Services

Design, Development & Manufacturing Services 2017-10-18T10:46:28+00:00

END-TO-END PRODUCT DEVELOPMENT SERVICES

Aran Biomedical offers a complete solution to medical device companies who seek a contract partner to help realise their product development needs, from concept to finished packaged medical implants.

From concept design and development through to the production transfer of approved medical devices, Aran Biomedical is committed to providing an unparalleled degree of service. Dedicated consultation, project management, and technical resources are provided throughout to ensure clients’ expectations are surpassed in taking quality products to market.

Complete Design Development and Manufacturing Services for Medical Implants

Concept Development

During the concept development phase, products are clearly defined. Aran Biomedical will develop a concept design according to a client’s brief or refine an existing client design for prototype development. From intended indication for use, to preferred features, this requires an examination of the commercial opportunity, predicate devices already on the market, patent landscape and definition of product specifications. At this phase of the design process, every aspect of the product is open for discussion and anything is possible. However even at this early stage, consideration of the design for volume manufacturing is taken into account.

Complete Design Development and Manufacturing Services for Medical Implants

Prototype Development

To facilitate rapid prototyping Aran Biomedical offers a dedicated R&D materials laboratory, along with a substantial inventory of resorbable and non-resorbable materials. Our research, design and development personnel create concept prototypes, for evaluation and testing. Prototype production is undertaken in a controlled environment, leveraging our biomaterials conversion processes. This is followed by characterisation of prototypes to the appropriate international testing standards, forming the basis of product engineering specifications. Testing may include:

  • Mechanical performance – strength and stiffness in tensile, compression, bend, burst, and shear loading; as well as suture retention and coefficient of friction testing
  • Dimensional properties – metrology & microscopy
  • Biocompatibility screening*
  • Bench-top tissue testing*
  • Sterilization method compatibility*

*outsourced

Complete Design Development and Manufacturing Services for Medical Implants

Product Development

Aran Biomedical provides customers with a verification and validation management service to help them meet the challenge of FDA and MDD directives:

  • Product specification establishment (design inputs)
  • Design risk analysis (FMEA)
  • Design verification and validation protocol generation
  • Material/component/product specification and traceability management
  • Test method development and validation
  • Testing execution and report generation:
  • Bench testing
  • Predicate testing
  • Shelf life / stability studies
  • Packaging/labelling qualification
  • Biocompatibility
  • Transit and climatic conditioning (ISTA)*
  • Clinical literature reviews

*outsourced

Complete Design Development and Manufacturing Services for Medical Implants

Production Transfer & Pilot Manufacturing

During this phase product design specifications are transferred to production and the production processes are established to support volume manufacturing. Following process validation, the manufacturing of commercial product can commence, scaling up to meet commercial volume requirements.

The transfer to production activities include:      *outsourced

  • Establishment of manufacturing and inspection specifications and procedures
  • Establishment of routing / bill of materials / DMR
  • Process risk analysis (FMEA)
  • Process validation planning (MVP)
  • Process validation execution (IQ/OQ/PQ)
  • Sterilisation validation*
  • Product microbial monitoring schedule (bioburden/LAL)
  • Operator training / certification

Complete Design Development and Manufacturing Services for Medical Implants

Clinical & Regulatory

Aran Biomedical can provide a comprehensive regulatory compliance consulting service to its customers, including:

  • Strategy development and device classification
  • Predicate device selection
  • Clinical scientific literature review
  • 510(k) Pre-market notifications submission
  • CE Mark / Technical files and design dossiers
  • Canadian medical device licensing
  • FDA establishment registration and device listing
  • International registration
  • Regulatory program development

Complete Design Development and Manufacturing Services for Medical Implants

Volume Manufacturing

Aran Biomedical offers high quality and flexible manufacturing solutions for finished devices and biomaterial components. We partner with some of the world’s largest OEMs and smaller emerging medical technology companies and maintain production facilities to produce volumes from custom-builds, right up to large-scale lean manufacturing.