How to Speed Time to Market: Our CEO’s Take on Emerging Challenges and Acceleration Opportunities for Medical Device Companies

A Q&A With Gerald Wesel, Cognition Chairman and CEO  

Gerald Wesel, Cognition’s Chairman and CEO, is responsible for setting the company’s strategic direction. He is known for propelling innovative, disruptive technology companies to next level success, and has previously served in leadership roles at seven startups and four large enterprises. In this Q&A, he provides his take on how medical device development is evolving—and the persistent and emerging challenges that device companies are facing as a result. He also shares some key strategies that device company leaders should be employing to help their organizations adapt and thrive.

What are some of the biggest changes within medical device development that you’ve observed in recent years? How are these changes creating new challenges for the leaders at medical device companies?

GW: Time is, and has always been, money when it comes to medical device development. As a result, the pressure to get to market fast is nothing new. What is new, however, is the increasing complexity associated with meeting regulatory requirements. That complexity, and the added burden it is placing on development teams, is creating a very challenging dynamic for device companies. Device development leaders must balance the need for efficiency and agility during the product development phase, while also ensuring that they are not sacrificing one ounce of quality that could prevent them from gaining regulatory approval upon the first submission. It is extremely challenging and the pressure that these company leaders face is extraordinary.

How has Cognition taken these challenges into consideration when developing Compass and Compass PRO? What are some ways the solutions (known jointly as Compass) can help?

GW: Unlike any other software tools, Compass is specifically created for medical device companies. It automates, integrates, and enhances processes across risk, requirements, and test management, enabling device companies to easily build relevant connections between data items, automatically create complex trace matrices, and export submission-ready documents instantly.

That all, of course, results in significant time savings—speeding time to market and enhancing data integrity.

Compass also includes built-in workflows and templates to ensure compliant processes for authoring, reviewing, and releasing information. Other key features include:

• Guided design controls
• Change once, update everywhere functionality
• Submission-ready documents that can be exported instantly in the formats required for health authorities

Finally, we’ve designed Compass to seamlessly integrate into the workflows employed by medical device companies, with highly configurable and adaptable processes that can match their current SOPs. It also includes a flexible work environment for different design definition approaches, including both data-centric workspaces and document-centric environments.

These are just a few of the many ways Compass can help speed time to market—safely.

Can you take us behind the curtain and share how Cognition continually adapts to provide the best solution for medical device companies?

GW: Our team includes professionals that have previously worked in medical device companies in either development, risk, or quality roles. They understand what customers face in their day-to-day tasks, which provides us with a unique advantage when we are discussing Compass architectures, features, configurations, and workflow capabilities with customers and prospects.

We also retain several consultants that have worked in various executive positions in large OEM medical device companies such as Medtronic and Smith + Nephew. They regularly review our product features and roadmap and comment on what is most compelling. Other Cognition consultants have decades of experience working with regulatory standards authorities such as the European Association of Medical Devices Notified Bodies and the International Accreditation Forum Working Group on ISO 13485 and Medical Devices quality management systems. These consultants ensure that our products implement the latest standards (e.g. ISO 13485, IEC 62366, and ISO 14971).

Finally—and something we find extremely valuable—are the regular conversations we have with customers regarding their needs and our solutions. We learn what new capabilities would be useful to them, and we often release new features based on those insights.

What is your top advice for leadership teams at organizations that are currently using a manual approach but are considering transitioning to a device design control solution like Compass?

GW: It is absolutely critical that they select a partner that not only will provide the best solution for their needs, but that will also work with their team to provide a seamless transition. At Cognition, this is one of our top priorities because we understand that the experience associated with the transition can very much dictate overall solution adoption as well as long-term success related to its use.

Some of my top recommendations for companies that are evaluating solution partners include:

• Find a partner that provides highly configurable and adaptable workflows—both to industry-wide best practices and to your company’s unique standard operating procedures and process
• Make sure the partner will be able to easily import data from your pre-existing documents (i.e., Word and Excel) into their solution with no risk of lost data or data errors
• Find a solution that will integrate with the other systems you already have in place

The partner should also work closely with your leadership team across all domains—including development, quality, regulatory, and IT—to ensure the transition plan best addresses their needs. Although these individuals will recognize the value of the solution, each will be asking: “How will this tool help me and my group?”

What’s your top advice for medical device development company leaders as they guide their organizations through 2024?

GW: If you are still using tools like Word and Excel it is time to transition to a purpose-built tool for medical device development. Medical device products are becoming more complex by the day. At the same time, standards and regulations are evolving and the complexity of risk analysis is increasing. Medical device company leaders must take steps to help their approach to data management keep pace. Those that continue to rely on traditional practices face an increased risk of product safety and quality problems, and are more likely to experience difficulties with regulatory submissions and audits.

Finally, if you already have a platform partner, take some time to reevaluate if they are the right partner for your needs:

• Does your current tool help you stay ahead in the race for time to market?
• Does it help you deliver the highest quality products?
• Does it help you meet regulatory standards?
• Can you glide through a surprise audit?

If the answers to any of these questions are not 100% yes, it’s time to rethink your approach.

Interested in learning more about how Compass can address your challenges? We would love to connect, answer your questions, and share a demo. Click here to schedule a meeting.