II

Biomaterials and biomedical materials

Discussed in Session I
Session I Plenary Presentation: David Williams
Session I Moderator: Kai Zhang
Session I Reporter: Carl Simon

Naturally, the most fundamental term to be discussed is that of “biomaterial” itself. This
was considered alongside “biomedical material” in an attempt to determine whether these
were synonymous or whether there was some subtle difference.

A Biomaterial

(a) Possible Definitions of “Biomaterial” Included in Final Program

1. A nonviable material used in a medical device, intended to interact with biological
systems; Definition that achieved consensus in Chester 1986
2. Any matter, surface, or construct that interacts with biological systems1
3. A material intended to interface with biological systems to evaluate, treat, augment or
replace any tissue, organ, or function of the body
4. A substance that has been engineered to take a form which, alone or part of a complex
system, is used to direct, by control of interactions with components of living systems,
the course of any therapeutic or diagnostic procedure, in human or veterinary medicine

(b) David Williams; Perspectives on “Biomaterial” and Suggested Definition

David Williams presented the four options given above, together with a simplified
version of (4), as follows:
5. A substance that has been engineered to take a form which can direct, by control of
interactions with living systems, the course of any therapeutic or diagnostic procedure
1
National Institute of Biomedical Imaging and Bioengineering (USA: NIH).

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16 II. Biomaterials and biomedical materials

In deciding on his recommendation, he drew attention to the fact that although the
first definition above did achieve consensus in 1986, the extension of applications of
biomaterials to situations other than conventional medical devices, and the doubtful
validity of descriptors such as “nonviable,” suggested that this definition was probably
no longer valid. The second possibility is an example of a broader definition found in
some glossaries. However, it does not specify medical applications and appears too
imprecise to have any value in the present context. The third suggestion appeared in
his own 1999 dictionary of biomaterials, but he suggested that it was too cumbersome
now and too much resembled an FDA type definition with the emphasis on specific
applications.
Option (4) was included in an essay on the nature of biomaterials published by
Williams in 2009. He considered it to be still valid, being factually correct, but perhaps it
was too long. He also pointed out that definition referred to both human and veterinary
applications, the latter gaining increasing emphasis in clinical practice; however, if this
phrase was included in this definition it would have to be included in many others and
probably was not sufficiently important for this to be done.

(c) Edited Discussion of “Biomaterial”

In view of the above considerations, David Williams suggested that the more concise
derivative of (4) was the best and proposed that this should be considered for consensus
voting. Thus, the proposed definition of “Biomaterial” was:
A substance that has been engineered to take a form which can direct, by control of
interactions with living systems, the course of any therapeutic or diagnostic procedure
Rena Bizios I like the choices of the two terms: biomaterials and biomedical
biomaterials. The first one is broader, and the second one is more
specific. . .the first includes in my reading the composites, that we
have a lot of composites in biomedical application. I am flattered
because you used the term “engineer,” but a lot of the new
materials that I am familiar with are the result of scientists. And
I do not want them to be alienated by the concept that only
engineers that put together these materials. Thank you.
David Williams Thank you Rena. I do not imply any real differences between
engineers and scientists here, so I am not deprecating scientists
here. I like the phrase “to engineer.” I wrote a paper a number
years ago, that was called “to engineer is to create,” that was where
the word “engineer” comes from. But I think that a scientist can do
that as well as an engineer. If anybody wants to add that, I would
be quite happy.
Nicholas Peppas Congratulations David, this is a magnificent presentation, I wish all
of them will be as detailed as this. I want to make a comment
about “biomaterials,” however, because you capture something
that is happening in our field that is of concern to me. Other
societies and other organizations, as you said, agricultural, and
other organizations, have basically captured the term

