It is a legal requirement in most countries that products must conform to defined manufacturing standards. The EU requires manufacturers or their representatives to submit their product to a notification body, such as TUV, for assessment. These organisations have been approved to certify products conforming to the required European Standards (CE). A similar process (UL) overseen by Underwriters Laboratories occurs in the US.
These approvals unlike those for pharmaceuticals take no account of the efficacy of the technology. And like the approval process for pharmaceuticals whether they offer economic benefits to the health system or the patient.
This hasn’t posed a problem in promoting new medical technologies. Normally a company will have generated patient studies and these will be used to convince purchasers as to the usefulness of the device or procedure.
New technologies offer early adopters the opportunity to present or publish their findings. These studies usually involve limited numbers of patients but cover the range of potential applications for which the technique can be used. These become important in persuading new adopters. Clinicians weigh up this body of evidence in deciding whether to embrace the new technology. It is a qualitative process. The new technology may replace an existing technology and if it is cheaper and these benefits can be easily realised all well and good. The hospital may pay for the technology or alternatively there may be private patients happy to pay to receive diagnosis or treatment using the technology.
This was how medical technology was sold in the past but now money is more tightly controlled and those in charge of the budgets increasingly want evidence to decide on whether funding should be given to a new technology. Hospitals can’t necessarily subsidise new technologies. They depend on insurance companies or health systems to pay for or to reimburse patient treatments. A growing number of countries have organisations which assess health technologies. These include:
Health technology assessment is increasingly important in persuading payers to support a technology. Manufacturers and suppliers need to factor this into their marketing plan.
Like conformity, health technology assessment involves an external body. But unlike conformity, where the product is appraised, the health technology assessor is not interested in the product only in published evidence. The assessors are interested in whether:
Without published studies no appraisal can be made.
Each year numerous new technologies or new applications of existing technologies are introduced and therefore not all can be assessed. Technologies which are appraised are those which are expected to deliver benefits to the health system sponsoring the appraisal. These benefits are most often economic.
Assessors learn of new technologies because they are brought to their attention by users, by suppliers, by payers or by members of the public or their elected representatives. These technologies fall into two groups.
In the UK NICE carries out Health Technology assessments on behalf of the NHS. The Medical Technologies Advisory Committee (MTAC) selects the medical devices and diagnostics for which guidance is produced.
According to NICE Technologies evaluated by the programme are those which have the potential to offer substantial benefit to patients and/or the NHS compared with current practice and are likely to be adopted more consistently and more rapidly if NICE develops guidance on them. They need to have clear easily understood advantages over current practice.
Clinical Commissioning Groups (CCG) are less inclined to pay for treatments and diagnostics which have not been positively appraised by NICE.
So how do I go about getting my product approved and what are the pitfalls?
The biggest risk is having the technology appraised and then rejected. But the biggest challenge is having your technology assessed. The first step is notifying NICE that you have a technology which you feel should be assessed.