14 Lessons in Diagnostic Instrument Development

Estimated reading time: 4 minutes

With over 40 years of global leadership in the design, development and manufacture of life-saving medical technology, ITL Group offers invaluable experience and industry insight into what influences the success or failure of a product. Here are 14 lessons from ITL’s many years in diagnostic instrument development.

Lesson 1: Get enough investment

It can take significantly longer and cost more than you might expect to develop a diagnostic device. Many companies believe their product will be market ready within 6-12 months at minimal cost. Producing a reliable product that has been validated takes a lot of time, effort and significant investment, so an appreciation of that will feedback into having a sensible business plan.

Lesson 2: Know your market

Success comes from identifying a market and meeting it’s needs. Many companies develop technologies with hope that they will find an application further down the line. Unfortunately, several companies are unable to survive without having identified a strong market for their product for example; a breath sensor suitable for two applications was tried and neither application had a sufficient market to make a commercially viable product.

Lesson 3: Be realistic

Medical diagnostic instruments are not consumer products – consumer products are able to be manufactured in high volumes and achieve the low-cost that most desire. Diagnostic instruments on the other hand require smaller quantities per year making it incredibly difficult to achieve the low-costs most think of when you look at a consumer product such as a mobile phone.

Lesson 4: Complexity has cost

Developing a diagnostic instrument that is all singing and dancing, with complex functions, operation of single use disposables and implementation of elaborate chemistries, sounds great, right? Developing such a complex piece of kit often means the end-cost for both the instruments and the disposable is high, sometimes too high to make a product viable.

Lesson 5: Get to market soon

It is better to get to market with a simple product than an overly-complicated instrument that takes so long to develop that you run out of money, or the market changes before you get there.

Lesson 6: Do not over specify

Don’t ask an instrument to do things, unless it really has to. If you want a diagnostic test result think very carefully about whether a result in 15 minutes would be acceptable or whether you really need a result in 10 minutes. These specifications will add to both the cost of the instrument and the time it takes to develop it.

Lesson 7: Set your specifications & keep to them

Changing a products specification after you have begun development kills progress to market and bankrupts’ companies. There are several examples where companies have begun the development process and suddenly change requirements without realizing the implications.

Lesson 8: Focus or die

Development is fun. It’s fun to make an instrument work and to get it better and better but unfocused development drains resources, delays time to market and in term can destroy a company.

Lesson 9: Design for production

It’s one thing having an instrument and disposable designed to perfection, but ensuring it gets to market on-time and within budget is highly dependent on the transition between design and manufacture. It is very easy to design both instruments and disposables for one-off use but designing for manufacturability requires a greater attention to detail, especially materials. High-volume production is a complex part of the process and getting it right (first time) will help determine the chances of commercial success.

Lesson 10: Small is not always best

Previously, clients have come to ITL requesting a smaller instrument or disposable in order to make it easier to ship or to fit in a limited space, but in reality, smaller is sometimes worse, not better. Making an instrument smaller in design can create significant problems and are often more expensive to manufacture than a larger instrument that would have been equally or more acceptable.

Lesson 11: Chemistry and software take time

Clients who develop chemistries almost always underestimate the length of time is takes to get a chemistry correct, and the same applies to the development and validation of software. Chemistry and software is a common pitfall in instrument development and can significantly delay time to market.

Lesson 12: Be aware of the regulations

Diagnostic instruments are subject to numerous stringent regulations from the RoHS II directive to EMS and safety compliance, to FDA and CFDA approval. In order to sell a medical device into European, US or Asian markets it must first comply with the regulatory requirements otherwise the project is highly-likely to fail.

Lesson 13: Beware of prior patents

Even after 40 years in the development and manufacture of diagnostic devices, our engineers are still surprised by the simple ideas which are subject to patents. For example; when splitting cells by lysing the obvious technique would be by ultra-sonic vibration but surprisingly there are numerous patents restricting how this method can be implemented.

Lesson 14: The ‘best’ is the enemy to success

Being good enough but not the ‘best’ applies to every aspect of development from specifications to mechanics, to electronics and software. If the client and the developer are always striving to achieve the ‘best’ then the project is liable to fail due to either a change in market or lack of funding.