Regulatory Advice for MedTech

Issa K. is the founder of Ambrosia Ventures, a life sciences consultancy that provides strategic, regulatory, and quality compliance solutions. He’s consulted with pharma giants, yet over the last 10 years has used his experience to guide startups and small companies toward global market entry with his project management, quality assurance, and regulatory affairs expertise. 

In this episode, Issa describes taking EnBiologics, a pharma company with a manuka honey-based pet pain reliever, into Canada and Brazil. He advises early-stage companies to evaluate global markets and competitors to determine a way to stand out from competitors. Because Michigan is geographically close to Canada, for example, expansion into Brazil instead might be a better strategy. And always validate the market research, even if it’s your own. 

Interestingly, studies show that CEOs that speak other languages or come from other countries are more likely to export. And EnBiologics is a case in point – its CEO, born and raised in Egypt, was Issa’s college classmate! 

Building blocks for quality and regulatory requirements 

For early startups, every endeavor must be cost-effective, so Issa has created a regulatory strategy with built-in cost savings. His approach is to streamline and standardize international regulations to reduce redundancies: “instead of doing several independent audits we clump them together methodically,” he says, which in the end saves cost while acquiring customer brand trust, limiting liability, and standing out from the competition. 

Issa describes the European Medicines Agency (EMA) as the “international gold standard” for regulatory framework; their requirements are the most stringent and control quality, safety, and efficacy of a device throughout the product lifecycle. 

“How I like to approach this, aside from the market credibility of getting the ISO 13485 certificate,” says Issa, “is to take advantage of expanding past that by aligning it with other international standards.” Depending on a company’s maturity, Issa will determine whether to take a risk management approach using ISO 14971, adopt a more stringent European MDR/IVDR strategy, or incorporate WHO requirements for less regulated markets. 

Issa adds that pinpointing initial markets provides a roadmap for meeting regulatory requirements, which leads to a more comprehensive audit.

The process ultimately positions the brand as a serious player in the industry while “enhancing credibility and attractiveness to eventual strategic partners and global distributors.” 

It’s a key differentiator, according to Issa, unlike the common pitfall of starting with less-regulated markets, which “doesn’t help in terms of establishing consumer trust, or even brand reputation.” 

Similarly, approach global marketing from a position of solid regulatory compliance to “signal a commitment to quality and safety.” Messaging should emphasize: 

• Rigorous compliance. A track record of successful compliance boosts a company’s reputation. 
• Consistent interaction with regulatory bodies. Open lines of communication fosters trust with consumers, creating loyalty. 

The goal is to create messaging with a global eye view, which then makes adherence to ISO standards for translation that much easier. 

Listen to the full episode here:

“Translation is its own beast,” Issa says. He relies on study groups that mirror target populations to ensure that messaging is “global friendly” – messaging used in the US should resonate in Brazil and the EU, for example. Generative AI can be helpful for gist translations, Issa says, but “there are certain words that aren’t easily translatable, and AI won’t register that.” So always consult with an expert to ensure accuracy. 

Issa speaks four languages! His favorite word, among the lexicons of English, Spanish, Arabic, and Jamaican Patois is “na'eeman,” an expression generally used to denote cleanliness – “I just had a shower, na’eeman” or “I just got a haircut, na’eeman” – but can also stand in for other, unrelated situations, like “I’m late for a meeting, na’eeman.” 

“There isn’t a real definition or description, that’s why I love it so much,” he says, “you can just use it and input it in so many different instances, for ‘that sounds right’ or ‘that makes sense’.” Call it the “lah” of Singapore or the Hawaiian “da kine.”

Rapport International specializes in multilingual communications, providing language translation and interpretation services that are accurate and culturally appropriate. With our 100% satisfaction guarantee, you can trust that it’s done right. Contact us today if you would like more information or to get a free quote.