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 A Biomaterial 17

“biomaterials” to describe the area that would include their interest

and would make them workers and players in the field. I have a
continuous fight with the American Institute of Chemical
Engineers staff and members who want to use the word
“biomaterials” to describe corn stalks and other substances to make
ethanol. I think this body should express a very strong view about
what we feel are biomaterials, and I hope that we will ask these
organizations, such as the agricultural societies, to use alternative
terminology. Thank you.
David Williams Thank you, Nicholas. Very helpful. Obviously, that is not for a
vote. But I will be very interested to see if any consensus view here
to support what you said and I am very happy to include it in the
proceedings. Does anybody have any comments on this, the other
uses of the word biomaterials in the medical context? Is there
anyone who does not agree with what Nick just said?
Laura Poole- I think that number five is coming closer to what we should be
Warren using; it is probably a little too wordy. It somewhat tautological to
say “to take the form of” perhaps we can just say a substance or
even a material that has been engineered to. . .etc. rather than to
take the form.
David Williams I have written it this way because, if you think back to my
definition of a material, which is a substance used for making
objects, it has to have form. I start this way because I cannot start
by saying it is a material, a substance has been engineered to take a
form. In other words, that substance now has a form, it is not just a
gas, a fluid, or a solid.
Kai Zhang Why can’t you just use a material? A “material that can direct”
instead of substance?
Laura Poole- So a material that has been engineered to control interactions with
Warren living systems. Something along those lines.
Arthur Coury I have also taken a position in my definitions of biomaterial that it
does have a form, it is a structure, so a saline solution is a synthetic
solution, but it really doesn’t have a structure, and so I agree that a
form is another good word for structure.
Joachim Kohn David, over the last 20 years, people have repeatedly made a
comment about your definition of biomaterials, in the sense that it
is a functional definition. It does not tell us what the biomaterial is;
it only tells us what the biomaterial does. And that was perceived
as a weakness of the definition. And I see that many of your
definitions that you put forward now for biomaterials follow in
that same trend. I personally have no objection to it, don’t
misunderstand me, but I wanted to point out that a definition
usually defines what the material is, not defines a material by what
it does.

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David Williams Yes. Joachim, that is a very good point. I did consider that some
time ago and wasn’t sure how to handle that because of the wide
variety of materials that are used as biomaterials. So, I don’t think
we can define or characterize further any particular feature of a
biomaterial in that sense for example, we are not saying it is a
material which is metallic or polymeric, or ceramic, or composite;
and it becomes too difficult and cumbersome to say it could be any
of the above. I believe we are talking of biomaterials in the broad
context of materials. I take your point. I don’t know how to handle
that any better.
Brendan Harley I appreciate that in the definition of biomaterial that there is an
action, maybe different from what Joachim was saying, because I
have taken to now being asked to review a lot of biomaterial
papers that are leaning to cellulose and other such materials. I
think one thing that could set us apart is that our material, the
biomaterial, that is designed for an action in the context of medical
device. I think that may be one way by which we could have a
strong definition of what we think biomaterials are.
David Williams Thank you, Brendan. I think that is very helpful. The only issue I
have with your first comment is that we end up with a definition
which gets into mechanisms. That is what I have tried to say; it is a
problem we often have, especially as we do not know all the
mechanisms at this point. If we are very specific to one or two
mechanisms, then we become self-limiting.
Mario Barbosa This is about the beginning and the end of the list of definitions. I
have difficulties in distinguishing between biomaterial, biological
material, and biomedical material. If you use the definition of
biomaterial, based on the application, to me biomedical material is
more or less synonymous. The other thing I notice is that there is
probably another term which we should use, which is biological
material. Of course, wood is a biological material; bone and skin
are biological materials, so maybe tomorrow this idea of
introducing new terms could be raised again. I believe that the
term “biological material” is needed somewhere.
David Williams Thank you. I think that might be worth discussing. I think you are
absolutely right, Mario; we have to be very clear what the
difference is. That is why I was trying to say that the prefix “bio”
can either mean “living” or “related to medical.” I think we have to
be very clear when we use those.
Andrés Garcı́a David, I like definition five better than the other ones simply
because it is cleaner and reflects some of the ongoing work. Just a
general suggestion; I am a little concerned about the word, or the
phrase “by control of interactions with living systems.” You could

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argue that there are many cases in which there is no designed

control, so potentially just simply say, “through interactions with
living systems” to remove “control.”
David Williams Good point, Andrés. I was trying to be very forward looking, then.
You know what the intention is, but I accept your point.
Xiaobing Fu Why do you emphasize “engineered,” because there are some
natural materials that are also biomaterials, such as when we treat
burns we use skin from pigs. It is not engineered, but it is a
biomaterial. So, why do you emphasize “engineered?”
David Williams I mentioned before why we’re talking about engineering, because
with the vast majority of biomaterials in clinical applications, they
are specifically arranged or created to have their function ! that’s
why I used the word “engineer.”
Nicholas Peppas I have an alternative explanation. I think the problem, David, is
because the word “engineer,” as we use it in Europe and the
United States, in plain English, means “to design.” I don’t think
people appreciate that. So maybe, you might consider
wordsmithing it and put the word “design” in parentheses, or you
know . . . People are getting afraid when they hear the word
“engineer.” We use this term in the United States all the time.
David Williams That’s a very good point. I will be happy to remove “engineered”
and say “designed.” Okay?
Nicholas Peppas Good.
Joachim Kohn While we are waiting, can I make a comment about the number
five for “biomaterials?” Okay, so I actually disagree with Andrés. I
think this is the worst definition of all that are out there. Before we
go there, I would like to make sure that they understand it. It’s the
most complex one. It includes within the definition several terms
that need to be defined again, like “interaction,” “living system,”
and so I think it is the one that is the most convoluted and most
difficult to understand by people outside of the field. I think that
David, you said that definitions should be simple, self-contained
and easily understandable, and that is not what I would call
definition number five. Thank you for considering this.
Kai Zhang Do you have an alternative?
Joachim Kohn Yes. I was asked if I have an alternative. Any of the one or two I
think are simpler, and can be more readily used. We can more
readily reach consensus around those than number five.
William Wagner I think the problem with number five, is it is in our dreams. We
would exclude 95% of biomaterials by that definition such as
Dacron, and ePTFE. Just go down the list of things that are well-
recognized as biomaterials today. We have no idea how we are
controlling anything or any biological interaction. Is it protein

