How to Create a Medical Device Innovation Strategy

Posted in Research and Development by Qmed Staff on April 19, 2016

You need your own medical device innovation A-Team that you can run through the stages of a development process. Silicon Valley–based consultant Bruce Lichorowic provides the basics when it comes to doing that.  

Bruce Lichorowic

Bruce Lichorowic
Bruce Lichorowic

Few if any medical professionals have the time or inclination for creating new medical devices. Clinicians typically use devices they've learned in medical school and make do. If asked, “Is there a better way of doing this?” they'll likely agree but aren't in a position to devote time or effort to applying new technology or improving an existing medical device. They’re too busy taking care of patients.

There are many potential breakthrough medical device solutions waiting to escape the nation's top R&D laboratories and become commonly applied in medical practice. Thousands of new medical technologies have been developed at top universities and research hospitals and are awaiting entrepreneurial sponsors to develop them into commercial products and take them to market.

In a wide range of situations, the technology has the potential to vastly improve the “gold standard of care” associated with today’s devices—many of which have been in use, unchanged for decades. But without strong entrepreneurship, these inventions wait unused, untried and unavailable to patients who would benefit from their availability and application.

The Problem

The process is painfully slow and suffers from a range of institutional requirements set in place by FDA. These FDA requirements are needed to ensure efficacy and safety for all new devices. Developing, manufacturing, and gaining market approval for new inventions is a time-consuming and resource-intensive enterprise. It requires a team with specialized skills to achieve full commercial realization of an invention. Large companies face internal bureaucracies that lengthen the time for new innovating inventions to become commercialized. This overhead often poses enough of a burden that large organizations shy away from promising new technologies posing unknown risk profiles.

Clearly a new approach for fast-tracking medical device developments—a fresh, systematically successful approach—is required to rapidly bringing desperately-needed medical device inventions to market.

Discover more about the secrets of successful medical device innovation at MD&M East, June 14–15, 2016 in New York City.

Keys to Rapid Execution

What's needed to bridge this medical device delivery gap is support for and adoption of a highly-disciplined, commercializing team between “raw or bare-iron” medical device innovations languishing in R&D labs and the established device manufacturer. 

A key advantage in this situation is creating and employing smaller, and generally more nimble, development teams, of taking new technologies through a development and approval process that is rigorous and necessary in order to meet regulatory body requirements at a lower costs.

Also required are a clear set of criteria. With thousands of inventions available at research universities and hospitals waiting on entrepreneurial sponsorship, a rigorous selection criterion is necessary, because not all of these inventions are equally viable. The appropriate model serves as the litmus test to sort out the many potential technologies and identify ones best suited for further development. Recommended key criteria include:

Inventions for commercialization must contain the following:

  • Technology that impacts best practices;
  • Technology effects an existing medical device in use today;
  • Technology that is patented or patent-pending;
  • Significant impact on health care costs and better outcomes;
  • Technology which provides equal cost and/or substantial savings over comparable devices;
  • Large addressable market;
  • 510(k) FDA candidate;
  • Medical device companies interested and/or invested.

Other selection factors include:

  • Devices;
  • Savings;
  • Improvements that are easy to understand and are obvious;
  • Regulatory strategy.

After the selected technology is licensed, a lifecycle management process begins. This includes a number of parallel tracks, including:

  • Targeted strategic partner’s relationship;
  • Comprehensive Freedom to Operate (FTO) and patentability IP analysis;
  • Product development milestones;
  • Product launch and strategy development.

The product development process is largely focused on the meeting of regulatory requirements and the manufacture of a commercially viable embodiment of the licensed technology.

To comply with normal regulatory requirements, each technology is run through a series of phases to develop and demonstrate a so-called “design history.” These phases are a part of the overall quality control system that governs each technology as it progresses from initial technology to a market ready product.

The development process is based on a series of phases:

  • Phase 1 & 2: Design Inputs
  • Phase 3 & 4: Design & Developments
  • Phase 5: Verification
  • Phase 6: Validation
  • Phase 7: Design Transfer

These steps are part of the statutory requirements dictated by FDA for medical device products sold in the United States. Similar procedures are required as part of the CE Mark certification for products sold in the EU and are followed by all medical device manufacturers regardless of size. By applying these phases in a repeatable process, the entire Quality Management System (QMS) for a medical device can be copied and ingested by the the larger medical device companies.

Required Team Talents

Just as the military adopted smaller, highly-skilled special force strategies versus large, traditional combat methods, far more effective medical device delivery demands a combined mix of special talents which can nurture and rapidly execute.

The most effective kind of team for meeting the medical device delivery challenge has a broad range of experience in taking modern concepts and products through the steps required for commercial development and regulatory approval and connecting these products with their best-suited markets.

While many large organizations certainly include talented, hardworking people, the ideal team is well-conditioned for operating in a fast-paced, lean environment that constantly focuses on moving toward product and market goals. This attitude of constant advancement and a bias for action, combined with minimal corporate overhead, creates an ideal organizational scenario for shepherding innovative new technologies into complete, market-ready products.

Once developed and approved (FDA, CE), new medical products can be handed off to a larger, medical device company, with the new devices having shed much of the development risk. This risk assumption benefits the larger companies. They'll willing pay a premium for “market-ready” medical products, compared to “bare metal” technologies in various R&D stages.

Discover more about the secrets of successful medical device innovation at MD&M East, June 14–15, 2016 in New York City.

Bruce Lichorowic, is CEO of Corocent Medical Technologies, a Silicon Valley-based company that helps prepare new medical devices for market commercialization