Test Labs’ Florida Trip: FIME
Why Florida International Medical Expo?
For many of our customers starting in the UK/EU market, branching into the USA can be both an exciting and challenging endeavour. The differences in regulations, from MDR to FDA, can be confusing. Test Labs team focus on medical device testing and we also strive to support our customers in understanding and managing these regulatory differences.
To enhance our service support and better understand the US market, attending key industry events is crucial. Finding the right trade show, however, isn’t straightforward—there is no ‘compare the market’ for medical device shows (perhaps a project for the future!).
Among the various options, the Florida International Medical Expo (FIME) in Miami stood out for several reasons:
- Focus on both Northern and South America: In addition to its strong presence in the US market, FIME has a significant focus on Latin America. This dual emphasis offers a unique opportunity to explore new business prospects and understand regulatory environments across multiple regions.
- Diverse Exhibitor and Attendee Base: The conference hosts a diverse range of manufacturers and consultancy-based support services. This enabled us to better understand the market from not only a regulatory perspective, but also from a manufacturer standpoint.
- Educational Opportunities: FIME features a variety of short seminars, and keynote sessions that provide critical information on regulatory requirements, market trends, and technological advancements. This allowed for the prospect of listening to key personnel in this area, thus gaining valuable knowledge.
Our Experience at FIME: Insights and Learnings
Upon arriving in Miami, we were greeted by the welcoming warmth of 32°C sunshine – a refreshing change from six months of rain back home. The three-day FIME conference and exhibition was really well organised and held at a stunning venue. The event attracted a diverse range of representatives mainly from China, Latin America, and Asia, we were expecting to see more US companies represented, however upon walking the floor we found this not to be the case. We found that the FIME event is primarily focussed on the Latin American market, with many companies from China and Pakistan representing there.
Networking and Regional Insights
We had the opportunity to connect with several consultants from the UK, Brazil, and the US. These conversations provided valuable regional insights. In Brazil, we learned about the challenges in finding resources for clinical evaluation – a critical component of the technical file necessary for regulatory submissions. The scarcity of companies offering clinical evaluation services in Brazil is causing delays in submissions.
US consultants shared that few labs offer Instructions for Use (IFU) validations for cleaning, disinfection, and sterilisation. This was surprising, as many companies face pushbacks from regulators in the UK/EU or the FDA due to insufficient validation data around their IFUs. This gap in the US market presents an opportunity for us to offer support with many companies operating globally so transportation of samples not creating barriers to this.
Key Discussions: MDR and FDA Regulations
As expected, the Medical Device Regulation (MDR) was a hot topic of discussion. Many companies expressed challenges in navigating this complex regulatory change. Opinions on MDR were split: some manufacturers felt that it might not enhance safety but could lead to fewer devices on the market, potentially risking patient safety due to shortages. Conversely, others saw MDR as a chance to demonstrate their commitment to quality, viewing it as a competitive advantage that could lead to a larger market share due to reduced competition.
…many attendees discussed the FDA as an ‘easier’ route to market…
Additionally, many attendees discussed the FDA as an ‘easier’ route to market. The FDA’s 510(k) process, allowing submissions based on established similar devices, was highlighted as a simpler pathway compared to the MDR. This insight suggests that some UK/EU companies might prioritise FDA registration, possibly delaying or even foregoing EU market entry.
Some down time
With a 5-hour time difference between Miami and the UK, we found ourselves bright-eyed and ready to go at 4am every day! This early start gave us an excellent opportunity to catch up on emails and support the team back home before heading off to FIME. After two full days of networking and exploration, having walked nearly 25,000 steps and spoken to almost every company, we decided to spend our final day exploring Miami.
Our hotel was located just a short stroll from the beach and around the corner from the conference venue, so we wanted to make the most of our remaining time. First, we have to rave about the food – it was amazing. Tautvydas thrived on quesadillas for lunch over the three days. As a picky eater, I had my concerns about finding suitable options, but there truly was something for everyone.
Venturing beyond Miami Beach, we explored the city itself. What a beautiful city it is! From the opulent mansions and towering skyscrapers to the warm hospitality, Miami offered a delightful mix of sights and experiences. We enjoyed a wonderful day sightseeing on a boat tour, which provided stunning views of the city and its landmarks, followed by a visit to a local museum that enriched our understanding of the area’s culture and history. We even got to see the Aston Martin building which boasts a free car for the small price tag of just £54,000,000!
Our trip to FIME was not only productive but also incredibly enjoyable. We highly recommend FIME to anyone looking to explore the Latin American market or expand their products into this region. However, for those specifically aiming to understand the US market and its regulatory challenges, this might not be the most relevant event. Overall, it was a fantastic experience, and we look forward to building on the insights and connections we gained.
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