Could it Work? Biomaterials/Bioengineering Prof Sheila MacNeil 1

Could it work? Where are you going? Developing a requirements brief Questions re whether it is worth doing and will you get funding for it SWOT analysis Commercial questions Estimation in bioengineering Assumptions Things you should know 2

Solving a problem or developing a technology? Is it an existing problem that you’re seeking to solve? Have you got a cute technology you’re wanting to apply? Both can work but there are different challenges. 3

What is it you need? Do not underestimate how important this is and that your understanding of this may be incomplete to begin with and may develop as time goes on! How to achieve this – use a range of sources to come up with your initial product analysis, product requirement. Test and check your assumptions rigorously. This is an iterative process and materials that may not be adequate for the initial purpose may prove useful for related or entirely different projects… 4

What is it you need? Questions to help you do a biomaterials requirement analysis: – How is it going to be used ? – Is the material to be in contact with the body? – Is it to be implanted in the body? – How long do you need it to last-a few hours,days, weeks or years? – There are ISO9000 standards which describe what tests you will need to do re safety issues for your biomaterial ( too much detail to go into now) BUT all are dependent on you having a clear requirements analysis 5

What is it you need? Stability and storage questions – What range of temperatures does it need to perform over? – What conditions of light, pressure, storage and stability does it need to meet? – How stable does it need to be? Single use disposable? Biodegradable material which disappears over several weeks or months? Permanent material? Stable for a long shelf life under appropriate use or storage conditions? 6

What is it you need? More tough questions: – Is it worth doing? – What are the competing technologies? – Who will buy it? – How much will it cost to develop versus the number that you’re going to sell? 7

Introducing a new technology? There are pivotal examples in medicine, for example, where surgeons were capable of organ transplantation but all of this was on hold until the development of immunosuppression. Once immunosuppressive regimes were working then this removed a barrier and this led to the beginning of transplant programmes such as kidney and eventually heart and heart lung. Initial cost of kidney transplantation and heart lung was horrendous. Would have prevented introduction of these technologies if it had been costed rigidly at this point. Clearly worth doing however. Luckily it wasn’t and kidney transplants are now viewed as very cost effective. Heart lung transplants still viewed as very expensive high end medicine….. 8

Technology breakthroughs and timing Is your technology going to be innovative enough, effective enough or economically attractive that it competes with others? Time to get it to market. Following the introduction of a technology that works, others may be introduced rapidly thereafter and take away the market. Best if your technology has got real strengths compared to others. 9

Technology breakthroughs and timing SWOT analysis. Easy reminder that you should always have the answers to this. What are the – S trengths of your approach – W eaknesses of your approach – O pportunities this approach offers – T hreats that might act against your solution. 10

Examples of strengths You propose a solution to a problem that’s large, can’t be solved using existing technologies and will benefit lots of patients/customers safely at a price that leads to good economic take up. 11

Examples of weaknesses Your solution would only make a marginal difference to the current problem and you are introducing a technology that others could readily copy. 12

Examples of opportunities The development of this technology allows you to apply it to more than one clinical problem/market, e.g. development of immunosuppression meant that it opened the door to a range of organ transplantations. 13

Examples of threats Most likely other competing technologies;- other, more economically viable solutions; other, safer solutions; other solutions more likely to be adopted by the customer/patient, Also the climate at time of introduction-e.g. bad press on nanotechnology or stem cells might act to prevent uptake of these technologies. 14

Safety issues What are the safety threats to your solution? What is the worst that might happen? Start from there and think it through. What can you do to reduce or remove these risks? 15

Creative solutions to problems Look for solutions outside of current technology space. Explore how similar problems are solved in the plant and animal kingdom. Essentially raid many toy boxes for ideas in your initial thinking. 16

Examples of raiding the plant and animal kingdom Jellyfish fluorescent proteins now used to track location of fluorescent stem cells when introduced into animals (not yet judged as safe to go into patients). Chitosan extracted from the shells of shrimps and other animals with exoskeletons, used to produce scaffolds for tissue engineering. Spider silk used to produced scaffold materials for tissue engineering. 17

Commercial questions Once developed, is there a sufficiently big market for this biomaterial? Who will buy it? Can the costs post-development be made sensible? Don’t try to do a detailed costing here in Pounds, Euros or Dollars the best way to view this is can it be made comparable to other solutions currently in clinical or commercial use? Will the use of the biomaterial for example reduce the length of a patient’s stay in hospital? Will the use of a medical device, for example, keep patients out of hospitals, e.g. asthma inhalers? 18

Developing a market If you are producing a solution to a current problem, then the justification for doing this can be simple. If, however, you have a cute technology and you are looking for applications for it, this is more likely to fail! 19

Blue skies research through to economic product Blue skies research – it’s new, it’s creative, it’s innovative, you don’t necessarily know how it’s going to be applied. Translational research – you have some research that you are pretty sure can be used to solve a particular problem in man and you take it to the clinic initially to do a safety test, then to see if it works (efficacy) Economic product-people want to buy it…. 20

Blue skies research through to economic product Developing a commercial product – the best technology and research in the world may fail to become a product for a number of reasons: – Insufficient market – Insufficient interest – Too expensive – Bad timing – (and many more) 21

Estimation in Engineering Also known as “Rules of thumb” or “back of the envelope calculations” Can save time avoiding detailed analysis where a simple calculation reveals the answer The approach can help where any decision based on known principles needs to be made 22

Making Assumptions Usually we will need to make some assumptions In a big number, small differences are insignificant; we only need rough accuracy Useful to know some standard data (e.g. Typical weight of a person, materials data, etc) If you are making a big assumption, you could repeat your calculation with different values to see the effect – i.e. does it change anything? Is the relationship linear or power? 23

Expectations of Bioengineering students Biomaterial Scientists/ Bioengineers should know something about human physiology Should have an appreciation of where biomaterials have been developed to help man –eg. hip implants, coronary stents Should have an appreciation of where medical devices have helped man –e.g kidney dialysis machines Should be used to thinking how a biomaterial or device or instrument will interact with man ( and how man will interact with it) -whole systems thinking Should be comfortable with thinking across disciplines to achieve new solutions to problems of human health 24