Faced with new regulations, the pharmaceutical and medical device industries have an obligation to comply.

For example, the implementation of the EU Falsified Medicines Directive, initiated 4 years ago, will make it possible, from February 2019, in most of the 28 EU Member States, to track and identify each box of medicinal product using a unique serial number. This number, represented by a QR code printed on the packaging of the product, is registered in a European Union database and is checked by the Pharmacist before the drug is given to the patient, thus eliminating any risk of counterfeiting.

Challenges:

• Qualify and validate the production and distribution systems impacted
• Master the regulatory issues related to the emergence of combined products
• Anticipate potential future requirements such as aggregation

All medical devices are potentially connectible. Some are already connected and working through applications that provide health professionals and patients with decision aids, diagnostic possibilities or automatic treatment management. There are many areas of application, including telemedicine, addiction management and chronic disease management.

Experiencing a growth rate above 10% per year, the e-health market is estimated to be worth $400 billion by 2022.

Challenges:

• Develop these embedded software in compliance with the regulatory standards of the target market
• Prove the regulatory compliance of these products, which is complex due to the requirements related to the status of DM (Medical Device) and the presence of a software
• Ensure personal data security and stakeholder trust

A combination product is a health product in which a drug and a medical device are combined. Similarly to an embedded software, innovation and technological progress are making this type of alliance possible more and more and here again the fields of application are numerous. One association that has become commonplace is the combination of hip replacement and antibiotics, which aims to inhibit bacterial adhesion.

For the manufacturers, the issue is complex because these “borderline” products have only one status, Drug or DM, and that each status has its own specific regulatory regime. Here, the regulatory strategy is the most important, from the design phases.

Challenges:

• Master both the normative constraints of DMs and those of drugs, to develop a registrable combined product
• Validate the manufacturing process for these combination products
• Be able to qualify and classify the combined product to determine the applicable regulatory status, and file for registration

The pharmaceutical industries must produce more at competitive cost in order to meet the budgetary efforts required by health systems, increased competition from generic drugs and growing demand from emerging countries.

In 2017, the global drug market exceeded the threshold of 1,000 billion dollars of revenue, increasing by 6% compared to 2016, with a market share in the United States of 49%.

Challenges:

• Share R&D investments
• Renew production tools (e.g.: automation)
• Requalify these upgraded production sites