OUR EXPERTISE
RESEARCH AND DEVELOPMENT.
Next-Biomed provides comprehensive support to its clients in the design of both active and passive medical devices, including implantable ones, with a particular focus on the cardiovascular field. The development of innovative medical devices is initiated by conducting a feasibility assessment in collaboration with the client. Following this, the initial design phase is carried out, incorporating Finite Element Analysis (FEA) to create the first functional prototypes of the device.
Next-Biomed’s time-to-cost design approach utilizes high-performance biomaterials and advanced manufacturing technologies to produce safe and efficient devices. We also have specialized expertise in the manual assembly of medical devices requiring manufacturing skills for stitching materials such as fabrics, silicones, and biological components like bovine or porcine pericardium. These devices are suitable for clinical evaluation and certification under MDR (Medical Device Regulation) or FDA (Food and Drug Administration) standards and are optimized for large-scale industrial production.
Innovate. Build. Advance.
REGULATORY PATHWAYS.
For devices under development, regulatory development plans are created to guide the path toward market approval. These plans include certification costs, execution timelines based on the desired type of certification, and consideration of applicable requirements under either MDR or FDA regulations. Regulatory planning enables the definition of a detailed testing strategy, which may involve special tests based on risk analysis or tests aligned with relevant International Standards.
Next-Biomed supports clients in drafting test protocols and reports. Testing is performed through a network of selected certified external laboratories. On behalf of the client, Next-Biomed manages the preparation and submission of regulatory technical files to obtain approval for market authorization.
CLINICAL STRATEGIES.
Next-Biomed develops comprehensive clinical plans for devices in development or already certified. These plans include strategic design of clinical studies, encompassing the creation of investigation protocols, study budgeting, study execution, and data analysis. In addition, Next-Biomed supports the preparation of the clinical study report, ensuring that all documentation meets regulatory expectations and scientific standards.
The clinical planning process is aligned with regulatory requirements, helping to generate high-quality clinical evidence to support device approval and market access.
Compliance today, confidence tomorrow.
For each medical device development project, our company offers comprehensive project management support, working with the client to define the development timeline. This timeline takes into account the design, regulatory, and clinical plans. Effective project management ensures that critical project activities are closely monitored, preventing unnecessary financial resource consumption.
As part of its Project Management services, Next-biomed can, upon client request, prepare Business Plans and Profit & Loss (P&L) Plans, which can be used in investor presentations. These activities enable startup founders to present their project with a clear definition of the project timeline, associated costs, and investments, about the return on investment (ROI) timeline and the achievement of breakeven.
PROJECT MANAGEMENT, BUSINESS PLAN, P&L.
Plan smart. Execute flawlessly. Grow sustainably.
FINANCIAL PROJECT MANAGEMENT.
The daily financial management of a project is complex, requiring careful attention, particularly in relation to supplier interactions, expense reporting, and cash flow management, while ensuring close monitoring of financial consumption. Our company supports clients by providing easy calculation models that enable comprehensive expense control throughout the project.
FUNDRAISING.
Fundraising is a complex and demanding activity that founders must approach with continuous, serious, and rigorous effort. Next-biomed offers support in the preparation of technical, business, and financial presentations for the project, and, if necessary, assists the client during investor presentations. Additionally, our company can provide informational services to help identify suitable investors aligned with the specific type of medical device under development, as well as support in identifying and applying for European grants and funding opportunities.
"I was taught that the way of progress was neither swift nor easy."
Marie Curie
DUE DILIGENCE.
Our company specializes in comprehensive due diligence support for the biomedical sector, with a strong focus on Regulatory Strategic pathway. We assist Companies and Venture Capital firms, in the frame of their investment projects, identifying key risks and opportunities by thoroughly evaluating Regulatory pathways for CE marking or FDA approval, R&D strategies and technological feasibility, Existing clinical data and its relevance, Intellectual Property landscape , and competitive positioning.
Our expert-driven approach ensures a detailed assessment of both technological and regulatory aspects, enabling informed decisions in investments, mergers, and acquisitions. By analyzing technical documentation from a specialized perspective, we provide critical insights that go beyond compliance and feasibility, offering strategic guidance for company growth and development.
PATENTS.
Protect.
Validate.
Accelerate.
Next-biomed provides support to clients with innovative medical device development ideas by assisting in the formulation of patenting strategies. This service includes the drafting of patent applications and the preparation of patent drawings, in close collaboration with a network of Patent Attorneys specialized in medical devices. Our company also helps the client conducting preliminary Freedom to Operate (FTO) analyses to identify potential patent conflicts in the early stages of development.
COLLABORATION WITH:
