We have recently sat down with Gideon Elkayam, Founder & CEO at Obelis Group, to reflect on the results of the past year and the achievements of the company. We’ve had the pleasure to hear from him some personal insights and stories that are part of the history of the organization and we would like to share them with you!

1. Gideon Elkayam, Founder & CEO of Obelis Group, you are the design and creative force behind the company’s services. Kindly discuss some of his qualities which have transformed the organization.

That’s an easy one (smiling). The organizational skills we built over the years, that transformed the company and defined who we are today, come down to planning, data analysis, human capital management, customer orientation, business technology and empathy. In my mind, it all starts with planning, pure guessing will not get you far. You need a strategic plan to deliver exceptional customer experience, and you have to be able to spot challenges and opportunities and interpret customer and market insights. To implement change that really matters, you need to put your employees first, which will put customers first. So, employees satisfaction and customer-centricity are key ingredients, but you also need to back it up with new technologies and empathy for the people who support the whole process.

2. Why was Obelis Group born? What are the market pain points you wanted to address through the inception of the company?

Back in 1988, I founded Obelis: a small, one-man company with the vision to create a bridge between non-European manufacturers and the European market by “creating compliance for safer markets”. My goal from the very beginning was to simplify European regulations to manufacturers around the world and, ultimately, help them to safely place their products on the European market.

Back then, Obelis’ core business was import & distribution of products on the Belgian Market. Given our line of business, we needed to familiarize ourselves with the applicable Directives and Regulations. One day, one of our non-European manufacturers presented me with the requirement for any manufacturer not based in Europe to designate a single Authorized Representative (AR) in the European Union under the draft New Approach European Directive  93/42/EEC. A spark ignited in my mind and we sent a query to the European Commission, asking them if one Authorized Representative can act as the single AR for several manufacturers. Mr. Peter Ruys, who was at the time General Manager of KEMA medical Notified Body replied that: ”well, we didn’t think about it this way but there is no reason why not…” – the next day, with his mentorship, we launched Obelis European Authorized Representative Center and the rest is history.

Given our strategic location in Brussels, Belgium, we have always worked closely with the EU institutions. Over the years, this gave us a real edge and competitive advantage, and today we can state that we have shaped the compliance industry. I can proudly say that we have helped over 3,000 manufacturers from more than 70 countries. Today, we are the larger center in Europe for CE marking & EU Representative Services, and a proud member of EAAR (The European Association of Authorized Representative) & ERPA (European Cosmetics Responsible Person Association) & EU Commission Working Groups.

3. You have mentioned the role of the distributor and the Authorized Representative. There are talks in the industry suggesting that manufacturers should not allow distributors to register their products in Europe. What is your take on this?

There are many good reasons why you should never allow your importer or distributors to act as your Authorized Representative/Responsible Person in Europe. The Authorized Representative (EC REP) should always be 1) neutral, 2) professional, 3) independent from commercial interests and 4) knowledgeable on EU Regulations.

With this in mind, if you were a manufacturer or a brand owner, would you be comfortable to disclose confidential information (such as product formulation, designs, your suppliers or your customers) with one of your distributors? Would you accept advice from someone that knows very little or mostly nothing about on EU Regulatory Affairs?

Would you allow a distributor to have control over your market? Over the years, we have had manufacturers that came to us with heartbreaking stories on how distributors assumed control over their brand in Europe – either by registering themselves as brand owners or by forcing the manufacturer’s hand into discounts, exclusivity and even forbidding relationships with other distributors.

The role of the Authorized Representative and Responsible Person have recently been augmented by the European Union. This is a new trend that can be found in more and more regulations – such as the Cosmetics, Medical Device, In Vitro Diagnostics and the new Market Surveillance. For example, under the Medical Device Regulation, the Authorized Representative will be liable severely and jointly with the manufacturer in case the latter has not complied with the obligations laid down in Article 10 of the new regulations. This means that Authorized Representatives will have no alternative but apply a far more rigorous review of the devices’ specifications and conformity.

Meaning, a manufacturer choosing not to designate a professional agency as EAR, will expose himself to higher risks, both in terms of fines and market access – not to mention that distributors that will accept this role without having the pre-requisite knowledge, background and expertise, expose themselves even more.

4. How are you providing the most effective processes for helping your clients achieve what’s necessary to sell and maintain their products on the European market?

Our value proposition is based on several components. First, we have been certified under a Quality Management System for the profession of European Authorized Representative, certified by an external body against the ISO standards 13485 & 9001. While there was no legal obligation for us to do so, and there is still none today, I believed this would upgrade our operations and create a quality-oriented mindset – and it did!

Secondly, we have always operated with what I call a “balanced approach”, because we have always maintained a commercial perspective in reference to understanding the difficulties of moving shipments around, the hardships of finding good distributors to partner with and the challenges to successfully brand your product in multiple markets and cultures. This balanced approach enables us today to be a solution-oriented service provider, meaning that we never just tell our clients (the manufacturers) what they cannot do, rather we focus on what can be done instead.

The Obelis Internship Program (OIP) also plays an important part here. Since 1997, we have been bringing the best minds of the future to intern at Obelis, be it regulatory, marketing, sales, administration, law, etc. As one of our key values is entrepreneurship, we believe in fresh ideas by young minds, and so we tapped into their innovative ideas and gave them the floor to flourish. Each generation that passed through the company enriched the organization, and added another brick into our foundations. This allowed us to sharpen again and again our message, our way of work and our processes. I am so very thankful to them and I remain eager to welcome the new ones!

Lastly, I want to mention our service packages. About 7 or 8 years ago, with the coming into force of the Cosmetic Regulation, we faced a special breakthrough that allowed us to truly lift our market share and bring the number of our clients to new heights. With it, came the huge challenge to manage the multitude of issues and urgencies – we had to come up with something and we had to do it fast. As we strongly believe in innovation and knowledge, we have always made time for educational activities and personal growth. I remember that one day my son called me up while he was in New York managing our booth at a local exhibition, and he asked me if he could stay longer as there was a special training he wished to attend – I said, sure. Shortly after we were able to initiate the Obelis’ three-level service options, which is now a key foundation in our regulatory process – giving clients the opportunity to choose between different levels of services in relation to key benefits and their specific urgencies. All custom-made to the needs of the customer.

5. How does your team of lawyers, chemists, pharmacists and other experts collaborate to provide a combination of representative services, CE marking, and compliance consultation?

Our added value lies in our quality-driven and experienced team that brings together knowledge from different fields. This allows us to provide professional representative services in the healthcare and beauty care domains, but also many others. I would also like to mention our membership in the EAAR and ERPA associations, as well as our presence in the EU Commission Working Groups, which provides us with intelligence needed to best assist our clients.

We also provide advisory services in several industries, such as Industrial & Mechanical, Chemicals, Technology & Innovation, Consumer Goods. Our compliance frameworks and processes support aspiring non-European exporters to expand on into European markets.

In addition, I have always been driven by the goal to set a strong international footprint, this is how we have built a strong network of international representatives, named the Obelis International Offices (OIO).

6. How do you turn the latest technology trends into advantages for your customers? Which are the key technologies you are adopting at present?

At Obelis, customer experience drives the digital transformation process. For instance, we have addressed the challenges experienced by our clients linked to the Medical Device Regulation (MDR). In this sense, we have put in place a cloud system for the management of all MDR-related documents where our Clients just send all their documentation.

We also developed MDlaw.eu, the most extensive information platform on MDR & IVDR, with the objective to simplify the new regulations and provide our users with a comprehensive and up-to-date information available all in one place.

Lastly, we adopted new digital solutions to make regulatory updates, news and information more easily accessible to our clients. Moreover, we deliver live and pre-recorded events, podcasts, webinars, guidelines and templates on an ongoing basis.

7. Regulatory work is at the heart of your business. How do you reconcile regulatory strategy with business or marketing strategy?

In our line of work, we see on a regular basis beautifully designed products and cutting-edge technologies that never enter the market because their respective manufacturers ignored almost completely the regulatory requirements when designing their products.

From our perspective, regulatory strategy always comes before marketing strategy. Regulatory strategy is the blueprint of the mid to long-term goals that ensures the product will be able to enter the market.

A very good example of this was the RoHS Directive (Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment). This Directive placed clear restrictions on substances such as lead, mercury, cadmium and others in Electrical and Electronic Equipment. If manufacturers of such products do not consider these requirements when designing and manufacturing their products, they will find themselves unable to market their products in the European Union.

So my advice to product developers is to have a regulatory consultant onboard at the get-go. Make sure your product is classified under the correct legislative framework, the regulatory requirements are identified and an action plan is put in place to uphold these requirements while designing and manufacturing the product.

8. To understand your solutions and products better, can you share a case where clients have benefited from your solutions? What problems did they face and after the implementation of your solution, what were the benefits they received?

I believe times of crisis call for creative solutions, transparency and team coordination. This is how we approached the recent COVID-19 crisis. We adopted new policies to empower our clients to truly make a difference by rapidly notifying In-Vitro Diagnostic kits, hand sanitizers, face masks and other protective equipment. On top of that, we took extra measures to redesign our internal procedures to remove any bottlenecks. We also took the decision to assign senior consultants to applications for such products. All, towards ensuring the regulatory process is completed in a timely manner and up to the highest standards.

How did everyone benefit from the new set-up? By putting in place a fast notification system, we enabled manufacturers to place their products on the market and patients and users to take advantage of these products. Bottom line, we did our part to reduce shortages experienced by hospitals.

9. What is one of the biggest achievements of your company owing to its revolutionary approach, which has transformed the way organizations progress?

In 30 years, we have many large-scale achievements. I would evidently start by the fact that my children chose to be part of Obelis. Then, there is the founding of the European Cosmetic Responsible Person Association (ERPA) and Obelis being accepted to the European Association of Authorized Representatives (EAAR). However, if I really need to choose, two stand out in my mind. The first is when we became engaged in a European- funded project under the FP7 (later to become H2020) innovation program of the European Union – contributing to leading professionals from the academia and industry to create a real treatment to spinal injuries. The second was being invited to meet with the European Commission writers of the new Medical Device Regulation (MDR 745/2017), before it was even drafted. During this meeting, we provided them with a practical outlook on the role of the European Authorized Representative as a professional agency, and not as a simple post-box as it used to be until not so long ago. I believe this meeting was paramount to establish the qualifications and standards for our profession for many years to come and served as the basics for the role of the EAR within this new legislation – I am very proud of this accomplishment.

10. What is your advice to the future leaders who want to make it big in the market?

Without revealing too much of the secrets that made my organization successful, I strongly encourage young people to have grit and perseverance. Be passionate and challenge yourself, don’t be afraid of taking risks and never lose sight of the big picture and, most importantly, ensure that you articulate very clearly to yourself WHY you are doing what you are doing. Hiring great people and surrounding yourself with trusted partners might also help (smiles).

11.  Kindly elaborate on any upcoming projects/plans of Obelis Group that would benefit your customers in the end.

Well, 2021 is expected to be a unique year by the coming into force of two major events within our sector, namely, the final departure of the UK from the European single market (Brexit) on January 1st, 2021, and the coming into force of the new Medical Device Regulation (MDR) on May 26th, 2021.

We are currently putting into place a compliance strategy for both events to enable medical device manufacturers and cosmetics products manufacturers to maintain their sales on the European and the UK market. For instance, we have launched Obelis UK Ltd. at the end of 2018 and put the infrastructure in place to serve our clients wishing to continue selling their products on the UK Market, while providing the same level of solutions to the UK industry wishing to continue selling products in the European Union.

In addition, we have also launched the Surveillance Regulation 2019/1020/EU project, where we partnered up with a key player in the testing and certification sector, and created the 2-step Compliance program for Online Sellers. The objective of the latter is to assist such sellers to comply with the EU Regulation on Market Surveillance and Compliance of Products.

Some of our upcoming projects are also worth mentioning here. The first one is COSLAW, an online platform intended to centralize all information on cosmetic Regulation in a single place. This will soon be available online. Within our continuous drive to touch upon other sectors and bring our vision to create safer markets beyond the industries we currently engage with, our R&D department is investing extraordinary efforts to launch new services towards Food Supplements and Biocides. By 2021, these will form part of our standard services.

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