Medical device startups: Here are the secrets of success


medical device startups beach seashell

[Image from Unsplash]

Bill Betten, Betten Systems Solutions

It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry.

The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University. So the cost of failure or even delay is high.

Unlike the consumer world – where an app or prototype can be developed in a garage (or dorm room), then publicized on YouTube and funded via Kickstarter – the regulated medical device development world requires a different level of commitment, process and demonstration of efficacy.

(See Bill Betten discuss innovation and product development at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)

The topic of medical device development success could easily fill a book. This is the first in a series of articles discussing the design of innovative products in a highly-regulated environment. What are the critical elements to consider before diving into product development, and how do you pivot your process after the dive? Applying these principles to your development process will result in a faster and cheaper path to market.

Let’s focus on the definition and execution of product development activities post-funding.

The good news on the funding front is that more funding is going into early stage medtech venture capital financing.  In 2016–2017 nearly $4 billion was raised in 407 early stage venture deals, beating the prior 12 months then-record $2.2 billion total including 126 venture rounds worth at least $5 million, according to the Ernst and Young “Pulse of the Industry 2016–2017” report.

However, availability of capital is inconsequential if you can’t convince potential investors that you have not only the good idea, but also the vision, the team and the plan to bring your startup from a concept through to at least a demonstrated level of performance. Let’s assume that an FDA submission will be required for the product, too.

The critical success elements to be discussed include:

  • Idea – Without it, nothing to be developed
  • Process – The structure for development
  • Plan – The blueprint
  • Requirements – The details
  • Regulatory/reimbursement – Critical to the medical device space
  • Verification/validation – The right product doing the right thing

We’re going to take a detailed dive into each of the elements in future articles. Since you’ve already got the idea, let’s begin with process, the umbrella under which the other activities are conducted.  While processes vary from organization to organization and have evolved over time, successful product developments require a certain level of structure to accomplish the goals in a timely and efficient fashion.  A product development process defines the requirements and serves as a guide to ensure that products meet or exceed customer and business needs. The process also describes the stages, inputs, outputs and responsibilities associated with the subsequent activities to be performed. The process applies to all product development activities and includes significant changes in function and/or intended use on released products. Your development process also includes the Quality Management System (QMS).  Many medical device companies choose to implement a quality system and have it certified to ISO 13485 to ensure consistency in this regulated industry.

FDA waterfall product development medical device startups

“Waterfall” product development process [Image courtesy of FDA]

For years the FDA (and industry) reflected a “waterfall” process (image to the right) as described in the FDA Design Control guidance in 1997.  This views the product development process as a set of sequential activities.  Basically, requirements are developed, and a device is designed to meet those requirements. The design is then evaluated, transferred to production, and the device is manufactured. However, in the mid-2000’s, it was recognized that development is really an iterative process that incorporates interactions between a variety of stakeholders and the input of every group involved in the development process.  The emphasis now is on sharing information throughout the different product lifecycle stages and those different groups, resulting in a much messier (but more realistic) interaction diagram. (See below.)  It also encourages the use of Preventive Actions over Corrective Actions.

FDA CDRH product lifecycle management medical device startups

FDA CDRH total product lifecyle management [Image courtesy of FDA]

In summary, the process and QMS help ensure that product development activities are conducted in a cross-functional environment. In addition to driving the initial development of the product, it also applies to the updating of a product after launch.  In the regulated world where 60–80% of the development effort is associated with documentation in various forms, the process provides the framework for a successful effort.  From a practical perspective, a well-managed process should enable you to answer the following questions:

  1. What is important and why, and
  2. Why decisions were made

…without having to ask anyone!

In the next installment of this series, we will examine how the development of a project plan contributes to the successful development of your medical product.

Bill Betten is the president of Betten Systems Solutions, a product development realization consulting organization based in the Twin Cities. Bill utilizes his years of experience in the medical industry to advance device product developments into the medical and life sciences industries.

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