Trending in 2020, Implications

welocalize January 29, 2020

From regulatory changes to mergers, here is a look at life sciences industry trends to watch in the coming year and how they could impact your organization.

As we identified in our previous post, the key theme across the trends we pinpointed for 2020 involves technology, either in terms of implementing new technologies or implications for the year ahead. Here is a look at a few.

MDR 2020 + a Delay in EUDAMED

The medical device industry spent 2019 preparing for the European Commission launch of the new EUDAMED, the database which is used to monitor the safety and performance of devices. The new regulations on medical devices (MDR) and on in vitro diagnostic medical devices (IVDR) establish a much wider EUDAMED database than the existing one under the current directive. In addition, the new database will have portions open to the public in an effort to increase transparency and accessibility.

In late 2019, EUDAMED was postponed until May 2022. The new launch date coincides with the implementation date for the In Vitro Diagnostic Regulation. The delay, according to MedTechDive, will give companies more time to prepare their systems and populate the database. It adds, the EUDAMED project is expensive for companies in terms of time and resources, and it’s particularly challenging in terms of IT resources.

The delay will not extend the effective date of the MDR, which remains at May 26, 2020. MDR will require that medical device content, such as instructions for use (IFUs) be translated into the official language of each EU member state where the product will be marketed (up to 24 official languages). In addition, the content for products intended for commercial use must be written so that it can be understood by a layperson.

Legal + Patents

With some high-demand drugs losing patent protection and fewer drugs entering the market than before, pharmaceutical companies are racing to obtain patent protection in order to recoup their research and development expenditures. It’s not hard to understand why competition in the patent arena is so high: approximately 80% of a pharmaceutical company’s revenue is derived directly or indirectly from the patents it holds. (Source: DrugPatentWatch)

One legal battle to watch in 2020 is the dispute over who invented CRISPR-Cas9 genome editing in eukaryotic cells. According to an article in GEN News, the parties have discussed settlement, but no agreement has been reached at this time. The article further details that this has led to confusion about what sort of licensing people need in order to commercialize the technology.

Lisa A. Haile, JD, PhD, a partner with the law firm DLA Piper in San Diego, told GEN, “Right now, some of my clients are confused: Do we go to University of California? Do we go to Broad? What licenses do we really actually need?” Haile said. “So many of them are taking both licenses, just because it’s a big question mark as to how the patent landscape is going to fall out. I have gone to both entities for licenses for my clients.”

Patent disputes are not uncommon in the life sciences industry. In addition, the process for developing a new drug is lengthy and costly, and the same can be said for the process of obtaining patent protection internationally.

 DID YOU KNOW, according to Forbes, in 2019 the world’s most innovative medical technology companies’ patent focus is on biosensors, surgical robotics, shortening the time-to-market for pharmaceutical drugs, and funding startup incubators that yield new patents. 

Plan for the commercialization of a drug or device in markets outside of your home country with accurate patent translations.  A translation error that materially alters the language of your application could increase the risk of invalidation, opposition, and weaken the patent’s position during infringement litigation.

+ More Mergers

The first three quarters of 2019 saw 242 mergers and acquisitions (M&A) deals for a combined value of $195 billion, according to Informa Pharma Intelligence. In the coming years, the life sciences industry will continue to face a wide range of pressures—from regulatory to economic.

Keeping pace with the changes, according to research and consulting firm Deloitte, will require “alternative business models, additional skills, greater efficiencies, new paths to innovation and creative strategies for growth.” The firm contends that much of this can be achieved by adopting new collaborative business models, including mergers and acquisitions, to “increase capabilities and expand geographic footprints.”

Many life sciences companies are looking to partner with or acquire tech-focused companies. “Some of the skills that tech companies have are exactly what the industry needs,” said Ernst & Young (EY) global life sciences industry leader Pamela Spence.

EY says there have been nearly 90 deals since 2014 where life sciences companies have partnered with tech companies.

M&A often means that the combined businesses are now looking at new markets. Whether contact lenses or digital health devices, product localization is critical for success in international markets. Recognizing that ‘international’ is part of the growth equation allows brands to get ahead and to get it right. Getting a new product ready for global markets is a multi-step process that requires a cross-functional team of experts. Follow these key steps for international success.

Then and Now

As in year’s past, rising costs and the increasing complexities involved in bringing drugs and devices to market drives life sciences organizations to re-examine their business operations and technology platforms.

Welocalize Life Sciences has helped many companies streamline processes to reduce translation turnaround times and costs, improve trial transparency, and reach more patients and practitioners in more markets.

Contact us for information on our language services and AI-enabled technology solutions for highly regulated industries.