The following topic appears to be a marketing topic, actually it occurs as part of creation.

In developing any new medical device, the speed in which the device ultimately enters the U.S. market is as critical.

New technologies have potentially shorter life spans. The faster to market, the more likely the product will succeed.

Seldom are products conceived in a vacuum. Once technology provides a route to a new product, it is NOT unlikely that others will also conceive of a derivative idea. Many marketing studies address the advantage and market share for whomever is able to capture initial sales.

Compliance Consultants can dramatically reduce the time to market accelerating the value of a new product and increasing its equity to potential investors. Our process moves the product from a clever idea to:  a product in motion and moving toward defined goals. We assist in defining, identifying, qualifying, procuring, auditing and managing the creative process to control:

            performance,

            cost,

            schedule,

            regulatory compliance.

How often does a company's value double upon announcement that regulatory approval has been granted?

Background

Since most medical device start up companies discover that FDA regulatory compliance is the critical path of the product development cycle, we are often asked to participate in the overall scheduling and in accelerating the development cycle. This is what we do...

When to start...

For an emerging product, creative technical minds view definition as frivolous, a nuisance and an impediment to creativity {since designs are subject to change}. A common error of designers is: to only view what is not known and must be discovered as the reason to not define the 80% of the design {which is known}. We define & schedule the 80% {known} to move these designs into the scientific process.  We define & control the 20% {unknown} as critical issues on separate paths for critical attention. Consider what is achieved. Your best people focus on the 20% critical issues and the 80% is handled as routine science.  

You speed designs...

Compliance Consultants adds structure to design. The known (80%) is forecast and planned using conventional controls. The Critical Issues (20%) are worked on separate paths. Schedules are devised to identify where each critical issue plugs into known paths. Schedules work for any complex task and are a tried and proven discipline. This process is parallel, concurrent development and is used to build bridges and was used to place a man on the moon. Any arguments to this process shows lack of understanding the flexibility and power of this process {and its effects on reducing cost and adding certainty to definition}.

Definition...

We create a requirements specification. Consider it like an athlete having a good breakfast. The requirements specification becomes the basis for the product’s definition. That definition is created. A good definition will speed creation. A poor definition will cause re-work and re-design.

Remember the old saying, we did not have time to do it right the first time but we had time to do it three more times before we got it right!

That typifies what happens when an engineering project starts without a definition. Many inventors may consider they understand how to define this. Unless they are skilled at this they will not be able to.

Definition of performance for each function establishes a boundary of the design effort. Your core design group does not exploring unfamiliar areas and slow down the schedule duplicating available technologies or designing to unrealistic goals.

You communicate technical goals...

Specifications have value. Each specification can be submitted to prospective subcontractors to recruit subcontractors as team members and impart their knowledge of the performance and feasibility of their component to the system design. By inviting comments to proposed definitions the system is structured to constraints realistic to the subcontractor and industry.

You reduce costs ...

We identify qualified subcontractors skilled at creating components to suit performance. This adds dimension and structure to the system design without costly prototypes and tooling to create experiments in a vacuum. Your design becomes more realistic and saves money since all efforts only occur on paper. You can cut months off payroll - consider this savings!!

You reduce risks ...

Since most medical products have marketing, technical and regulatory risks, we can assist in the reduction of those risks. This accelerates the development.

You accelerate the schedule...

By bringing subcontractors on board early in the design, you benefit from their expertise and identify the givens and the unknowns, isolating  risks from reasonable certainties. Tasks can be scheduled on an independent basis. Instead of making every event A.S.A.P you can now assign dates for events with meaning and integrity.

You see better ... 

Once all the clutter is removed from the schedule, you can see critical events, routine events, and independent events. You can see how the overall program fits together to meets an orchestrated, integrated goal.   

What you get...

You get better vision to manage development.

You achieve clear definition of the product by a structured specification program. You involve subcontractors who know what you expect. You minimize risks by charting critical issues as separate scheduled paths. You create a time phased schedule to improve the likelihood of success. You cut overall development costs by eliminating those persistent factors, which inflate development costs: uncertainty, risk, lack of definition, and rework. You gain control for free - if you start soon and formalize your development. 

Who is sophisticated?

High technology companies tend to believe since a product is high tech; the process used to develop it is high tech. Only when the above processes are used, can a product development effort be truly high tech and achieve faster time to market at a lower cost.