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Patients are waiting on what you make. Plan like it.

Biopharmaceutical, medical device, and medical products companies run on regulated plants, long supply chains, and products patients can’t do without. When a site goes down, a cyberattack stops production, or a quality issue hits the news, the questions come from patients, regulators, and your board at the same time.

We help life sciences companies build crisis management, business continuity, and IT disaster recovery programs that work on the worst day, connect the plant floor to your executives, and stay simple enough for your teams to use.

✅ Practitioner-led, not advisory

✅ One crisis structure across quality, cyber, privacy, and operations

✅ Tested in real exercises, not just on paper

What we hear from life sciences leaders

We work with medical device, medical products, and global health companies. We hear the same things from the people who run their programs:

“I’m managing it from the middle. Unless you have a champion who really owns it, it’s hard.”

“The board told us which products are critical. Now the program has to protect them.”

“We don’t know what we’d recover first, or what’s tied to what.”

“We need to build the case for cyber recovery.”

“Let’s talk about the dollars it takes to buy down the risk.”

“Our previous lead left. We’re inheriting a program that’s out of date.”

“I don’t have enough time and hands.”

Sound familiar? You don’t need another consultant to tell you what you already know. You need practitioners who will simplify the program, build what’s missing, and help you run it.

The life sciences reality

Life sciences companies carry risks most industries never see together: product safety and quality, regulatory action, intellectual property, and a global supply chain that can’t easily switch sources. Mergers, acquisitions, and spinoffs reshape the company every few years, and the resilience program has to keep up.

Some of the expectations are in law:

  • Drug supply. Since the CARES Act of 2020, manufacturers of certain critical drugs and their active ingredients must develop, maintain, and implement a redundancy risk management plan that identifies and evaluates risks to supply. They must also tell FDA at least six months before a permanent discontinuance or an interruption likely to meaningfully disrupt U.S. supply, or as soon as practicable.
  • Cyber disclosure. A public company has four business days after it determines a cyber incident is material to disclose it to the SEC.

The threats don’t wait for the rules. Ransomware can stop production at a manufacturing site and force a ransom decision, a disclosure decision, and a law enforcement decision in the same afternoon. Hurricanes, activist campaigns, and geopolitical disruption have all reached life sciences operations.

The answer isn’t a separate plan owned by every function. It’s one program, with one crisis structure that quality, cyber, privacy, and operations all plug into, site continuity plans that match it, and one testing calendar.

How we help life sciences companies

  • Resiliency Diagnosis®. A standards-based evaluation of your crisis management, continuity, and recovery capabilities, with a maturity score and a prioritized roadmap, in about 12 weeks.
  • Crisis management. One crisis framework aligned with your privacy, cybersecurity, and product quality response, with role checklists and a trained corporate crisis team.
  • Business continuity and Business Continuity as a Service. BIAs, site continuity plans for manufacturing and distribution, and governance, built with you or run for you.
  • Resilience as a Service. Business continuity, crisis management, IT disaster recovery, and exercises, run as one program.
  • IT disaster recovery. Recovery requirements, sequencing, and testing that match what production and quality systems actually need.
  • Cyber incident response planning. A cyber response that carries a ransomware attack from technical detection to your executives, with disclosure decisions built in.
  • Cyber crisis exercises. Enterprise simulations that move from the security team to the crisis teams, the manufacturing sites, and the chief executive.
  • Tabletop exercises. Product, supply chain, reputation, and geopolitical scenarios built from your own data.
  • Crisis communications. Communication plans for patients, customers, regulators, investors, activists, and the media.

< 4 months

to build a complete resilience program for a global health spinoff

20+

discovery interviews in the spinoff’s Resiliency Diagnosis®

40+

participants in one global healthcare organization’s crisis tabletop

Medical Products

An Enterprise Cyber Crisis Simulation for a Global Medical Products Manufacturer

A ransomware and data-extortion scenario that moved from technical detection through the crisis teams and manufacturing sites to the chief executive.

Global Health

Ensuring Resilience for a Global Healthcare Spinoff

A complete resilience program in less than four months for the global health division of one of the world’s largest corporations.

Global Health

A Crisis Tabletop Exercise for a Global Healthcare Company

A European scenario that moved from a reputation crisis to a cyberattack, with more than forty participants.

Programs aligned to

ISO 22301 · ISO 22361 · ISO/IEC 27031 · NIST SP 800-61

Our life sciences work

Our life sciences work covers medical technology and devices, medical products, biopharmaceuticals, generics, and the companies that support them. All of our case studies are anonymized.

Medical products manufacturing

  • An enterprise cyber crisis simulation for a global medical products manufacturer, testing ransom payment, regulatory disclosure, federal law enforcement, and disrupted production decisions from the cyber crisis team to the chief executive. Read the case study.

Global health

  • A complete resilience program in less than four months for the global health division of one of the world’s largest corporations, during its spinoff, with a crisis framework aligned to privacy, cybersecurity, and product quality response. Read the case study.
  • A crisis management tabletop exercise for a global healthcare organization recently spun off from its parent company, built on a European geopolitical scenario and a cyberattack. Read the case study.

More of our life sciences work

  • A rapid maturing of an international biopharmaceutical provider’s business continuity and disaster recovery program. We built a standard approach rooted in ISO 22301, including governance, the business continuity and disaster recovery lifecycle, an exercise strategy, and a process for continuous improvement.
  • The first enterprise crisis management framework for an international medical device manufacturer after the 2017 hurricane season, including a cross-functional incident management team, training for managers and executives, and an exercise to validate the new framework.

Frequently asked questions

Will this help with FDA's drug supply requirements?

Your quality and regulatory teams own the risk management plan and the notifications to FDA. We make sure the business continuity program, site plans, and crisis structure that a supply disruption depends on are ready, and that the notification decision is built into your crisis playbook.

We're in the middle of a spinoff or acquisition. Can you help now?

Yes. We built a complete resilience program for a global health spinoff in less than four months, starting with a Resiliency Diagnosis® that reviewed what the parent company provided and what the new company needed on day one.

Can you exercise a ransomware attack that reaches our manufacturing sites?

Yes. We design enterprise cyber simulations that move from technical detection to your cyber and corporate crisis teams, site continuity plans, and executives, including the ransom, disclosure, and law enforcement decisions.

Do you work with medical device and biopharmaceutical companies?

Yes. Our work includes medical device and medical products manufacturers, biopharmaceutical providers, and global health organizations.

Where do we start?

With a Resiliency Diagnosis®. It shows what you have, what overlaps, and what to fix first, then gives you a prioritized roadmap.

Can you run the program for us?

Yes. Through Business Continuity as a Service or Resilience as a Service, our team runs your program day to day, with your people owning the decisions.

We can help.

Let Bryghtpath put its life sciences experience to work for your organization

From your next site continuity plan to your next cyber simulation, we’ll help you build a program that holds up when it matters.