Question

your duty in a private medical device manufacturing company is to develop, manufacture, and CE certified osteoinductive bone tissue engineering scaffold. Select one proper scaffold and scaffold manufacturing method that would allow manufacturing osteoinductive scaffold, and briefly explain. Define and explain two different adequate vasculogenesis strategies that you can apply to your scaffold. This scaffold will be implantable and permeable (long term). Define and explain the biocompatibility process for CE certification. What would be the classification of your developed medical device? Please briefly explain CE certification process. What are the factors that affects classification of your medical deviceyour duty in a private medical device manufacturing company is to develop, manufacture, and CE certified osteoinductive bone tissue engineering scaffold. Select one proper scaffold and scaffold manufacturing method that would allow manufacturing osteoinductive scaffold, and briefly explain. Define and explain two different adequate vasculogenesis strategies that you can apply to your scaffold. This scaffold will be implantable and permeable (long term). Define and explain the biocompatibility process for CE certification. What would be the classification of your developed medical device? Please briefly explain CE certification process. What are the factors that affects classification of your medical device

Answer 1

Material choice:

I would like to propose using of composite material made up of magnesium doped hydroxyapatite (MgHA) and collagen type I ( hydroxyapatite and collagen type I are the components of the natural bone, it is expected to posses osteoinduction).

Scaffold fabrication:

The MgHA nanocrystals are nucleated onto the collagen I fibres. Briefly, collagen I is dissolved in acetic buffer and to which phospharic acid was added. This solution was transferred to the basic aqueous solution of calcium hydroxide and magnesium chloride in the presence of crosslinking agent 1,4-butanediol diglycidyl ether. Then the slurry is washed multiple times to remove unreacted crosslinking agent and residual solvents.

Later, the slurry is transferred to the well plates and freeze dried to obtain porous structure.

This material is characterized for its porosity and mechanical strength as bone structure is highly porous and having high mechanical strength.

Strategy used for angiogenesis:

1. Generating highly porous structure: Porosity is prerequisite for angiogenesis process.

2. Once scaffold is fabricated, endothelial cells are seeded into these scaffold along with VEGF growth factor. Over a period of time vascular network are formed within the scaffold which is used for in vivo implantation (pre-formed vascular structure).

Biocompatibility process for CE certification:

There are series of ISO 10993 standards which need to assessed for evaluating biocompatibility of the medical device. This tests include, evaluation and testing within a risk management process, heamocompatibility, genotoxicity, carcinogenecity, reproductive toxicity, in vitro cytotoxicity, local effects after implantation, irritation and skin sensitization etc.

Process of obtaining CE certification:

To obtain CE certification, material is classified under four categories based on the risk level (class I, class IIa, class IIb and class III). To identify under which class particular material falls under, each class is given with annexure. Based on the information given in annexure, material is classified.

While during initial submission, all the required documentation regarding the product is to be given. This includes all necessary tests required for the material. This again depends on duration of use, anatomical position where it is implanted, fabrication process etc.

Once submitted, based on the class into which the material falls under, notified bodies carry out conformity tests. These notified bodies are independent, third party organization which are state authorized. Once conformity test is carried out by notified bodies, CE certification is allotted to the medical device.