I have been involved in orthopaedic research, implant design and innovation for more than ten years. It has been a very exciting journey with all the highs and lows you may encounter in any innovation work. In the following series of small articles, I will try to shed light on how I experienced innovation in medical devices in general and orthopaedic implants in particular.
When it comes to innovation in medical device field, one should consider the hard reality that taking an innovative concept all the way through to a clinically available product/service may sometimes take as long as ten years. This is mainly due to regulatory hurdles which a product must rightly pass before it is granted access to clinical use. Depending on the level of the innovation, you may need to carry out in-vitro lab tests, animal and human trials to demonstrate that your procedure is safe and effective. Computer simulations have also gained more acceptability, especially for cardiovascular devices, among regulatory bodies recently, but will not replace experimental tests and trials.
Another factor which must be kept in mine is the constantly changing clinical practice and regulatory landscape; meaning that by the time you have spent many years and a great amount of investment on the development and clinical trial of your product, a better solution enters the market and changes the clinical practice or new regulations are placed so that you have re-develop at least part of your product.
My solution to this is to be more aware, agile and responsive to the changes so that, if necessary, you can make in time modifications to your product. This is indeed easier for smaller organisations like start-ups with less stake in place than the large organizations with a well in-place culture and position in the market.
For this reason, I believe innovation takes place more effectively in smaller ‘innovation companies’ rather than big corporations. However, this must be done under a regulatory expert supervision to prevent unpredicted issues down the line which are easily overlooked by those who do not have experience in the process. Once the technology seems to be working in the lab, then, regulatory approval can be outsourced to those who specialise in testing the product according to the standards and generate relevant regulatory documents. If the technology is proved to be working and attractive to the early users, then it can be acquired by a larger organisation who can make it widely available to the public.
This is already taking place in Pharma industry where majority of innovation is carried out in academia or start-up companies, then tested by Control Research Organisations (CRO) and, if promising, is taken up by large Pharma organizations. However, innovation and product development in an academic environment has its own concerning issues, at least in medical devices based on my experience, which needs to be addressed. In the next series, I will try to discuss these issues further.
Hamidreza Alidousti, PhD, MEng
Research Associate – Biomechanics
Department of Mechanical Engineering
Imperial College London