NSF’s Medical Devices executive vice president James Pink has the experience and the know-how to guide manufacturers through even the most complex regulatory quandaries. With over two decades experience in the medical devices industry, including ten years as a healthcare technology expert and lead auditor for a leading European notified body, he understands the big issues facing the medical device industry.
Here, he sheds some light on the medical device consultancy services offered by NSF and how they can be used to tackle the challenges device manufacturers must overcome.
Chloe Kent: How to NSF’s medical device consultancy services work?
James Pink: Globally, we’ve got four regions – North America, DAC (Germany, Austria and Switzerland), UK & Ireland, and China where we have an extractables and reachables laboratory. The experience depends upon the location, but essentially the companies who contact us will have a couple of pervasive issues or challenges they want to overcome.
They might be looking to achieve market authorisation in a particular region – primarily the US, or in Europe – or they might be in a position where they already have market authorisation for their devices but are facing an impending regulation challenge. There might be more business-like, operational challenges as well – they may be looking at moving one manufacturing process from one location to another while still remaining compliant with the law.
A large portion of our work deals with companies that are now facing some level of enforcement action from a regulatory authority. The reason that they’ll look to NSF is because we have a blend of people who have quality regulatory and technical backgrounds.
At NSF we’ve got a blend of both regulation and compliance experts and we’ve worked at creating that blend across the US, Europe, and international markets such as Asia as well. Many of us have actually worked in European notified bodies or worked in the FDA, giving us a unique insight into the operations of those organisations. Those who haven’t still have a high level of experience as somebody who’s worn our client’s shoes, people with more than 25 – 35 years operational experience.
CK: What are the biggest issues you are currently seeing in the medical device sector?
JP: Most medical device manufacturers’ first responsibility is patient safety, and there are a number of international situations at the moment where that has been brought into question. In the US there have been a number of journalistic investigations into this, in particular regarding the quality of implants. Netflix did a documentary called The Bleeding Edge where it was challenging the FDA over how it oversees the clinical safety of products, in particular with implants.
In Europe, everybody’s getting their head down to prepare for compliance with new medical device regulations. Manufacturers aren’t only facing the challenges of preparing for regulation, they’re facing the challenges of why the regulation came into force in the first place. The public and worldwide governments are really expecting a higher degree of responsibility over the clinical safety of their products and manufacturers are taking a lot more steps towards demonstrating that their devices have the appropriate clinical data to support their claims.
Manufacturers are also being chased with problems such as having to ensure that they have higher scrutiny of data clinically, that the devices are performing and assessed post-market, on the backdrop that they are then being asked to reduce the cost per unit in various jurisdictions. That’s a very careful balance and if you get one side wrong there’s always an impact on the other.
CK: What is it about NSF’s consulting services which set it apart others?
JP: We’re helping our clients through a process of evidence-based consulting. We’re looking at how we can find the sweet spot in quality management systems, clinical data, post-market surveillance systems, and of course the in all the necessary clinical and pre-clinical testing which drives that. We’re looking to make sure that we’re doing so using the least burdensome approach, generating value for the patient, the manufacturer and the regulator.
CK: How can a medical device company minimise risk and maximise efficiency?
JP: By starting in the right place, creating quality systems and operational processors that are completely driven towards the risks inherent within a device. For instance, if you have an implantable medical device, you need to ensure your quality management system includes the design, manufacture and post-market surveillance for all the risks this entails, ensuring those processes are all responding in the most efficient manner.
I think that’s one of the areas where NSF excels. In European medical device legislation there are over 800 requirements, and therefore over 800 solutions to address them. We cut through all of that and provide that necessary clarity for our clients to give them efficient processes and efficient risk-based decision making.
CK: What excites you the most about your work?
JP: What motivates me is the industry that we’re in. We’re making a difference and we’re helping companies address this fine balance between clinical safety and efficacy with real world healthcare business issues.
NSF implements long term regulatory fixes so that our clients can concentrate on making safe, efficient products available to the many.