Part 2: Readiness of Medical Technologies for the U.S. Markets: Designing for FDA

by Mathieu M. Petitjean, Ph.D [1] and Susan Z. Paquette, MBA, MS[2],

Part 2: Designing for FDA

The Center for Devices and Radiological Health  (CDRH) department of the Food and Drug Administration (FDA) has released a few weeks ago (on July 28th 2014) an updated Guidance for Industry and Staff on the 510(k) Premarket Notification Process and in particular the evaluation of Substantial Equivalence in Premarket Notifications[i]. This illustrates the genuine effort that FDA is doing to educate industry on the most used pre-market notification process for medical devices. This is the preferred submission process for MedTech companies (other Premarket Notification processes such as the deNovo or PMA are excluded from this discussion).

One of the key concepts that CDRH has been clarifying and enforcing over the past years is “Substantial Equivalence” (SE).  SE is used to identify “Predicates Devices” which are existing legally marketed medical devices. They play a key role in the Traditional 510(k) process to “triangulate” and position any new medical device pre-market submission by comparison to existing approved devices. There is copious amounts of information and training materials to further study and apply this fundamental concept[ii], [iii].

To set the stage for the remaining discussion in this paper, let’s quote the definition:

“A device is Substantially Equivalent if, in comparison to a predicate device, this device:

·        Has the same Intended Use as the predicate. AND

·        Has the same technological characteristics as the predicate


·        Has the same Intended Use as the predicate. AND

·        Has different technological characteristics and the information submitted to FDA (1) does not raise new questions of safety and effectiveness and (2) demonstrates that the device is at least as safe and effective as the legally marketed device.”


This pivotal definition translates the mission of FDA’s CDRH to balance safety and effectiveness of a specific new medical device, which must be demonstrated / proven during the development of the product, and secured during the product life-cycle. This perspective can be fundamentally different from other regulatory agencies in other countries, for instance when safety is the only concern for marketing approval. This alone can influence a global market entry plan.


The “Intent of Use” of a medical device has a direct linkage to its clinical value and obviously its competitive position. It relates directly to the “clinical outcomes” as discussed above in “the pain points of the U.S. Market” but is loosely linked to the other “outcome” or “access” attributes (such as care workflow effectiveness and/or defect reductions, or place of care.

The technological characteristics of a new device will enable the Intent of Use, but can also have a huge impact on cost and access, and hence competitiveness.

Both need to be optimized to preserve the benefits of “Substantial Equivalence”

Fig. 2

Fig. 2

The impact of the FDA goes beyond regulatory clearance (See Figure 2) , influencing all aspects of the product’s value proposition and must hence be included and optimized at the very early stages of product definition, in the same way product design characteristics and features are selected.

While the technological characteristics of a new product are regularly evaluated and verified during the product development cycle, it is rare that such characteristics are also compared to the selected predicates at the same time, using the same laboratory standards (there are multiple ways to rent or buy the targeted predicates for a comparative evaluation).

While clinical outcomes of a new product are regularly evaluated in small animal studies and later in clinical trials, it is rare that adjacent economic or workflow outcomes and “access” attributes are included in the evaluation protocols (as secondary outcomes for instance).

Early planning of such experiments and trials can generate substantial value and savings as the data can be used to document Substantial Equivalence and support product claims, pricing and competitive advantages.

Needless to say, company quality assurance policies, standards and documentation processes need to be aligned with FDA requirements and prepared in English from the  the beginning of the product development process!

This is why “Designing for FDA” becomes an essential part of any new product development process, which needs to be implemented 10 to 18 months before specific U.S. Market Entry and FDA submission plans are drafted.

Continue Reading: Part 3: Designing for CMS


[i] The 510(k) Program: Evaluating  Substantial Equivalence in Premarket Notifications [510(k)], Guidance for Industry and Food and Drug  Administration Staff  Document issued on: July 28, 2014  (web link)

[ii] “How to Find and Effectively Use Predicate Devices”, FDA Webpage (web link)

[iii] “Evaluating Substantial Equivalence in Premarket Notifications or 510(k)s”. Training webcast by Elias Mallis, Director at CDRH, on the CDRH Learn website. (web link)

[1] Mathieu M. Petitjean, Ph.D. is the CEO of MedNest, based in Princeton, NJ, USA

[2] Susan Z. Paquette, MBA is an Executive Consultant at MedNest, based in Minneapolis, MN, USA