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20 II. Biomaterials and biomedical materials

adsorption and the response to that? I think that is a flaw with that
definition that has to be changed.
Kai Zhang Any other comments on number five? Definition number five for
biomaterial?
Rena Bizios Someone brought a comment regarding the word “control.” Did
we decide how this would be included, or not included, or
substituted by another word?
Kai Zhang Yes, let’s work to modify this based from the number five
definition of biomaterials. It feels to me that it’s the most focused
definition during the discussion.
David Williams I have changed “engineered” to “designed.” I think that met with
approval. I am still trying to hear what the change by control of
interactions. Was there a suggestion there? Maybe It should be
changed to “through interactions.”
Elizabeth Could we just have “design for use as in therapeutic and
Cosgriff-H diagnostic procedures?” Keep it super broad?
Carl Simon Then you could add on things on top of it such as “an instructive
biomaterial.” It would give you some ability to think about
“control.”
Carl Simon I was agreeing with Elizabeth and saying that perhaps this is what
Bill is getting at, perhaps the biomaterial could be very generic, but
you could then think about adding an additional definition on the
front such as an instructive material that brings in the idea of
control or driving a desired response through an engineered
process. But the biomaterial itself doesn’t necessarily have to have
that specificity.
Serena Best Can we not just have “designed to interact with living systems?”
David Williams: I do not think so because it has got to be deliberate, that is why
you have controlled, it is a deliberate interaction, not just one that
is taking place without any control over it. Or without any
intention.
Laura Poole- What about actually referring to “a material” rather than a
Warren substance? So “a material designed for use in a diagnostic and
therapeutic application?”
Peter Ma I also question the very beginning of the definition We said, “has
been designed.” In some ways if you’re doing something that is
not “has been used or designed” you’re doing something with a
material for the first time, is that considered still a biomaterial?
Kai Zhang That makes sense.
David Williams I am not quite sure. Obviously, there are several different options
coming up here right now.
Kai Zhang David, you’re being bombarded. Let’s take them one at a time. Let
us take the simplest one. Peter. How would you feel if we said,

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 A Biomaterial 21

“substances designed to take.” He’s concerned about the past

tense. I personally am not concerned. I like it as it is. He’s
concerned about the use “that has been designed.”
Kam Leong We’re doing something new. Has not been designed.
David Williams Do you mean that anything that’s been done before is no longer a
biomaterial?
Kam Leong No.
David Williams No. I think that is perfect except for the English “that has been
designed” that encompasses what you do tomorrow, will have
been designed.
Laura Poole- It is a little bit superfluous though. I think you can remove “has
Warren been” it is just a “material designed to” I don’t think you need the
“has been.”
Rena Bizios In respect to this tense question, the present perfect indicates an
action that started in the past and continues in the present,
according to grammatic definition. Therefore, this particular
definition, “has been” in my opinion encompasses all kinds of
materials that have already been designed and formulated and are
being used, not only the ones we’re preparing today and perhaps
in the future. That’s why the present will designate a truth and that
is another alternative, but I like the present perfect because of the
continuity.
Xingdong Zhang I say the difference between biomaterials and drugs; with this
definition, we can understand the difference, between biomaterials
and drugs.
David Williams I think we have taken care of that by talking about substance
which “takes a form.” A drug is not taking a form. I think that
does emphasize the difference between that. We could say “a
material.” I have no objection to “material” instead of “substance.”
Kam Leong I do think “material” make better sense because we are talking
about biomaterials, which are materials.
Kai Zhang What about bioactive materials? So we get the word in front of
“the substance” or the “material.”
David Williams I have changed “substance” to “material.” I think that was
receiving a fair amount of approval. Okay. How does that sound.
Carl Simon Yes, that is right. That looks good.
David Williams Okay. So we move on from that?
Kai Zhang Are we all okay with this? Then we should move to the next term.
James Anderson Are we voting on this?
David Williams I thought we were going through and modifying and then we
come back to vote. I am happy if you want to take a vote now.
Carl Simon I think we should do the vote now.

