Developing novel Medical Devices is a difficult business. As an Entrepreneur, doing so is even more difficult. They are usually pre-revenue and have a hard limited budget – i.e. when the money runs out, the company is bust. There are two different strategies for developing medical devices – the Smart-Way and the LeapFrog way.
We have already discussed the differences between Proof of concepts and Products in another post. This entry covers the stages in-between proof of concept and units out the door – how many steps to a final product?
The Smart Product Development Way
The smart approach, popular among those from a disciplined background such as Scientists and Engineers, is to have several prototypes, each one being an incremental improvement over the previous. At Starfish Medical, we call these the Alpha and Beta prototypes. This reduces development risk as each prototype addresses a specific requirement.
The usual course of action is to develop the usability concepts, user interface designs and renderings developed during a proof of concept stage into an Alpha that demonstrates the technology, often using rapid prototype techniques. The Alpha may also be used in small scale (pilot) investigational studies.
Once proven, this developed into a Beta, which takes the learning from the Alpha and finalizes the design with production tooling. Note, both the Alpha and/or Beta prototypes may require several revisions, depending on test results, but all stakeholders understand the intent of the deliverable i.e. they are not Products until all testing requirements have been demonstrated. Beta devices are also often used for Regulatory submissions and for regulatory compliance testing, such as IEC60601-1 Medical Electrical Devices safety and IEC60601-1-2 Medical Device Electromagnetic Compatibility.
From then on, a small number (e.g. 5 off) Pre-Productions Units (PPU) are manufactured, which is the first version of the actual end-product, and sometimes used for tests at friendly sites ‘in the wild’ or sent to potential collaborators. Finally, actual Full Production Units (FPU) are manufactured, and they too may be re-engineered later for cost reduction when going to mass production.
Not to be overlooked, the iterative product development process builds company value: Lab Studies can be obtained with a Proof of Concept, Pilot studies obtained with an Alpha and efficacy studies for regulatory clearance obtained with the Beta. Clear stage gates provide good communication anchors for management and investor discussions, as well as permitting staged investment, preferably at increased valuation.
The Leapfrog Product Development Way
An all or nothing strategy, common with those from a Consumer Electronics Company (CEC), is to Leapfrog Alpha and Beta development with the intent to develop a Product in one go.
Driven by ambition and cashflow constraints, many Entrepreneurs do not see the value in, or cannot wait for, multiple iterations due to timescales imposed by internal cash burn issues. For them, jumping to a final product design (effectively a Beta) is, at the time, deemed an acceptable risk. However, each time I have been involved in a project like this, the project has taken much longer than anticipated, putting the Entrepreneur in difficult positions with their investors.
In one case, a client (a fan of a Cupertino based CEC) wanted something that had the same look and feel as their favorite gadget, which does not necessarily translate to a usable Medical Device. The same client had unrealistic expectations on the achievable look and feel of their Medical Device. A CEC may commission a million custom Hi-DPI displays, but these are not unavailable to Joe Public. We could have placed a commission to develop similar displays, but that would exceed the available time and cash budgets. This results in an unhappy client, as it is difficult to deliver their product vision in the needed timescales for the budget they have, and an unhappy end-user, since polished metal and glass designs may look swish but don’t meet their usability requirements.
Another leapfrog issue is mixed R&D. Here the client attempts to leapfrog the Proof of Concept and Alpha stages by specifying an overly configurable product – essentially using the same device as a both end product and research tool. However, since Basic Research has not yet ironed out all the wrinkles, late breaking revisions are often needed. In one case, the business requirements called for the design to be as small as possible for aesthetic reasons, requiring tiny components developed for cell phones. When technical issues became apparent it was not realistic to hand modify the design, necessitating a re-spin of the whole system – enclosure, electronics, etc. If an earlier prototype had been used for lab testing, these issues would have become apparent before developing the Final Product (Beta).
Connected with mixed R&D, the Leapfrog also sometimes increases work in other areas. The extra lab configurability required above for lab tests required complex design, with extensive design, development and verification costs, in addition to increasing device Bill of Materials (BoM), manufacturing and Product QC testing. When the end product is very cost sensitive, every dollar counts. Unnecessary flexibility also works against those designs that are space/volume constrained. The optimum system parameters could have been established at an Alpha stage, giving simpler product requirements that are quicker to develop and verify with lower BoM and manufacturing costs.
Strangely, on one occasion the Leapfrog approach created delays due to ‘fear of finishing’, which is common with novelists and fine artists – Leonardo da Vinci once said ‘Art is never finished, only abandoned’. Here, the client was trying to consider every possible aspect of the product in one go, and developed hesitancy that they may have missed something. A staged approach gives comfort that certain aspects have been addressed, and crucial requirements have not been forgotten.
In general, there are no short cuts in Medical Device Product Development. It is very difficult to leapfrog the iterative design process and develop a single prototype that will hit all the checkboxes – technology, industrial design, usability, proof of concept, manufacturability, etc., all in one go. Attempting to leapfrog is highly risky – it is definitely not Smart.
Reducing risk has a cost. If you are a glass half-empty person, then the Proof of Concept stages quickly demonstrate if the technology is viable or not, the so called ‘fail fast’ model preferred by some equity investors. If you are a glass half-full person, the staged approach builds confidence that your product will be a success when it hits the market, as you have considered all aspects of the design during each stage.
If your cash and /or timescale budget does not permit a staged approach, you must ask yourself if you truly have sufficient funds for the task in hand, as development is only part of successful Medical Device commercialization. A clinical investigation managed by a CRO is likely to cost the same, if not more, than a rigorous development program. A careful, properly strategized product launch will cost the same again. Given the product is the most important part in this triumvirate, isn’t it worth the investment to get it right?
Vincent Crabtree, Ph.D., is a Regulatory Advisor & Project Manager at StarFish Medical. Starfish Medical have developed the staged process mentioned above over 15 years of developing Medical Devices. If you have novel ways of reducing Medical Device Product Development timescales and cost, he would be very happy to hear them.