Director, AUM MEDITEC |
To my perception, ‘innovation’ means a new way of doing something or maybe a new invention. In other words any change in a process, product or a system for improvement and customer satisfaction by an idea or an invention or a new concept or even maybe a new application of an existing set-up can be termed as innovation. This change may be based on voice of customer / process / stakeholders. I am sure we all agree; that “Change is constant”. Hence, we can say every organisation that has an ongoing improvement process; driving to improve their productivity / customer satisfaction / business excellence approach is in a constant mode of innovation. Incremental Innovation is also an approach that many organisations follow to increase efficacy of a product or service.
The traditional approach of an organisation towards ideation and concept development begins with the idea developed in-house and then evaluated or validated through the process of concept screening and testing. I suggest an approach that is customer oriented to evolve with the ideation process; i.e. understand the needs and ideate to solutions in the form of innovations.
Are all Idea generations done by Engineers/ Technocrats?
I feel, all idea generations are not necessarily done by technocrats. We observe many innovations in our day to day life, which may be a concept evolved out of need, necessity and availability of resources, just plain innovative use of resources in a slightly different manner for the intended use by the user and not by any special technical head. For example, we may have seen many housewives use add a layer of sand to a pressure cooker and then use it as an oven. The other day I came across a photograph of a coffee stall owner using a pressure cooker with a hollow pipe and a screw driver, to brew expresso coffee! All such makeshift uses evolve out of availability of resources and a desire to meet customer demand motivates these users with such alternative solutions. These users are all not necessarily technical knowledge heads; they are users who understand the nuances of the product’s intended use and ideate to innovative solutions.
Innovation = Invention?
I would like to share an interaction I had with a doctor from the north western part of India, who had come to a medical equipment exhibition in Mumbai to explore some equipment purchases for his clinic. (See illustration 1) (On a lighter note; to my fellow colleagues and peer groups of medical electronics: hope our medical equipment production sponsors and senior heads back in office don’t chase us out after reading this illustration!)
The illustration shows how a prospective sale of a product can be affected with such influencing interactions with a buyer! The highlight can be that there is an accomplished sale of another version of the product, instead!
In this doctor’s case, we see that the doctor in spite of being in general practice wants to be well equipped and at the same time keep in mind his budget. An honest admission on his part and on understanding his constraints, I suggested a solution. I did that by virtue of my profession as a technical consultant, although this was suggested impromptu at the exhibition venue, without any commercial interest. Further, it is again not an invention but an innovative use (in this case, to an extent, a compromise?) of an existing product.
10 electrodes or 12 lead ECGs are very cumbersome and at times many patients exhibit discomfort with so many chest electrodes on them.
Therefore, to my perception, this isn’t a compromise, as we see many ECG manufacturing companies suggest this option to clients who have constraints in terms of budget, convenience, comfort, etc.
Today about 30 to 40 per cent of the users use five lead ECG with alternating use in a sequential form; as a solution for Vector ECG whenever required, although our cardiologists still prefer the conventional ECG for analysis and detailing purpose.
What I would like to point out here is that innovations are not necessarily inventions. Innovations are also not necessarily ideation of the retrospective technical knowledge heads. They are basically an expression of the needs, desires of the users and feasible solutions of the retrospective technical knowledge heads, who further give shape to these ideations.
Innovation, but is the MRP appropriate?
Another aspect of innovation that I would like to share here with an example of a medical disposable product innovation is; the price factor of an innovation. (See illustration 2). This is a classic example that we observe in the innovation arena. The innovation maybe an excellent application, a world class technical invention, but when it comes to its price, it may not match the market economics and so is largely disapproved or maybe accepted after intensive marketing strategies. An exercise of aggressive and intensive marketing becomes a mandate to get acceptance of the product and to sustain the research and development cost. At times a brand attitude establishes or enforces a higher price tag exhibiting an arrogance of monopoly and at times the price tag is a derivation of comparison of competition and status quo. More often it is the financial sensibility to meet the product development costs.
In any case, it is assumed that the price so derived is a perfect fit and would or rather be imposed onto the market as an accepted price tag, as it is an innovation. In such cases the product failure / non acceptance dawns only after it reaches the market or the product acceptance testing phase. Even if identified in the product acceptance testing phase, not much can be done to reduce the production cost and pass the benefit to the market, because in this haste, the tendency to compromise on quality becomes high.
