Navigating regulations to launch OTC consumer health products
It is a major operation to launch a new product into the consumer healthcare market and there are many components that need to work cohesively to achieve success. From a planning perspective, mapping the roll-out of an innovation based on consumer needs and ability to execute in market are key, but an often underestimated part of the process is navigating the regulatory environment.
It is important to look carefully into regulatory affairs that affect your product in your local market, and in wider markets when you’re looking to expand. As a central Innovation function, my team works closely with Global Regulatory colleagues to ensure we understand the many compliance intricacies that need to be considered at both local and global levels.
Here are some considerations on how to navigate regulations:
Understand what the end goal is for the product
Mapping the product roadmap and working towards clearly defined milestones not only lays out ambition but provides tangible goals for you and your team. This process should be used for a brand-new product, and when considering alternative, credible applications for existing ones too. Research from Enterprise Nation, commissioned by RB, found that 77% of British small businesses want to drive growth by repurposing their existing products. For example, this could be taking a medical device, such as a thermometer, and re-engineering it to compliment a pain-based medicinal brand.
Weigh-up pros and cons for different classifications
One of the biggest challenges with any global launch is navigating product classifications, as they vary from region to region. Taking a sore throat product as an example, when developed for the UK market, it could be classified as a medical device or a drug. However, as my global regulatory colleagues advise, when rolling out into different markets such as the US or China, it could be considered a monographed medicine or health food, respectively.
The product’s change in classification would impact its formulation, the supporting test data needed and registration requirements. This could set a smaller producer back by five to seven years when trying to enter a new market.
Outline the regulatory framework strategy
Anyone can undertake desk-based research to find out regulatory details, but this isn’t the hard part. It’s important that regulations are interpreted and actioned in the right way – that’s the real skill that takes mastering. You could potentially waste years of effort pursuing a development programme, only to realise you’ve gone in the wrong direction.
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The speed of launch into a new market accelerates dramatically where a company seeks help from experts with dedicated regulatory teams. They will understand different markets and can help make ‘conscious decisions’ about what is the right regulatory strategy. For example, is it worth creating the information now to register in Brazil, when you may not be looking to do this for another three or more years.
Get close to the authorities in proposed market(s)
Regulators are approachable and will engage in conversation. However, the trick is knowing the right questions to ask to get the information needed to support a launch. This really does matter. Questions can’t be sweeping, they must be specific, tailored to your product and prospective classification and market. It can take years to build up close relationships with regulators and understand how they work. So, if you’re not in this position, the registration process will likely be a slow one.
Ensure continued compliance after launch
With any product launched into market, a company is legally and ethically responsible for compliance. That’s why regulatory considerations don’t just stop once a product is launched – there are challenges to navigate throughout the entire shelf-life.
For example, a change in legislation can require additional supporting documentation or an update to the product itself. Where issues arise with consumers, the governing body, such as the Medicines and Healthcare Products Regulatory Agency, will need to be updated and products will need to be checked to ensure they’re safe for public use. For medicines, registrations also need to be renewed annually. It is therefore essential to stay at the forefront of legislation, know how the product is performing in the market, and keep close to regulators.
Consider seeking out expert advice to help navigate regulations
While you may have the most innovative idea for a new product or breakthrough ideas on pivoting the use of an existing one, navigating the regulations to bring a compliant product to market can be a minefield.
We’ve seen first-hand how companies’ progress can be hampered by the regulatory environment. That’s where finding a partner to help you in this process helps. In as little as 12 months, an agile partnership can deliver a new product to market.
While it may be a daunting prospect to pitch to a corporate, there’s a lot to gain in terms of navigating regulations, market expertise, product development and more. Equally, finding a partner who is on the lookout for fresh ideas to grow into innovative consumer health products, creates a win-win situation.
Women leading in healthcare means better patient outcomes
I know I’m pointing out the obvious, but women are different to men. In the context of healthcare—a woman’s physiology, symptoms and sometimes even treatment options are different from a man's. We have witnessed this in cardiovascular health, where there is ample research and evidence that women’s symptoms are often different to men’s. We also know that heart disease is responsible for 1 in 3 deaths in women annually—it is the number one killer.
