The continued development of pharmaceuticals and medical devices is critical to world health. No one actually wants to see these efforts stifled or impeded in any way. By the same token, no one would argue that these sectors should be allowed to operate without regulation and oversight. Clearly, consumer and patient safety cannot be ignored.

Given the myriad pressures and constraints on life sciences companies today, on can’t help but wonder how Louis Pasteur or Marie Curie would fare in the current environment. How would they be dealing with big data and venture capitalists, with the FDA and GDPR?

What’s Ailing Life Sciences Manufacturers?

Venture Capital

Investment in venture capital-backed companies in the US has shown a constant decline in recent years, with fluctuations in the number of deals closed and the dollar value of those investments.1 Life sciences companies need to win back the confidence of investors by demonstrating how they can still gain a reasonable ROI (Return on Investment) despite increasing product development costs and the length of time it takes to bring a product to market.

Regulation

Regulatory bodies in the US and the EU continue to issue more stringent requirements that add time and cost to the delivery of new drugs and devices. While this is a necessary requirement for the security of sensitive healthcare data in particular and consumer protection in general, it needs to be better simplified or unified by industry bodies.2

Cybersecurity

Cyberattack vulnerability in the life sciences sector can be life-threatening. A hack can result in much more than a financial loss or a loss of system uptime. Take for example Johnson & Johnson’s recent revelation regarding the potential vulnerability of its Animas OneTouch insulin pump to hacking.3

It’s therefore not surprising that breaches are a major concern and a hurdle that is plaguing the industry.

How Can Technology Help?

Venture Capital

Advances in AI (Artificial Intelligence), ML (Machine Learning), 3D Printing, and IoT (Internet of Things) sensors may eventually result in cost savings that will shorten time to market and increase profitability, thus potentially attracting more venture capital once again.

Regulation

Tighter controls are not going away. But software solutions that help companies comply with US and EU regulations will reduce the cost of compliance.

Cybersecurity

Here, too, software systems can alleviate at least some concerns. Microsoft Windows 10, for example, incorporates a higher level of Intelligent Security than ever before, with built-in security at every level of the operating system. This includes threat, identity, and information protection, as well as advanced security management.

Summary Thoughts

What comes to mind is the old saying, where there’s a will there’s a way. Clearly, there’s a will. So there’s hope that with so many advances in technology, developing at the speed of light in the 21st century, life sciences manufacturing companies will overcome their current ailments.

Next Steps

At Strategic Systems Group (SSG), our domain is manufacturing and our eyes are on potential software solutions for life sciences manufacturers, in particular, the ERP (Enterprise Resource Planning) software solutions for manufacturing companies.

Contact us today. Call SSG at 310.539.4645 or email us at info@ssgnet.com.

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1 https://www.infinitiresearch.com/thoughts/pharmaceutical-industry-challenges-2018

2 https://www.medicaldesignandoutsourcing.com/5-trends-that-could-affect-medtech-2018/

3 http://advertising.lww.com/resources/healthcare-marketing-industry-trends/medical-device-industry-outlook.html