of medical devices, including mechanical, electronic, and software engineering. We design ergonomic and innovative devices that meet modern market requirements and regulatory standards, with particular attention to patient safety and product functionality.
— Electronics and Embedded Software Development. Software Development for Medical Products
Development of electronic components and integration of embedded systems for medical and wellness products. Our services include schematic design, PCB manufacturing, microcontroller programming, and user interface development. We also create mobile device applications, web interfaces, and data analysis systems.
— Product Preparation for Manufacturing (DFM)
Preparation of the product for mass production, including design optimization for manufacturing (DFM) and reduction of production costs. We develop technical documentation, select materials and components, ensure testing, and verify manufacturing processes to ensure quality and efficiency.
— Power Management and Battery Integration
— Risk Analysis and Regulatory Support
Conducting risk analysis for medical products in accordance with FDA standards and other regulatory bodies. We provide consultations on preparing technical documentation and certification processes for market entry.
— Manufacturing Support and Quality Assurance
Supporting the manufacturing process, including quality control, supplier and production line audits. We provide recommendations for process improvements and quality issue resolutions, as well as organize technical support to ensure smooth production operations.
— Consulting Services for Startups and Companies in the Field of Medical Technologies
We help develop U.S. market entry strategies, formulate business plans, analyze market opportunities, and create growth plans.
You will definitely benefit from working with Liza if you have:
- A proof of concept and a team ready to quickly advance it to production.
- A startup at any of these stages: conceptual design and prototyping, production scaling, market entry.
- A company engaged in the development and manufacturing of medical devices and wellness products.
Cases
An orthopedic startup from Israel developed an innovative product for rehabilitation but faced challenges in entering the market and attracting customers. When they approached Liza, they had a finished product but lacked a market entry strategy and a clear understanding of how to find their target audience.
Lisa developed a comprehensive go-to-market strategy, including market analysis, target audience identification, unique selling proposition definition, distribution channels, and clinical trials organization. After implementing this strategy, the startup attracted several key clients and signed contracts with a DME provider for product supply worth $80,000.
A project from Argentina developing specialized equipment for neonatal intensive care units (NICU) faced difficulties obtaining a reimbursement code necessary for insurance companies to cover equipment costs. When they approached Liza, they had a product that met all medical standards, but the lack of reimbursement limited their market opportunities.
Lisa conducted a detailed analysis of regulatory requirements, developed the necessary documentation, and facilitated communication with regulatory bodies. The company obtained a reimbursement code, allowing them to secure contracts with several medical institutions worth over $200,000 and start collaborating with an insurance company as part of their innovation program.
A wellness technology startup from Nashville developed a de-novo device but faced challenges in scaling production. When they approached Liza, they only had a product prototype.
Lisa analyzed existing production processes and identified key issues. Afterward, they developed DFM, improved logistics processes, created an effective management system, and set up a QMS. This allowed the startup to launch production from the prototype stage to mass production within 6 months.
Listen and read:
Magic or Medtech Podcast - How to balance innovation and limitations
Interview “Insights of Medical Devices Development”
