Accelerating Medical Innovation To Enhance Patient Wellbeing

At the core of PBC Biohub’s mission is our accelerator model. We combine deep scientific expertise with strong clinical partnerships to drive forward a new generation of medical devices that shape the future of patient care.

Services

PBC Biomed is your strategic partner in innovation, offering the commercial insight, technical expertise, and collaborative spirit needed to drive success. Through our global network of clinical advisors, you gain first-hand feedback, while our in-house teams bring deep knowledge across medical devices, biomaterials, pharmaceuticals, and combination products. We provide tailored support at every stage of the product development lifecycle, from initial concept to commercial launch.

Innovation

We turn clinical concepts into validated technologies using our proprietary Accelerating Innovation Model (AIM).
Core Capabilities:
• Research: Clinical needs assessment, feasibility studies, and IP landscape analysis.
• Development: Prototyping, design controls (DHF), and engineering for scale.

Learn More

Consultancy

Navigate global markets with a team that doesn't just advise, but executes. We manage the regulatory complexity so you can focus on innovation.
Core Capabilities:
• Regulatory Affairs:
US: FDA Submissions: 510(k), De Novo, PMA Premarket Approval (PMA), Q-Subs
EU: CE Marking & EU MDR (2017/745) Transition
Post-Market Surveillance (PMS) .
• Clinical Evidence & Safety:
Clinical Evaluation Plan and Reports (CEP) (CER)
Biological Safety Assessments (ISO 10993).
Post-Market Clinical Follow-up plans.
• Quality: QMS implementation and auditing (ISO 13485).

Learn More

Manufacturing

Your scalable commercialisation partner. We bridge the gap between R&D and mass production in our ISO-certified facilities.
Core Capabilities:
• Tech Transfer: Seamless scaling from prototype to pilot line.
• Contract Manufacturing: Precision assembly and packaging in Class 7/8 Cleanrooms.
• Distribution: Global logistics and warehousing from our Shannon & Memphis hubs.

Learn More

Connected by AIM

Our services do not exist in silos. They are connected by the Accelerating Innovation Model. R&D informs Regulatory strategy, and Manufacturing constraints are considered during Design. This integrated approach de-risks your journey.

We believe MedTech innovation must be accelerated. AIM is our structured roadmap to reduce risk and speed up commercialization.

At PBC Biomed we believe that Medtech innovation must be accelerated. We have developed a model designed to accelerate the journey from idea to commercialisation, whilst identifying and reducing risks along the way. Our Accelerating Innovation Model (AIM) provides a structured roadmap for every project, whether it involves internal IP, client collaboration, or consultancy, always keeping patient wellbeing as the ultimate goal.