In 2005/6 over 2 million trauma or orthopaedic outpatient ‘first attendances’ were received by the NHS [1]. Overall there was an average of 2.3 follow-up visits per patient, which typically increased with age, up to 3.1 for every patient aged 75-84; this demonstrates the cost to the NHS of the aging population and the need for medical treatments that reduce or eliminate the follow up care. 1 in 2 women and 1 in 5 men over the age of 50 will suffer an osteoporotic fracture, costing the UK NHS £2.3 billion in the year 2007 alone. Additional orthopaedic interventions are required due to tumours, bone necrosis and arthritis. Joint replacements account for a significant proportion of orthopaedic procedures. For example, in 2009 there were 144,000 completed hip and knee procedures in Wales and England [2], which can be estimated to have cost £750 million, based on historical cost data [3].

It is envisaged that regenerative medicine for bone – restoring the tissue to its healthy state prior to injury or disease – will transform the quality of life for patients and allow the desired level of activity for their lifetime.

Regulator challenges and potential solutions (the answer COULD include some/all of the below considerations):
– What do you need to do to satisfy the regulator? (Can we just take a molecule from the lab and inject it into a patient?).
– What does the regulator need to know about the product?
– What does the regulator need to know about the process?
– How do you report the above considerations to the regulator?

This coursework should refer back to lectures, seminars and other module topics.
This is the last set of lecture slides which may/may not be relevant and should help give an idea of how broad the topic is taught so far. Anything relating to regulatory challenges that face on bone solutions not mentioned in the slides should essentially not be included in the report.


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