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Test to understand where a product design fails and use parallel solution paths

Several listeners have asked about medical device products and I searched for someone with deep experience in this area. I realize most of us are not involved with medical devices, but there is much any product manager can learn from the upcoming discussion. This ability to learn from product managers in different industries is one of the things I most enjoy about this podcast. We have a lot in common regardless of the industry we work in.

The topic of this episode is pricing. It is a frequently asked about topic and I have a great guest to help us understand the components of a pricing strategy and how to price a product.

My guest is Mike Lawless, who has over 25 years of experience in medical devices, starting as a mechanical engineer. For more than a decade he has been helping to create medical devices for a variety of organizations through his own company, Lawless Consulting.

In the discussion you will learn the:

1. Challenges of creating a high-volume manufactured product,
2. Importance of prototyping and testing to failure, and
3. Benefits of using parallel problem-solving and development.

 

Summary of some concepts discussed for product managers

• [2:38] What are the types of medical devices you have helped develop? I work on a wide range of medical devices, with several focused on drug delivery, such as insulin and IV pumps, as well as diagnostic devices.

 

• [3:27] How is the development of medical devices different from other products? There are a lot of similarities with other types of products. Most of my work has been in the development and management of high-volume manufactured products. Such products require attention to the functionality of the product as well as design for manufacturing, tooling, and production. Medical devices have an additional challenge to comply with FDA regulations. If the product uses disposable items (such as the tubing set for an IV pump), this introduces additional risks. Also, there is a great deal of innovation in medical devices and of course innovation introduces risk because we are attempting what has not been done before. The greater the innovation, the greater the potential for a technical risk or glitches in manufacturing.

 

• [4:48] What are the challenges of high volume products, like disposables? With disposables that may be manufactured in the millions to tens of millions a year, the tooling and automation becomes critical and can be complicated. A very small mistake is very costly. The core challenge with this type of product development is…

you need to find the problems before they find you.

• [8:21] How does encountering a problem impact medical devices given the regulation needs? It depends, as the FDA regulatory process has many steps including submission of the product for approval. Depending on when the problem is encountered, if the product must be resubmitted it could create months or years of delay. This is a difference between medical devices and other products as the development cycle is longer because the regulations must be met. It’s not uncommon for a medical device cycle to be 3 to 5 years.

 

• [10:05] What kind of challenges do you find with clients who are developing medical devices? The biggest challenge is that the culture is not aligned well with what is needed for product development. The norm is business operations and information that can be put on a Gantt chart. This effects how engineers approach development, with a focus on if something works or not instead of having deeper knowledge of the nuances of why something works. When a problem arises they are caught off guard. The solution to this is to gain a knowledge of failure conditions.

 

• [11:21] Can you share an example of a medical device project? The Archer project was creating a disposable applicator for a wearable blood glucose sensor. It is one of the most popular devices for diabetics. It uses Bluetooth to connect to smartphones and provides constant monitoring. I worked on this project in 2008 when it was a startup company. By 2014 they were very successful, growing at 50% year. The volume of the product had increased to millions per year. They decided to launch a new easier to use disposable product with the objective of selling 5 million the first year. The mechanical complexity of this disposable was a magnitude higher than the previous disposable. I got involved in this project after it was a year late and the R&D team was overwhelmed by the challenge. The path to success is managing the risk while developing the product. They did not have a backup plan. They needed to scale up their technical rigor, which is what my team brought to the project.

 

• [15:51] What problems arose in developing this product and how did you resolve them? Innovation creates risk because we are doing something new. To manage this, parallel paths should be used, which means creating more than one solution for each need. Also, be aggressive on analysis and testing. Knowledge drives the project. Each innovation project will have several unknowns and you have to break them down and find solutions for each. Use the Rule of 3 – pursue three paths of solutions for each challenge. Add transparency to the process so everyone involved understands what needs to be accomplished. Also, understand where products fail.

 

Useful links:

• Mike’s medical device team and services at Lawless Consulting.
• Connect with Mike on LinkedIn.

 

Innovation Quote

“Divide problems, integrate solutions.”– Mike Lawless

 

Thanks!

Thank you for being an Everyday Innovator and learning with me from the successes and failures of product innovators, managers, and developers. If you enjoyed the discussion, help out a fellow product manager by sharing it using the social media buttons you see below.