4 – Medical devices

Background

Dr. D. J., a consultant gynaecologist, has set up the company “Valida” to design and develop innovative medical devices and procedures to benefit women’s health and wellbeing. The company consists, at the moment, only of Dr. D. J. herself.

The main product that has been designed to date is an intrauterine device and a surgical procedure for its implantation. Dr. D. J. is working with a leading surgeon under a confidentiality agreement to refine the product and the surgical procedures. The final design is now ready – the next step is commercialisation.

The problem

Dr. D. J. is fully aware that to make a successful product she must not only design and test the product but she must also convince a large number of surgeons and doctors of the value of her product so that they are prepared to use it. She has built up a large number of professional contacts over the years – now she is going to have to find a way to capitalise on this goodwill to market her product.

She is in a quandary – to market her product she will need to reveal a lot about it. How can she prevent others from taking her ideas and marketing them on their own?

Also she is aware that early disappointments could ruin the future of her product. So she needs to keep control, at least initially, of any trials to make sure that her product is only used in situations where it is sensible and appropriate to do so.

How to do all this and at the same time maintain her medical practice? Does she need to consider running her business in a different way?

The challenge

• How can Valida understand its present limitations and future opportunities?
• How should Valida set up the right partnership arrangements, e.g. with surgeons for trials, with a manufacturer of the product?
• Should Valida target an exit strategy of sale of the company to an existing medical device supplier – or should Valida go it alone?
• What intellectual property does the company need? What should Valida consider - patents, trademarks, designs?
• How should Valida protect itself in matters of product liability?

The solution

If these are the kind of problems that you have, please contact BIRD GOËN by email (ipadmin@birdgoen.com) and refer to “case study 4” to arrange for consultation.