Folks,

We were recently approached by an early stage medical device company. Without revealing any product details, they’ve designed a specialized bandage that’s used to control traumatic bleeding. The company is led by two physicians and a finance professional. The founders have hacked several bandages and asked for our assistance in making product models to be used for fund raising meetings. They’ve committed to fund the development process with $250,000.00.

While we admire the founders’ ingenuity, sincere desire to advance the state-of-the-art and save lives, we cannot take their money. Why not?

Before making medical device models or prototypes (or most any product) it’s necessary to define the business model, the path to FDA certification, the raw materials and the underlying fabrication methods. And have enough money to get close to the goal line.

Specific to this bandage concept, there are many factors to be explored and defined including:
• Mechanical properties of the materials (stretch in the X and Y axii, permeability, etc.); physical properties (standard thickness, length and width of the roll stock, type and compatibility of the adhesives).
• Biocompatibility of the materials.
• How the materials will interact/react when combined.
• Their general availability in geographies where the finished product may be fabricated

It’s relatively simple to fabricate “looks like/appearance” models which will look like the finished product, but will not be functional. It’s more difficult to fabricate “looks like/works like” models without first defining the variables listed above.

The next step is to fabricate functional prototypes in the candidate factory. These prototypes will be hand built by manufacturing engineers, utilizing manufacturing methods and techniques that approach factory methods.

Once that step is completed, we can move to “PVT” (Product Validation Testing) and build prototypes using true factory production techniques.

To make all of this happen, our work follows a Venn diagram. The overlapping circles are: material properties; factory capabilities & constraints; packaging format; sterilization method; and specification. The finished product will in time appear at the center of the diagram.

To arrive at the point when we should make looks like models that will be useful for fund raising, public relations and general promotions, we should first march through the processes listed above. If we don’t, the eventual finished product will look nothing like the models.

Stated another way, the materials, factory processes, product features and the target purchase price should inform the design process. We collectively need to navigate the design process and material definition in order to arrive at a manufacturable product.

This integrated approach requires the participation of many parties including industrial designers, material scientists, compliance consultants and others. In order to be seen as sincere and keep the interest of everyone involved requires our close interaction, approximately eighteen months and much more than $250,000.00.
There’s no short cutting any of this. We politely and respectfully said no and introduced the client to an excellent consultant who specializes in medical device regulatory and clinical trial services.

Sometimes applying the brakes is the most useful tool in our toolbox. Don’t be afraid to apply them yourself.

Cheers,
Jack Daniels +1.617.285.2486