Medical Device and Pharmaceutical Product Development and Compliance

How a risk-based design approach provides safer and ultimately better quality products to market. Product designs are stronger when risk is inherently considered. Not everyone has the experience and instincts to naturally consider the critical factors required in a comprehensive approach. A solid process ensures risk is addressed consistently throughout product development by all of the stakeholders. It is not enough to intuitively consider risk when designing a product; decisions need to be articulated and documented - this documentation is used to support the design choices throughout the product's life.

Medical device development is a complex process, with a critical element focusing on risk management. The consequences of not managing risk properly can be catastrophic.

An introduction to how smart data utilizes information and actionable context to support business-critical decisions.

“The Only Constant in Life Is Change.”- Heraclitus Managing information goes straight to the heart of managing change. Why? Because without a rationale, checks and balances, evidence, and assurance of safety, information change – if left unchecked – can potentially lead to hazardous situations. This is especially critical in the intensely regulated medical device industry.

In the highly regulated world of medical device manufacturing, the relentless requirement to minimize and mitigate risk places a huge onus on design, development, and manufacturing teams. That’s why companies, large and small, are looking for software solutions to help ensure consistency and objectivity in the creation, auditing, and monitoring of critical risk management processes.

Key takeaway: The ability to reuse product data can dramatically reduce the time taken to design, gain regulatory approvals, and ultimately bring new medical devices to market. Time equates to money in any business, and in the world of medical device design and manufacturing, that can mean BIG numbers! Depending on the route taken, following FDA regulations, the average cost to bring a medical device to market through the Premarket Approval pathway is $94 million. The less intensive 510(k) process averages out at $31 million.

Using unstructured tools such as Word and Excel when doing risk management for medical devices could result in harm to a patient. Why? Because many medical devices are complex, with hundreds to thousands of inter-related design inputs/outputs, testing, and risk management data. Managing that amount of data manually is nearly impossible when using tools like Word and Excel...

The delicate balance between investing and cost-saving at a venture-backed startup or SME is challenging. Particularly at pre-revenue, the CEO and leadership team must steward the capital responsibly and make tough decisions about where to invest – decisions that affect the company’s survival and success.

Giving customers more time to focus on developing great products.  If you are part of a product development team, you know how tedious and time-consuming documentation can be to manage in various word or excel files. We set out to solve that problem over 10 years ago when we launched our solution, Cockpit.  Our goal was to provide a unified and scalable environment to enable companies to structure data and automate processes for more efficient and accurate product development.