Designing products in regulated industries

From her childhood and studies in Croatia, to a PhD in experimental physics in Dortmund, Germany, and an 18-year career at Philips in the Netherlands, Vanja Hommes has encountered a broad set of regulatory environments. As a specialist in light therapy appliances and their impact on human physiology, she is passionate about delivering effective solutions to consumers while ensuring efficacy and safety via clinical studies and scientific validation. In Vanja’s latest role as Regulatory Affairs and Product Compliance Lead, she currently oversees compliance of Philips’ Personal Health portfolio of consumer products and devices.

We met with her to understand the challenges and opportunities associated with designing products in regulated industries.

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Clotilde Grimault

As a regulation expert within your industry, what best practices would you recommend for innovators who want to design the future within a heavily regulated industry?

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Vanja Hommes

When people think about regulated industries, they often think of medical devices, but actually consumer products are also regulated, only in a different way. At their core, regulations exist to ensure that products have a certain quality, effectiveness, and performance and are safe for the public. Manufacturers should design products that work well and that we would like to use on ourselves and our next of kin; that is why certain regulations specify that manufacturers should validate products with users before a commercial launch. User validation is always very insightful after spending many months developing a product or solution, and some regulations specify that this step should be done objectively, under controlled circumstances. Additionally, different fields may have additional requirements as part of regulations: the medical device industry has requirements around documentation called Design Controls, and may require that you ask permission to have market access. Ultimately, regulations make sure that a manufacturer takes responsibility for putting products on the market.

When startup companies create innovative products from scratch, at some point they become aware of the regulations for their industry, and they often either freeze and stop or delay everything, or they continue on their previous track not taking into account steps needed to meet regulations. These behaviors have consequences for the success of the endeavor and one needs to find a balanced way. In general, when you start fresh with a new product, I recommend taking small steps and building your presence gradually instead of trying to conquer the world overnight. Start by establishing a strong competence, then build a first solution, and then expand. By engaging with a regulatory specialist early in the design process, you can understand the applicable requirements for your industry, determine the pace of your innovation roadmap, and build a sound strategy for your company.

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Clotilde Grimault

Regulations are established to protect humans collectively and individually. What mindset do you recommend to work within regulated industries to address unmet user needs and create innovative solutions?

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In addition to regulations, there are many industry standards for established fields, which are a great resource to learn about what has worked and not worked in the past.

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Vanja Hommes

Indeed, regulations exist primarily to protect users, and that is what I find inspiring about them: they want us to do good and be responsible when designing products. When you have a great idea for a product you start with a bold ambition and great motivation, and you might get discouraged by hurdles typically involving extra time and money, but you should look at regulations as outside guidance to help you design safe and effective products. Regulations are based on industry best practices, and they summarize the lessons learned from previous experiences to prevent making the same mistakes. In addition to regulations, there are many industry standards for established fields, which are a great resource to learn about what has worked and not worked in the past.

Following regulations can seem like a daunting task; start by teaming up with regulatory experts who can help you identify the regulations that will be applicable and interpret them. There are some common parts to all regulations, and there are also specific ones per field, so make sure to build your network of experts if you have versatile needs in your portfolio. A lot of regulatory experts like to work with innovative companies like startups, not only with large, established companies. Don’t hesitate to ask for advice when in doubt; most experts are able to adjust their thinking based on the scale of the initiative. The biggest wins come from involving experts early on, when they can help you make the right choices for the short and long term.

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Clotilde Grimault

Given the importance of compliance at every step of the design process, how do you find reliable business partners who can think beyond the status quo and also deliver the quality standards required for your industry?

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Vanja Hommes

In my experience, in order to bring something truly innovative to the market, it is fundamental to bring a very diverse mix of people together. You will need some energetic entrepreneurs, but also some established experts who have a deep understanding of the field. Make sure to respect more traditional expertise within the team, and to combine deep industry knowledge with an innovative mindset.

While regulations make sure that your product will be safe and effective, you still have a lot of leeway in the design process itself. It is up to you to create the process that will lead to the best product or service for your company, as long as you mitigate risks appropriately. Products with a higher risk for the patient or consumer will have more stringent guidelines, but if you are designing a consumer app, you have a lot of flexibility.

Thank you for your insights Vanja, what a fascinating conversation!