The Starting Line: Turning the Corner with a Device Concept

Surgeons approach me with new product ideas on a near-weekly basis. I consider myself lucky to see these in the “wishes and dreams” stages of development. Orthopaedic surgeons have many great thoughts for innovative medical devices in a field where bringing a new medical device to market can be a long and arduous journey, with unexpected challenges—everything from funding to FDA approvals.

The conversations usually start at a height of about 40,000 feet before the realities of a regulated industry are presented by yours truly. The discussion’s outcome is commonly aligned with a smattering of disbelief (that this device is regulated), a hard dose of “We had better go back to the drawing board,” a spoonful of “I can’t believe that we have to comply with the Quality System Regulation for Design Controls,” and the realization that a Premarket Notification has an FDA user fee attached to it and (later on) a registration/listing fee, as well.

I find myself laying out the regulations and costs involved rather swiftly because the early-on, 40,000-foot drop to the runway should include a safe and effective landing for all parties concerned. Mind you, we sometimes never land the plane. Other times, we land the plane but can’t find the gate. In any case, the excitement and enthusiasm is contagious and the thrill of talking about the prospects for the future is energizing.

In light of my experience, I believe that design engineers might be helped by a blueprint for walking a surgeon—or a startup—or any novice—through the process of commercialization, beginning at the starting line. This article highlights the early, basic stages of regulatory and development, as well as what catches novice inventors by surprise.

Prototype/Predicate Bubble
The first bubble is usually broken when I explain how we must identify a predicate device for Premarket Notification (premarket clearance or 510(k)) purposes and how this predicate doesn’t have to be exactly like your device, but should be substantially equivalent for the intended use or have either the same technological characteristics, or technological differences that do not change its safety and effectiveness. “Do you mean that there is another device like mine out there?” My answer is always, “hopefully.” Hopefully, substantially equivalent to the conceptual prototype you’ve made, because that would, in fact, make this journey much smoother. Breaking fresh ground with new indications for use or new technology could mean having to file a Premarket Approval (PMA) submission, which is far more inclusive, time-consuming and more expensive than you could ever imagine.

Some surgeons and manufacturers have difficulty determining where research ends and design and development begins. Research activities may be undertaken in an effort to determine basic characteristics for a new product. It may be necessary to develop a prototype to explore the feasibility of a concept or design approach. But, the inventor and the manufacturer should avoid tripping into the maze of equating the prototype design with a finished product design. Prototypes at this stage lack safety features and ancillary functions necessary for a finished product. They are commonly developed under conditions which preclude adequate consideration of product variability due to manufacturing. The safety and efficacy of the device becomes entwined in the manufacturing process without engineering-aligned acceptance criteria.

How Much Does it Cost to File
This is where the rubber hits the road. For fiscal year 2014, the user fee for a 510(k) is $5,170, whether you succeed or not. In other words, this is a non-refundable, up-front fee paid directly to FDA. The registration and listing user fee is $3,313 for fiscal year 2014. You have 30 days after 510(k) clearance to pay that bill.

Regulatory Reality
Many Class I devices are exempt from premarket clearance or approval requirements because they are low risk. Class II devices generally require 510(k) clearance, while Class III devices will require PMA. Premarket clearance is by far the most common pathway to market, with more than 93 percent of devices being cleared through the 510(k) process.

As you can imagine, it is a joyful day when the inventor learns that his concept device is Class I. The trail is straight and lacks many of the encumbrances realized when filing a submission to the Federal government. Of course, there is still labeling, instructions for use, packaging, manufacturing, etc., but definitely not the maze that has to be negotiated with a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as (that is, substantially equivalent to) a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Until the submitter receives an order declaring a device Safe and Effective (SE), the submitter may not proceed to market the device. Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter. FDA is required to rule on a 510(k) submission within 90 days of receipt, but the process often takes considerably longer due to questions raised by FDA while it evaluates the submission, which can reset the 90-day clock depending upon the extent of questioning.

A claim of substantial equivalence does not mean that the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards and other characteristics, as applicable.

Note: FDA does not perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance. There is always that possibility. In this case, the contract manufacturer may draw the short straw.

