2021 is shaping up to be a big year for MedTech mergers and acquisitions. Last week, Siemens Healthineers and Varian announced that they had completed the combination of their organizations and that Siemen’s purchase of Varian was officially finalized.1 The deal, valued at $16.4 billion, is one of the largest of the year.
The purchase of Varian provides Siemen’s Healthineers with a whole suite of advanced cancer treatment technologies. Varian is an industry leader in radiotherapy and the growing industry of proton therapy. As with any MedTech acquisition, there is a reasonable amount of due diligence that must be performed. This includes performing an in-depth assessment of the compliance status of a company and its products.
Regulatory due diligence is not a task for the light-hearted. Especially with an acquisition the size of Siemens Healthineers and Varian, it requires months of hard work. The first step is investigating the overall organization and regulatory structure of the company. The purchasing company must ensure that they fully understand the acquired company’s reporting structure because it is the foundational element of the subsequent activities. Next, a gap analysis should be conducted to investigate the current marketing authorizations of all products, if there are any products currently undergoing regulatory review, a review of all complaints and complaint handling measures, reported adverse events, cGMP compliance, and any outstanding regulatory enforcement actions. All of these activities are just the tip of the iceberg but require a lot of human and financial resources, not to mention time.
Due diligence is an important process of any MedTech organization that is looking to merge or acquire another company. Once you have signed up to own that company, you have also volunteered to be the responsible body for any and all regulatory non-compliances. Conducting the gap analysis of current regulatory status is just the beginning; the best-case scenario is that there are no findings, but you still must determine how you are going to merge the two QA/RA systems, and the worst-case scenario requires a complete QA/RA overhaul.
Often, it is extremely beneficial to have an extra set of eyes work with your team on the regulatory due diligence efforts. This can ensure that all details are captured and that there are no stones left unturned. EMMA International’s team of experts can help by conducting the gap analysis and addressing and implementing any necessary corrective actions. Give us a call at 248-987-4497 or email info@emmainternational.com to find out more!
1Varian (April 2021) Press Release retrieved on 04/15/2021 from: https://www.varian.com/about-varian/our-combination-siemens-healthineers