One more outstanding example that would leave this article incomplete if not mentioned is the predicament our design engineers or innovators face when they come across a situation of demand by management or other stakeholders that brainstorm to impose a change in label of the product after its regulatory approval; which invariably changes the intended use of the product and thereby the certification recognition and its validity!
Imagine you have a cardiac monitor with defibrillator approved after all the clinical trials process required as regulatory norms and then some stakeholder imposes to market the product as “defibrillator” and not as cardiac monitor. The goal of such a move is to get the product under life saving category and reduce its price to the market.
In such situations, the R&D and production and QA department have a long task at hand; of repeat processes for approvals, not that a cardiac monitor with a defibrillator doesn’t go through the necessary testing and trials but finally the certificates and approvals are based on what you pitch the product as; in the document that intents the use of the product in the market.
Just as we observe a difference in labelling and its intended use of a product with same ingredients i.e. “drug” and a “dietary supplement” of a pharmaceutical product which impacts FDA approvals, the same way such labelling issues and claims impact a medical device too. A product designer and developer need to be conceptually clear with the intended use of the product and aware of such regulatory requirements well in advance. To change such files or documents at a stage after approvals is not as easy as erasing some words and revising the same. It requires repetition of many tasks and modifications (at times in product design as well) resulting in quality wastes, more poor quality costs (COPQ) and delay in bringing the product to market.
Innovation Matrix for Medical Equipments (IM ME!)
Based on project experiences, I observe that a customer driven and business process voice oriented innovation strategy is the key to successful innovations. Exploring the innovation strategy that we all may have read about in management books, I suggest a revision in the strategy with a customer focus, or shall we say quality focus, because by and large quality tends towards optimal customer satisfaction and safety too, especially in healthcare.
So who are these customers that we need to focus on? Is it the end user?
For us; the pharmaceutical and/or the medical device manufacturing who is the customer? Is it the doctor/ hospital, which uses our equipment/prescribes medicines or the patient who consumes/uses the product? I am sure we all agree both are our customers whom we need to focus on. But this isn’t the end, for need/ demand analysis, we have other stakeholders that need to be considered with equal focus and a balanced weight score; these are our standards, regulations, business investors, competition and technology demands.
Let us understand this in more detail. This revised strategy is not challenging or contradicting our management theories but it is complementing the innovation strategy; it is re-inventing the innovation strategy with a slight twist in the application focus. This strategy suggests not only design and market research before the start of an innovation project but strongly recommends evolving the design questions based on ideations derived from customer needs, demands and projected requirements.
Arriving at an idea based on customer requirements is not the ultimate step. The idea so derived needs to be identified as a perfect fit in the IM ME (I enjoy terming this matrix as a command “I am Me!” because this matrix commands us to meet the criteria that invariably needs to be met for a higher success rate of an innovation, especially of medical devices/ equipment.)
Although this matrix is congruent and can be used for other innovations too with a slight modification in the set criteria, I formulated this matrix whilst working on a few medical equipment innovation projects with a value addition research on the innovation strategy to be followed, thus the befitting term “IM ME”
These criteria of “IM ME” are prominently based on medical device requirements and other customer strategic requirements; a combination of to be met (a mandate set) and would (can) be met (opportunities to improve set).
“IM ME” has a rigid score to be achieved as a guiding benchmark; at the same time it has its elasticity within; on a continuum of parametric and non parametric scores; based on applications. The matrix is still evolving with due diligence of its applications in on going medical equipment innovation projects. It is currently verified as an effective tool, however I shall share more on this soon, after its validation.
As a Certified Six Sigma Master Black belt trainer, practitioner and as a quality management professional, I believe that “Quality is a journey to customer delight”. Customer demands are dynamic, we must constantly listen to the ‘voice” of our customer, business and the identified process to assure quality product/service and thereby gain more loyal customers. We must ensure that we keep up with the trends and pace of competition.
I often come across a project/process demand that calls for innovation and adaptable application solutions. As a bio-medical engineer and as a hospital planner, I aspire to innovate and introduce new designs/ equipment/applications in the system.
Providing best applicable solution at affordable costs is a driving passion for me in this journey of customer delight. In my work I have constantly observed creativity and innovation as a key enabler of this passion of mine.
The author can be contacted at meeta@meditecindia.com