It is Never Too Early to Start Thinking about Design Controls
Probably one of the hardest parts of this early development process is convincing a research-oriented surgeon that design and development planning is needed to ensure that the design process is appropriately controlled, and that device quality objectives are met. The plans must be consistent with the remainder of the design control requirements, and lay a foundation for further development in a methodical and documented fashion. Typically, the following elements would be addressed in the design and development plan:
• Description of the goals and objectives of the design and development program; i.e., what is to be developed;
• Delineation of organizational responsibilities with respect to assuring quality during the design and development phase, to
  include interface with any contractors;
• Identification of the major tasks to be undertaken, deliverables for each task and individual or organizational responsibilities for
  completing each task;
• Scheduling of major tasks to meet overall program time constraints;
• Identification of major reviews and decision points;
• Selection of reviewers, the composition of review teams (contract manufacturer in many cases) and procedures to be followed
  by reviewers;
• Controls for design documentation;
• Notification activities—suppliers, contract manufacturers, clinicians, etc.

Planning enables greater control over the design and development process by clearly communicating the facets of design control and documenting the simple stages that we must have in place at the end of this early-on process. The plan keeps everyone on track and conscious of all basic deliverables necessary when bringing a Class II or III medical device to market.

Design activities should be specified at the level of detail necessary for carrying out the design process. The extent of design and development planning is dependent upon the size of the developing organization and the size and complexity of the product to be developed. As you can imagine, the design process should be kept at a minimum because commonly, it’s only the inventor, maybe a lawyer friend who wants to own part of the device (and future royalties) and me, the consultant. I usually develop a comprehensive (but very simple) design and development plan specifically tailored to each device type.

No amount of planning can eliminate all development risk. There is inherent conflict between the desire to maximize performance and the need to meet business objectives, including development deadlines. Impending deadlines create colossal pressures to cut regulatory corners. Effective and enforceable plans help to combat this dilemma by ensuring that everyone is totally aware of the commercialization pressure points. When allowances to the clock are proposed, they must be justified and supported with reliable science, documented engineering and regulatory/quality compliance.

Who Will Manufacture this Technology?
In most cases, the inventor has already sought assistance from a manufacturer or two to help with initial prototyping and official drawings. If not, we seek someone to manufacture this device early on because this contract manufacturer will get involved with the documentation and planning, as well. It is important to remember that this life cycle process must be compliant with 21 CFR, Part 820 to whatever degree is necessary and that compliance should be established sooner rather than later. Timing is important and compliance even more so to keep in mind. There is nothing worse than coming to me with a great concept, early prototypes, maybe even a patented device/idea and then introduce me to “a friend” who plans on making this device in a garage. Prototypes, maybe. Finished devices for commercialization, I don’t think so. I recommend performing a due-diligence audit to assure that the cGMPs are in place and that manufactured medical devices don’t end up being adulterated—that is, hitting the ground running in the wrong directions.

It is a good idea to make sure that the lines of ownership are clearly marked in the sand so that at the end of this process you and the inventor have delineated who owns the drawings, the tools and dies, the rights to make changes, the labeling, the manufacturing process, etc. Commonly, the device design and concept of operation are part of an ongoing patent process before I even get involved. Every inventor has heard of patents (to at least protect the coveted ideas and technology), whereas not many of them have heard of the cGMPs or a design history file or of documenting design changes. This will sound pedestrian, but when this process of early-on development and continuing design controls starts moving forward, these lines of ownership are sometimes hazy or non-existent, from my experiences. You must be mindful of this frame of mind if you’re thinking of getting this done with companies that don’t honor patents and lack knowledge of GMP. Don’t forget, no matter where this device is designed or manufactured, it still has to abide by U.S. laws and regulations if you want to sell it in the U.S.

Where is the Magic?
There’s no enchanted formula for turning an idea into a regulated medical device that will be safe and effective for human use. I have shared my process with you in terms of subjects that must be addressed, but frankly, the subjects are always altered, the process sequence is never the same and the deliverables, even though they are much the same, contain certain confusing variables. Research, concept and feasibility are like that. Basically, what my colleagues desire is to take the haze around multiple ideas and requirements and build a House of Quality1 that includes a large dose of regulatory affairs and, of course, design controls. This is not a “paint-by-numbers” scenario but, in fact, more of “Renoir event” while walking on the Avenue des Champs-Élysées.


1. House of Quality is a diagram…a tool, resembling a house, used for defining the relationship between customer desires and the product capabilities. It is a part of the Quality Function Deployment (QFD) and it utilizes a planning matrix to relate what the end-user (the customer) wants to how a physician’s medical device idea is going to meet those wants. It looks like a house with a “correlation matrix” as its roof, customer wants vs. product features as the main part, competitor evaluation as the porch, etc. It is based on “the belief that products should be designed to reflect customers’ desires and tastes.” It also is reported to increase cross functional integration within organizations that use it, especially among marketing, engineering and manufacturing.

John Gagliardi has had success over the past 40+ years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC