Finding the Future of Medical Device Innovation in the Kingdom of Saudi Arabia - October Newsletter Feature

Not long after I started my consulting business, I received an invitation that would change my life.  The Saudi Food and Drug Authority asked me to speak at the 3rd Annual Saudi FDA Conference and Exhibition (SFDACE), which was focused on consumer engagement and consumer-centered regulation.  SFDA wanted me to speak about patient-focused policy in their first ever session on patient engagement and regulatory decision-making.  It was the opportunity of a lifetime.  Knowing that my regulatory colleagues on the other side of the world wanted to hear what I had to say buoyed my professional self-esteem at a time when I needed it most and gave me something amazing to look forward to.

What I never expected is that I would fall in love with the Kingdom of Saudi Arabia.  It is a beautiful, stark place with some of the kindest people I have ever met.  From the minute I arrived until the time I left, I was treated with respect and warmth.  There is a feeling of hope in Saudi Arabia as they are undergoing a tremendous amount of change and progress.  Everyone, including my taxi driver from the airport, the hotel staff, and attendees at the conference talked about the opening of tourist visas to the country and the hopes they have for what it will bring. I felt welcomed and respected.  The SFDACE is one of the most enjoyable conferences I have ever attended.

There are many changes happening in the regulation of medical products in the KSA.  Admittedly, I only attended the medical device sessions at the SFDACE. But, SFDA has embarked on modernization of their regulatory system that will have impacts across medical products and improve regulatory oversight and enforcement in the country.  I was especially excited to see SFDA’s enthusiasm for patient input throughout the medical product lifecycle.  Of course, the interest in patient engagement is why I was there.  But the enthusiasm expressed by the speakers and regulators I spoke with about engaging with patients was sincere and committed.  I have no doubt that we will see effective patient-focused policy to come from SFDA’s efforts.

For medical devices, there are efforts at SFDA to modernize their regulatory policy. Until now, to market a medical device in the KSA required prior approval/clearance from U.S. FDA or a CE mark.  SFDA is now in the process of creating a primary pathway to market for medical devices in the KSA, with particular focus on innovative medical devices.  Regulators want to open the Saudi market to medical device manufacturers with innovative devices that offer more effective treatments or address unmet needs.  Beyond marketing devices, the Saudi government is interested in developing the country as a hub for a medical device manufacturing and encourage sponsors to conduct clinical trials in the KSA.

To say I am honored to have been a part of the SFDACE is an understatement.  I felt a part of something greater than the presentations and exhibition hall.  I felt a part of a movement toward modernization and cultural approachability that is exciting and infectious.  There is a sincere desire in the KSA to grow and welcome new investment and ideas.  The feeling is palpable and inspiring.  

You will notice that I avoided any mention of geopolitical factors.  That’s on purpose.  Every country – EVERY COUNTRY – has its issues.  If you look at the U.S. State Department website, you would wonder if I was in my right mind to travel to Saudi Arabia as a single woman.  Let me be clear that I felt absolutely safe and comfortable the entire time I was in the KSA.  The risk level listed for the KSA is Level 2.  But, so is Belgium. And many, many others, including western countries with lots of tourists.  For those who may be reluctant to visit the KSA for these reasons, let me put your mind at ease.  It was beautiful and the people were kind and respectful.  That respect goes both ways, of course.  I wore an abaya and hijab during my entire visit.  My hosts were grateful for the respect I showed their culture, and I felt entirely comfortable.  The real or perceived barriers to engaging with our Saudi colleagues are falling, my friends.  If you have a chance to visit Saudi Arabia, do not think twice.  Just go.  You may just fall in love with it and find your future there like I did.