The fact is women do not always get the treatment they need. A lot of that has to do with who is treating them, how they are being treated by their physicians and the healthcare systems that are designed to support patient needs.
The proof is in the research at the care level; a 2017 study of hospitalised patients over the age of 65, examined differences in outcomes based on the gender of the treating physician. The results of the study concluded that patients treated by female physicians had lower mortality and readmission rates compared with those cared for by male physicians.
Gender equity starts at the top
I believe that gender equity in healthcare starts at the top with the leaders who set expectations around workplace culture, and that trickles down to the workforce.
You might think gender has nothing to do with how patients are treated—a patient is a patient, regardless of age, ethnicity, religion, creed, color or gender. But I believe there is a correlation between female leadership in healthcare and better patient outcomes—for men and women. Despite a predominantly female workforce in healthcare (65% of healthcare workers are women), only 13% of healthcare CEOs are women.
The disparity in the number of women in the healthcare C-suite is irrefutable, but I believe the more diversity we have at the boardroom table in hospitals and health systems— and that includes women—the more perspectives we bring to the decisions that ultimately impact patients and their families.
Female healthcare leaders are also caregivers
Many women are still the primary caregivers at home. The responsibility of grocery shopping and meal planning, making doctor and dentist appointments for children and elderly parents, and everything in between still tends to fall to women.
This lived experience gives women the ability to think about innovations and solutions from the perspective of the caregiver—not just the patient. The fact is when someone is sick in the family, it affects the whole family.
As a woman, I often think about solutions and technologies that facilitate holistic healing and health that support the whole family. Bringing the mentality of inclusion to healthcare leadership means programs like the American Heart Association’s Go Red for Women campaign, will ensure research and treatment for cardiovascular disease in women will get the attention it deserves and ultimately, better outcomes for patients.
The bottom line and meaningful work are equally important
A 2019 study found that public companies with a female CEO were more profitable than their competitors with men at the helm, but that didn’t come at the cost of job fulfillment.
Women who lead companies and organisations can influence their workforce by rallying around a common cause. Having meaningful work and the opportunity to make a difference in the world is powerful motivation that doesn’t have to come at the cost of profitability.
The work we do at Abbott is a good example—I consistently reinforce the good that comes from the research and development of the products we make with my team. Clinical trials, like the current LIFE-BTK trial, is consciously recruiting female principal investigators who work with underserved populations to enroll patients from communities of color and women. Knowing the work we do has a social impact on society might be difficult to quantify, but in my opinion, it’s priceless and could lead to meaningful treatment options that improve patient outcomes in the long-term.
Emotional intelligence and empathy are not soft skills
Interpersonal skills, problem-solving and self-awareness are considered “soft skills”—skills that might not be required to do the job, but in leadership positions, they are no longer “nice to haves,” they are “need to haves” if you are going to inspire high-performing teams.
Research suggests women tend to score higher on social and emotional competencies than men. In the words of Joanne Conroy, the CEO and President of Dartmouth-Hitchcock Health in New Hampshire, “Diverse representation at the table changes the conversation. It becomes more collaborative; there is more listening and less interrupting. We have better conversations about how we are functioning as a team and we create a safe space when people can be honest with their feedback to all members of the team, including the leader.”
I’m not suggesting women have a monopoly on soft skills, however having gender diversity around the boardroom table means a diversity of skills. Being aware of your team’s morale and what motivates them is equally important as managing your supply chain.
When it comes to health, we know that patients want more personalised care. The emergence of artificial intelligence (AI) has the potential to generate data that is tailored to the health needs of women and ultimately lead to better treatment options and outcomes. But the data insights generated by AI are only as good as the patients’ data available for analysis. To maximize the potential of AI—and meet the expectation of personalised care for patients—healthcare leaders need to be aware of who is and isn’t being included in studies and clinical trials, like women, and telegraph the need for greater inclusion to their teams.
These ideas are just the tip of the iceberg. Sure, we have come a long way since Elizabeth Blackwell—the first female physician in the United States—founded New York Presbyterian Hospital. Sure, there is still plenty of work to do, but I do hope my contribution is paving the way for more women to take on leadership roles in healthcare and make a positive impact on lives of all patients and their families.