A Successful Technology Strategy for Medical Device Teams Asking, "Own Or Partner?"

By Chris Danek, Bessel LLC

Rapid innovation is a breakthrough that scales — and delivers on target, on budget, and on time. That’s a tall order for medical device development teams. In my first post in this series, I suggested a medical device development approach rooted in continuous learning. Continuous learning helps teams move forward, learn, and grow faster.

Another way to move forward faster is to have the right technology strategy to decide what to do — and what not to do. A solid technology strategy gives you confidence in what to tackle yourself, what to partner on, and what to buy off the shelf.

Benefits Of A Solid Technology Strategy

A solid technology strategy brings several important benefits to your project teams. By knowing what to work on and what not to work on, you will be able to:

• Focus your efforts on the most critical aspects of your development.
• Leverage outside expertise effectively to accelerate your program while improving the solution you deliver.

Another huge boost: A clear strategy will guide how you invest in your team. Once you know your technology strategy, you can invest in critical areas, from hiring plans to professional development to acquiring key equipment and software capabilities.

How To Develop A Technology Strategy For Device Development Projects

Follow these steps to build your team’s technology strategy.

Identify Technology Needs.

The first step is to identify the main technology needs. What are the most important aspects to develop for a successful project? Consider your device's user needs, patient needs, and technical performance challenges. Also, consider logistical needs — the testing and simulation capabilities you’ll need during development and manufacturing.

Classify The Technology Needs.

After identifying the technology needs, classify them to help you decide where to prioritize your efforts and where to partner. Consider this framework:

• Core technologies — own these: Core technologies are vital, and you need to own them. You need to know everything about the technology and how to manufacture it.

These core technologies will often differentiate your product, giving your marketing a natural boost and leading to valuable patented features or trade secrets. If you do bring in external partners to accelerate your core technologies, tread carefully. You should bring that expertise into your company during the development project or ensure you’ll have long-term access to the external partner’s know-how.

Here’s an example. In neurovascular catheters, trackability is a core technology. Trackability is the ability of a catheter to follow a guidewire through tortuous anatomy, and it’s vital to a procedure’s success. Many companies design the materials and dimensions of their catheters themselves, maintaining the expertise in crucial design details as trade secrets. The companies that don’t keep this core expertise in-house ensure they understand and own the designs.

• Pacing technologies — find a strategic partner: Pacing technologies are critical, and you need to be on the leading edge of these technologies for your product to perform. But you can achieve that goal by working with a strategic partner. If you need to focus resources on core technologies, leveraging strategic partners for these second-tier pacing technologies makes sense.

Let’s look at two examples. First, many startups consider the core technologies in ablation procedures to be the catheter, active electrode configuration, and waveforms. They control those in-house. They might bring in strategic partners to develop the capital equipment for energy delivery.

Another example: Many companies work with strategic partners to develop test models and methods. While testing is intimately connected to the device requirements, design, and risk analysis, it is one step away from the core elements of the design and can be considered a pacing technology.

• Enabling technologies — use suppliers or develop internally: These technologies are required to make the product work, but you can purchase them off the shelf or from a supplier. You also can develop them internally at a lower priority than other design aspects.

It’s not especially important to build these technologies in-house, but knowing how to integrate them into your design is important. Sometimes, that integration is as simple as qualifying and managing supplier relationships.

Example: Many companies consider packaging systems an enabling technology. While packaging is essential in protecting devices during shipping and storage, especially for sterile devices, designing and customizing packaging is a good fit for an outside supplier.

Identifying and classifying technology needs with this framework establishes a technology strategy.

Follow Your Technology Strategy To Inform Key Decisions

Your technology strategy frames important decisions: building your development team, identifying key hires, focusing your internal efforts, complementing internal teams with external partners and suppliers, and deciding whether and what to delegate to contract manufacturers.

Use your technology strategy to frame these decisions. Test your thinking: What are the ramifications if you reclassify your technology needs? For example, a team that classifies the ergonomics of a handle design as “core” because of procedural requirements may hire an industrial designer and usability engineer. Reclassifying ergonomics as “pacing” may lead to different decisions, like leaning on an external product design firm.

By strategically dedicating resources to key technologies and having a discipline of continuous improvement, you will accelerate development and improve the solution you deliver. Establishing a solid technology strategy will build confidence and create a cohesive approach to major decisions in building your team, focusing its efforts, and leveraging strategic partners.

About The Author:

Chris Danek is the CEO of Bessel LLC. He is a serial entrepreneur and veteran of the life sciences industry. At Bessel, he works with entrepreneurs, startups, and established company teams to develop breakthrough medical device technologies. In prior roles, he was co-founder and CEO of AtheroMed (now Philips AtheroMed) and VP of R&D at Asthmatx (acquired by Boston Scientific). He is a visiting professor at the W.M. Keck Center for 3D Innovation at the University of Texas at El Paso, an advisor to the Santa Clara University Healthcare Innovation and Design Lab, and an inventor of more than 85 U.S. patents.