As we move further into 2018, we find that regulatory uncertainty in the life science industry remains to be a challenge for most companies. Waiting for regulation changes to roll out is driving life science companies to update their standard operating procedures for reporting and compliance programs. Doing so has proven useful in making improvements and efficiencies in day-to-day operations.

Mitigating Regulatory Risks

In 2018, life science companies will work more diligently to put controls in place to help mitigate regulatory risks associated with industry relationships. The life science industry has gone under great scrutiny in recent years in regards to ethical relationships between physicians, pharmaceutical companies, and other industry organizations. Because of this, companies are managing their operations more closely. They are documenting all client interactions to justify the need and value of the relationships. Consistent auditing and monitoring will be the key to successful relationships in 2018.

Keeping Up with the EU Regulations

In 2017, new European Union (EU) regulatory requirements hit the market. The EU Medical Device Regulation (MDR) and the EU in Vitro Diagnostic Regulations (IVDR) both established new regulations which will help advances in medical device technology. Most importantly, they reclassified some of the technologies and added classification software and new technologies that were previously exempt from regulation. In addition, new EU regulatory requirements have resulted in elevated clinical requirements for higher risk devices and an increase in post-market surveillance for many devices. Visit the European Commission for details.

ISO IDMP Provides Collaboration

Identification of medical products (IDMP) is a set of five International Organization for Standardization (ISO) standards. It is supported by European legislation and regulation because it provides product identification standards which facilitate the exchange of medicinal product information in a comprehensive and reliable manner throughout the lifecycle of product development and merchandising.

Connecting Medical Devices to the Internet

Cybersecurity and risks to patients’ safety remain the top concerns for medical device connectivity to the internet. Although there are benefits of opening devices for accessibility via hospital networks, life science companies must consider the potential effects it may have on their business if they do so. For starters, it is important that cybersecurity teams have input during product development stages of equipment. Having security teams in place during the entire lifecycle of a product will help to avoid security issues early on. To achieve this, many life science companies will adopt and integrate Technical Information Report 57 (TIR57) risk management principles for medical device security into their organization’s product security programs.

21st Century Cures Act Reduces Barriers

The 21st Century Cures Act (the Act), signed into law in 2016, is FDA’s initiative to incorporate patients’ perspectives into the development of drugs, biological products, and medical devices. The Act modernizes clinical trial designs and outcome assessments in order to speed up the development of medical products. Life science companies benefit from the reduction of barriers to research collaboration. Through the Act, diseases are identified earlier because of the personalized medical treatment patients receive.

Uncertainty in Life Science Regulations Creates Opportunities

Regulatory uncertainty will remain a constant in 2018.Although this creates a stressor to many life science companies, it can also create opportunities. Many of the changes coming down the pipeline are forcing life sciences companies to make updates to their business models that result in efficiencies and overall good business practices.