Each new year presents a new set of opportunities and obstacles for medical device and life sciences industries. As the lines between pharmaceutical, biotechnology, medical device and life sciences continue to blur, new bills, new fees, and new regulations keep industry professionals, especially medical device developers, on their toes.
These four legal trends will shape the industry in 2018, and likely for years to come:
Patient-driven healthcare systems backed by blockchain: While blockchain technologies are making waves across all industries, the ramifications carry particular weight in the medical device and life sciences industries. While device companies are integrating blockchain technologies into their innovative and technological updates to navigate data exchange issues, the documentation of confidential patient information, data transfer, and the access and housing of all information is a top priority for organizations and their legal teams. Blockchain startups for the healthcare industry are cropping up everywhere.
The rise of information security breaches: As technology and healthcare advance, security risks rise. Security breaches may put patients’ physical, personal and professional lives at risk. This risk is causing a mindset shift and forcing medical technology companies to go through their security infrastructure with a fine-tooth comb. Ultimately, this proactive mindset will have tremendous benefits and make the industry smarter and stronger. What’s more, in 2015 the National Institutes of Health reported, “compromised medical devices can be used to attack other sections of the health care organization network.”
The fusion of pharma and med tech: Historically, pharmaceutical and medical technology companies have stayed in separate lanes. As technology advances, the healthcare industry is increasingly overlapping, and medical device companies are directly conducting clinical trials. By teaming with pharmaceutical giants, medical device companies are leveraging their expertise to drive the product to market. The fusion has direct legal implications, with the combining of two industries, as well as patient-based implications, allowing patients access to technology, medications and devices all in one, creating value in the industry that has previously not existed.
Continued changes in taxes and fees: While the medical device tax has been delayed for another two years, costing the federal government about $3.7 billion in that time period, the FDA revealed various updated fees. Among them were the MDUFA user fees, which allow the FDA to collect set monetary amounts “from medical device companies for consistent reviews of their medical products” for the 2018 fiscal year, according to Medical Device Investing News. Critics see these laws working against the innovation, creativity and vision for accessible healthcare for all, which is a value many medical device companies hold at the forefront of their organizations.
The medical device industry is evolving and changing at lightening speed, impacting all surrounding industries – legal, IT, sales, and beyond. Staying on top of industry trends will help ensure your organization stands out above the rest.