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22 II. Biomaterials and biomedical materials

Kai Zhang It should be “in the course of any therapeutic;” there are missing
words. We are moving forward. Seems like people want to take the
vote. On your module it is “one” for yes, “two” for no “three” for
abstain. We have the term. We have the vote. Go ahead Carl.
(d) Final Definition and Voting for “Biomaterial”
Biomaterial
A material designed to take a form which can direct, through interactions with living
systems, the course of any therapeutic or diagnostic procedure
Voting Yes 41
Voting No 4
Abstain 3
Total Votes 48
Number voting Yes or No 45
Percentage Yes Votes 91.1%
The definition achieved Consensus, having more than 75% Yes votes, with absolute
number greater than 30.

(e) Further Commentary on the Definition of “Biomaterial”

Several points arise. First, in the context that David Williams was given the authority to
make minor grammatical alterations, a slightly better wording is as follows, and it is this
which is confirmed to have consensus:

Biomaterial
A material designed to take a form that can direct, through interactions with living
systems, the course of any therapeutic or diagnostic procedure
Second, there was no enthusiasm for generically including references to human and/or
veterinary applications in these definitions.
Third, David Williams, in his presentation, pointed out the increasing use of the term
“biomaterial” within the context of forestry and agriculture. For example, one University
in the United States has a Biomaterials Initiative, defining biomaterials as “any organic
materials extracted from ecosystems, green materials that include wood, mushrooms, edi-
ble berries, and plant sap in terrestrial ecosystems, and algae in aquatic ecosystems.”2
Obviously, one scientific community cannot prevent another community using terminol-
ogy that they believe is proprietary to them, but caution has to be taken to avoid confu-
sion. This position was supported by Nicholas Peppas, who noted “Other societies and other
organizations, as you said, agricultural, and other organizations, have basically captured the term
“biomaterials” to describe the area that would include their interest and would make them workers
2
School of Forestry Resources and Environmental Sciences, Michigan Technological University, 2018,
www.mtu.edu.

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 B Biomedical Material 23
and players in the field. I have a continuous fight with the American Institute of Chemical
Engineers staff and members who want to use the word biomaterials to describe corn stalks and
other substances to make ethanol. I think this body should express a very strong view about what
we feel is biomaterials and I hope that we will ask these organizations, such as the agricultural soci-
eties, to use alternative terminology.”

B Biomedical Material

In his preconference notes, David Williams indicated that the 1986 Chester conference
did discuss the term “biomedical material” which achieved consensus definition as:
An instrument, apparatus, implement, machine, contrivance, in vitro reagent, or other
similar or related article, including any component, part or accessory, which is intended
for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment or prevention of disease in man
The question arose as to whether there was a need to consider this term at all or
whether this community considered it to be synonymous with biomaterial. A show of
hands indicated that there was no need for further discussion, indicating that these terms
were, indeed, synonymous. The conclusions of this conference would therefore indicate
that biomaterial was synonymous with biomedical material with the following definition:

Biomaterial, synonymous with Biomedical Material

A material designed to take a form that can direct, through interactions with living
systems, the course of any therapeutic or diagnostic procedure
One further point concerning the terms “biomaterial” and “biomedical material” was raised
by several delegates in the context of the phrase “biological material.” This was not included
in the agenda since it is normally considered to be analogous to a “natural material,” or a
“substance produced by living organisms,” etc., without reference to any medical applications.
As noted earlier, one comment was made on this matter by Mario Barbosa:
Mario Barbosa It’s about the beginning and the end of the list of definitions. I have
difficulties in distinguishing between “biomaterial,” “biological material,”
and “biomedical material.” If you use the definition of biomaterial, based
on the application, to me biomedical material is more or less
synonymous. The other thing I notice is that there’s probably another
term which we should use, which is “biological material.” Of course,
wood is a biological material; bone and skin are biological materials, so
maybe tomorrow this idea of introducing new terms could be raised
again. I believe that the term biological material is needed somewhere.
This view was not supported and was not discussed further.

Definitions of Biomaterials for the Twenty-First Century