Industry Consolidation Puts Focus on Service
Recent mergers and acquisitions in Europe have many predicting the days are numbered for small Notified Bodies. If you add in the increased level of oversight and regulation being introduced by the Competent Authorities, this prediction is probably not too far off. But this era of transition also has its opportunities.
“Currently there are over 80 Notified Bodies in Europe, which is too many to ensure the requirements of the directives are being effectively enforced. I think it’s a safe bet to say in two years’ time we’ll see a significantly smaller number, but still enough to give the market a robust choice of service providers. Those that will be left will represent a mix of large companies that provide a full spectrum of services and medium sized Notified Bodies that provide targeted services,” says Dr. John O’Dwyer, European Manager Medical Devices with the National Standards Authority of Ireland (NSAI). “Just like what happened in the global automotive industry in the 1990s, our industry is undergoing a rapid transition with larger companies buying out smaller ones and eliminating redundancies in the system. But smart Notified Bodies are taking advantage of this tumult to position themselves as an alternative to large organizations that are saddled with multiple services and complex bureaucracies and highlight their competitive advantages.”
O’Dwyer points to NSAI as an example of a mid-sized company that has defined itself as just such an alternative. A few years ago, NSAI made the strategic decision to focus solely on medical device Notified Body certifications so that it could expand its competencies and still have the economy of scale to offer certifications on all types of medical devices. The company realized that many medical device manufacturers would find the idea of working with a medium-sized, flexible and responsive Notified Body a much more attractive alternative. Since that time, NSAI has substantially increased its market share in the medical devices realm, primarily by delivering a transparent time-to-market service.
“There will always be a need for large, diversified Notified Bodies. They play an important part in the certification industry,” says O’Dwyer. “But at the same time there will always be a need for a responsive, predictable medium-sized organization like NSAI. You can look at any industry to see this strategy play out. While the Wal-Marts of the world will always be the kings of their particular industries, you still have the H&Ms and Safeways that focus on a particular niche and are successful. Wal-Mart does sell food and apparel, but most savvy consumers know that they will get better selection at competitive prices at stores that focus on those industries.”
So how does a company like NSAI stay successful in an increasingly competitive marketplace dominated by a handful of large players? The keywords are service and predictability. A medium-sized company will naturally have more streamlined procedures and the flexibility to provide personal service to a range of companies looking for a certification.
“We’ve surveyed our clients and asked them what they are looking for in a Notified Body. We’ve been told time and again that many would rather stay with a competent and responsive Notified Body that is approachable and focused on their particular industry,” says Claire McKenna, Medical Devices Program Manager with NSAI. “Many medical device companies see us as more responsive and easier to talk to because our lines of communication are always open. Most clients fear they would be small fish in a big pond at a larger Notified Body. Plus, the medical device industry has a constant influx of new, emerging companies who appreciate the extra handholding and focused attention we can offer. That’s why we offer pre-submission conference calls and webinars as standard operating procedure. It’s important to let our clients know that every day counts and that their Notified Body shares the same sense of urgency and that their product’s success is as important to them as it is to us.”
In fact, “time-to-market” has been NSAI’s rallying cry since deciding to focus its efforts on the Medical Device industry. Medical Device companies are in the business of saving lives and NSAI’s commitment to fast and flexible turn around on certifications fits most companies’ core missions. By getting products to market faster, more market share is gained, and more lives are saved.
“We’ve created a culture at NSAI focused on delivering predicable results in a personable manner,” says O’Dwyer. “When clients work with us they know where they stand every step of the way. Our whole approval model is built on time to market. We’re aware of the pressures our clients feel and by ensuring we do things quickly and have a consistent timetable for our services, we become a partner in our clients’ success. In an essence we have become a customer-led Notified Body.”
O’Dwyer and McKenna readily agree with some in the industry that point out that some very small Notified Bodies are not keeping up their internal competence with regards to the ever-changing medtech directives. Both say that these types of companies will face increasing pressure as the European Union works to tighten the standards regulating Notified Bodies, leading to more acquisitions and a portion of the smaller companies’ client base left behind.
“There’s something to be said for having the ability to make a quick phone call or send an email and be able to contact the company leaders. That’s how it works at a mid-sized Notified Body like NSAI. We may never be able to have offices at every point on the globe, but in order for us to be successful we don’t have to,” says McKenna. “Clients take comfort in the fact that we offer the core competencies in technical and clinical areas that they need to have confidence in their certification. NSAI is large enough to be represented at all of the key regulatory notified body meetings and working groups. This message is resonating with the industry because despite the down economy, we’ve been able to expand our medical device offerings and brought on many highly-qualified experts.”
O’Dwyer says it all comes down to personal choice and what type of relationship a company is looking for. “Across the entire business spectrum you find that every industry has its market share leader and then you’ll find thriving businesses at the mid level. If you’re a General Electric and have a line of business in almost every industry, you’ll probably have a better affinity with a large Notified Body because they too will cover all industry sectors. But many companies simply don’t need that much scope. They are looking for a Notified Body that can provide better, more responsive services and this is why NSAI has enjoyed such success.”
For over 50 years, the National Standards Authority of Ireland has been offering a full range of services relating to Management Systems Standards and Certification Services throughout the world. Known for offering the industry’s only time-to-market and fast track options for certifications, NSAI specializes in the Medical Device, Environmental, and Tele-communications industries. For more information visit www.NSAIinc.com or call 603-882-4412.