Six Questions Every Product Development Engineer Should Consider

As economic pressures continue to mount, medical device manufacturers need to consider questions about the market forces that allow the possibility of competing generic entrants.

1. How novel is a manufacturer’s product? What steps can the branded producer take to differentiate the device from succumbing to a generic substitute?

2. How long will a patent yield any exclusivity?

3. Who are the likely new entrants in the medical device market? Will they come from the current crop of entrenched branded producers that choose to balance portions of their portfolios with generics, or will wholly new companies emerge, funded by venture capital?

4. At which point will hospitals abandon or be forced to abandon the GPO status quo? For example, will the physician payment Sunshine provisions of the Patient Protection & Affordable Care Act affect payments manufacturers make to GPOs? Will the Kaiser Permanente’s of the world force the medical effectiveness issues on hospital purchasing decisions?

5. Does the GPO offer more than one comparable product to create competitive pricing? Will GPOs be forced to essentially create formulary offerings equivalent to managed care insurers who today place a generic alongside a prescription option?

6. What is the future profit picture for the class II device market? How will these companies manage or shift their portfolios in the decade ahead?
 

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