Nemera Responds to the Changing Pharma and Healthcare Landscape with an Innovative, End-to-End Development Solution


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The pharmaceutical industry is currently experiencing one of its greatest transformations in recent times. But as companies lead the way to developing the drug and healthcare solutions of the future, several factors are adding a unique set of challenges and complexities to getting their products to the market. With Insight by Nemera’s Combination Product Consultancy Services Offering, customers now have access to our years of expert knowledge and capabilities in device manufacturing, but also in the areas of Human Factors, testing, Quality, and Regulatory Compliance, expertise which can help usher in a new generation of products and services to better serve patients on a global level.

The Changing Pharma Landscape

Companies in the pharmaceutical industry today are faced with several major trends that are requiring them to rethink their drug delivery device strategy. Beginning with the patient, we are witnessing the emergence of more chronic disease as well as an aging population worldwide. This is coupled with a shift away from administering drug solutions in a clinical environment to a home care setting, requiring an entire new set of solutions.

On the pharma side, companies are under increasing pressure to reduce risk to the patient, accelerate time-to-market, improve treatments adherence, and comply with an ever-increasing complex regulatory environment. All this while re-focusing on their core business – drug development, which has made their activity even more complicated than before.

Pharma companies,” confirms Ahmed Mallek, Global Regulatory & Compliance and Insight Quality Director, “have been taken by surprise by all these new requirements coming out of Europe and the U.S., from a human factor standpoint, but also from a regulatory and quality testing standpoint. They are required to have a full understanding of the combination product which, in this context, is a multifaceted therapeutic and diagnostic solution that integrates drug (or biologic) and device components into a single entity to achieve a specific health outcome.”Smaller companies, such as bio-techs, often don’t have the technical knowledge or experience to engineer such a drug delivery device. They require more integrated solutions that help get the combination product registered, get it to the market, and then sustain it.

Three Pillars of Service to Meet Any Client Needs

Nemera’s offering today includes three pillars of service that can help our pharma clients through their drug delivery device and combination product journey and value chains. The first pillar, Front-End Innovation and Device Development, includes everything from Patient Journey Research and Device Development to Connected Device UX/UI Design. The second pillar is Clinical and Commercial Device Manufacturing, with cGMP Clinical Device Supply, Process Definition and Manufacturing Planning, and Small Series and High Scale Manufacturing. Our third and most recent pillar is the expanded Combination Product Services, which means we offer lab and analytical services, risk management, human factors and user experience aspects such as instructions for use and packaging, regulatory and quality, and more.

Developing the Combination Product Services Offering

2019 was a major turning point for Nemera with the acquisition of Insight Product Development, an innovative services firm based in Chicago, IL (USA). “Historically, customers knew us for our device development, innovative proprietary devices, precision injection molding focused manufacturing expertise,” says Mark Tunkel, Global Category Director Services. “The added capabilities of Insight have brought a different, and complementary kind of service to our existing business, with early-stage capabilities in design research, human factors, user experience design, and engineering.” By combining our innovation team in France with Insight in Chicago we have formed Insight by Nemera, an independent consultancy organization that covers the full development cycle of the medical device and combination product.

“What we saw,” continues Mark Tunkel, “was that it wasn’t enough just to provide the device, or just provide the manufacturing. We wanted to be the single, integrated partner to provide a complete offering to help our customers through each step in the process of getting their combination product to the market. Today we are well equipped to meet any needs our clients might have.”

What’s noteworthy is that Nemera had been offering customers various services in the quality, regulatory, compliance, and testing areas for many years, even before 2019. At the time, it was usually a one-off, or isolated request. As Ahmed Mallek explains, “We were already offering support to our customers throughout the various stages of their product journey, whether it was with basic requirements for their dossier or their design history file for combination products, or helping them obtain positive notified body opinion for their final drug submission. All of this accelerated, of course, as we responded to the changes and trends that have been affecting the industry as a whole.”

Why Customers Choose Insight by Nemera

As mentioned above, many pharma companies don’t have the technical skills needed to develop a drug delivery device for a combination product that will meet the requirements of today’s changing healthcare landscape. Insight by Nemera has the proven design and link to Nemera’s manufacturing expertise, and can also support customers through the entire product journey.

“In the U.S., and with the FDA in particular,” says Mark Tunkel, “there’s much more focus today on patient adherence to the regiment and treatment administration. The attention now is on making sure the user experience is right. This includes everything from instructions and packaging to the way the patient is trained to use the device. The FDA is reinforcing the importance of integrating the voice of the patient into the design control process, what we refer to as patient centricity.”

“With over 50,000 hours patient journey research,” says Ahmed Mallek, “as well as extensive experience managing patient usability requirements, we can simplify the process for the customer to make sure the combination product is compliant. And by being involved in human factors, but also design thinking, we can be sure the product is bringing value to the industry in a global way. It’s another way we put patients first. That’s why we’re in a unique position of offer this expertise.”

Nemera’s Services Offering saves time, of course, but also reduces costs, because we know the product and how it was designed and manufactured. “We understand how to manage all those elements in order to mitigate patient risk and obtain regulatory compliance for the customer,” continues Mark Tunkel.

We also have a global team, in Europe and the U.S., working on standards development, and we participate in different working groups where we dialogue with regulators to make sure we continue to bring the best quality products to the market.

The Future of Combination Products Services Offering

Any future is uncertain, but if current trends in the healthcare industry are any indication, we can be sure there are more changes — and challenges — in store. One thing is sure: the devices of the future will be even more patient centric than today. “Digital health integration, personalized medicine delivery platforms, and more autonomous drug delivery systems are where we are headed,” predicts Ahmed Mallek. “And I believe Nemera has an important role to play in that.”

“And because human factors, support materials like instructions for use or secondary packaging, and regulatory compliance are so inextricably linked,” adds Mark Tunkel, “you really need someone who understands how to successfully navigate every step of the process. One of our roles is to make our customer’s lives easier by reducing their risk of managing multiple partners and leveraging our expertise to accelerate their time to registration and the market. Looking forward, we will consider geographic expansion to serve more markets directly with our core services as well as expand our services in more adjacent areas to our current offering. At the end of the day, if they have a device, if they have a drug, we want to help them across that whole process.”

To know more about us: Insight by Nemera – Nemera

About Nemera

As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy.

We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards.

Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfil our mission.

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